Conference Coverage

The results from a prognostic genomic assay called HER2DX convinced a group of Spanish oncologists to change treatment plans for 56% of 89 patients with HER2-positive (HER2+) early breast cancer, according to new research.

The prospective pilot study is small, and the researchers didn’t report on how the patients fared, according to a poster presented at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Plus, the test itself hasn’t been analyzed prospectively. But the study’s lead author, Olga Martínez-Sáez, MD, PhD, said in an interview that the 56% number is significant.

“We consider this percentage to be clinically very relevant,” said Dr. Martínez-Sáez, an oncologist at Hospital Clinic of Barcelona and the University of Barcelona. “HER2DX can change practice.”

Also in an interview, Kent Hoskins, MD, associate chief of hematology/oncology at University of Illinois at Chicago, described HER2DX as a next-generation genomic test that builds on assays developed 2 decades ago to help identify patients who would benefit – or not – from adjuvant chemotherapy.

Dr. Hoskins, who isn’t connected to the new study but has studied genomic tests for breast cancer, said the HER2DX test seeks to provide guidance to oncologists about which of several treatments are most effective in treating patients with HER2+ breast cancer.

“The overall trend in the HER2+ space is escalating therapy, and the cure rates have improved quite substantially,” he said. “But do they all need that much therapy? That’s the clinical question that this assay is addressing.”

The assay examines clinical features and the expression of 4 gene signatures, Dr. Martínez-Sáez said. It provides a risk score estimating the likelihood of recurrence plus a score that estimates the likelihood of achieving pathological complete response (pCR) with trastuzumab-based neoadjuvant therapy and an ERBB2 mRNA score.

In a retrospective 2022 study published in eBioMedicine, researchers reported that the assay “predicts response following neoadjuvant letrozole in combination with dual HER2 blockade with trastuzumab and pertuzumab in early-stage HER2-positive/hormone receptor–positive breast cancer.”

In the 2022 study, researchers wrote that assay results and other scores “might help better tailor systemic therapy in this context and identify candidates for avoiding chemotherapy, a therapy associated with short- and long-term toxicities and impact in quality of life.”

For the new study, a decision-impact analysis, researchers tracked 89 patients with HER2+ breast cancer (median age = 53 years, range 30-79, and 52% postmenopausal), the poster says. Most had T1-2 tumors (87%), negative nodes (64%), grade 2 (56%) or 3 (41%) tumors, and ductal histology (87%). And most were hormone receptor positive (65%). Seventy-eight percent of patients received neoadjuvant therapy (NAT), and 22% underwent upfront surgery.

In 56% of cases, oncologists changed their treatment decisions after getting the results of the HER2DX assays. In 59% of these cases, oncologists de-escalated therapy; in 41%, they escalated therapy, opting for more intense chemotherapy 65% of the time, according to the poster.

Clinician confidence in their decisions improved in 67% of cases, the researchers reported in their poster. Among 56 patients treated with neoadjuvant therapy who could be evaluated, “HER2DX pCR score was significantly associated with pCR (81% in pCR-medium/high and 32% in pCR-low; odds ratio=9.3, P = 0.001) independently of the rest of variables.”

Dr. Hoskins said the new report suggests that the assay can change treatment decisions, although he cautioned that “this study does not in itself establish its place in standard of care.” Large, prospective, randomized research is still needed, he said.

Dr. Martínez-Sáez said, in an interview, that the HER2DX assay should cost about as much as genomic assays for other breast cancer subtypes. These kinds of tests have cost several thousand dollars each in recent years.

What’s next? The decision impact study is ongoing. As for research into the assay itself, “prospective clinical trials are planned to demonstrate its clinical utility to de-escalate and guide therapy,” Dr. Martínez-Sáez said.

No funding is reported. Reveal Genomics is the developer of the HER2DX assay. Dr. Martinez- Saez reports financial relationships with Novartis, Eisai, Roche, and Reveal Genomics. Other study authors report multiple disclosures. Dr. Hoskins discloses non-financial research support from Agendia, which makes the MammaPrint early-breast-cancer assay.

The results from a prognostic genomic assay called HER2DX convinced a group of Spanish oncologists to change treatment plans for 56% of 89 patients with HER2-positive (HER2+) early breast cancer, according to new research.

The prospective pilot study is small, and the researchers didn’t report on how the patients fared, according to a poster presented at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Plus, the test itself hasn’t been analyzed prospectively. But the study’s lead author, Olga Martínez-Sáez, MD, PhD, said in an interview that the 56% number is significant.

“We consider this percentage to be clinically very relevant,” said Dr. Martínez-Sáez, an oncologist at Hospital Clinic of Barcelona and the University of Barcelona. “HER2DX can change practice.”

Also in an interview, Kent Hoskins, MD, associate chief of hematology/oncology at University of Illinois at Chicago, described HER2DX as a next-generation genomic test that builds on assays developed 2 decades ago to help identify patients who would benefit – or not – from adjuvant chemotherapy.

Dr. Hoskins, who isn’t connected to the new study but has studied genomic tests for breast cancer, said the HER2DX test seeks to provide guidance to oncologists about which of several treatments are most effective in treating patients with HER2+ breast cancer.

“The overall trend in the HER2+ space is escalating therapy, and the cure rates have improved quite substantially,” he said. “But do they all need that much therapy? That’s the clinical question that this assay is addressing.”

The assay examines clinical features and the expression of 4 gene signatures, Dr. Martínez-Sáez said. It provides a risk score estimating the likelihood of recurrence plus a score that estimates the likelihood of achieving pathological complete response (pCR) with trastuzumab-based neoadjuvant therapy and an ERBB2 mRNA score.

In a retrospective 2022 study published in eBioMedicine, researchers reported that the assay “predicts response following neoadjuvant letrozole in combination with dual HER2 blockade with trastuzumab and pertuzumab in early-stage HER2-positive/hormone receptor–positive breast cancer.”

In the 2022 study, researchers wrote that assay results and other scores “might help better tailor systemic therapy in this context and identify candidates for avoiding chemotherapy, a therapy associated with short- and long-term toxicities and impact in quality of life.”

For the new study, a decision-impact analysis, researchers tracked 89 patients with HER2+ breast cancer (median age = 53 years, range 30-79, and 52% postmenopausal), the poster says. Most had T1-2 tumors (87%), negative nodes (64%), grade 2 (56%) or 3 (41%) tumors, and ductal histology (87%). And most were hormone receptor positive (65%). Seventy-eight percent of patients received neoadjuvant therapy (NAT), and 22% underwent upfront surgery.

In 56% of cases, oncologists changed their treatment decisions after getting the results of the HER2DX assays. In 59% of these cases, oncologists de-escalated therapy; in 41%, they escalated therapy, opting for more intense chemotherapy 65% of the time, according to the poster.

Clinician confidence in their decisions improved in 67% of cases, the researchers reported in their poster. Among 56 patients treated with neoadjuvant therapy who could be evaluated, “HER2DX pCR score was significantly associated with pCR (81% in pCR-medium/high and 32% in pCR-low; odds ratio=9.3, P = 0.001) independently of the rest of variables.”

Dr. Hoskins said the new report suggests that the assay can change treatment decisions, although he cautioned that “this study does not in itself establish its place in standard of care.” Large, prospective, randomized research is still needed, he said.

Dr. Martínez-Sáez said, in an interview, that the HER2DX assay should cost about as much as genomic assays for other breast cancer subtypes. These kinds of tests have cost several thousand dollars each in recent years.

What’s next? The decision impact study is ongoing. As for research into the assay itself, “prospective clinical trials are planned to demonstrate its clinical utility to de-escalate and guide therapy,” Dr. Martínez-Sáez said.

No funding is reported. Reveal Genomics is the developer of the HER2DX assay. Dr. Martinez- Saez reports financial relationships with Novartis, Eisai, Roche, and Reveal Genomics. Other study authors report multiple disclosures. Dr. Hoskins discloses non-financial research support from Agendia, which makes the MammaPrint early-breast-cancer assay.

The results from a prognostic genomic assay called HER2DX convinced a group of Spanish oncologists to change treatment plans for 56% of 89 patients with HER2-positive (HER2+) early breast cancer, according to new research.

The prospective pilot study is small, and the researchers didn’t report on how the patients fared, according to a poster presented at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Plus, the test itself hasn’t been analyzed prospectively. But the study’s lead author, Olga Martínez-Sáez, MD, PhD, said in an interview that the 56% number is significant.

“We consider this percentage to be clinically very relevant,” said Dr. Martínez-Sáez, an oncologist at Hospital Clinic of Barcelona and the University of Barcelona. “HER2DX can change practice.”

Also in an interview, Kent Hoskins, MD, associate chief of hematology/oncology at University of Illinois at Chicago, described HER2DX as a next-generation genomic test that builds on assays developed 2 decades ago to help identify patients who would benefit – or not – from adjuvant chemotherapy.

Dr. Hoskins, who isn’t connected to the new study but has studied genomic tests for breast cancer, said the HER2DX test seeks to provide guidance to oncologists about which of several treatments are most effective in treating patients with HER2+ breast cancer.

“The overall trend in the HER2+ space is escalating therapy, and the cure rates have improved quite substantially,” he said. “But do they all need that much therapy? That’s the clinical question that this assay is addressing.”

The assay examines clinical features and the expression of 4 gene signatures, Dr. Martínez-Sáez said. It provides a risk score estimating the likelihood of recurrence plus a score that estimates the likelihood of achieving pathological complete response (pCR) with trastuzumab-based neoadjuvant therapy and an ERBB2 mRNA score.

In a retrospective 2022 study published in eBioMedicine, researchers reported that the assay “predicts response following neoadjuvant letrozole in combination with dual HER2 blockade with trastuzumab and pertuzumab in early-stage HER2-positive/hormone receptor–positive breast cancer.”

In the 2022 study, researchers wrote that assay results and other scores “might help better tailor systemic therapy in this context and identify candidates for avoiding chemotherapy, a therapy associated with short- and long-term toxicities and impact in quality of life.”

For the new study, a decision-impact analysis, researchers tracked 89 patients with HER2+ breast cancer (median age = 53 years, range 30-79, and 52% postmenopausal), the poster says. Most had T1-2 tumors (87%), negative nodes (64%), grade 2 (56%) or 3 (41%) tumors, and ductal histology (87%). And most were hormone receptor positive (65%). Seventy-eight percent of patients received neoadjuvant therapy (NAT), and 22% underwent upfront surgery.

In 56% of cases, oncologists changed their treatment decisions after getting the results of the HER2DX assays. In 59% of these cases, oncologists de-escalated therapy; in 41%, they escalated therapy, opting for more intense chemotherapy 65% of the time, according to the poster.

Clinician confidence in their decisions improved in 67% of cases, the researchers reported in their poster. Among 56 patients treated with neoadjuvant therapy who could be evaluated, “HER2DX pCR score was significantly associated with pCR (81% in pCR-medium/high and 32% in pCR-low; odds ratio=9.3, P = 0.001) independently of the rest of variables.”

Dr. Hoskins said the new report suggests that the assay can change treatment decisions, although he cautioned that “this study does not in itself establish its place in standard of care.” Large, prospective, randomized research is still needed, he said.

Dr. Martínez-Sáez said, in an interview, that the HER2DX assay should cost about as much as genomic assays for other breast cancer subtypes. These kinds of tests have cost several thousand dollars each in recent years.

What’s next? The decision impact study is ongoing. As for research into the assay itself, “prospective clinical trials are planned to demonstrate its clinical utility to de-escalate and guide therapy,” Dr. Martínez-Sáez said.

No funding is reported. Reveal Genomics is the developer of the HER2DX assay. Dr. Martinez- Saez reports financial relationships with Novartis, Eisai, Roche, and Reveal Genomics. Other study authors report multiple disclosures. Dr. Hoskins discloses non-financial research support from Agendia, which makes the MammaPrint early-breast-cancer assay.

SEATTLE – The majority of patients who underwent a teledermatology follow-up after Mohs micrographic surgery reported that they preferred it to in-person follow up, according to new findings.

In addition, nearly all patients surveyed (91.4%) were willing to go through electronic follow-up again.

“A big takeaway from our study is that streamlining this process is really essential for successful implementation,” said study author Laura Rezac, MD, a PGY IV dermatology resident at the University of Mississippi, Jackson. “This study demonstrated the flexibility and convenience for both patients and surgeons and can serve as a prototype for future innovation.”

The study results were presented at the annual meeting of the American College of Mohs Surgery.

The role of telehealth has rapidly expanded over the past decade, with its use accelerating during the COVID-19 pandemic and transforming into an indispensable resource. It can be synchronous, Dr. Rezac explained, which is when telehealth happens in live, real-time settings where the patient interacts with a clinician. This usually occurs via phone or video, and providers and patients communicate directly.

Conversely, asynchronous telehealth, also known as “store-and-forward,” is often used for patient intake or follow-up care. For example, in dermatology, a patient can send a photo of a skin condition that is then reviewed by a dermatologist later.

“A pilot survey regarding the adoption of telemedicine in Mohs surgery found that, although most dermatologic surgeons felt that it can play a role, most said that they didn’t plan on using it after the pandemic,” said Dr. Rezac.

The survey, which was reported by this news organization, found that 80% of surveyed surgeons said that they turned to telemedicine during the pandemic, compared with just 23% who relied on the technology prior to the pandemic.

There were numerous perceived barriers to the use of telemedicine, and the one most commonly cited was the uncertainty of how telemedicine fits in the workflow of clinical practice. Other limitations reported were for physical exams (88%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).

“The survey did identify one key use of telemedicine in Mohs and that was for [postoperative] visits,” she said. “But thus far, a postoperative evaluation after Mohs via an integrated asynchronous ‘store and forward’ teledermatology platform has not yet been evaluated.”

In the study, Dr. Rezac and colleagues sought to evaluate feasibility and efficacy, as well as patient attitudes, using a telemedicine platform for postoperative follow-up. A total of 163 patients who were treated with Mohs at a single academic institution during the 9-month study period (December 2021 through August 2022) responded to a survey and elected to participate in postoperative follow-up using telemedicine.

Dr. Rezac explained how their procedure was implemented for the patient. “On the day of the follow-up, the patient receives a text with a link that takes them to the MyChart website or app on their phone,” she said. “Once they log in, they see that they have a message telling them that they have a teledermatology message waiting for them. When they view it, they are taken to the curated message with instructions and a phone call if they need assistance, and then at the bottom, it shows they have a task to complete, which is the questionnaire.”

The patient will then be prompted to upload photos, which can be taken with their phone camera. The next step is to answer questions regarding the surgical site or pain concerns, and finally, patients are asked to respond to a few short questions about this type of follow-up. Once submitted, then they wait to be contacted by the surgeon.

On the surgeon’s side, these answers come into their EPIC inbox, and they can respond via a MyChart message.

Patient response was overwhelmingly positive, Dr. Rezac noted. Of the patients, 80.4% found the electronic surgery follow-up process to be “easy” or “very easy,” while only 4% found it “difficult” or “very difficult,” she said. “Also, 75.5% preferred electronic follow-up while 17.2% preferred in-person follow-up.”

There were limitations to this study, primarily that the asynchronous method does reduce live interaction, which could be an issue, depending on person’s needs, she pointed out. “But it is easy to schedule a phone call or video call or office visit.”

“The universal barrier is how to adopt it into the workflow, which includes training of staff,” she continued, “But this was a very streamlined process and gave very detailed instructions to the staff. Additionally, widespread use is limited to dermatological proficiency and access, and patients have to be amenable to it, so there is a selection bias since these patients chose to participate.”

Asked to comment on the study, Vishal Patel, MD, director of cutaneous oncology at George Washington University in Washington, said: “The COVID pandemic changed how practices and providers considered follow-up visits for small routine matters. Postoperative visits are often simple and do not require an in-depth, in-person evaluation.” Dr. Patel was not involved with this research.

“This study highlights the comfort of the vast majority of patients to have follow-up postoperative visits conducted via teledermatology – an approach that can help cut overall costs and also increase access for patients who are more in need of in-office care,” he added.

No external funding of the study was reported. Dr. Rezac reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
 

A version of this article originally appeared on Medscape.com.

SEATTLE – The majority of patients who underwent a teledermatology follow-up after Mohs micrographic surgery reported that they preferred it to in-person follow up, according to new findings.

In addition, nearly all patients surveyed (91.4%) were willing to go through electronic follow-up again.

“A big takeaway from our study is that streamlining this process is really essential for successful implementation,” said study author Laura Rezac, MD, a PGY IV dermatology resident at the University of Mississippi, Jackson. “This study demonstrated the flexibility and convenience for both patients and surgeons and can serve as a prototype for future innovation.”

The study results were presented at the annual meeting of the American College of Mohs Surgery.

The role of telehealth has rapidly expanded over the past decade, with its use accelerating during the COVID-19 pandemic and transforming into an indispensable resource. It can be synchronous, Dr. Rezac explained, which is when telehealth happens in live, real-time settings where the patient interacts with a clinician. This usually occurs via phone or video, and providers and patients communicate directly.

Conversely, asynchronous telehealth, also known as “store-and-forward,” is often used for patient intake or follow-up care. For example, in dermatology, a patient can send a photo of a skin condition that is then reviewed by a dermatologist later.

“A pilot survey regarding the adoption of telemedicine in Mohs surgery found that, although most dermatologic surgeons felt that it can play a role, most said that they didn’t plan on using it after the pandemic,” said Dr. Rezac.

The survey, which was reported by this news organization, found that 80% of surveyed surgeons said that they turned to telemedicine during the pandemic, compared with just 23% who relied on the technology prior to the pandemic.

There were numerous perceived barriers to the use of telemedicine, and the one most commonly cited was the uncertainty of how telemedicine fits in the workflow of clinical practice. Other limitations reported were for physical exams (88%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).

“The survey did identify one key use of telemedicine in Mohs and that was for [postoperative] visits,” she said. “But thus far, a postoperative evaluation after Mohs via an integrated asynchronous ‘store and forward’ teledermatology platform has not yet been evaluated.”

In the study, Dr. Rezac and colleagues sought to evaluate feasibility and efficacy, as well as patient attitudes, using a telemedicine platform for postoperative follow-up. A total of 163 patients who were treated with Mohs at a single academic institution during the 9-month study period (December 2021 through August 2022) responded to a survey and elected to participate in postoperative follow-up using telemedicine.

Dr. Rezac explained how their procedure was implemented for the patient. “On the day of the follow-up, the patient receives a text with a link that takes them to the MyChart website or app on their phone,” she said. “Once they log in, they see that they have a message telling them that they have a teledermatology message waiting for them. When they view it, they are taken to the curated message with instructions and a phone call if they need assistance, and then at the bottom, it shows they have a task to complete, which is the questionnaire.”

The patient will then be prompted to upload photos, which can be taken with their phone camera. The next step is to answer questions regarding the surgical site or pain concerns, and finally, patients are asked to respond to a few short questions about this type of follow-up. Once submitted, then they wait to be contacted by the surgeon.

On the surgeon’s side, these answers come into their EPIC inbox, and they can respond via a MyChart message.

Patient response was overwhelmingly positive, Dr. Rezac noted. Of the patients, 80.4% found the electronic surgery follow-up process to be “easy” or “very easy,” while only 4% found it “difficult” or “very difficult,” she said. “Also, 75.5% preferred electronic follow-up while 17.2% preferred in-person follow-up.”

There were limitations to this study, primarily that the asynchronous method does reduce live interaction, which could be an issue, depending on person’s needs, she pointed out. “But it is easy to schedule a phone call or video call or office visit.”

“The universal barrier is how to adopt it into the workflow, which includes training of staff,” she continued, “But this was a very streamlined process and gave very detailed instructions to the staff. Additionally, widespread use is limited to dermatological proficiency and access, and patients have to be amenable to it, so there is a selection bias since these patients chose to participate.”

Asked to comment on the study, Vishal Patel, MD, director of cutaneous oncology at George Washington University in Washington, said: “The COVID pandemic changed how practices and providers considered follow-up visits for small routine matters. Postoperative visits are often simple and do not require an in-depth, in-person evaluation.” Dr. Patel was not involved with this research.

“This study highlights the comfort of the vast majority of patients to have follow-up postoperative visits conducted via teledermatology – an approach that can help cut overall costs and also increase access for patients who are more in need of in-office care,” he added.

No external funding of the study was reported. Dr. Rezac reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
 

A version of this article originally appeared on Medscape.com.

SEATTLE – The majority of patients who underwent a teledermatology follow-up after Mohs micrographic surgery reported that they preferred it to in-person follow up, according to new findings.

In addition, nearly all patients surveyed (91.4%) were willing to go through electronic follow-up again.

“A big takeaway from our study is that streamlining this process is really essential for successful implementation,” said study author Laura Rezac, MD, a PGY IV dermatology resident at the University of Mississippi, Jackson. “This study demonstrated the flexibility and convenience for both patients and surgeons and can serve as a prototype for future innovation.”

The study results were presented at the annual meeting of the American College of Mohs Surgery.

The role of telehealth has rapidly expanded over the past decade, with its use accelerating during the COVID-19 pandemic and transforming into an indispensable resource. It can be synchronous, Dr. Rezac explained, which is when telehealth happens in live, real-time settings where the patient interacts with a clinician. This usually occurs via phone or video, and providers and patients communicate directly.

Conversely, asynchronous telehealth, also known as “store-and-forward,” is often used for patient intake or follow-up care. For example, in dermatology, a patient can send a photo of a skin condition that is then reviewed by a dermatologist later.

“A pilot survey regarding the adoption of telemedicine in Mohs surgery found that, although most dermatologic surgeons felt that it can play a role, most said that they didn’t plan on using it after the pandemic,” said Dr. Rezac.

The survey, which was reported by this news organization, found that 80% of surveyed surgeons said that they turned to telemedicine during the pandemic, compared with just 23% who relied on the technology prior to the pandemic.

There were numerous perceived barriers to the use of telemedicine, and the one most commonly cited was the uncertainty of how telemedicine fits in the workflow of clinical practice. Other limitations reported were for physical exams (88%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).

“The survey did identify one key use of telemedicine in Mohs and that was for [postoperative] visits,” she said. “But thus far, a postoperative evaluation after Mohs via an integrated asynchronous ‘store and forward’ teledermatology platform has not yet been evaluated.”

In the study, Dr. Rezac and colleagues sought to evaluate feasibility and efficacy, as well as patient attitudes, using a telemedicine platform for postoperative follow-up. A total of 163 patients who were treated with Mohs at a single academic institution during the 9-month study period (December 2021 through August 2022) responded to a survey and elected to participate in postoperative follow-up using telemedicine.

Dr. Rezac explained how their procedure was implemented for the patient. “On the day of the follow-up, the patient receives a text with a link that takes them to the MyChart website or app on their phone,” she said. “Once they log in, they see that they have a message telling them that they have a teledermatology message waiting for them. When they view it, they are taken to the curated message with instructions and a phone call if they need assistance, and then at the bottom, it shows they have a task to complete, which is the questionnaire.”

The patient will then be prompted to upload photos, which can be taken with their phone camera. The next step is to answer questions regarding the surgical site or pain concerns, and finally, patients are asked to respond to a few short questions about this type of follow-up. Once submitted, then they wait to be contacted by the surgeon.

On the surgeon’s side, these answers come into their EPIC inbox, and they can respond via a MyChart message.

Patient response was overwhelmingly positive, Dr. Rezac noted. Of the patients, 80.4% found the electronic surgery follow-up process to be “easy” or “very easy,” while only 4% found it “difficult” or “very difficult,” she said. “Also, 75.5% preferred electronic follow-up while 17.2% preferred in-person follow-up.”

There were limitations to this study, primarily that the asynchronous method does reduce live interaction, which could be an issue, depending on person’s needs, she pointed out. “But it is easy to schedule a phone call or video call or office visit.”

“The universal barrier is how to adopt it into the workflow, which includes training of staff,” she continued, “But this was a very streamlined process and gave very detailed instructions to the staff. Additionally, widespread use is limited to dermatological proficiency and access, and patients have to be amenable to it, so there is a selection bias since these patients chose to participate.”

Asked to comment on the study, Vishal Patel, MD, director of cutaneous oncology at George Washington University in Washington, said: “The COVID pandemic changed how practices and providers considered follow-up visits for small routine matters. Postoperative visits are often simple and do not require an in-depth, in-person evaluation.” Dr. Patel was not involved with this research.

“This study highlights the comfort of the vast majority of patients to have follow-up postoperative visits conducted via teledermatology – an approach that can help cut overall costs and also increase access for patients who are more in need of in-office care,” he added.

No external funding of the study was reported. Dr. Rezac reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
 

A version of this article originally appeared on Medscape.com.

Hagop Kantarjian, MD, has been named the recipient of the 2023 David A. Karnofsky Memorial Award by the American Society of Clinical Oncology in recognition of his practice-changing clinical-translational research in leukemia.

This award is the society’s “highest scientific honor, and I am extremely happy and honored to receive it,” Dr. Kantarjian commented in an interview with this news organization.

Dr. Kantarjian serves as the chair of the department of leukemia and currently holds the Samsung Distinguished University Chair in Cancer Medicine at the University of Texas MD Anderson Cancer Center, Houston.

“No doubt that this is not an individual award. It represents an award for the accomplishments of all the leukemia faculty at MD Anderson across 4 decades. It’s really a teamwork effort that led to so many discoveries and improvements in treatment and care of patients with leukemia,” he commented.

The David A. Karnofsky Memorial Award has been presented annually since 1970 to recognize oncologists who have made outstanding contributions to cancer research, diagnosis, or treatment, ASCO noted.
 

From Lebanon to Texas

Dr. Kantarjian received his medical degree from the American University of Beirut, in Lebanon, in 1979 and completed his residency in internal medicine at the same institution in 1981.

It was his experience at MD Anderson as a young medical student and later as a fellow that fueled his interest and career in leukemia, he said.

“In 1978, I took a 4-month elective at MD Anderson, and I soon realized how different and innovative the atmosphere at MD Anderson was, compared to where I was training in Lebanon,” Dr. Kantarjian told this news organization.

Working with mentors that included MD Anderson heavyweights Emil Freireich, MD, Kenneth McCredie, MD, and Michael Keating, MD, helped shape his career and guide his leukemia research, he said.
 

Transformative impact on leukemia outcomes

The award citation notes that over the past 4 decades, Dr. Kantarjian’s research has transformed some standards of care and has dramatically improved survival in several leukemia subtypes, including chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and acute lymphocytic leukemia (ALL).

“Four decades ago, most of the leukemias were incurable. Today, most of the leukemias are potentially curable with targeted therapies. That’s what I am most proud of,” Dr. Kantarjian told this news organization.

Among Dr. Kantarjian’s contributions to the field of leukemia:

• Developing the HYPER-CVAD regimen (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) as a standard-of-care, frontline therapy for adults with ALL.
• Establishing clinical biology parameters of CML, including definitions of CML phases and cytogenetic responses, and establishing new prognostic factors that were subsequently adopted in studies of tyrosine kinase inhibitors.
• Leading the development of decitabine and epigenetic hypomethylation therapy for MDS and for older/unfit patients with AML.
• Pioneering research with hypomethylating agents (HMAs) in combination with venetoclax, which led to FDA approval of HMA-venetoclax combinations for older/unfit patients with AML.
• Championing the development of clofarabine, conducting animal toxicology studies, and leading subsequent phase 1 and 2 trials and pivotal phase 3 and 4 trials that led to FDA approval of clofarabine for pediatric ALL.
• Developing several FLT3 inhibitors, isocitrate dehydrogenase inhibitors, and venetoclax, which all received FDA approval for the treatment of AML and its subsets.
• Developing regimens for inotuzumab and blinatumomab combined with chemotherapy for adults with pre-B ALL.
• Working on the development of imatinib, dasatinib, nilotinib, bosutinib, ponatinib, and omacetaxine, which all received FDA approval for CML therapy.

“Dr. Kantarjian’s long list of accomplishments and groundbreaking discoveries are a testament to his lifelong commitment to impactful cancer research and patient care,” Giulio Draetta, MD, PhD, chief scientific officer at MD Anderson, said in a statement.
 

Giving back

Dr. Kantarjian has written more than 2,200 peer-reviewed articles and more than 100 book chapters. In 2012, he cofounded the Society of Hematologic Oncology, which has now expanded worldwide.

He has served on multiple ASCO committees throughout the years and served on the ASCO board of directors from 2010 to 2015.

Dr. Kantarjian is passionately involved in mentoring and education. In 2000 he created the MD Anderson Leukemia Fellowship, which now trains about 10 fellows in leukemia annually.

He is a nonresident fellow in health care at the Rice Baker Institute and has written extensively on important health care issues in cancer, including the importance of universal equitable health care, health care safety nets, health care as a human right, and the problem of drug shortages.

Dr. Kantarjian is a strong advocate for more affordable drug therapies. For years he has been outspoken about the high price of leukemia drugs and has written high-profile articles in medical journals. He has even appeared on a popular television program to publicize the issue.

“Drug costs have been increasing over time. If you think about it, even if you discover a drug that cures cancer, but the drug is affordable for the 1% of the patients, then you have no cure for cancer,” Dr. Kantarjian told this news organization.

“I started speaking about the issue of the cancer drug costs in 2012. Unfortunately, we have not made progress simply because of the for-profit nature of health care and the strong lobbying by drug companies,” he added. Dr. Kantarjian hopes new legislation will eventually turn the tide.

Dr. Kantarjian has received many other honors throughout his distinguished career, including the American Lebanese Medical Association’s Lifetime Achievement Award, the American Association for Cancer Research’s Joseph H. Burchenal Memorial Award, and the Leukemia Society of America’s Outstanding Service to Mankind Award. He also was named an ASCO Fellow and a Leukemia Society of America Special Fellow and Scholar.

Dr. Kantarjian will be presented with the 2023 David A. Karnofsky Memorial Award, which includes a $25,000 honorarium, and will give a scientific lecture about his research at the ASCO annual meeting in Chicago in early June.

A version of this article originally appeared on Medscape.com.

Hagop Kantarjian, MD, has been named the recipient of the 2023 David A. Karnofsky Memorial Award by the American Society of Clinical Oncology in recognition of his practice-changing clinical-translational research in leukemia.

This award is the society’s “highest scientific honor, and I am extremely happy and honored to receive it,” Dr. Kantarjian commented in an interview with this news organization.

Dr. Kantarjian serves as the chair of the department of leukemia and currently holds the Samsung Distinguished University Chair in Cancer Medicine at the University of Texas MD Anderson Cancer Center, Houston.

“No doubt that this is not an individual award. It represents an award for the accomplishments of all the leukemia faculty at MD Anderson across 4 decades. It’s really a teamwork effort that led to so many discoveries and improvements in treatment and care of patients with leukemia,” he commented.

The David A. Karnofsky Memorial Award has been presented annually since 1970 to recognize oncologists who have made outstanding contributions to cancer research, diagnosis, or treatment, ASCO noted.
 

From Lebanon to Texas

Dr. Kantarjian received his medical degree from the American University of Beirut, in Lebanon, in 1979 and completed his residency in internal medicine at the same institution in 1981.

It was his experience at MD Anderson as a young medical student and later as a fellow that fueled his interest and career in leukemia, he said.

“In 1978, I took a 4-month elective at MD Anderson, and I soon realized how different and innovative the atmosphere at MD Anderson was, compared to where I was training in Lebanon,” Dr. Kantarjian told this news organization.

Working with mentors that included MD Anderson heavyweights Emil Freireich, MD, Kenneth McCredie, MD, and Michael Keating, MD, helped shape his career and guide his leukemia research, he said.
 

Transformative impact on leukemia outcomes

The award citation notes that over the past 4 decades, Dr. Kantarjian’s research has transformed some standards of care and has dramatically improved survival in several leukemia subtypes, including chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and acute lymphocytic leukemia (ALL).

“Four decades ago, most of the leukemias were incurable. Today, most of the leukemias are potentially curable with targeted therapies. That’s what I am most proud of,” Dr. Kantarjian told this news organization.

Among Dr. Kantarjian’s contributions to the field of leukemia:

• Developing the HYPER-CVAD regimen (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) as a standard-of-care, frontline therapy for adults with ALL.
• Establishing clinical biology parameters of CML, including definitions of CML phases and cytogenetic responses, and establishing new prognostic factors that were subsequently adopted in studies of tyrosine kinase inhibitors.
• Leading the development of decitabine and epigenetic hypomethylation therapy for MDS and for older/unfit patients with AML.
• Pioneering research with hypomethylating agents (HMAs) in combination with venetoclax, which led to FDA approval of HMA-venetoclax combinations for older/unfit patients with AML.
• Championing the development of clofarabine, conducting animal toxicology studies, and leading subsequent phase 1 and 2 trials and pivotal phase 3 and 4 trials that led to FDA approval of clofarabine for pediatric ALL.
• Developing several FLT3 inhibitors, isocitrate dehydrogenase inhibitors, and venetoclax, which all received FDA approval for the treatment of AML and its subsets.
• Developing regimens for inotuzumab and blinatumomab combined with chemotherapy for adults with pre-B ALL.
• Working on the development of imatinib, dasatinib, nilotinib, bosutinib, ponatinib, and omacetaxine, which all received FDA approval for CML therapy.

“Dr. Kantarjian’s long list of accomplishments and groundbreaking discoveries are a testament to his lifelong commitment to impactful cancer research and patient care,” Giulio Draetta, MD, PhD, chief scientific officer at MD Anderson, said in a statement.
 

Giving back

Dr. Kantarjian has written more than 2,200 peer-reviewed articles and more than 100 book chapters. In 2012, he cofounded the Society of Hematologic Oncology, which has now expanded worldwide.

He has served on multiple ASCO committees throughout the years and served on the ASCO board of directors from 2010 to 2015.

Dr. Kantarjian is passionately involved in mentoring and education. In 2000 he created the MD Anderson Leukemia Fellowship, which now trains about 10 fellows in leukemia annually.

He is a nonresident fellow in health care at the Rice Baker Institute and has written extensively on important health care issues in cancer, including the importance of universal equitable health care, health care safety nets, health care as a human right, and the problem of drug shortages.

Dr. Kantarjian is a strong advocate for more affordable drug therapies. For years he has been outspoken about the high price of leukemia drugs and has written high-profile articles in medical journals. He has even appeared on a popular television program to publicize the issue.

“Drug costs have been increasing over time. If you think about it, even if you discover a drug that cures cancer, but the drug is affordable for the 1% of the patients, then you have no cure for cancer,” Dr. Kantarjian told this news organization.

“I started speaking about the issue of the cancer drug costs in 2012. Unfortunately, we have not made progress simply because of the for-profit nature of health care and the strong lobbying by drug companies,” he added. Dr. Kantarjian hopes new legislation will eventually turn the tide.

Dr. Kantarjian has received many other honors throughout his distinguished career, including the American Lebanese Medical Association’s Lifetime Achievement Award, the American Association for Cancer Research’s Joseph H. Burchenal Memorial Award, and the Leukemia Society of America’s Outstanding Service to Mankind Award. He also was named an ASCO Fellow and a Leukemia Society of America Special Fellow and Scholar.

Dr. Kantarjian will be presented with the 2023 David A. Karnofsky Memorial Award, which includes a $25,000 honorarium, and will give a scientific lecture about his research at the ASCO annual meeting in Chicago in early June.

A version of this article originally appeared on Medscape.com.

Hagop Kantarjian, MD, has been named the recipient of the 2023 David A. Karnofsky Memorial Award by the American Society of Clinical Oncology in recognition of his practice-changing clinical-translational research in leukemia.

This award is the society’s “highest scientific honor, and I am extremely happy and honored to receive it,” Dr. Kantarjian commented in an interview with this news organization.

Dr. Kantarjian serves as the chair of the department of leukemia and currently holds the Samsung Distinguished University Chair in Cancer Medicine at the University of Texas MD Anderson Cancer Center, Houston.

“No doubt that this is not an individual award. It represents an award for the accomplishments of all the leukemia faculty at MD Anderson across 4 decades. It’s really a teamwork effort that led to so many discoveries and improvements in treatment and care of patients with leukemia,” he commented.

The David A. Karnofsky Memorial Award has been presented annually since 1970 to recognize oncologists who have made outstanding contributions to cancer research, diagnosis, or treatment, ASCO noted.
 

From Lebanon to Texas

Dr. Kantarjian received his medical degree from the American University of Beirut, in Lebanon, in 1979 and completed his residency in internal medicine at the same institution in 1981.

It was his experience at MD Anderson as a young medical student and later as a fellow that fueled his interest and career in leukemia, he said.

“In 1978, I took a 4-month elective at MD Anderson, and I soon realized how different and innovative the atmosphere at MD Anderson was, compared to where I was training in Lebanon,” Dr. Kantarjian told this news organization.

Working with mentors that included MD Anderson heavyweights Emil Freireich, MD, Kenneth McCredie, MD, and Michael Keating, MD, helped shape his career and guide his leukemia research, he said.
 

Transformative impact on leukemia outcomes

The award citation notes that over the past 4 decades, Dr. Kantarjian’s research has transformed some standards of care and has dramatically improved survival in several leukemia subtypes, including chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and acute lymphocytic leukemia (ALL).

“Four decades ago, most of the leukemias were incurable. Today, most of the leukemias are potentially curable with targeted therapies. That’s what I am most proud of,” Dr. Kantarjian told this news organization.

Among Dr. Kantarjian’s contributions to the field of leukemia:

• Developing the HYPER-CVAD regimen (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) as a standard-of-care, frontline therapy for adults with ALL.
• Establishing clinical biology parameters of CML, including definitions of CML phases and cytogenetic responses, and establishing new prognostic factors that were subsequently adopted in studies of tyrosine kinase inhibitors.
• Leading the development of decitabine and epigenetic hypomethylation therapy for MDS and for older/unfit patients with AML.
• Pioneering research with hypomethylating agents (HMAs) in combination with venetoclax, which led to FDA approval of HMA-venetoclax combinations for older/unfit patients with AML.
• Championing the development of clofarabine, conducting animal toxicology studies, and leading subsequent phase 1 and 2 trials and pivotal phase 3 and 4 trials that led to FDA approval of clofarabine for pediatric ALL.
• Developing several FLT3 inhibitors, isocitrate dehydrogenase inhibitors, and venetoclax, which all received FDA approval for the treatment of AML and its subsets.
• Developing regimens for inotuzumab and blinatumomab combined with chemotherapy for adults with pre-B ALL.
• Working on the development of imatinib, dasatinib, nilotinib, bosutinib, ponatinib, and omacetaxine, which all received FDA approval for CML therapy.

“Dr. Kantarjian’s long list of accomplishments and groundbreaking discoveries are a testament to his lifelong commitment to impactful cancer research and patient care,” Giulio Draetta, MD, PhD, chief scientific officer at MD Anderson, said in a statement.
 

Giving back

Dr. Kantarjian has written more than 2,200 peer-reviewed articles and more than 100 book chapters. In 2012, he cofounded the Society of Hematologic Oncology, which has now expanded worldwide.

He has served on multiple ASCO committees throughout the years and served on the ASCO board of directors from 2010 to 2015.

Dr. Kantarjian is passionately involved in mentoring and education. In 2000 he created the MD Anderson Leukemia Fellowship, which now trains about 10 fellows in leukemia annually.

He is a nonresident fellow in health care at the Rice Baker Institute and has written extensively on important health care issues in cancer, including the importance of universal equitable health care, health care safety nets, health care as a human right, and the problem of drug shortages.

Dr. Kantarjian is a strong advocate for more affordable drug therapies. For years he has been outspoken about the high price of leukemia drugs and has written high-profile articles in medical journals. He has even appeared on a popular television program to publicize the issue.

“Drug costs have been increasing over time. If you think about it, even if you discover a drug that cures cancer, but the drug is affordable for the 1% of the patients, then you have no cure for cancer,” Dr. Kantarjian told this news organization.

“I started speaking about the issue of the cancer drug costs in 2012. Unfortunately, we have not made progress simply because of the for-profit nature of health care and the strong lobbying by drug companies,” he added. Dr. Kantarjian hopes new legislation will eventually turn the tide.

Dr. Kantarjian has received many other honors throughout his distinguished career, including the American Lebanese Medical Association’s Lifetime Achievement Award, the American Association for Cancer Research’s Joseph H. Burchenal Memorial Award, and the Leukemia Society of America’s Outstanding Service to Mankind Award. He also was named an ASCO Fellow and a Leukemia Society of America Special Fellow and Scholar.

Dr. Kantarjian will be presented with the 2023 David A. Karnofsky Memorial Award, which includes a $25,000 honorarium, and will give a scientific lecture about his research at the ASCO annual meeting in Chicago in early June.

A version of this article originally appeared on Medscape.com.

Patients with long COVID-19 – where the effects of an initial COVID infection last more than 12 weeks – had lower levels of 25(OH) vitamin D than other patients who survived COVID-19, in a retrospective, case-matched study.

The lower levels of vitamin D in patients with long COVID were most notable in those with brain fog.

Reasonable to test vitamin D levels, consider supplementation

Invited to comment, Amiel Dror, MD, PhD, who led a related study that showed that people with a vitamin D deficiency were more likely to have severe COVID-19, agreed.

“The novelty and significance of this [new] study lie in the fact that it expands on our current understanding of the interplay between vitamin D and COVID-19, taking it beyond the acute phase of the disease,” said Dr. Dror, from Bar-Ilan University, Safed, Israel.

“It’s striking to see how vitamin D levels continue to influence patients’ health even after recovery from the initial infection,” he noted. 

“The findings certainly add weight to the argument for conducting a randomized control trial [RCT],” he continued, which “would enable us to conclusively determine whether vitamin D supplementation can effectively reduce the risk or severity of long COVID.”

“In the interim,” Dr. Dror said, “given the safety profile of vitamin D and its broad health benefits, it could be reasonable to test for vitamin D levels in patients admitted with COVID-19. If levels are found to be low, supplementation could be considered.”

“However, it’s important to note that this should be done under medical supervision,” he cautioned, “and further studies are needed to establish the optimal timing and dosage of supplementation.”

“I anticipate that we’ll see more RCTs [of this] in the future,” he speculated.
 

Low vitamin D and risk of long COVID

Long COVID is an emerging syndrome that affects 50%-70% of COVID-19 survivors.

Low levels of vitamin D have been associated with increased likelihood of needing mechanical ventilation and worse survival in patients hospitalized with COVID-19, but the risk of long COVID associated with vitamin D has not been known.

Researchers analyzed data from adults aged 18 and older hospitalized at San Raffaele Hospital with a confirmed diagnosis of COVID-19 and discharged during the first pandemic wave, from March to May 2020, and then seen 6-months later for follow-up.

Patients were excluded if they had been admitted to the intensive care unit during hospitalization or had missing medical data or blood samples available to determine (OH) vitamin D levels, at admission and the 6-month follow-up.

Long COVID-19 was defined based on the U.K. National Institute for Health and Care Excellence guidelines as the concomitant presence of at least two or more of 17 signs and symptoms that were absent prior to the COVID-19 infection and could only be attributed to that acute disease.

Researchers identified 50 patients with long COVID at the 6-month follow-up and matched them with 50 patients without long COVID at that time point, based on age, sex, concomitant comorbidities, need for noninvasive mechanical ventilation, and week of evaluation.

Patients were a mean age of 61 years (range, 51-73) and 56% were men; 28% had been on a ventilator during hospitalization for COVID-19.

The most frequent signs and symptoms at 6 months in the patients with long COVID were asthenia (weakness, 38% of patients), dysgeusia (bad taste in the mouth, 34%), dyspnea (shortness of breath, 34%), and anosmia (loss of sense of smell, 24%).

Most symptoms were related to the cardiorespiratory system (42%), the feeling of well-being (42%), or the senses (36%), and fewer patients had symptoms related to neurocognitive impairment (headache or brain fog, 14%), or ear, nose, and throat (12%), or gastrointestinal system (4%).

Patients with long COVID had lower mean 25(OH) vitamin D levels than patients without long COVID (20.1 vs 23.2 ng/mL; P = .03). However, actual vitamin D deficiency levels were similar in both groups.

Two-thirds of patients with low vitamin D levels at hospital admission still presented with low levels at the 6-month follow-up.

Vitamin D levels were significantly lower in patients with neurocognitive symptoms at follow-up (n = 7) than in those without such symptoms (n = 93) (14.6 vs. 20.6 ng/mL; P = .042).

In patients with vitamin D deficiency (< 20 ng/mL) at admission and at follow-up (n = 42), those with long COVID (n = 22) had lower vitamin D levels at follow-up than those without long COVID (n = 20) (12.7 vs. 15.2 ng/mL; P = .041).

And in multiple regression analyses, a lower 25(OH) vitamin D level at follow-up was the only variable that was significantly associated with long COVID (odds ratio, 1.09; 95% confidence interval, 1.01-1.16; P = .008).

The findings “strongly reinforce the clinical usefulness of 25(OH) vitamin D evaluation as a possible modifiable pathophysiological factor underlying this emerging worldwide critical health issue,” the researchers concluded.

The study was supported by Abiogen Pharma. One study author is an employee at Abiogen. Dr. Giustina has reported being a consultant for Abiogen and Takeda and receiving a research grant to his institution from Takeda. Dr. Di Filippo and the other authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients with long COVID-19 – where the effects of an initial COVID infection last more than 12 weeks – had lower levels of 25(OH) vitamin D than other patients who survived COVID-19, in a retrospective, case-matched study.

The lower levels of vitamin D in patients with long COVID were most notable in those with brain fog.

Reasonable to test vitamin D levels, consider supplementation

Invited to comment, Amiel Dror, MD, PhD, who led a related study that showed that people with a vitamin D deficiency were more likely to have severe COVID-19, agreed.

“The novelty and significance of this [new] study lie in the fact that it expands on our current understanding of the interplay between vitamin D and COVID-19, taking it beyond the acute phase of the disease,” said Dr. Dror, from Bar-Ilan University, Safed, Israel.

“It’s striking to see how vitamin D levels continue to influence patients’ health even after recovery from the initial infection,” he noted. 

“The findings certainly add weight to the argument for conducting a randomized control trial [RCT],” he continued, which “would enable us to conclusively determine whether vitamin D supplementation can effectively reduce the risk or severity of long COVID.”

“In the interim,” Dr. Dror said, “given the safety profile of vitamin D and its broad health benefits, it could be reasonable to test for vitamin D levels in patients admitted with COVID-19. If levels are found to be low, supplementation could be considered.”

“However, it’s important to note that this should be done under medical supervision,” he cautioned, “and further studies are needed to establish the optimal timing and dosage of supplementation.”

“I anticipate that we’ll see more RCTs [of this] in the future,” he speculated.
 

Low vitamin D and risk of long COVID

Long COVID is an emerging syndrome that affects 50%-70% of COVID-19 survivors.

Low levels of vitamin D have been associated with increased likelihood of needing mechanical ventilation and worse survival in patients hospitalized with COVID-19, but the risk of long COVID associated with vitamin D has not been known.

Researchers analyzed data from adults aged 18 and older hospitalized at San Raffaele Hospital with a confirmed diagnosis of COVID-19 and discharged during the first pandemic wave, from March to May 2020, and then seen 6-months later for follow-up.

Patients were excluded if they had been admitted to the intensive care unit during hospitalization or had missing medical data or blood samples available to determine (OH) vitamin D levels, at admission and the 6-month follow-up.

Long COVID-19 was defined based on the U.K. National Institute for Health and Care Excellence guidelines as the concomitant presence of at least two or more of 17 signs and symptoms that were absent prior to the COVID-19 infection and could only be attributed to that acute disease.

Researchers identified 50 patients with long COVID at the 6-month follow-up and matched them with 50 patients without long COVID at that time point, based on age, sex, concomitant comorbidities, need for noninvasive mechanical ventilation, and week of evaluation.

Patients were a mean age of 61 years (range, 51-73) and 56% were men; 28% had been on a ventilator during hospitalization for COVID-19.

The most frequent signs and symptoms at 6 months in the patients with long COVID were asthenia (weakness, 38% of patients), dysgeusia (bad taste in the mouth, 34%), dyspnea (shortness of breath, 34%), and anosmia (loss of sense of smell, 24%).

Most symptoms were related to the cardiorespiratory system (42%), the feeling of well-being (42%), or the senses (36%), and fewer patients had symptoms related to neurocognitive impairment (headache or brain fog, 14%), or ear, nose, and throat (12%), or gastrointestinal system (4%).

Patients with long COVID had lower mean 25(OH) vitamin D levels than patients without long COVID (20.1 vs 23.2 ng/mL; P = .03). However, actual vitamin D deficiency levels were similar in both groups.

Two-thirds of patients with low vitamin D levels at hospital admission still presented with low levels at the 6-month follow-up.

Vitamin D levels were significantly lower in patients with neurocognitive symptoms at follow-up (n = 7) than in those without such symptoms (n = 93) (14.6 vs. 20.6 ng/mL; P = .042).

In patients with vitamin D deficiency (< 20 ng/mL) at admission and at follow-up (n = 42), those with long COVID (n = 22) had lower vitamin D levels at follow-up than those without long COVID (n = 20) (12.7 vs. 15.2 ng/mL; P = .041).

And in multiple regression analyses, a lower 25(OH) vitamin D level at follow-up was the only variable that was significantly associated with long COVID (odds ratio, 1.09; 95% confidence interval, 1.01-1.16; P = .008).

The findings “strongly reinforce the clinical usefulness of 25(OH) vitamin D evaluation as a possible modifiable pathophysiological factor underlying this emerging worldwide critical health issue,” the researchers concluded.

The study was supported by Abiogen Pharma. One study author is an employee at Abiogen. Dr. Giustina has reported being a consultant for Abiogen and Takeda and receiving a research grant to his institution from Takeda. Dr. Di Filippo and the other authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients with long COVID-19 – where the effects of an initial COVID infection last more than 12 weeks – had lower levels of 25(OH) vitamin D than other patients who survived COVID-19, in a retrospective, case-matched study.

The lower levels of vitamin D in patients with long COVID were most notable in those with brain fog.

Reasonable to test vitamin D levels, consider supplementation

Invited to comment, Amiel Dror, MD, PhD, who led a related study that showed that people with a vitamin D deficiency were more likely to have severe COVID-19, agreed.

“The novelty and significance of this [new] study lie in the fact that it expands on our current understanding of the interplay between vitamin D and COVID-19, taking it beyond the acute phase of the disease,” said Dr. Dror, from Bar-Ilan University, Safed, Israel.

“It’s striking to see how vitamin D levels continue to influence patients’ health even after recovery from the initial infection,” he noted. 

“The findings certainly add weight to the argument for conducting a randomized control trial [RCT],” he continued, which “would enable us to conclusively determine whether vitamin D supplementation can effectively reduce the risk or severity of long COVID.”

“In the interim,” Dr. Dror said, “given the safety profile of vitamin D and its broad health benefits, it could be reasonable to test for vitamin D levels in patients admitted with COVID-19. If levels are found to be low, supplementation could be considered.”

“However, it’s important to note that this should be done under medical supervision,” he cautioned, “and further studies are needed to establish the optimal timing and dosage of supplementation.”

“I anticipate that we’ll see more RCTs [of this] in the future,” he speculated.
 

Low vitamin D and risk of long COVID

Long COVID is an emerging syndrome that affects 50%-70% of COVID-19 survivors.

Low levels of vitamin D have been associated with increased likelihood of needing mechanical ventilation and worse survival in patients hospitalized with COVID-19, but the risk of long COVID associated with vitamin D has not been known.

Researchers analyzed data from adults aged 18 and older hospitalized at San Raffaele Hospital with a confirmed diagnosis of COVID-19 and discharged during the first pandemic wave, from March to May 2020, and then seen 6-months later for follow-up.

Patients were excluded if they had been admitted to the intensive care unit during hospitalization or had missing medical data or blood samples available to determine (OH) vitamin D levels, at admission and the 6-month follow-up.

Long COVID-19 was defined based on the U.K. National Institute for Health and Care Excellence guidelines as the concomitant presence of at least two or more of 17 signs and symptoms that were absent prior to the COVID-19 infection and could only be attributed to that acute disease.

Researchers identified 50 patients with long COVID at the 6-month follow-up and matched them with 50 patients without long COVID at that time point, based on age, sex, concomitant comorbidities, need for noninvasive mechanical ventilation, and week of evaluation.

Patients were a mean age of 61 years (range, 51-73) and 56% were men; 28% had been on a ventilator during hospitalization for COVID-19.

The most frequent signs and symptoms at 6 months in the patients with long COVID were asthenia (weakness, 38% of patients), dysgeusia (bad taste in the mouth, 34%), dyspnea (shortness of breath, 34%), and anosmia (loss of sense of smell, 24%).

Most symptoms were related to the cardiorespiratory system (42%), the feeling of well-being (42%), or the senses (36%), and fewer patients had symptoms related to neurocognitive impairment (headache or brain fog, 14%), or ear, nose, and throat (12%), or gastrointestinal system (4%).

Patients with long COVID had lower mean 25(OH) vitamin D levels than patients without long COVID (20.1 vs 23.2 ng/mL; P = .03). However, actual vitamin D deficiency levels were similar in both groups.

Two-thirds of patients with low vitamin D levels at hospital admission still presented with low levels at the 6-month follow-up.

Vitamin D levels were significantly lower in patients with neurocognitive symptoms at follow-up (n = 7) than in those without such symptoms (n = 93) (14.6 vs. 20.6 ng/mL; P = .042).

In patients with vitamin D deficiency (< 20 ng/mL) at admission and at follow-up (n = 42), those with long COVID (n = 22) had lower vitamin D levels at follow-up than those without long COVID (n = 20) (12.7 vs. 15.2 ng/mL; P = .041).

And in multiple regression analyses, a lower 25(OH) vitamin D level at follow-up was the only variable that was significantly associated with long COVID (odds ratio, 1.09; 95% confidence interval, 1.01-1.16; P = .008).

The findings “strongly reinforce the clinical usefulness of 25(OH) vitamin D evaluation as a possible modifiable pathophysiological factor underlying this emerging worldwide critical health issue,” the researchers concluded.

The study was supported by Abiogen Pharma. One study author is an employee at Abiogen. Dr. Giustina has reported being a consultant for Abiogen and Takeda and receiving a research grant to his institution from Takeda. Dr. Di Filippo and the other authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Shock-wave therapy looks like an effective method for treating erectile dysfunction (ED), but injections of platelet-rich plasma (PRP) proved no better than placebo, according to results from two studies presented at the annual meeting of the American Urological Association.

In a single-blind prospective study that evaluated low-intensity shock-wave therapy, researchers randomly assigned 36 men with ED to receive mechanical therapy (n = 22) or sham treatment (n = 14) on their flaccid penises.

The patients in arm 1 of the study received three treatments of 5,000 shocks (4 Hz, 0.12 mJ/mm²) with the UroGold 1000 device (SoftWave) at weeks 0, 3, and 6. Those in arm 2 received a regimen of 5,000 shocks at week 0 and 3,000 at weeks 2 and 3, which was repeated 3 weeks later. Patients who completed sham treatment were unblinded and crossed over to the opposite arm for active treatment.

At weeks 20 and 32, the researchers assessed changes in gray-scale ultrasound erectile tissue homogeneity of the corpora cavernosa using visual grading scores as well as changes in color Duplex Doppler ultrasound assessments of artery blood flow parameters between baseline and follow-up.
 

Better blood flow – But is that enough?

After shock-wave therapy, more men experienced either improvements in or no worsening of blood flow parameters relative to baseline than after sham treatment. The decrease in end-diastolic volume was statistically significant for men in the active treatment arm 2 at week 32 (P = .003), according to the researchers.

The number of men whose visual grading scores for ultrasound gray-scale images improved in the proximal region was consistently higher with active treatment than with placebo (arm 1: 88.9% vs. 11.1%; arm 2: 40% vs. 20%), with statistical significance in arm 1 at weeks 20 (P = .005) and 32 (P = .001). Patients who received sham treatment and who subsequently received active shock-wave therapy also had improved scores on gray-scale ultrasound (arm 1: 33.3% vs. 11.1%; arm 2: 40% vs. 20%).

Scores on the International Index of Erectile Function (IIEF) were nominally higher for men in active treatment whose visual grading scores had improved compared with those who did not show improvement.

The most common adverse event was transient discomfort after the shock-wave treatment, according to the researchers.

The study provides “a glimpse into the concept” that the mechanotransduction from a shock wave results in biochemical changes, including “activation of stem cells within the corpus cavernosum,” said Irwin Goldstein, MD, director of San Diego Sexual Medicine and clinical professor of surgery at the University of California, San Diego, who led the trial. “If I can activate stem cells,” he added, “theoretically, I can improve the health of tissue.”

Dr. Goldstein noted that the study is the first to use before-and-after objective gray-scale ultrasound imaging along with color Doppler ultrasound. “We could see gray scale changes and peak systolic velocity changes even with a small group,” he said.

Dr. Goldstein added that the trial is the first in which zero energy was used in the sham phase instead of less energy than active treatment. With the sham treatment, there was no benefit on the gray scale, which he said is “very important.”

He said his team is in the process of submitting a proposal for a larger prospective trial to confirm the findings.

Although the results are promising, the study did not evaluate what matters most to men, said Louis Kuritzky, MD, a family medicine physician and assistant professor emeritus at HCA UCF Family Medicine Residency, in Gainesville, Fla.

“Men don’t care what the flow velocity is – they care [whether] they get an erection sufficient for penetration and completion of intercourse. That trial did not look at those endpoints. It looked at surrogates. Those are encouraging, but that’s not what I think a clinician would base their decision upon about whether or not a patient should possibly participate in shock therapy.”
 

Plasma injections a bust

The trial that assessed platelet-rich plasma was not encouraging. The results of the prospective, double-blind, randomized, placebo-controlled trial suggest that PRP is safe but not effective.

‌A proprietary version of the PRP injection is marketed as the “Priapus shot,” or the “P-shot,” despite a lack of solid evidence the therapy helps.

Brian Ledesma, MD, an andrology research fellow at the University of Miami, led the study, which received a “best abstract” award at the meeting. “We wanted to actually check and see – does this work or not?” Dr. Ledesma said of PRP injections generally.

Dr. Ledesma and his colleagues randomly assigned 61 men with mild to moderate ED to receive two intracavernosal injections of PRP 1 month apart (n = 28) or placebo treatment (n = 33). The primary outcome was change in IIEF score and the percentage of men meeting minimum clinically important difference (MCID) at 1 month. Complete data were available for 24 men who received PRP and for 28 who received placebo injections.

There was no significant difference in outcomes between the groups. IIEF scores changed from 17.4 (95% confidence interval [CI], –15.8 to 19.0) to 21 (95% CI, 17.9-24.0) for men who received PRP and from 18.6 (95% CI, 17.3-19.8) to 21.6 (95% CI, 19.1-24.1) for men in the placebo group (P = .756). Fourteen men (58.3%) in the PRP group, compared with 15 (53.6%) in the placebo group, met MCID. No differences were seen in mean penile Doppler parameters between PRP and placebo. The two adverse events reported in the trial were minor – a hematoma and “a new plaque that did not cause any curvature of the penis,” Dr. Ledesma said.

Platelet-rich plasma may be “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”

The study showed that “PRP was not more efficacious than placebo.” This treatment is “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”

Based on these findings, he said, “We would recommend sticking to the data primary care providers should tell their patients, ‘Don’t waste your money,’ because it’s pretty expensive.”

Dr. Kuritzky said more studies are needed for a definitive answer. “I think the results of PRP have been largely disappointing across most of the spheres of influence in which it’s been tried. So, it’s not so surprising to me that this trial would, again, not prove efficacious, but I’d have to hold judgment, dependent upon other trials,” he said.

Dr. Ledesma and his colleagues are conducting a prospective, randomized, double-blind trial “investigating whether PRP combined with shock-wave therapy could make a difference.” He said the trial, which is funded by the National Institutes of Health, is in the enrollment phase; results are expected in mid-2024.

Charles Runels, MD, who pioneered the P-Shot and other popular cosmetic procedures, defended the effectiveness of the injections.

“One of the legitimate criticisms of all of the review articles regarding PRP therapies in every field is that there is a significant variability in what people call PRP. The P-Shot represents a very specific protocol in the methods of preparing PRP, activating PRP, and injecting the PRP – all of which differ significantly from what was done in Ledesma’s study and which could account for their lack of results,” Dr. Runels said in an interview.

Dr. Runels added that “multiple studies” do show benefit of the injection of PRP for both erectile dysfunction and Peyronie’s disease and support the success of his protocol. “Also, all of our providers – there are over 3,000 people in our Cellular Medicine Association – offer money back to our patients if there are not satisfactory results,” he said.

Dr. Kuritzky said that when patients ask him about investigational treatments for ED, he tells them to stick to the more traditional approaches, such as phosphodiesterase type 5 inhibitors, intracorporeal injections, and vacuum devices.

But, he added, if other therapies are shown to be safe and effective “in a large population of men with diverse etiologies associated with their erectile dysfunction, including advanced age, diabetes, dyslipidemia, hypertension, cigarette smoking, then I think [they] could be recommended on a more consistent basis.”

Both studies were independently supported. Dr. Goldstein, Dr. Kuritzky, and Dr. Ledesma reported no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Shock-wave therapy looks like an effective method for treating erectile dysfunction (ED), but injections of platelet-rich plasma (PRP) proved no better than placebo, according to results from two studies presented at the annual meeting of the American Urological Association.

In a single-blind prospective study that evaluated low-intensity shock-wave therapy, researchers randomly assigned 36 men with ED to receive mechanical therapy (n = 22) or sham treatment (n = 14) on their flaccid penises.

The patients in arm 1 of the study received three treatments of 5,000 shocks (4 Hz, 0.12 mJ/mm²) with the UroGold 1000 device (SoftWave) at weeks 0, 3, and 6. Those in arm 2 received a regimen of 5,000 shocks at week 0 and 3,000 at weeks 2 and 3, which was repeated 3 weeks later. Patients who completed sham treatment were unblinded and crossed over to the opposite arm for active treatment.

At weeks 20 and 32, the researchers assessed changes in gray-scale ultrasound erectile tissue homogeneity of the corpora cavernosa using visual grading scores as well as changes in color Duplex Doppler ultrasound assessments of artery blood flow parameters between baseline and follow-up.
 

Better blood flow – But is that enough?

After shock-wave therapy, more men experienced either improvements in or no worsening of blood flow parameters relative to baseline than after sham treatment. The decrease in end-diastolic volume was statistically significant for men in the active treatment arm 2 at week 32 (P = .003), according to the researchers.

The number of men whose visual grading scores for ultrasound gray-scale images improved in the proximal region was consistently higher with active treatment than with placebo (arm 1: 88.9% vs. 11.1%; arm 2: 40% vs. 20%), with statistical significance in arm 1 at weeks 20 (P = .005) and 32 (P = .001). Patients who received sham treatment and who subsequently received active shock-wave therapy also had improved scores on gray-scale ultrasound (arm 1: 33.3% vs. 11.1%; arm 2: 40% vs. 20%).

Scores on the International Index of Erectile Function (IIEF) were nominally higher for men in active treatment whose visual grading scores had improved compared with those who did not show improvement.

The most common adverse event was transient discomfort after the shock-wave treatment, according to the researchers.

The study provides “a glimpse into the concept” that the mechanotransduction from a shock wave results in biochemical changes, including “activation of stem cells within the corpus cavernosum,” said Irwin Goldstein, MD, director of San Diego Sexual Medicine and clinical professor of surgery at the University of California, San Diego, who led the trial. “If I can activate stem cells,” he added, “theoretically, I can improve the health of tissue.”

Dr. Goldstein noted that the study is the first to use before-and-after objective gray-scale ultrasound imaging along with color Doppler ultrasound. “We could see gray scale changes and peak systolic velocity changes even with a small group,” he said.

Dr. Goldstein added that the trial is the first in which zero energy was used in the sham phase instead of less energy than active treatment. With the sham treatment, there was no benefit on the gray scale, which he said is “very important.”

He said his team is in the process of submitting a proposal for a larger prospective trial to confirm the findings.

Although the results are promising, the study did not evaluate what matters most to men, said Louis Kuritzky, MD, a family medicine physician and assistant professor emeritus at HCA UCF Family Medicine Residency, in Gainesville, Fla.

“Men don’t care what the flow velocity is – they care [whether] they get an erection sufficient for penetration and completion of intercourse. That trial did not look at those endpoints. It looked at surrogates. Those are encouraging, but that’s not what I think a clinician would base their decision upon about whether or not a patient should possibly participate in shock therapy.”
 

Plasma injections a bust

The trial that assessed platelet-rich plasma was not encouraging. The results of the prospective, double-blind, randomized, placebo-controlled trial suggest that PRP is safe but not effective.

‌A proprietary version of the PRP injection is marketed as the “Priapus shot,” or the “P-shot,” despite a lack of solid evidence the therapy helps.

Brian Ledesma, MD, an andrology research fellow at the University of Miami, led the study, which received a “best abstract” award at the meeting. “We wanted to actually check and see – does this work or not?” Dr. Ledesma said of PRP injections generally.

Dr. Ledesma and his colleagues randomly assigned 61 men with mild to moderate ED to receive two intracavernosal injections of PRP 1 month apart (n = 28) or placebo treatment (n = 33). The primary outcome was change in IIEF score and the percentage of men meeting minimum clinically important difference (MCID) at 1 month. Complete data were available for 24 men who received PRP and for 28 who received placebo injections.

There was no significant difference in outcomes between the groups. IIEF scores changed from 17.4 (95% confidence interval [CI], –15.8 to 19.0) to 21 (95% CI, 17.9-24.0) for men who received PRP and from 18.6 (95% CI, 17.3-19.8) to 21.6 (95% CI, 19.1-24.1) for men in the placebo group (P = .756). Fourteen men (58.3%) in the PRP group, compared with 15 (53.6%) in the placebo group, met MCID. No differences were seen in mean penile Doppler parameters between PRP and placebo. The two adverse events reported in the trial were minor – a hematoma and “a new plaque that did not cause any curvature of the penis,” Dr. Ledesma said.

Platelet-rich plasma may be “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”

The study showed that “PRP was not more efficacious than placebo.” This treatment is “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”

Based on these findings, he said, “We would recommend sticking to the data primary care providers should tell their patients, ‘Don’t waste your money,’ because it’s pretty expensive.”

Dr. Kuritzky said more studies are needed for a definitive answer. “I think the results of PRP have been largely disappointing across most of the spheres of influence in which it’s been tried. So, it’s not so surprising to me that this trial would, again, not prove efficacious, but I’d have to hold judgment, dependent upon other trials,” he said.

Dr. Ledesma and his colleagues are conducting a prospective, randomized, double-blind trial “investigating whether PRP combined with shock-wave therapy could make a difference.” He said the trial, which is funded by the National Institutes of Health, is in the enrollment phase; results are expected in mid-2024.

Charles Runels, MD, who pioneered the P-Shot and other popular cosmetic procedures, defended the effectiveness of the injections.

“One of the legitimate criticisms of all of the review articles regarding PRP therapies in every field is that there is a significant variability in what people call PRP. The P-Shot represents a very specific protocol in the methods of preparing PRP, activating PRP, and injecting the PRP – all of which differ significantly from what was done in Ledesma’s study and which could account for their lack of results,” Dr. Runels said in an interview.

Dr. Runels added that “multiple studies” do show benefit of the injection of PRP for both erectile dysfunction and Peyronie’s disease and support the success of his protocol. “Also, all of our providers – there are over 3,000 people in our Cellular Medicine Association – offer money back to our patients if there are not satisfactory results,” he said.

Dr. Kuritzky said that when patients ask him about investigational treatments for ED, he tells them to stick to the more traditional approaches, such as phosphodiesterase type 5 inhibitors, intracorporeal injections, and vacuum devices.

But, he added, if other therapies are shown to be safe and effective “in a large population of men with diverse etiologies associated with their erectile dysfunction, including advanced age, diabetes, dyslipidemia, hypertension, cigarette smoking, then I think [they] could be recommended on a more consistent basis.”

Both studies were independently supported. Dr. Goldstein, Dr. Kuritzky, and Dr. Ledesma reported no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Shock-wave therapy looks like an effective method for treating erectile dysfunction (ED), but injections of platelet-rich plasma (PRP) proved no better than placebo, according to results from two studies presented at the annual meeting of the American Urological Association.

In a single-blind prospective study that evaluated low-intensity shock-wave therapy, researchers randomly assigned 36 men with ED to receive mechanical therapy (n = 22) or sham treatment (n = 14) on their flaccid penises.

The patients in arm 1 of the study received three treatments of 5,000 shocks (4 Hz, 0.12 mJ/mm²) with the UroGold 1000 device (SoftWave) at weeks 0, 3, and 6. Those in arm 2 received a regimen of 5,000 shocks at week 0 and 3,000 at weeks 2 and 3, which was repeated 3 weeks later. Patients who completed sham treatment were unblinded and crossed over to the opposite arm for active treatment.

At weeks 20 and 32, the researchers assessed changes in gray-scale ultrasound erectile tissue homogeneity of the corpora cavernosa using visual grading scores as well as changes in color Duplex Doppler ultrasound assessments of artery blood flow parameters between baseline and follow-up.
 

Better blood flow – But is that enough?

After shock-wave therapy, more men experienced either improvements in or no worsening of blood flow parameters relative to baseline than after sham treatment. The decrease in end-diastolic volume was statistically significant for men in the active treatment arm 2 at week 32 (P = .003), according to the researchers.

The number of men whose visual grading scores for ultrasound gray-scale images improved in the proximal region was consistently higher with active treatment than with placebo (arm 1: 88.9% vs. 11.1%; arm 2: 40% vs. 20%), with statistical significance in arm 1 at weeks 20 (P = .005) and 32 (P = .001). Patients who received sham treatment and who subsequently received active shock-wave therapy also had improved scores on gray-scale ultrasound (arm 1: 33.3% vs. 11.1%; arm 2: 40% vs. 20%).

Scores on the International Index of Erectile Function (IIEF) were nominally higher for men in active treatment whose visual grading scores had improved compared with those who did not show improvement.

The most common adverse event was transient discomfort after the shock-wave treatment, according to the researchers.

The study provides “a glimpse into the concept” that the mechanotransduction from a shock wave results in biochemical changes, including “activation of stem cells within the corpus cavernosum,” said Irwin Goldstein, MD, director of San Diego Sexual Medicine and clinical professor of surgery at the University of California, San Diego, who led the trial. “If I can activate stem cells,” he added, “theoretically, I can improve the health of tissue.”

Dr. Goldstein noted that the study is the first to use before-and-after objective gray-scale ultrasound imaging along with color Doppler ultrasound. “We could see gray scale changes and peak systolic velocity changes even with a small group,” he said.

Dr. Goldstein added that the trial is the first in which zero energy was used in the sham phase instead of less energy than active treatment. With the sham treatment, there was no benefit on the gray scale, which he said is “very important.”

He said his team is in the process of submitting a proposal for a larger prospective trial to confirm the findings.

Although the results are promising, the study did not evaluate what matters most to men, said Louis Kuritzky, MD, a family medicine physician and assistant professor emeritus at HCA UCF Family Medicine Residency, in Gainesville, Fla.

“Men don’t care what the flow velocity is – they care [whether] they get an erection sufficient for penetration and completion of intercourse. That trial did not look at those endpoints. It looked at surrogates. Those are encouraging, but that’s not what I think a clinician would base their decision upon about whether or not a patient should possibly participate in shock therapy.”
 

Plasma injections a bust

The trial that assessed platelet-rich plasma was not encouraging. The results of the prospective, double-blind, randomized, placebo-controlled trial suggest that PRP is safe but not effective.

‌A proprietary version of the PRP injection is marketed as the “Priapus shot,” or the “P-shot,” despite a lack of solid evidence the therapy helps.

Brian Ledesma, MD, an andrology research fellow at the University of Miami, led the study, which received a “best abstract” award at the meeting. “We wanted to actually check and see – does this work or not?” Dr. Ledesma said of PRP injections generally.

Dr. Ledesma and his colleagues randomly assigned 61 men with mild to moderate ED to receive two intracavernosal injections of PRP 1 month apart (n = 28) or placebo treatment (n = 33). The primary outcome was change in IIEF score and the percentage of men meeting minimum clinically important difference (MCID) at 1 month. Complete data were available for 24 men who received PRP and for 28 who received placebo injections.

There was no significant difference in outcomes between the groups. IIEF scores changed from 17.4 (95% confidence interval [CI], –15.8 to 19.0) to 21 (95% CI, 17.9-24.0) for men who received PRP and from 18.6 (95% CI, 17.3-19.8) to 21.6 (95% CI, 19.1-24.1) for men in the placebo group (P = .756). Fourteen men (58.3%) in the PRP group, compared with 15 (53.6%) in the placebo group, met MCID. No differences were seen in mean penile Doppler parameters between PRP and placebo. The two adverse events reported in the trial were minor – a hematoma and “a new plaque that did not cause any curvature of the penis,” Dr. Ledesma said.

Platelet-rich plasma may be “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”

The study showed that “PRP was not more efficacious than placebo.” This treatment is “really popular, but, objectively speaking, so far, we don’t have any evidence showing that it actually works.”

Based on these findings, he said, “We would recommend sticking to the data primary care providers should tell their patients, ‘Don’t waste your money,’ because it’s pretty expensive.”

Dr. Kuritzky said more studies are needed for a definitive answer. “I think the results of PRP have been largely disappointing across most of the spheres of influence in which it’s been tried. So, it’s not so surprising to me that this trial would, again, not prove efficacious, but I’d have to hold judgment, dependent upon other trials,” he said.

Dr. Ledesma and his colleagues are conducting a prospective, randomized, double-blind trial “investigating whether PRP combined with shock-wave therapy could make a difference.” He said the trial, which is funded by the National Institutes of Health, is in the enrollment phase; results are expected in mid-2024.

Charles Runels, MD, who pioneered the P-Shot and other popular cosmetic procedures, defended the effectiveness of the injections.

“One of the legitimate criticisms of all of the review articles regarding PRP therapies in every field is that there is a significant variability in what people call PRP. The P-Shot represents a very specific protocol in the methods of preparing PRP, activating PRP, and injecting the PRP – all of which differ significantly from what was done in Ledesma’s study and which could account for their lack of results,” Dr. Runels said in an interview.

Dr. Runels added that “multiple studies” do show benefit of the injection of PRP for both erectile dysfunction and Peyronie’s disease and support the success of his protocol. “Also, all of our providers – there are over 3,000 people in our Cellular Medicine Association – offer money back to our patients if there are not satisfactory results,” he said.

Dr. Kuritzky said that when patients ask him about investigational treatments for ED, he tells them to stick to the more traditional approaches, such as phosphodiesterase type 5 inhibitors, intracorporeal injections, and vacuum devices.

But, he added, if other therapies are shown to be safe and effective “in a large population of men with diverse etiologies associated with their erectile dysfunction, including advanced age, diabetes, dyslipidemia, hypertension, cigarette smoking, then I think [they] could be recommended on a more consistent basis.”

Both studies were independently supported. Dr. Goldstein, Dr. Kuritzky, and Dr. Ledesma reported no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Sores on the feet can signal problems with the eyes in patients with diabetes.

Prior research and anecdotal experience show that diabetic foot ulcers and diabetic retinopathy frequently co-occur. New research further clarifies this link and shows that patients with foot ulcers may receive fewer treatments to protect their sight.

David J. Ramsey, MD, PhD, MPH, director of ophthalmic research at Lahey Hospital & Medical Center, Burlington, Mass., said when clinicians detect either condition, they should involve a team that can intervene to help protect a patient’s vision and mobility.

For example, they should ensure patients receive comprehensive eye and foot evaluations and help them optimize diabetes management.

The new study, presented at the annual meeting of the Association for Research in Vision and Ophthalmology, “adds an important dimension” to understanding the association between the conditions, said Dr. Ramsey, who recently reviewed correlations between diabetic foot ulcers and diabetic retinopathy and their underlying causes.

“Patients with diabetic foot ulcers appear to receive less attention to their diabetic retinopathy and may receive fewer treatments with eye injections targeting vascular endothelial growth factor (VEGF), an important driver of progression of diabetic retinopathy,” said Dr. Ramsey, who is also an associate professor of ophthalmology at Tufts University School of Medicine, Boston. He was not involved in the study presented at ARVO 2023.

In the new study, Christopher T. Zhu, a medical student at UT Health San Antonio, and colleagues analyzed data from 426 eyes of 213 patients with type 2 diabetes who had had at least two eye exams between 2012 and 2022; 72 of the patients had diabetic foot ulcers. Patients were followed for about 4 years on average.

Patients with diabetic foot ulcers had a higher percentage of eyes with macular edema on their initial exam (32.6% vs. 28%). By the final exam, the percentage of eyes with macular edema was significantly greater in the group with diabetic foot ulcers (64.6% vs. 37.6%; P < .0001), Mr. Zhu’s group reported.

Eyes with nonproliferative diabetic retinopathy progressed to proliferative diabetic retinopathy, the worst grade, at a higher rate in the group with foot ulcers (50.6% vs. 35.6%; P = .03). In addition, patients with foot ulcers were more likely to experience vitreous hemorrhage (55.6% vs. 38.7%), the researchers found.

Despite patients with foot ulcers tending to have worse disease, they received fewer treatments for retinopathy. Those without ulcers received an average of 6.9 anti-VEGF injections per eye, while those with ulcers averaged 4.3.

Foot ulcers may hinder the ability of patients to get to appointments to receive the injections, Mr. Zhu and colleagues wrote. “For many patients in our part of the country [South Texas], a lack of transportation is a particular barrier to health care access,” Mr. Zhu told this news organization.

Mr. Zhu’s team conducted their study after noticing that patients with diabetes and foot ulcers who presented to their eye clinics “appeared to progress faster to worse grades of retinopathy” than patients with diabetes who did not have ulcers.

“Similar to how foot ulcers develop due to a severe disruption in blood flow [vascular] and a loss of sensation [neurologic], diabetic retinopathy may have a relation to microvascular disease, neurologic degeneration, and inflammation,” he said.

The findings confirm “that poor perfusion of the eye and foot are linked and can cause ischemic retinopathy leading to the development of proliferative diabetic retinopathy and vitreous hemorrhages, both serious, vision-threatening conditions,” Dr. Ramsey said.

To some extent, fewer treatments with anti-VEGF agents may account for why patients with foot ulcers have more eye complications, Dr. Ramsey added. “Additional research needs to be done to further dissect the cause and the effect, but it’s a very important finding that we need to increase awareness about,” he said.

Dr. Ramsey and Mr. Zhu reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Sores on the feet can signal problems with the eyes in patients with diabetes.

Prior research and anecdotal experience show that diabetic foot ulcers and diabetic retinopathy frequently co-occur. New research further clarifies this link and shows that patients with foot ulcers may receive fewer treatments to protect their sight.

David J. Ramsey, MD, PhD, MPH, director of ophthalmic research at Lahey Hospital & Medical Center, Burlington, Mass., said when clinicians detect either condition, they should involve a team that can intervene to help protect a patient’s vision and mobility.

For example, they should ensure patients receive comprehensive eye and foot evaluations and help them optimize diabetes management.

The new study, presented at the annual meeting of the Association for Research in Vision and Ophthalmology, “adds an important dimension” to understanding the association between the conditions, said Dr. Ramsey, who recently reviewed correlations between diabetic foot ulcers and diabetic retinopathy and their underlying causes.

“Patients with diabetic foot ulcers appear to receive less attention to their diabetic retinopathy and may receive fewer treatments with eye injections targeting vascular endothelial growth factor (VEGF), an important driver of progression of diabetic retinopathy,” said Dr. Ramsey, who is also an associate professor of ophthalmology at Tufts University School of Medicine, Boston. He was not involved in the study presented at ARVO 2023.

In the new study, Christopher T. Zhu, a medical student at UT Health San Antonio, and colleagues analyzed data from 426 eyes of 213 patients with type 2 diabetes who had had at least two eye exams between 2012 and 2022; 72 of the patients had diabetic foot ulcers. Patients were followed for about 4 years on average.

Patients with diabetic foot ulcers had a higher percentage of eyes with macular edema on their initial exam (32.6% vs. 28%). By the final exam, the percentage of eyes with macular edema was significantly greater in the group with diabetic foot ulcers (64.6% vs. 37.6%; P < .0001), Mr. Zhu’s group reported.

Eyes with nonproliferative diabetic retinopathy progressed to proliferative diabetic retinopathy, the worst grade, at a higher rate in the group with foot ulcers (50.6% vs. 35.6%; P = .03). In addition, patients with foot ulcers were more likely to experience vitreous hemorrhage (55.6% vs. 38.7%), the researchers found.

Despite patients with foot ulcers tending to have worse disease, they received fewer treatments for retinopathy. Those without ulcers received an average of 6.9 anti-VEGF injections per eye, while those with ulcers averaged 4.3.

Foot ulcers may hinder the ability of patients to get to appointments to receive the injections, Mr. Zhu and colleagues wrote. “For many patients in our part of the country [South Texas], a lack of transportation is a particular barrier to health care access,” Mr. Zhu told this news organization.

Mr. Zhu’s team conducted their study after noticing that patients with diabetes and foot ulcers who presented to their eye clinics “appeared to progress faster to worse grades of retinopathy” than patients with diabetes who did not have ulcers.

“Similar to how foot ulcers develop due to a severe disruption in blood flow [vascular] and a loss of sensation [neurologic], diabetic retinopathy may have a relation to microvascular disease, neurologic degeneration, and inflammation,” he said.

The findings confirm “that poor perfusion of the eye and foot are linked and can cause ischemic retinopathy leading to the development of proliferative diabetic retinopathy and vitreous hemorrhages, both serious, vision-threatening conditions,” Dr. Ramsey said.

To some extent, fewer treatments with anti-VEGF agents may account for why patients with foot ulcers have more eye complications, Dr. Ramsey added. “Additional research needs to be done to further dissect the cause and the effect, but it’s a very important finding that we need to increase awareness about,” he said.

Dr. Ramsey and Mr. Zhu reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Sores on the feet can signal problems with the eyes in patients with diabetes.

Prior research and anecdotal experience show that diabetic foot ulcers and diabetic retinopathy frequently co-occur. New research further clarifies this link and shows that patients with foot ulcers may receive fewer treatments to protect their sight.

David J. Ramsey, MD, PhD, MPH, director of ophthalmic research at Lahey Hospital & Medical Center, Burlington, Mass., said when clinicians detect either condition, they should involve a team that can intervene to help protect a patient’s vision and mobility.

For example, they should ensure patients receive comprehensive eye and foot evaluations and help them optimize diabetes management.

The new study, presented at the annual meeting of the Association for Research in Vision and Ophthalmology, “adds an important dimension” to understanding the association between the conditions, said Dr. Ramsey, who recently reviewed correlations between diabetic foot ulcers and diabetic retinopathy and their underlying causes.

“Patients with diabetic foot ulcers appear to receive less attention to their diabetic retinopathy and may receive fewer treatments with eye injections targeting vascular endothelial growth factor (VEGF), an important driver of progression of diabetic retinopathy,” said Dr. Ramsey, who is also an associate professor of ophthalmology at Tufts University School of Medicine, Boston. He was not involved in the study presented at ARVO 2023.

In the new study, Christopher T. Zhu, a medical student at UT Health San Antonio, and colleagues analyzed data from 426 eyes of 213 patients with type 2 diabetes who had had at least two eye exams between 2012 and 2022; 72 of the patients had diabetic foot ulcers. Patients were followed for about 4 years on average.

Patients with diabetic foot ulcers had a higher percentage of eyes with macular edema on their initial exam (32.6% vs. 28%). By the final exam, the percentage of eyes with macular edema was significantly greater in the group with diabetic foot ulcers (64.6% vs. 37.6%; P < .0001), Mr. Zhu’s group reported.

Eyes with nonproliferative diabetic retinopathy progressed to proliferative diabetic retinopathy, the worst grade, at a higher rate in the group with foot ulcers (50.6% vs. 35.6%; P = .03). In addition, patients with foot ulcers were more likely to experience vitreous hemorrhage (55.6% vs. 38.7%), the researchers found.

Despite patients with foot ulcers tending to have worse disease, they received fewer treatments for retinopathy. Those without ulcers received an average of 6.9 anti-VEGF injections per eye, while those with ulcers averaged 4.3.

Foot ulcers may hinder the ability of patients to get to appointments to receive the injections, Mr. Zhu and colleagues wrote. “For many patients in our part of the country [South Texas], a lack of transportation is a particular barrier to health care access,” Mr. Zhu told this news organization.

Mr. Zhu’s team conducted their study after noticing that patients with diabetes and foot ulcers who presented to their eye clinics “appeared to progress faster to worse grades of retinopathy” than patients with diabetes who did not have ulcers.

“Similar to how foot ulcers develop due to a severe disruption in blood flow [vascular] and a loss of sensation [neurologic], diabetic retinopathy may have a relation to microvascular disease, neurologic degeneration, and inflammation,” he said.

The findings confirm “that poor perfusion of the eye and foot are linked and can cause ischemic retinopathy leading to the development of proliferative diabetic retinopathy and vitreous hemorrhages, both serious, vision-threatening conditions,” Dr. Ramsey said.

To some extent, fewer treatments with anti-VEGF agents may account for why patients with foot ulcers have more eye complications, Dr. Ramsey added. “Additional research needs to be done to further dissect the cause and the effect, but it’s a very important finding that we need to increase awareness about,” he said.

Dr. Ramsey and Mr. Zhu reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Hyperbaric oxygen therapy (HBOT) increased markers of heart function in a small randomized, controlled trial of patients with long COVID.

Patients with reduced left ventricular global longitudinal strain (GLS) at baseline who received HBOT had a significant increase in GLS, compared with those who received sham treatment.

GLS is a measure of systolic function that is thought to be a predictor of heart failure–related outcomes.

The study also showed that global work efficiency (GWE) and the global work index (GWI) increased in HBOT-treated patients, though not significantly.

“HBOT is an effective treatment for diabetic foot ulcers, decompression sickness in divers, and other conditions, such as cognitive impairment after stroke,” Marina Leitman, MD, of the Sackler School of Medicine, Tel Aviv, said in an interview. Her team also studied HBOT in asymptomatic older patients and found that the treatment seemed to improve left ventricular end systolic function.

“We should open our minds to thinking about this treatment for another indication,” she said. “That is the basis of precision medicine. We have this treatment and know it can be effective for cardiac pathology.

“Now we can say that post-COVID syndrome patients probably should be evaluated with echocardiography and GLS, which is the main parameter that showed improvement in our study,” she added. “If GLS is below normal values, these patients can benefit from HBOT, although additional research is needed to determine the optimal number of sessions.”

Dr. Leitman presented the study at the European Association of Cardiovascular Imaging 2023, a scientific congress of the European Society of Cardiology.
 

Biomarker changes

The study enrolled 60 hospitalized and nonhospitalized post-COVID syndrome patients with ongoing symptoms for at least 3 months after having mild to moderate symptomatic COVID-19.

Participants were randomized to receive HBOT or a sham procedure five times per week for 8 weeks, for a total of 40 sessions. They underwent echocardiography at baseline and 1-3 weeks after the final session to assess GLS.

The HBOT group received 100% oxygen through a mask at a pressure of two atmospheres for 90 minutes, with 5-minute air breaks every 20 minutes.

The sham group received 21% oxygen by mask at one atmosphere for 90 minutes.

At baseline, 29 participants (48%) had reduced GLS, despite having a normal ejection fraction, Dr. Leitman said. Of those, 16 (53%) were in the HBOT group and 13 (43%) were in the sham group.

The average GLS at baseline across all participants was –17.8%; a normal value is about –20%.

In the HBOT group, GLS increased significantly from –17.8% at baseline to –20.2% after HBOT. In the sham group, GLS was –17.8% at baseline and –19.1% at the end of the study, with no statistically significant difference between the two measurements.

In addition, GWE increased overall after HBOT from 96.3 to 97.1.

Dr. Leitman’s poster showed GLS and myocardial work indices before and after HBOT in a 45-year-old patient. Prior to treatment, GLS was –19%; GWE was 96%; and GWI was 1,833 mm Hg.

After HBOT treatment, GLS was –22%; GWE, 98%; and GWI, 1,911 mm Hg.
 

Clinical relevance unclear

Scott Gorenstein, MD, associate professor in the department of surgery and medical director of wound care and hyperbaric medicine at NYU Langone–Long Island, New York, commented on the study for this news organization.

“The approach certainly warrants studying, but the benefit is difficult to assess,” he said. “We still don’t understand the mechanism of long COVID, so it’s difficult to go from there to say that HBOT will be an effective therapy.”

That said, he added, “This is probably the best study I’ve seen in that it’s a randomized controlled trial, rather than a case series.”

Nevertheless, he noted, “We have no idea from this study whether the change in GLS is clinically relevant. As a clinician, I can’t now say that HBOT is going to improve heart failure secondary to long COVID. We don’t know whether the participants were New York heart failure class 3 or 4, for example, and all of a sudden went from really sick to really good.”

“There are many interventions that may change markers of cardiac function or inflammation,” he said. “But if they don’t make a difference in quantity or quality of life, is the treatment really valuable?”

Dr. Gorenstein said he would have no problem treating a patient with mild to moderate COVID-related heart failure with HBOT, since his own team’s study conducted near the outset of the pandemic showed it was safe. “But HBOT is an expensive treatment in the U.S. and there still are some risks and side effects, albeit very, very low.”

The study received no funding. Dr. Leitman and Dr. Gorenstein have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Hyperbaric oxygen therapy (HBOT) increased markers of heart function in a small randomized, controlled trial of patients with long COVID.

Patients with reduced left ventricular global longitudinal strain (GLS) at baseline who received HBOT had a significant increase in GLS, compared with those who received sham treatment.

GLS is a measure of systolic function that is thought to be a predictor of heart failure–related outcomes.

The study also showed that global work efficiency (GWE) and the global work index (GWI) increased in HBOT-treated patients, though not significantly.

“HBOT is an effective treatment for diabetic foot ulcers, decompression sickness in divers, and other conditions, such as cognitive impairment after stroke,” Marina Leitman, MD, of the Sackler School of Medicine, Tel Aviv, said in an interview. Her team also studied HBOT in asymptomatic older patients and found that the treatment seemed to improve left ventricular end systolic function.

“We should open our minds to thinking about this treatment for another indication,” she said. “That is the basis of precision medicine. We have this treatment and know it can be effective for cardiac pathology.

“Now we can say that post-COVID syndrome patients probably should be evaluated with echocardiography and GLS, which is the main parameter that showed improvement in our study,” she added. “If GLS is below normal values, these patients can benefit from HBOT, although additional research is needed to determine the optimal number of sessions.”

Dr. Leitman presented the study at the European Association of Cardiovascular Imaging 2023, a scientific congress of the European Society of Cardiology.
 

Biomarker changes

The study enrolled 60 hospitalized and nonhospitalized post-COVID syndrome patients with ongoing symptoms for at least 3 months after having mild to moderate symptomatic COVID-19.

Participants were randomized to receive HBOT or a sham procedure five times per week for 8 weeks, for a total of 40 sessions. They underwent echocardiography at baseline and 1-3 weeks after the final session to assess GLS.

The HBOT group received 100% oxygen through a mask at a pressure of two atmospheres for 90 minutes, with 5-minute air breaks every 20 minutes.

The sham group received 21% oxygen by mask at one atmosphere for 90 minutes.

At baseline, 29 participants (48%) had reduced GLS, despite having a normal ejection fraction, Dr. Leitman said. Of those, 16 (53%) were in the HBOT group and 13 (43%) were in the sham group.

The average GLS at baseline across all participants was –17.8%; a normal value is about –20%.

In the HBOT group, GLS increased significantly from –17.8% at baseline to –20.2% after HBOT. In the sham group, GLS was –17.8% at baseline and –19.1% at the end of the study, with no statistically significant difference between the two measurements.

In addition, GWE increased overall after HBOT from 96.3 to 97.1.

Dr. Leitman’s poster showed GLS and myocardial work indices before and after HBOT in a 45-year-old patient. Prior to treatment, GLS was –19%; GWE was 96%; and GWI was 1,833 mm Hg.

After HBOT treatment, GLS was –22%; GWE, 98%; and GWI, 1,911 mm Hg.
 

Clinical relevance unclear

Scott Gorenstein, MD, associate professor in the department of surgery and medical director of wound care and hyperbaric medicine at NYU Langone–Long Island, New York, commented on the study for this news organization.

“The approach certainly warrants studying, but the benefit is difficult to assess,” he said. “We still don’t understand the mechanism of long COVID, so it’s difficult to go from there to say that HBOT will be an effective therapy.”

That said, he added, “This is probably the best study I’ve seen in that it’s a randomized controlled trial, rather than a case series.”

Nevertheless, he noted, “We have no idea from this study whether the change in GLS is clinically relevant. As a clinician, I can’t now say that HBOT is going to improve heart failure secondary to long COVID. We don’t know whether the participants were New York heart failure class 3 or 4, for example, and all of a sudden went from really sick to really good.”

“There are many interventions that may change markers of cardiac function or inflammation,” he said. “But if they don’t make a difference in quantity or quality of life, is the treatment really valuable?”

Dr. Gorenstein said he would have no problem treating a patient with mild to moderate COVID-related heart failure with HBOT, since his own team’s study conducted near the outset of the pandemic showed it was safe. “But HBOT is an expensive treatment in the U.S. and there still are some risks and side effects, albeit very, very low.”

The study received no funding. Dr. Leitman and Dr. Gorenstein have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Hyperbaric oxygen therapy (HBOT) increased markers of heart function in a small randomized, controlled trial of patients with long COVID.

Patients with reduced left ventricular global longitudinal strain (GLS) at baseline who received HBOT had a significant increase in GLS, compared with those who received sham treatment.

GLS is a measure of systolic function that is thought to be a predictor of heart failure–related outcomes.

The study also showed that global work efficiency (GWE) and the global work index (GWI) increased in HBOT-treated patients, though not significantly.

“HBOT is an effective treatment for diabetic foot ulcers, decompression sickness in divers, and other conditions, such as cognitive impairment after stroke,” Marina Leitman, MD, of the Sackler School of Medicine, Tel Aviv, said in an interview. Her team also studied HBOT in asymptomatic older patients and found that the treatment seemed to improve left ventricular end systolic function.

“We should open our minds to thinking about this treatment for another indication,” she said. “That is the basis of precision medicine. We have this treatment and know it can be effective for cardiac pathology.

“Now we can say that post-COVID syndrome patients probably should be evaluated with echocardiography and GLS, which is the main parameter that showed improvement in our study,” she added. “If GLS is below normal values, these patients can benefit from HBOT, although additional research is needed to determine the optimal number of sessions.”

Dr. Leitman presented the study at the European Association of Cardiovascular Imaging 2023, a scientific congress of the European Society of Cardiology.
 

Biomarker changes

The study enrolled 60 hospitalized and nonhospitalized post-COVID syndrome patients with ongoing symptoms for at least 3 months after having mild to moderate symptomatic COVID-19.

Participants were randomized to receive HBOT or a sham procedure five times per week for 8 weeks, for a total of 40 sessions. They underwent echocardiography at baseline and 1-3 weeks after the final session to assess GLS.

The HBOT group received 100% oxygen through a mask at a pressure of two atmospheres for 90 minutes, with 5-minute air breaks every 20 minutes.

The sham group received 21% oxygen by mask at one atmosphere for 90 minutes.

At baseline, 29 participants (48%) had reduced GLS, despite having a normal ejection fraction, Dr. Leitman said. Of those, 16 (53%) were in the HBOT group and 13 (43%) were in the sham group.

The average GLS at baseline across all participants was –17.8%; a normal value is about –20%.

In the HBOT group, GLS increased significantly from –17.8% at baseline to –20.2% after HBOT. In the sham group, GLS was –17.8% at baseline and –19.1% at the end of the study, with no statistically significant difference between the two measurements.

In addition, GWE increased overall after HBOT from 96.3 to 97.1.

Dr. Leitman’s poster showed GLS and myocardial work indices before and after HBOT in a 45-year-old patient. Prior to treatment, GLS was –19%; GWE was 96%; and GWI was 1,833 mm Hg.

After HBOT treatment, GLS was –22%; GWE, 98%; and GWI, 1,911 mm Hg.
 

Clinical relevance unclear

Scott Gorenstein, MD, associate professor in the department of surgery and medical director of wound care and hyperbaric medicine at NYU Langone–Long Island, New York, commented on the study for this news organization.

“The approach certainly warrants studying, but the benefit is difficult to assess,” he said. “We still don’t understand the mechanism of long COVID, so it’s difficult to go from there to say that HBOT will be an effective therapy.”

That said, he added, “This is probably the best study I’ve seen in that it’s a randomized controlled trial, rather than a case series.”

Nevertheless, he noted, “We have no idea from this study whether the change in GLS is clinically relevant. As a clinician, I can’t now say that HBOT is going to improve heart failure secondary to long COVID. We don’t know whether the participants were New York heart failure class 3 or 4, for example, and all of a sudden went from really sick to really good.”

“There are many interventions that may change markers of cardiac function or inflammation,” he said. “But if they don’t make a difference in quantity or quality of life, is the treatment really valuable?”

Dr. Gorenstein said he would have no problem treating a patient with mild to moderate COVID-related heart failure with HBOT, since his own team’s study conducted near the outset of the pandemic showed it was safe. “But HBOT is an expensive treatment in the U.S. and there still are some risks and side effects, albeit very, very low.”

The study received no funding. Dr. Leitman and Dr. Gorenstein have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LONG BEACH, CALIF. – Ms. S had recently arrived home after a stay at a skilled nursing facility to recover from a hip fracture resulting from osteoporosis. For many patients, follow-up care would have included a DEXA scan or a prescription for a bisphosphonate from a primary care clinician not trained in geriatrics.

But the 85-year-old received care that went further and that is considered best practice for the management of geriatric fractures: A physical therapist visited her after discharge and provided education on the importance of maintaining mobility. Ms. S also underwent assessment for fall risk and gait balance, and a team of multidisciplinary clinicians managed other factors, from postural hypotension to footwear and foot problems.

Sonja Rosen, MD, professor of medicine and chief of geriatric medicine at Cedars-Sinai Medical Center, Los Angeles, talked about Ms. S as part of a panel discussion on applying the “Geriatric 5Ms” for patients with osteoporosis at the annual meeting of the American Geriatrics Society.

“You have to figure out why they are falling and help them not fall again,” Dr. Rosen said.

Approximately 10 million Americans have osteoporosis, and another 44 million have low bone density. One in two women and up to one in four men will experience a bone fracture as a result of osteoporosis, according to the Bone Health and Osteoporosis Foundation.

Geriatric health care providers view the 5Ms as core principles to be mindful of as their patients age – mobility, medications, mind, multicomplexity, and matters most, which involves considering the care preferences and goals for health care outcomes of individuals.

Ms. S eventually visited a geriatrician through the Cedars-Sinai Geriatric Fracture Program, which has been shown to lower costs and shorten hospital stays. In the program, she was advised to use a walker. Initially, she saw the aid as a hindrance – she felt she should be able to walk without it, like before. But with education, she learned that it is impossible to predict falls and that the walking aid could reduce her risk of a stumble.

Dr. Rosen said clinicians should address any vision problems, prescriptions for psychotropic drugs,which can affect balance, and heart rate and rhythm abnormalities, and they should suggest modifications to the home environment, such as installing grab bars in showers and removing rugs that can easily be tripped over.

The program at Cedars-Sinai, like similar initiatives, offers a team with resources that some clinicians may not have access to, such as a care coordinator and bone-health coach. But health care providers can utilize aspects, such as making referrals to community exercise classes.

Dr. Rosen and her colleagues studied the effects of such exercise programs and found that the programs lessen loneliness and social isolation. Fear of falling decreased in 75% of participants, “which is so key to these postfracture patients in getting back out into the world and engaging in their prior level of functional status,” Dr. Rosen said.
 

The second ‘M’: Medication management

The second “M,” medications, can help clinicians sequence osteoporosis drugs, depending on patient characteristics and scenarios.

Cathleen Colon-Emeric, MD, MHS, chief of geriatrics at Duke University, in Durham, N.C., dived into the case history of Ms. S, who had hypertension and insomnia in addition to osteoporosis.

First-line treatment for Ms. S – and for most patients – was an oral bisphosphonate, Dr. Colon-Emeric said. Compared with placebo, the drugs decrease the risk of overall osteoporotic fractures by nearly 40% (odds ratio, 0.62). But the medications are linked to injury of the esophageal mucosa. This risk is decreased when a patient stays upright for 30 minutes after taking oral bisphosphonates. Dr. Colon-Emeric displayed a slide of a woman receiving a pedicure at a nail salon.

“The picture of the pedicure is to share the wonderful idea I got from one skilled nursing facility I was working with, who makes sure they do safe administration to prevent esophagitis in their patients by having them all go to a spa day, where they all sit up and get their nails done while they wait their 30 minutes [after taking the pill] sitting up safely,” Dr. Colon-Emeric said.

This strategy drew applause from the audience.

Dr. Colon-Emeric advised that clinicians use judgment in the interpretation of results from the Fracture Risk Assessment Tool (FRAX). Incorporating race into estimates of fracture risk has pros and cons. While there are racial and ethnic differences in average bone density, the data for race calibrations to estimate risk are dated, she said. Clinicians should compare FRAX estimates with and without race input to help patients understand a range of risks.

Some patients may be reluctant to begin taking osteoporosis drugs because of misinformation originating from inaccurate news reports or anecdotes from friends. Dr. Colon-Emeric advised clinicians to remind patients that one in five who experience a fracture will have another injury in the following 2 years.

“A major osteoporotic fracture is akin to a heart attack; it has a very similar 1-year mortality rate and a very similar rate of a subsequent secondary event,” Dr. Colon-Emeric said. “We have a class of medications that decrease both those risks by nearly a third.”

Shared decision-making can help patients understand the risks and benefits of treatment, she said.

“People are really scared about the side effects,” Michelle Keller, PhD, MPH, a research scientist at Cedars-Sinai who attended the session, said. “The idea that a “bone attack” is like a heart attack gets the message across.”
 

Mind and multicomplexity

Medical complexity of a patient must be considered when making decisions on treatment, according to Joshua Niznik, PharmD, PhD, assistant professor of medicine in the Center for Aging and Health at the University of North Carolina at Chapel Hill.

“Medical complexity is an acknowledgment of the entire person, the burden of their multiple chronic conditions, advanced illnesses, and also their biopsychosocial needs and how those together might augment treatment selection and decision-making,” Dr. Niznik said.

Studies by Dr. Niznik and others have shown that swallowing difficulties, severe dementia, and being older than 90 are linked with a lower likelihood of receiving treatment for osteoporosis.

But therapies for fracture prevention, especially bisphosphonates, appear to be at least as effective for adults with medical complexity as they are for people without such conditions, Dr. Niznik said. Physicians must consider the potential treatment burden and the likelihood of benefit, he said.

Dr. Niznik’s research has shown a lack of strong evidence on how clinicians can manage patients in nursing homes. In some cases, deprescribing is reasonable, such as for patients who have undergone treatment for several years and whose life expectancy is less than 2 years.

“In the absence of any of those, if they are not already treated for osteoporosis, it makes sense to initiate treatment at that time,” Dr. Niznik said.
 

Matters most: Patient input

Clinicians need to educate patients on how long they must undergo a treatment before they experience benefits, according to Sarah D. Berry, MD, MPH, associate professor of medicine at Harvard Medical School, in Boston.

A meta-analysis of studies that included more than 20,000 women who were randomly assigned to receive bisphosphonate or placebo found that one nonvertebral fracture was avoided during a 12-month period for every 100 persons treated. One hip fracture was avoided during a 20-month period for every 200 patients treated.

“In general, in persons with a 2-year life expectancy, time to benefit favors bisphosphonate use,” Dr. Berry said. “Anabolics may have an even quicker time to benefit.”

Dr. Berry said a shared a decision-making model can help clinicians facilitate discussions that help patients prioritize goals and compare options while considering results, benefits, and harms. And she offered a final tip: Use tools with absolute risk reduction to convey risks and benefits, as the relative risk calculations overestimate how effective treatment will be.

Dr. Rosen has disclosed no relevant financial relationships. Dr. Colon-Emeric has received grants from the National Institutes of Health and VA Health Services Research and Development Funding; has served as endpoint adjudication chair for UCB Pharma; and has received royalties from Wolters Kluwer. Dr. Niznik has received funding from the National Institute of Aging and the Centers for Disease Control and Prevention. Dr. Berry has received funding from the NIH and royalties from Wolters Kluwer.

A version of this article originally appeared on Medscape.com.

LONG BEACH, CALIF. – Ms. S had recently arrived home after a stay at a skilled nursing facility to recover from a hip fracture resulting from osteoporosis. For many patients, follow-up care would have included a DEXA scan or a prescription for a bisphosphonate from a primary care clinician not trained in geriatrics.

But the 85-year-old received care that went further and that is considered best practice for the management of geriatric fractures: A physical therapist visited her after discharge and provided education on the importance of maintaining mobility. Ms. S also underwent assessment for fall risk and gait balance, and a team of multidisciplinary clinicians managed other factors, from postural hypotension to footwear and foot problems.

Sonja Rosen, MD, professor of medicine and chief of geriatric medicine at Cedars-Sinai Medical Center, Los Angeles, talked about Ms. S as part of a panel discussion on applying the “Geriatric 5Ms” for patients with osteoporosis at the annual meeting of the American Geriatrics Society.

“You have to figure out why they are falling and help them not fall again,” Dr. Rosen said.

Approximately 10 million Americans have osteoporosis, and another 44 million have low bone density. One in two women and up to one in four men will experience a bone fracture as a result of osteoporosis, according to the Bone Health and Osteoporosis Foundation.

Geriatric health care providers view the 5Ms as core principles to be mindful of as their patients age – mobility, medications, mind, multicomplexity, and matters most, which involves considering the care preferences and goals for health care outcomes of individuals.

Ms. S eventually visited a geriatrician through the Cedars-Sinai Geriatric Fracture Program, which has been shown to lower costs and shorten hospital stays. In the program, she was advised to use a walker. Initially, she saw the aid as a hindrance – she felt she should be able to walk without it, like before. But with education, she learned that it is impossible to predict falls and that the walking aid could reduce her risk of a stumble.

Dr. Rosen said clinicians should address any vision problems, prescriptions for psychotropic drugs,which can affect balance, and heart rate and rhythm abnormalities, and they should suggest modifications to the home environment, such as installing grab bars in showers and removing rugs that can easily be tripped over.

The program at Cedars-Sinai, like similar initiatives, offers a team with resources that some clinicians may not have access to, such as a care coordinator and bone-health coach. But health care providers can utilize aspects, such as making referrals to community exercise classes.

Dr. Rosen and her colleagues studied the effects of such exercise programs and found that the programs lessen loneliness and social isolation. Fear of falling decreased in 75% of participants, “which is so key to these postfracture patients in getting back out into the world and engaging in their prior level of functional status,” Dr. Rosen said.
 

The second ‘M’: Medication management

The second “M,” medications, can help clinicians sequence osteoporosis drugs, depending on patient characteristics and scenarios.

Cathleen Colon-Emeric, MD, MHS, chief of geriatrics at Duke University, in Durham, N.C., dived into the case history of Ms. S, who had hypertension and insomnia in addition to osteoporosis.

First-line treatment for Ms. S – and for most patients – was an oral bisphosphonate, Dr. Colon-Emeric said. Compared with placebo, the drugs decrease the risk of overall osteoporotic fractures by nearly 40% (odds ratio, 0.62). But the medications are linked to injury of the esophageal mucosa. This risk is decreased when a patient stays upright for 30 minutes after taking oral bisphosphonates. Dr. Colon-Emeric displayed a slide of a woman receiving a pedicure at a nail salon.

“The picture of the pedicure is to share the wonderful idea I got from one skilled nursing facility I was working with, who makes sure they do safe administration to prevent esophagitis in their patients by having them all go to a spa day, where they all sit up and get their nails done while they wait their 30 minutes [after taking the pill] sitting up safely,” Dr. Colon-Emeric said.

This strategy drew applause from the audience.

Dr. Colon-Emeric advised that clinicians use judgment in the interpretation of results from the Fracture Risk Assessment Tool (FRAX). Incorporating race into estimates of fracture risk has pros and cons. While there are racial and ethnic differences in average bone density, the data for race calibrations to estimate risk are dated, she said. Clinicians should compare FRAX estimates with and without race input to help patients understand a range of risks.

Some patients may be reluctant to begin taking osteoporosis drugs because of misinformation originating from inaccurate news reports or anecdotes from friends. Dr. Colon-Emeric advised clinicians to remind patients that one in five who experience a fracture will have another injury in the following 2 years.

“A major osteoporotic fracture is akin to a heart attack; it has a very similar 1-year mortality rate and a very similar rate of a subsequent secondary event,” Dr. Colon-Emeric said. “We have a class of medications that decrease both those risks by nearly a third.”

Shared decision-making can help patients understand the risks and benefits of treatment, she said.

“People are really scared about the side effects,” Michelle Keller, PhD, MPH, a research scientist at Cedars-Sinai who attended the session, said. “The idea that a “bone attack” is like a heart attack gets the message across.”
 

Mind and multicomplexity

Medical complexity of a patient must be considered when making decisions on treatment, according to Joshua Niznik, PharmD, PhD, assistant professor of medicine in the Center for Aging and Health at the University of North Carolina at Chapel Hill.

“Medical complexity is an acknowledgment of the entire person, the burden of their multiple chronic conditions, advanced illnesses, and also their biopsychosocial needs and how those together might augment treatment selection and decision-making,” Dr. Niznik said.

Studies by Dr. Niznik and others have shown that swallowing difficulties, severe dementia, and being older than 90 are linked with a lower likelihood of receiving treatment for osteoporosis.

But therapies for fracture prevention, especially bisphosphonates, appear to be at least as effective for adults with medical complexity as they are for people without such conditions, Dr. Niznik said. Physicians must consider the potential treatment burden and the likelihood of benefit, he said.

Dr. Niznik’s research has shown a lack of strong evidence on how clinicians can manage patients in nursing homes. In some cases, deprescribing is reasonable, such as for patients who have undergone treatment for several years and whose life expectancy is less than 2 years.

“In the absence of any of those, if they are not already treated for osteoporosis, it makes sense to initiate treatment at that time,” Dr. Niznik said.
 

Matters most: Patient input

Clinicians need to educate patients on how long they must undergo a treatment before they experience benefits, according to Sarah D. Berry, MD, MPH, associate professor of medicine at Harvard Medical School, in Boston.

A meta-analysis of studies that included more than 20,000 women who were randomly assigned to receive bisphosphonate or placebo found that one nonvertebral fracture was avoided during a 12-month period for every 100 persons treated. One hip fracture was avoided during a 20-month period for every 200 patients treated.

“In general, in persons with a 2-year life expectancy, time to benefit favors bisphosphonate use,” Dr. Berry said. “Anabolics may have an even quicker time to benefit.”

Dr. Berry said a shared a decision-making model can help clinicians facilitate discussions that help patients prioritize goals and compare options while considering results, benefits, and harms. And she offered a final tip: Use tools with absolute risk reduction to convey risks and benefits, as the relative risk calculations overestimate how effective treatment will be.

Dr. Rosen has disclosed no relevant financial relationships. Dr. Colon-Emeric has received grants from the National Institutes of Health and VA Health Services Research and Development Funding; has served as endpoint adjudication chair for UCB Pharma; and has received royalties from Wolters Kluwer. Dr. Niznik has received funding from the National Institute of Aging and the Centers for Disease Control and Prevention. Dr. Berry has received funding from the NIH and royalties from Wolters Kluwer.

A version of this article originally appeared on Medscape.com.

LONG BEACH, CALIF. – Ms. S had recently arrived home after a stay at a skilled nursing facility to recover from a hip fracture resulting from osteoporosis. For many patients, follow-up care would have included a DEXA scan or a prescription for a bisphosphonate from a primary care clinician not trained in geriatrics.

But the 85-year-old received care that went further and that is considered best practice for the management of geriatric fractures: A physical therapist visited her after discharge and provided education on the importance of maintaining mobility. Ms. S also underwent assessment for fall risk and gait balance, and a team of multidisciplinary clinicians managed other factors, from postural hypotension to footwear and foot problems.

Sonja Rosen, MD, professor of medicine and chief of geriatric medicine at Cedars-Sinai Medical Center, Los Angeles, talked about Ms. S as part of a panel discussion on applying the “Geriatric 5Ms” for patients with osteoporosis at the annual meeting of the American Geriatrics Society.

“You have to figure out why they are falling and help them not fall again,” Dr. Rosen said.

Approximately 10 million Americans have osteoporosis, and another 44 million have low bone density. One in two women and up to one in four men will experience a bone fracture as a result of osteoporosis, according to the Bone Health and Osteoporosis Foundation.

Geriatric health care providers view the 5Ms as core principles to be mindful of as their patients age – mobility, medications, mind, multicomplexity, and matters most, which involves considering the care preferences and goals for health care outcomes of individuals.

Ms. S eventually visited a geriatrician through the Cedars-Sinai Geriatric Fracture Program, which has been shown to lower costs and shorten hospital stays. In the program, she was advised to use a walker. Initially, she saw the aid as a hindrance – she felt she should be able to walk without it, like before. But with education, she learned that it is impossible to predict falls and that the walking aid could reduce her risk of a stumble.

Dr. Rosen said clinicians should address any vision problems, prescriptions for psychotropic drugs,which can affect balance, and heart rate and rhythm abnormalities, and they should suggest modifications to the home environment, such as installing grab bars in showers and removing rugs that can easily be tripped over.

The program at Cedars-Sinai, like similar initiatives, offers a team with resources that some clinicians may not have access to, such as a care coordinator and bone-health coach. But health care providers can utilize aspects, such as making referrals to community exercise classes.

Dr. Rosen and her colleagues studied the effects of such exercise programs and found that the programs lessen loneliness and social isolation. Fear of falling decreased in 75% of participants, “which is so key to these postfracture patients in getting back out into the world and engaging in their prior level of functional status,” Dr. Rosen said.
 

The second ‘M’: Medication management

The second “M,” medications, can help clinicians sequence osteoporosis drugs, depending on patient characteristics and scenarios.

Cathleen Colon-Emeric, MD, MHS, chief of geriatrics at Duke University, in Durham, N.C., dived into the case history of Ms. S, who had hypertension and insomnia in addition to osteoporosis.

First-line treatment for Ms. S – and for most patients – was an oral bisphosphonate, Dr. Colon-Emeric said. Compared with placebo, the drugs decrease the risk of overall osteoporotic fractures by nearly 40% (odds ratio, 0.62). But the medications are linked to injury of the esophageal mucosa. This risk is decreased when a patient stays upright for 30 minutes after taking oral bisphosphonates. Dr. Colon-Emeric displayed a slide of a woman receiving a pedicure at a nail salon.

“The picture of the pedicure is to share the wonderful idea I got from one skilled nursing facility I was working with, who makes sure they do safe administration to prevent esophagitis in their patients by having them all go to a spa day, where they all sit up and get their nails done while they wait their 30 minutes [after taking the pill] sitting up safely,” Dr. Colon-Emeric said.

This strategy drew applause from the audience.

Dr. Colon-Emeric advised that clinicians use judgment in the interpretation of results from the Fracture Risk Assessment Tool (FRAX). Incorporating race into estimates of fracture risk has pros and cons. While there are racial and ethnic differences in average bone density, the data for race calibrations to estimate risk are dated, she said. Clinicians should compare FRAX estimates with and without race input to help patients understand a range of risks.

Some patients may be reluctant to begin taking osteoporosis drugs because of misinformation originating from inaccurate news reports or anecdotes from friends. Dr. Colon-Emeric advised clinicians to remind patients that one in five who experience a fracture will have another injury in the following 2 years.

“A major osteoporotic fracture is akin to a heart attack; it has a very similar 1-year mortality rate and a very similar rate of a subsequent secondary event,” Dr. Colon-Emeric said. “We have a class of medications that decrease both those risks by nearly a third.”

Shared decision-making can help patients understand the risks and benefits of treatment, she said.

“People are really scared about the side effects,” Michelle Keller, PhD, MPH, a research scientist at Cedars-Sinai who attended the session, said. “The idea that a “bone attack” is like a heart attack gets the message across.”
 

Mind and multicomplexity

Medical complexity of a patient must be considered when making decisions on treatment, according to Joshua Niznik, PharmD, PhD, assistant professor of medicine in the Center for Aging and Health at the University of North Carolina at Chapel Hill.

“Medical complexity is an acknowledgment of the entire person, the burden of their multiple chronic conditions, advanced illnesses, and also their biopsychosocial needs and how those together might augment treatment selection and decision-making,” Dr. Niznik said.

Studies by Dr. Niznik and others have shown that swallowing difficulties, severe dementia, and being older than 90 are linked with a lower likelihood of receiving treatment for osteoporosis.

But therapies for fracture prevention, especially bisphosphonates, appear to be at least as effective for adults with medical complexity as they are for people without such conditions, Dr. Niznik said. Physicians must consider the potential treatment burden and the likelihood of benefit, he said.

Dr. Niznik’s research has shown a lack of strong evidence on how clinicians can manage patients in nursing homes. In some cases, deprescribing is reasonable, such as for patients who have undergone treatment for several years and whose life expectancy is less than 2 years.

“In the absence of any of those, if they are not already treated for osteoporosis, it makes sense to initiate treatment at that time,” Dr. Niznik said.
 

Matters most: Patient input

Clinicians need to educate patients on how long they must undergo a treatment before they experience benefits, according to Sarah D. Berry, MD, MPH, associate professor of medicine at Harvard Medical School, in Boston.

A meta-analysis of studies that included more than 20,000 women who were randomly assigned to receive bisphosphonate or placebo found that one nonvertebral fracture was avoided during a 12-month period for every 100 persons treated. One hip fracture was avoided during a 20-month period for every 200 patients treated.

“In general, in persons with a 2-year life expectancy, time to benefit favors bisphosphonate use,” Dr. Berry said. “Anabolics may have an even quicker time to benefit.”

Dr. Berry said a shared a decision-making model can help clinicians facilitate discussions that help patients prioritize goals and compare options while considering results, benefits, and harms. And she offered a final tip: Use tools with absolute risk reduction to convey risks and benefits, as the relative risk calculations overestimate how effective treatment will be.

Dr. Rosen has disclosed no relevant financial relationships. Dr. Colon-Emeric has received grants from the National Institutes of Health and VA Health Services Research and Development Funding; has served as endpoint adjudication chair for UCB Pharma; and has received royalties from Wolters Kluwer. Dr. Niznik has received funding from the National Institute of Aging and the Centers for Disease Control and Prevention. Dr. Berry has received funding from the NIH and royalties from Wolters Kluwer.

A version of this article originally appeared on Medscape.com.

SEATTLE – At least for now, the number of physicians trained to perform Mohs surgery is not only stable but appears to be increasing. New findings show that the number of new fellows offsets the attrition rate and that has been the case for the past 5 years.

Using CMS billing codes as a surrogate, the researchers found that there was a steady increase in the number of physicians who billed from 2015 to 2020. With the exception of 2020, which was the height of the COVID-19 pandemic, the number of times that a specific code was billed for increased on average by 4.7% annually.

“Thus, if the attrition rate remains stable, even with changes in board certification and potential payer eligibility restrictions, the number of physicians will continue to increase,” study author Ji Won Ahn, MD, who specializes in dermatology and Mohs surgery at University of Pittsburgh Medical Center, said at the annual meeting of the American College of Mohs Surgery, where she presented the results.

The growth in the number of Mohs surgeons has been fueled by several factors, including a rising incidence of skin cancer as well as the superior cure rates and cosmetic outcomes with the procedure. Reimbursement has been favorable and training pathways have expanded. A 2019 retrospective study reported that there were 2,240 dermatologists who performed Mohs surgery in the United States, with nearly all of them (94.6%) residing in metropolitan areas.

Dr. Ahn explained that it was important to define the workforce because of several new factors that will be affecting it in the future. “With the establishment of Micrographic Surgery and Dermatologic Oncology [MSDO] board certification that went into effect 2 years ago, potential future payer eligibility restrictions may be coming,” she said. “The adequacy of the Mohs surgery workforce is an important consideration.”

Another issue is that new board certification will be limited to fellowship-trained physicians after the first 5 years. “We wanted to compare these numbers with the fellowship numbers,” she said. “Although fellowship numbers are something that the college potentially has the power to change.”

Dr. Ahn and colleagues used the Centers for Medicare & Medicaid Services database to evaluate the use of the Current Procedural Terminology (CPT) code 17311, which is one of the most common billing codes for Mohs micrographic technique. Looking at data from 2015-2020, they found that there was an annual increase in the number of unique national provider identifiers (NPIs) billing for 17311, at an average rate of 75.6 per year.

The total number of times that 17311 was billed also increased from 2015 to 2019 at an average rate of 4.7% per year but declined in 2020 by 8.4%. “Overall, there was an average of 135 new NPIs that appeared and an average of 59.4 NPIs that stopped billing for 17311,” thus, an attrition rate of 59 surgeons, Dr. Ahn explained.

She emphasized that notably, the number of approved MSDO fellowship spots has remained stable since 2016 and is about 92 to 93 per year. “There are about 135 new surgeons and about two-thirds are new fellowship graduates,” she said.

The researchers were also interested in seeing how saturated each surgeon was and looked at the approximate number of cases that they were handling.

Of the physicians who billed 17311 through CMS, over 26% billed less than 100 times and more than 45% billed less than 200 times, and over 80% billed less than 500 times.

“One might be able to conclude that there might be some potential flexibility depending on the future need for surgeons,” she said.

The study was limited by several factors, one being that the researchers looked only at CPT code 17311 and not other designated codes for Mohs surgery. Other factors such as staff and space limitations were not accounted for since only billing data were used.

Dr. Ahn and her team are going to continue their work, and the next steps are to look at geographic trends and monitor for insurance network eligibility changes. “We are currently doing a workforce survey so we can better understand our current workforce rather than just historical data,” she concluded.

Asked to comment on the results, Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington, who was not involved with the study, noted that the increase in the “billing rates of the first stage of Mohs micrographic surgery highlights not only the growing skin cancer epidemic, but also the number of providers who are providing these services. This underscores the importance of standardized training guidelines and board certifications of Mohs micrographic surgeons to assure high levels of patient care and the appropriate use of Mohs micrographic surgery,” he said.

No external funding of the study was reported. Dr. Ahn reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
 

A version of this article originally appeared on Medscape.com.

SEATTLE – At least for now, the number of physicians trained to perform Mohs surgery is not only stable but appears to be increasing. New findings show that the number of new fellows offsets the attrition rate and that has been the case for the past 5 years.

Using CMS billing codes as a surrogate, the researchers found that there was a steady increase in the number of physicians who billed from 2015 to 2020. With the exception of 2020, which was the height of the COVID-19 pandemic, the number of times that a specific code was billed for increased on average by 4.7% annually.

“Thus, if the attrition rate remains stable, even with changes in board certification and potential payer eligibility restrictions, the number of physicians will continue to increase,” study author Ji Won Ahn, MD, who specializes in dermatology and Mohs surgery at University of Pittsburgh Medical Center, said at the annual meeting of the American College of Mohs Surgery, where she presented the results.

The growth in the number of Mohs surgeons has been fueled by several factors, including a rising incidence of skin cancer as well as the superior cure rates and cosmetic outcomes with the procedure. Reimbursement has been favorable and training pathways have expanded. A 2019 retrospective study reported that there were 2,240 dermatologists who performed Mohs surgery in the United States, with nearly all of them (94.6%) residing in metropolitan areas.

Dr. Ahn explained that it was important to define the workforce because of several new factors that will be affecting it in the future. “With the establishment of Micrographic Surgery and Dermatologic Oncology [MSDO] board certification that went into effect 2 years ago, potential future payer eligibility restrictions may be coming,” she said. “The adequacy of the Mohs surgery workforce is an important consideration.”

Another issue is that new board certification will be limited to fellowship-trained physicians after the first 5 years. “We wanted to compare these numbers with the fellowship numbers,” she said. “Although fellowship numbers are something that the college potentially has the power to change.”

Dr. Ahn and colleagues used the Centers for Medicare & Medicaid Services database to evaluate the use of the Current Procedural Terminology (CPT) code 17311, which is one of the most common billing codes for Mohs micrographic technique. Looking at data from 2015-2020, they found that there was an annual increase in the number of unique national provider identifiers (NPIs) billing for 17311, at an average rate of 75.6 per year.

The total number of times that 17311 was billed also increased from 2015 to 2019 at an average rate of 4.7% per year but declined in 2020 by 8.4%. “Overall, there was an average of 135 new NPIs that appeared and an average of 59.4 NPIs that stopped billing for 17311,” thus, an attrition rate of 59 surgeons, Dr. Ahn explained.

She emphasized that notably, the number of approved MSDO fellowship spots has remained stable since 2016 and is about 92 to 93 per year. “There are about 135 new surgeons and about two-thirds are new fellowship graduates,” she said.

The researchers were also interested in seeing how saturated each surgeon was and looked at the approximate number of cases that they were handling.

Of the physicians who billed 17311 through CMS, over 26% billed less than 100 times and more than 45% billed less than 200 times, and over 80% billed less than 500 times.

“One might be able to conclude that there might be some potential flexibility depending on the future need for surgeons,” she said.

The study was limited by several factors, one being that the researchers looked only at CPT code 17311 and not other designated codes for Mohs surgery. Other factors such as staff and space limitations were not accounted for since only billing data were used.

Dr. Ahn and her team are going to continue their work, and the next steps are to look at geographic trends and monitor for insurance network eligibility changes. “We are currently doing a workforce survey so we can better understand our current workforce rather than just historical data,” she concluded.

Asked to comment on the results, Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington, who was not involved with the study, noted that the increase in the “billing rates of the first stage of Mohs micrographic surgery highlights not only the growing skin cancer epidemic, but also the number of providers who are providing these services. This underscores the importance of standardized training guidelines and board certifications of Mohs micrographic surgeons to assure high levels of patient care and the appropriate use of Mohs micrographic surgery,” he said.

No external funding of the study was reported. Dr. Ahn reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
 

A version of this article originally appeared on Medscape.com.

SEATTLE – At least for now, the number of physicians trained to perform Mohs surgery is not only stable but appears to be increasing. New findings show that the number of new fellows offsets the attrition rate and that has been the case for the past 5 years.

Using CMS billing codes as a surrogate, the researchers found that there was a steady increase in the number of physicians who billed from 2015 to 2020. With the exception of 2020, which was the height of the COVID-19 pandemic, the number of times that a specific code was billed for increased on average by 4.7% annually.

“Thus, if the attrition rate remains stable, even with changes in board certification and potential payer eligibility restrictions, the number of physicians will continue to increase,” study author Ji Won Ahn, MD, who specializes in dermatology and Mohs surgery at University of Pittsburgh Medical Center, said at the annual meeting of the American College of Mohs Surgery, where she presented the results.

The growth in the number of Mohs surgeons has been fueled by several factors, including a rising incidence of skin cancer as well as the superior cure rates and cosmetic outcomes with the procedure. Reimbursement has been favorable and training pathways have expanded. A 2019 retrospective study reported that there were 2,240 dermatologists who performed Mohs surgery in the United States, with nearly all of them (94.6%) residing in metropolitan areas.

Dr. Ahn explained that it was important to define the workforce because of several new factors that will be affecting it in the future. “With the establishment of Micrographic Surgery and Dermatologic Oncology [MSDO] board certification that went into effect 2 years ago, potential future payer eligibility restrictions may be coming,” she said. “The adequacy of the Mohs surgery workforce is an important consideration.”

Another issue is that new board certification will be limited to fellowship-trained physicians after the first 5 years. “We wanted to compare these numbers with the fellowship numbers,” she said. “Although fellowship numbers are something that the college potentially has the power to change.”

Dr. Ahn and colleagues used the Centers for Medicare & Medicaid Services database to evaluate the use of the Current Procedural Terminology (CPT) code 17311, which is one of the most common billing codes for Mohs micrographic technique. Looking at data from 2015-2020, they found that there was an annual increase in the number of unique national provider identifiers (NPIs) billing for 17311, at an average rate of 75.6 per year.

The total number of times that 17311 was billed also increased from 2015 to 2019 at an average rate of 4.7% per year but declined in 2020 by 8.4%. “Overall, there was an average of 135 new NPIs that appeared and an average of 59.4 NPIs that stopped billing for 17311,” thus, an attrition rate of 59 surgeons, Dr. Ahn explained.

She emphasized that notably, the number of approved MSDO fellowship spots has remained stable since 2016 and is about 92 to 93 per year. “There are about 135 new surgeons and about two-thirds are new fellowship graduates,” she said.

The researchers were also interested in seeing how saturated each surgeon was and looked at the approximate number of cases that they were handling.

Of the physicians who billed 17311 through CMS, over 26% billed less than 100 times and more than 45% billed less than 200 times, and over 80% billed less than 500 times.

“One might be able to conclude that there might be some potential flexibility depending on the future need for surgeons,” she said.

The study was limited by several factors, one being that the researchers looked only at CPT code 17311 and not other designated codes for Mohs surgery. Other factors such as staff and space limitations were not accounted for since only billing data were used.

Dr. Ahn and her team are going to continue their work, and the next steps are to look at geographic trends and monitor for insurance network eligibility changes. “We are currently doing a workforce survey so we can better understand our current workforce rather than just historical data,” she concluded.

Asked to comment on the results, Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington, who was not involved with the study, noted that the increase in the “billing rates of the first stage of Mohs micrographic surgery highlights not only the growing skin cancer epidemic, but also the number of providers who are providing these services. This underscores the importance of standardized training guidelines and board certifications of Mohs micrographic surgeons to assure high levels of patient care and the appropriate use of Mohs micrographic surgery,” he said.

No external funding of the study was reported. Dr. Ahn reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
 

A version of this article originally appeared on Medscape.com.

Adding neoadjuvant atezolizumab to chemotherapy was associated with a significantly improved response in patients with early-stage triple-negative breast cancer, based on final data from a randomized trial.

The IMpassion031 trial showed significant improvement in pathological complete response (pCR) with the addition of atezolizumab to chemotherapy, as well as an acceptable safety profile, said Carlos H. Barrios, MD, of the Latin American Cooperative Oncology Group, Oncoclinicas, in Porto Allegre, Brazil, at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Those findings were published in the Lancet in 2020.

Heidi Splete/MDedge News

Dr. Barrios reported data from a final analysis of the IMpassion031 trial, with data on event-free survival (EFS), disease-free survival (DFS) and overall survival (OS) in the intent-to-treat (ITT) and PD-L1–positive populations.

In the study, patients with early triple-negative breast cancer (eTNBC) and a primary tumor greater than 2 cm were randomized to 840 mg of atezolizumab once every 2 weeks plus a neoadjuvant chemotherapy regimen of nab-paclitaxel 125 mg/m² once weekly for 12 weeks, followed by doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m² once every 2 weeks for 8 weeks. A total of 333 patients were randomized (165 atezolizumab and 168 placebo). Patients were stratified by stage II versus stage III, and by status of PD-L1, a protein that can predict treatment response (PD-L1 less than 1% vs. 1% or higher).

The primary endpoints (previously reported) were pathological complete response (pCR) in the ITT and PD-L1 populations. After a median follow-up of 39 months, the pCR was 58% in patients treated with atezolizumab versus 41% in those treated with neoadjuvant chemotherapy alone (P = .0044) in the ITT population, Dr. Barrios said. The added benefit from atezolizumab occurred regardless of the status of PD-L1.

Dr. Barrios reported the secondary outcomes of EFS, DFS, and OS in the intent-to-treat and PD-L1–positive populations. “This is a descriptive analysis, with no statistical comparison,” he emphasized.

The 2-year data on EFS, DFS, and OS consistently favored atezolizumab across key clinical subgroups, Dr. Barrios said. In the ITT population, 2-year EFS, DFS, and OS was 85%, 87%, and 95%, respectively, in the atezolizumab group and 80%, 83%, and 90%, respectively, in the placebo group. The results were similar, irrespective of PD-L1 status.

In the PD-L1–positive population, 2-year EFS, DFS, and OS was 89%, 91%, and 95%, respectively, in atezolizumab patients and 80%, 87%, and 91% in placebo patients.

Among patients without pCR at the time of surgery, 14 of 70 patients (20%) in the atezolizumab group and 33 of 99 patients (33%) in the placebo group received additional adjuvant systemic therapy. The most common adjunctive therapy was capecitabine.

As for safety, no new safety signals or treatment-related deaths were observed in the study. Overall, 70% of atezolizumab patients and 62% of placebo patients experienced grade 3 or 4 adverse events (AEs); 59% and 54% of which were treatment related. A total of 1% of patients in each group experienced grade 5 AEs. A total of 25% of atezolizumab patients and 20% of placebo patients experienced AEs leading to treatment discontinuation.

In a further exploratory analysis, pCR was highly predictive of long-term outcomes. Exploratory analysis of circulating tumor DNA (ctDNA) showed clearance in 89% of atezolizumab patients and 86% of placebo patients by the time of surgery.

Looking at the relationship between ctDNA, DFS, and OS, positive ctDNA was associated with a worse prognosis following surgery. As demonstrated in previous studies, pCR patients with negative ctDNA had the best DFS and OS. “In non-pCR patients with positive ctDNA, a numerical trend suggests improved overall survival with atezolizumab,” although the caveat is the very small numbers, Dr. Barrios said.

More research is needed, but in the final analysis, the significant pCR benefit seen with the addition of atezolizumab to chemotherapy for eTNBC translated into numerically improved EFS, DFS and OS, said Dr. Barrios. Additionally, “we should further analyze ctDNA to help select patients for further therapy.”

In a question-and-answer session, Dr. Barrios was asked how the results compared with other studies.

“We should not overinterpret the results,” he said. However, “what the IMpassion031 study shows is consistency; the results are aligned with previous studies addressing the same question of introducing immunotherapy,” in the patient population. Although the numbers in the IMpassion031 study did not reach statistical significance, it is important to recognize that they reflect previous research.

“In my opinion, looking at the whole field, immunotherapy is something we need to consider as part of the treatment of these patients,” said Dr. Barrios. However, more research is needed to better identify which patients do and do not need chemotherapy.
 

Phase 2 data show increased response with added atezolizumab for PD-L1–negative patients

In a second study known as ABSCG-52/ATHENE, researchers evaluated neoadjuvant atezolizumab in combination with dual HER2 blockade plus epirubicin for the treatment of patients with early HER2-positive breast cancer.

Heidi Splete/MDedge News

For most of these patients, the current standard of care is neoadjuvant dual HER2 blockade with trastuzumab (T) and pertuzumab (P) plus poly-chemotherapy, said Gabriel Rinnerthaler, MD, of the Salzburg (Austria) Cancer Research Institute, said in his presentation at the meeting. However, de-escalation of chemotherapy has been a major focus of research in recent years, and more research is needed on a combination of anthracyclines, such as epirubicin and idarubicin, and immune-checkpoint modulators.

In the phase 2 study, the researchers randomized patients with previously untreated, histologically confirmed HER2-positive early breast cancer (defined as a clinical prognostic stage cT1c–4a-d, N0-3, M0) in a 1:1 ratio to two 3-weekly cycles of a chemotherapy-free induction phase (part 1) with TP plus 1,200 mg atezolizumab (TP-A) or TP alone.

“We hypothesized that the additive effect of immune checkpoint inhibitors plus anti-HER2 therapy and chemotherapy would not be linear,” he said.

At the end of this period, all patients underwent four cycles of TP-A in combination with epirubicin (part 2). The primary endpoint was pCR (defined as absence of invasive cancer in the breast and axillary nodes, or ypT0/Tis ypN0) in the overall study population, and a pCR of 40% was considered a positive result.

A total of 29 patients were randomized to TP-A and 29 to TP alone in nine treatment centers in Austria. The study population ranged from 33 to 82 years, with a median age of 57 years. Most patients (72.4%) had hormone receptor (HR)–positive tumors; a total of 45 patients had stage IIA cancer, and 13 had stage IIB.

The primary endpoint of pCR occurred in 35 patients overall (60.3%). In a univariate analysis, the response rates were lower in HR-positive patients, in premenopausal patients, and in histologies other than NST (invasive carcinoma of no special type), Dr. Rinnerthaler said, but none of the differences were statistically significant, likely because of the small numbers in each group.

In an exploratory analysis of the ITT population with available PD-L1 data, the pCR was 69.2% for PD-L1–negative patients and 55.2% for PD-L1–positive patients.

“We observed the highest pCR rates in PD-L1–negative patients treated in the TP-A group and the lowest in PD-L1–positive patients treated with TP alone,” Dr. Rinnerthaler said.

No new safety concerns were observed during the study, Dr. Rinnerthaler noted. AEs of grade 3 or higher occurred in 17 patients (29.3%), including 9 in the TP-A group and 8 in the TP group. The most common AEs in both groups were nausea, diarrhea, and fatigue. No AEs of special interest of grade 3 or higher (defined as immune-related AEs, cardiac disorders, or infusion-related reactions) were observed.

The study findings were limited by the small sample size, but the resulting pCR rate of 60.3% was higher than the predefined threshold of 40% and supports additional research, said Dr. Rinnerthaler.

“For HER2-positive early breast cancer, a neoadjuvant chemotherapy de-escalation immunotherapy regimen with trastuzumab, pertuzumab, atezolizumab, and epirubicin is highly effective and safe and merits further investigation,” he concluded.

During a question-and-answer session, Dr. Rinnerthaler was asked why pCR increased in PD-L1 negative patients.

Previous data have shown that PD-L1 is up-regulated in certain tumors, and may serve as a surrogate for sensitivity, he said. In previous studies the additional effect of atezolizumab was seen in a PD-L1–negative group.

Dr. Rinnerthaler said he hopes to clarify this question when his research team reviews biopsy data from baseline and after the induction phase.
 

Defining response is key to de-escalation

In the IMpassion031 trial, “what we saw is a tendency to better outcomes for those patients who received atezolizumab,” said Matteo Lambertini, MD, of the University of Genova (Italy), who served as discussant for the two studies. The IMpassion031 study raises the question of where we are in the use of immuno-oncology for eTNBC. The study is now one of five neoadjuvant trials in this population.

Heidi Splete/MDedge News

Dr. Lambertini cited the KEYNOTE-522 study, which showed significant results in EFS. However, sample sizes and statistical design were different between these studies. “I think we need large studies of data in the adjuvant and postneoadjuvant setting for patients with triple-negative breast cancer.”

Postneoadjuvant considerations from the IMpassion031 trial showed good outcomes with no additional benefit of an immune checkpoint inhibitors.

For those patients with a pCR, it is definitely time to de-escalate treatment,” he said. In patients without pCR, escalation is needed, but an improved definition of pCR is also needed.

With regard to the ATHENE study, “it may be considered a positive study because the threshold of 40% was reached,” he said. The question is what is the optimum chemotherapy backbone. There appears to be no added benefit to adding an immune checkpoint inhibitor.

There are needs for defining the role of immunotherapy in HER2-positive breast cancer and more biomarker research to inform patient selection and study design, he said.

Finally, “I am not sure that the addition of an immune checkpoint inhibitor can be considered a de-escalation,” he noted.

IMpassion031 was supported by F. Hoffmann–La Roche. Dr. Barrio disclosed financial relationships with numerous companies. ABSCG-52/ATHENE was supported by the Austrian Breast and Colorectal Cancer Study Group and Roche Austria. Dr. Rinnerthaler disclosed relationships with multiple companies including Amgen, Daiichi Sankyo, Lilly, Gilead, MSD, Novartis, Pfizer, Roche, Seagen, and Pierre Fabre. Dr. Lambertini disclosed relationships with multiple companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, MSD, Seagen, Gilead, Takeda, Sandoz, Ipsen, Libbs, Knight, and Daiichi Sankyo.

Adding neoadjuvant atezolizumab to chemotherapy was associated with a significantly improved response in patients with early-stage triple-negative breast cancer, based on final data from a randomized trial.

The IMpassion031 trial showed significant improvement in pathological complete response (pCR) with the addition of atezolizumab to chemotherapy, as well as an acceptable safety profile, said Carlos H. Barrios, MD, of the Latin American Cooperative Oncology Group, Oncoclinicas, in Porto Allegre, Brazil, at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Those findings were published in the Lancet in 2020.

Heidi Splete/MDedge News

Dr. Barrios reported data from a final analysis of the IMpassion031 trial, with data on event-free survival (EFS), disease-free survival (DFS) and overall survival (OS) in the intent-to-treat (ITT) and PD-L1–positive populations.

In the study, patients with early triple-negative breast cancer (eTNBC) and a primary tumor greater than 2 cm were randomized to 840 mg of atezolizumab once every 2 weeks plus a neoadjuvant chemotherapy regimen of nab-paclitaxel 125 mg/m² once weekly for 12 weeks, followed by doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m² once every 2 weeks for 8 weeks. A total of 333 patients were randomized (165 atezolizumab and 168 placebo). Patients were stratified by stage II versus stage III, and by status of PD-L1, a protein that can predict treatment response (PD-L1 less than 1% vs. 1% or higher).

The primary endpoints (previously reported) were pathological complete response (pCR) in the ITT and PD-L1 populations. After a median follow-up of 39 months, the pCR was 58% in patients treated with atezolizumab versus 41% in those treated with neoadjuvant chemotherapy alone (P = .0044) in the ITT population, Dr. Barrios said. The added benefit from atezolizumab occurred regardless of the status of PD-L1.

Dr. Barrios reported the secondary outcomes of EFS, DFS, and OS in the intent-to-treat and PD-L1–positive populations. “This is a descriptive analysis, with no statistical comparison,” he emphasized.

The 2-year data on EFS, DFS, and OS consistently favored atezolizumab across key clinical subgroups, Dr. Barrios said. In the ITT population, 2-year EFS, DFS, and OS was 85%, 87%, and 95%, respectively, in the atezolizumab group and 80%, 83%, and 90%, respectively, in the placebo group. The results were similar, irrespective of PD-L1 status.

In the PD-L1–positive population, 2-year EFS, DFS, and OS was 89%, 91%, and 95%, respectively, in atezolizumab patients and 80%, 87%, and 91% in placebo patients.

Among patients without pCR at the time of surgery, 14 of 70 patients (20%) in the atezolizumab group and 33 of 99 patients (33%) in the placebo group received additional adjuvant systemic therapy. The most common adjunctive therapy was capecitabine.

As for safety, no new safety signals or treatment-related deaths were observed in the study. Overall, 70% of atezolizumab patients and 62% of placebo patients experienced grade 3 or 4 adverse events (AEs); 59% and 54% of which were treatment related. A total of 1% of patients in each group experienced grade 5 AEs. A total of 25% of atezolizumab patients and 20% of placebo patients experienced AEs leading to treatment discontinuation.

In a further exploratory analysis, pCR was highly predictive of long-term outcomes. Exploratory analysis of circulating tumor DNA (ctDNA) showed clearance in 89% of atezolizumab patients and 86% of placebo patients by the time of surgery.

Looking at the relationship between ctDNA, DFS, and OS, positive ctDNA was associated with a worse prognosis following surgery. As demonstrated in previous studies, pCR patients with negative ctDNA had the best DFS and OS. “In non-pCR patients with positive ctDNA, a numerical trend suggests improved overall survival with atezolizumab,” although the caveat is the very small numbers, Dr. Barrios said.

More research is needed, but in the final analysis, the significant pCR benefit seen with the addition of atezolizumab to chemotherapy for eTNBC translated into numerically improved EFS, DFS and OS, said Dr. Barrios. Additionally, “we should further analyze ctDNA to help select patients for further therapy.”

In a question-and-answer session, Dr. Barrios was asked how the results compared with other studies.

“We should not overinterpret the results,” he said. However, “what the IMpassion031 study shows is consistency; the results are aligned with previous studies addressing the same question of introducing immunotherapy,” in the patient population. Although the numbers in the IMpassion031 study did not reach statistical significance, it is important to recognize that they reflect previous research.

“In my opinion, looking at the whole field, immunotherapy is something we need to consider as part of the treatment of these patients,” said Dr. Barrios. However, more research is needed to better identify which patients do and do not need chemotherapy.
 

Phase 2 data show increased response with added atezolizumab for PD-L1–negative patients

In a second study known as ABSCG-52/ATHENE, researchers evaluated neoadjuvant atezolizumab in combination with dual HER2 blockade plus epirubicin for the treatment of patients with early HER2-positive breast cancer.

Heidi Splete/MDedge News

For most of these patients, the current standard of care is neoadjuvant dual HER2 blockade with trastuzumab (T) and pertuzumab (P) plus poly-chemotherapy, said Gabriel Rinnerthaler, MD, of the Salzburg (Austria) Cancer Research Institute, said in his presentation at the meeting. However, de-escalation of chemotherapy has been a major focus of research in recent years, and more research is needed on a combination of anthracyclines, such as epirubicin and idarubicin, and immune-checkpoint modulators.

In the phase 2 study, the researchers randomized patients with previously untreated, histologically confirmed HER2-positive early breast cancer (defined as a clinical prognostic stage cT1c–4a-d, N0-3, M0) in a 1:1 ratio to two 3-weekly cycles of a chemotherapy-free induction phase (part 1) with TP plus 1,200 mg atezolizumab (TP-A) or TP alone.

“We hypothesized that the additive effect of immune checkpoint inhibitors plus anti-HER2 therapy and chemotherapy would not be linear,” he said.

At the end of this period, all patients underwent four cycles of TP-A in combination with epirubicin (part 2). The primary endpoint was pCR (defined as absence of invasive cancer in the breast and axillary nodes, or ypT0/Tis ypN0) in the overall study population, and a pCR of 40% was considered a positive result.

A total of 29 patients were randomized to TP-A and 29 to TP alone in nine treatment centers in Austria. The study population ranged from 33 to 82 years, with a median age of 57 years. Most patients (72.4%) had hormone receptor (HR)–positive tumors; a total of 45 patients had stage IIA cancer, and 13 had stage IIB.

The primary endpoint of pCR occurred in 35 patients overall (60.3%). In a univariate analysis, the response rates were lower in HR-positive patients, in premenopausal patients, and in histologies other than NST (invasive carcinoma of no special type), Dr. Rinnerthaler said, but none of the differences were statistically significant, likely because of the small numbers in each group.

In an exploratory analysis of the ITT population with available PD-L1 data, the pCR was 69.2% for PD-L1–negative patients and 55.2% for PD-L1–positive patients.

“We observed the highest pCR rates in PD-L1–negative patients treated in the TP-A group and the lowest in PD-L1–positive patients treated with TP alone,” Dr. Rinnerthaler said.

No new safety concerns were observed during the study, Dr. Rinnerthaler noted. AEs of grade 3 or higher occurred in 17 patients (29.3%), including 9 in the TP-A group and 8 in the TP group. The most common AEs in both groups were nausea, diarrhea, and fatigue. No AEs of special interest of grade 3 or higher (defined as immune-related AEs, cardiac disorders, or infusion-related reactions) were observed.

The study findings were limited by the small sample size, but the resulting pCR rate of 60.3% was higher than the predefined threshold of 40% and supports additional research, said Dr. Rinnerthaler.

“For HER2-positive early breast cancer, a neoadjuvant chemotherapy de-escalation immunotherapy regimen with trastuzumab, pertuzumab, atezolizumab, and epirubicin is highly effective and safe and merits further investigation,” he concluded.

During a question-and-answer session, Dr. Rinnerthaler was asked why pCR increased in PD-L1 negative patients.

Previous data have shown that PD-L1 is up-regulated in certain tumors, and may serve as a surrogate for sensitivity, he said. In previous studies the additional effect of atezolizumab was seen in a PD-L1–negative group.

Dr. Rinnerthaler said he hopes to clarify this question when his research team reviews biopsy data from baseline and after the induction phase.
 

Defining response is key to de-escalation

In the IMpassion031 trial, “what we saw is a tendency to better outcomes for those patients who received atezolizumab,” said Matteo Lambertini, MD, of the University of Genova (Italy), who served as discussant for the two studies. The IMpassion031 study raises the question of where we are in the use of immuno-oncology for eTNBC. The study is now one of five neoadjuvant trials in this population.

Heidi Splete/MDedge News

Dr. Lambertini cited the KEYNOTE-522 study, which showed significant results in EFS. However, sample sizes and statistical design were different between these studies. “I think we need large studies of data in the adjuvant and postneoadjuvant setting for patients with triple-negative breast cancer.”

Postneoadjuvant considerations from the IMpassion031 trial showed good outcomes with no additional benefit of an immune checkpoint inhibitors.

For those patients with a pCR, it is definitely time to de-escalate treatment,” he said. In patients without pCR, escalation is needed, but an improved definition of pCR is also needed.

With regard to the ATHENE study, “it may be considered a positive study because the threshold of 40% was reached,” he said. The question is what is the optimum chemotherapy backbone. There appears to be no added benefit to adding an immune checkpoint inhibitor.

There are needs for defining the role of immunotherapy in HER2-positive breast cancer and more biomarker research to inform patient selection and study design, he said.

Finally, “I am not sure that the addition of an immune checkpoint inhibitor can be considered a de-escalation,” he noted.

IMpassion031 was supported by F. Hoffmann–La Roche. Dr. Barrio disclosed financial relationships with numerous companies. ABSCG-52/ATHENE was supported by the Austrian Breast and Colorectal Cancer Study Group and Roche Austria. Dr. Rinnerthaler disclosed relationships with multiple companies including Amgen, Daiichi Sankyo, Lilly, Gilead, MSD, Novartis, Pfizer, Roche, Seagen, and Pierre Fabre. Dr. Lambertini disclosed relationships with multiple companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, MSD, Seagen, Gilead, Takeda, Sandoz, Ipsen, Libbs, Knight, and Daiichi Sankyo.

Adding neoadjuvant atezolizumab to chemotherapy was associated with a significantly improved response in patients with early-stage triple-negative breast cancer, based on final data from a randomized trial.

The IMpassion031 trial showed significant improvement in pathological complete response (pCR) with the addition of atezolizumab to chemotherapy, as well as an acceptable safety profile, said Carlos H. Barrios, MD, of the Latin American Cooperative Oncology Group, Oncoclinicas, in Porto Allegre, Brazil, at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Those findings were published in the Lancet in 2020.

Heidi Splete/MDedge News

Dr. Barrios reported data from a final analysis of the IMpassion031 trial, with data on event-free survival (EFS), disease-free survival (DFS) and overall survival (OS) in the intent-to-treat (ITT) and PD-L1–positive populations.

In the study, patients with early triple-negative breast cancer (eTNBC) and a primary tumor greater than 2 cm were randomized to 840 mg of atezolizumab once every 2 weeks plus a neoadjuvant chemotherapy regimen of nab-paclitaxel 125 mg/m² once weekly for 12 weeks, followed by doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m² once every 2 weeks for 8 weeks. A total of 333 patients were randomized (165 atezolizumab and 168 placebo). Patients were stratified by stage II versus stage III, and by status of PD-L1, a protein that can predict treatment response (PD-L1 less than 1% vs. 1% or higher).

The primary endpoints (previously reported) were pathological complete response (pCR) in the ITT and PD-L1 populations. After a median follow-up of 39 months, the pCR was 58% in patients treated with atezolizumab versus 41% in those treated with neoadjuvant chemotherapy alone (P = .0044) in the ITT population, Dr. Barrios said. The added benefit from atezolizumab occurred regardless of the status of PD-L1.

Dr. Barrios reported the secondary outcomes of EFS, DFS, and OS in the intent-to-treat and PD-L1–positive populations. “This is a descriptive analysis, with no statistical comparison,” he emphasized.

The 2-year data on EFS, DFS, and OS consistently favored atezolizumab across key clinical subgroups, Dr. Barrios said. In the ITT population, 2-year EFS, DFS, and OS was 85%, 87%, and 95%, respectively, in the atezolizumab group and 80%, 83%, and 90%, respectively, in the placebo group. The results were similar, irrespective of PD-L1 status.

In the PD-L1–positive population, 2-year EFS, DFS, and OS was 89%, 91%, and 95%, respectively, in atezolizumab patients and 80%, 87%, and 91% in placebo patients.

Among patients without pCR at the time of surgery, 14 of 70 patients (20%) in the atezolizumab group and 33 of 99 patients (33%) in the placebo group received additional adjuvant systemic therapy. The most common adjunctive therapy was capecitabine.

As for safety, no new safety signals or treatment-related deaths were observed in the study. Overall, 70% of atezolizumab patients and 62% of placebo patients experienced grade 3 or 4 adverse events (AEs); 59% and 54% of which were treatment related. A total of 1% of patients in each group experienced grade 5 AEs. A total of 25% of atezolizumab patients and 20% of placebo patients experienced AEs leading to treatment discontinuation.

In a further exploratory analysis, pCR was highly predictive of long-term outcomes. Exploratory analysis of circulating tumor DNA (ctDNA) showed clearance in 89% of atezolizumab patients and 86% of placebo patients by the time of surgery.

Looking at the relationship between ctDNA, DFS, and OS, positive ctDNA was associated with a worse prognosis following surgery. As demonstrated in previous studies, pCR patients with negative ctDNA had the best DFS and OS. “In non-pCR patients with positive ctDNA, a numerical trend suggests improved overall survival with atezolizumab,” although the caveat is the very small numbers, Dr. Barrios said.

More research is needed, but in the final analysis, the significant pCR benefit seen with the addition of atezolizumab to chemotherapy for eTNBC translated into numerically improved EFS, DFS and OS, said Dr. Barrios. Additionally, “we should further analyze ctDNA to help select patients for further therapy.”

In a question-and-answer session, Dr. Barrios was asked how the results compared with other studies.

“We should not overinterpret the results,” he said. However, “what the IMpassion031 study shows is consistency; the results are aligned with previous studies addressing the same question of introducing immunotherapy,” in the patient population. Although the numbers in the IMpassion031 study did not reach statistical significance, it is important to recognize that they reflect previous research.

“In my opinion, looking at the whole field, immunotherapy is something we need to consider as part of the treatment of these patients,” said Dr. Barrios. However, more research is needed to better identify which patients do and do not need chemotherapy.
 

Phase 2 data show increased response with added atezolizumab for PD-L1–negative patients

In a second study known as ABSCG-52/ATHENE, researchers evaluated neoadjuvant atezolizumab in combination with dual HER2 blockade plus epirubicin for the treatment of patients with early HER2-positive breast cancer.

Heidi Splete/MDedge News

For most of these patients, the current standard of care is neoadjuvant dual HER2 blockade with trastuzumab (T) and pertuzumab (P) plus poly-chemotherapy, said Gabriel Rinnerthaler, MD, of the Salzburg (Austria) Cancer Research Institute, said in his presentation at the meeting. However, de-escalation of chemotherapy has been a major focus of research in recent years, and more research is needed on a combination of anthracyclines, such as epirubicin and idarubicin, and immune-checkpoint modulators.

In the phase 2 study, the researchers randomized patients with previously untreated, histologically confirmed HER2-positive early breast cancer (defined as a clinical prognostic stage cT1c–4a-d, N0-3, M0) in a 1:1 ratio to two 3-weekly cycles of a chemotherapy-free induction phase (part 1) with TP plus 1,200 mg atezolizumab (TP-A) or TP alone.

“We hypothesized that the additive effect of immune checkpoint inhibitors plus anti-HER2 therapy and chemotherapy would not be linear,” he said.

At the end of this period, all patients underwent four cycles of TP-A in combination with epirubicin (part 2). The primary endpoint was pCR (defined as absence of invasive cancer in the breast and axillary nodes, or ypT0/Tis ypN0) in the overall study population, and a pCR of 40% was considered a positive result.

A total of 29 patients were randomized to TP-A and 29 to TP alone in nine treatment centers in Austria. The study population ranged from 33 to 82 years, with a median age of 57 years. Most patients (72.4%) had hormone receptor (HR)–positive tumors; a total of 45 patients had stage IIA cancer, and 13 had stage IIB.

The primary endpoint of pCR occurred in 35 patients overall (60.3%). In a univariate analysis, the response rates were lower in HR-positive patients, in premenopausal patients, and in histologies other than NST (invasive carcinoma of no special type), Dr. Rinnerthaler said, but none of the differences were statistically significant, likely because of the small numbers in each group.

In an exploratory analysis of the ITT population with available PD-L1 data, the pCR was 69.2% for PD-L1–negative patients and 55.2% for PD-L1–positive patients.

“We observed the highest pCR rates in PD-L1–negative patients treated in the TP-A group and the lowest in PD-L1–positive patients treated with TP alone,” Dr. Rinnerthaler said.

No new safety concerns were observed during the study, Dr. Rinnerthaler noted. AEs of grade 3 or higher occurred in 17 patients (29.3%), including 9 in the TP-A group and 8 in the TP group. The most common AEs in both groups were nausea, diarrhea, and fatigue. No AEs of special interest of grade 3 or higher (defined as immune-related AEs, cardiac disorders, or infusion-related reactions) were observed.

The study findings were limited by the small sample size, but the resulting pCR rate of 60.3% was higher than the predefined threshold of 40% and supports additional research, said Dr. Rinnerthaler.

“For HER2-positive early breast cancer, a neoadjuvant chemotherapy de-escalation immunotherapy regimen with trastuzumab, pertuzumab, atezolizumab, and epirubicin is highly effective and safe and merits further investigation,” he concluded.

During a question-and-answer session, Dr. Rinnerthaler was asked why pCR increased in PD-L1 negative patients.

Previous data have shown that PD-L1 is up-regulated in certain tumors, and may serve as a surrogate for sensitivity, he said. In previous studies the additional effect of atezolizumab was seen in a PD-L1–negative group.

Dr. Rinnerthaler said he hopes to clarify this question when his research team reviews biopsy data from baseline and after the induction phase.
 

Defining response is key to de-escalation

In the IMpassion031 trial, “what we saw is a tendency to better outcomes for those patients who received atezolizumab,” said Matteo Lambertini, MD, of the University of Genova (Italy), who served as discussant for the two studies. The IMpassion031 study raises the question of where we are in the use of immuno-oncology for eTNBC. The study is now one of five neoadjuvant trials in this population.

Heidi Splete/MDedge News

Dr. Lambertini cited the KEYNOTE-522 study, which showed significant results in EFS. However, sample sizes and statistical design were different between these studies. “I think we need large studies of data in the adjuvant and postneoadjuvant setting for patients with triple-negative breast cancer.”

Postneoadjuvant considerations from the IMpassion031 trial showed good outcomes with no additional benefit of an immune checkpoint inhibitors.

For those patients with a pCR, it is definitely time to de-escalate treatment,” he said. In patients without pCR, escalation is needed, but an improved definition of pCR is also needed.

With regard to the ATHENE study, “it may be considered a positive study because the threshold of 40% was reached,” he said. The question is what is the optimum chemotherapy backbone. There appears to be no added benefit to adding an immune checkpoint inhibitor.

There are needs for defining the role of immunotherapy in HER2-positive breast cancer and more biomarker research to inform patient selection and study design, he said.

Finally, “I am not sure that the addition of an immune checkpoint inhibitor can be considered a de-escalation,” he noted.

IMpassion031 was supported by F. Hoffmann–La Roche. Dr. Barrio disclosed financial relationships with numerous companies. ABSCG-52/ATHENE was supported by the Austrian Breast and Colorectal Cancer Study Group and Roche Austria. Dr. Rinnerthaler disclosed relationships with multiple companies including Amgen, Daiichi Sankyo, Lilly, Gilead, MSD, Novartis, Pfizer, Roche, Seagen, and Pierre Fabre. Dr. Lambertini disclosed relationships with multiple companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, MSD, Seagen, Gilead, Takeda, Sandoz, Ipsen, Libbs, Knight, and Daiichi Sankyo.