AVAHO

NEW ORLEANS – One third of patients with non–small cell lung cancers (NSCLC) bearing the KRASG12C mutation were alive 2 years after starting therapy with the first-in-class KRAS inhibitor sotorasib (Lumakras, Amgen).

The finding comes from an analysis of long-term follow-up data from the CodeBreaK100 trial, which showed a 2-year overall survival (OS) rate of 32.5% in pretreated patients with KRASG12C-mutant disease.

That rate compares favorably with historical data on NSCLC therapies, said Grace K. Dy, MD, from Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.

“We expect about half of that [survival rate] in patients who are treated with docetaxel,” she said in a plenary session at the annual meeting of the American Association for Cancer Research.

Sotorasib was approved by the Food and Drug Administration in May 2021 as the first drug for patients with NSCLC and KRAS mutations and was described as a “historic milestone.” 

In this most recent analysis, which combined data from patients enrolled in phases 1 and 2 of the trial, the “objective response rate of 41% of patients was achieved with sotorasib, with a durable [disease] control rate of 84% and a median duration of response of 12.3 months, with no new safety signals emerging,” she said.

Nearly one-fourth of patients saw long-term benefit, as defined by progression-free survival of at least 12 months, and this long-term benefit was seen across variant allele frequencies of KRASG12C, programmed death–ligand 1 (PD-L1) tumor proportion score, and other comutations, she noted.

“KRASG12C inhibitors represent a major advance in the treatment of KRAS-mutant lung cancers and other types as well,” said invited discussant Mark M. Awad, MD, PhD, director of clinical research at the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Center, Boston.

He cautioned, however, that “the therapeutic efficacy of these G12C inhibitors is currently limited by several things, including patient factors, intrinsic biology, and the emergence of complex resistance mechanisms.”

New approaches will be needed, he said, “to delay and overcome drug resistance to hopefully keep kicking cancer’s KRAS.”

At a media briefing where Dr. Dy presented the data prior to the oral abstract session, moderator Timothy A. Yap, MBBS, PhD, from the University of Texas MD Anderson Cancer Center, Houston, commented that the development of drug resistance is common in oncology.

“That is exactly why we’re now actively working on multiple different combinatorial approaches in the clinic. There have been pretty compelling data published from Mirati [Therapeutics] and from other companies, from Amgen, that really show the resistance mechanisms that actually come about upon monotherapy with KRASG12C inhibitors, including CDK4/6, including P13K-Akt pathways,” he said.

“The solution there really is, No. 1, we need to identify proactively the resistance mechanisms involved and driving each cancer’s resistance, and No. 2, then apply the combinatorial agent, to bring in a combination that’s a rational approach to match a patient’s molecular profile upon resistance,” he said.
 

Tarnished triumph

As previously reported, sotorasib was hailed as “a triumph of drug discovery” when early results of the trial were reported at the European Society of Medical Oncology annual meeting in 2020.

Sotorasib is a small-molecule, specific, and irreversible inhibitor of KRAS that interacts with a “pocket” on the gene’s surface that is present only in an inactive conformation of KRAS. The drug inhibits oncogenic signaling and tumorigenesis by preventing cycling of the oncogene into its active form.

But as Dr. Awad reported at the 2021 AACR annual meeting, the efficacy of sotorasib and other KRAS inhibitors in development has been threatened by the development of resistance caused by a wide range of genomic and histologic mechanisms.

Dr. Awad reported that among 30 patients with NSCLC or colorectal cancer bearing the KRASG12C mutation who had disease progression while being treated with the investigational inhibitor adagrasib in clinical trials, investigators found multiple on-target KRAS alterations and off-target bypass mechanisms of acquired resistance to the drug.

“Diverse mechanisms confer resistance to the KRASG12C inhibitors, including secondary KRAS mutations, MAP [mitogen-activated protein] kinase pathway alterations, acquired genomic rearrangements, and histologic transformation,” he said.
 

Long follow-up

The long-term data reported at the 2022 meeting by Dr. Dy and colleagues included data on 48 patients enrolled in phase 1 of the trial, which had a primary endpoint of safety and tolerability, and 126 patients enrolled in phase 2, with a primary endpoint of objective response rate by blinded independent review.

The trial was conducted in centers in the United States, Europe, Australia, Japan, and South Korea.

Nearly all patients were pretreated: 92.5% of patients had received prior platinum-based chemotherapy and 90.2% had received anti–PD-1/PD-L1 immunotherapy.

Patients received oral sotorasib 960 mg once daily and were followed with radiographic scans every 6 weeks for the first year and once every 12 weeks thereafter.

Of the 174 patients enrolled, two were not evaluable for response at 2 years because of a lack of measurable lesions at baseline.

At a median follow-up of 24.9 months, 5 patients (2.9%) had a complete response and 65 (37.8%) had a partial response, for an objective response rate of 40.7%. An additional 74 patients (43%) had stable disease, for a disease control rate of 83.7%. Of the remaining patients, 23 (13.4%) had disease progression, and 5 were either not evaluable or had missing scan data.

Median progression-free survival was 6.3 months. Median time to response was 6 weeks, and median duration of response was 12.3 months. Half of patients who had a response retained that response for at least 12 months.

Median OS was 12.5 months. The 1-year and 2-year OS rates were 50.8% and 32.5%, respectively.

Grade 3 or 4 treatment-related adverse events occurred in 21% of patients, and one patient had new-onset grade 3 hemolytic anemia 1 year after starting therapy. There were no treatment-related deaths and no treatment-related adverse events leading to discontinuation after the first year.

In exploratory analyses, the benefit of the drug was seen across tumors with varying levels of PD-L1 expression and the oncogenic STK11 comutation, and across KRASG12C variant allele frequency.

The investigators also reported that baseline circulating tumor DNA levels correlated with tumor burden, and that patients who had long-term benefits had lower baseline ctDNA. This finding is consistent with the documented role of ctDNA as a marker for poor prognosis regardless of therapy.

Dr. Dy reported receiving consulting fees from AstraZeneca, Eli Lilly, Mirati Therapeutics, and Takeda in the past 2 years. Dr. Yap disclosed receiving consulting fees from multiple companies. Dr. Awad disclosed consulting for multiple companies.

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

NEW ORLEANS – One third of patients with non–small cell lung cancers (NSCLC) bearing the KRASG12C mutation were alive 2 years after starting therapy with the first-in-class KRAS inhibitor sotorasib (Lumakras, Amgen).

The finding comes from an analysis of long-term follow-up data from the CodeBreaK100 trial, which showed a 2-year overall survival (OS) rate of 32.5% in pretreated patients with KRASG12C-mutant disease.

That rate compares favorably with historical data on NSCLC therapies, said Grace K. Dy, MD, from Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.

“We expect about half of that [survival rate] in patients who are treated with docetaxel,” she said in a plenary session at the annual meeting of the American Association for Cancer Research.

Sotorasib was approved by the Food and Drug Administration in May 2021 as the first drug for patients with NSCLC and KRAS mutations and was described as a “historic milestone.” 

In this most recent analysis, which combined data from patients enrolled in phases 1 and 2 of the trial, the “objective response rate of 41% of patients was achieved with sotorasib, with a durable [disease] control rate of 84% and a median duration of response of 12.3 months, with no new safety signals emerging,” she said.

Nearly one-fourth of patients saw long-term benefit, as defined by progression-free survival of at least 12 months, and this long-term benefit was seen across variant allele frequencies of KRASG12C, programmed death–ligand 1 (PD-L1) tumor proportion score, and other comutations, she noted.

“KRASG12C inhibitors represent a major advance in the treatment of KRAS-mutant lung cancers and other types as well,” said invited discussant Mark M. Awad, MD, PhD, director of clinical research at the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Center, Boston.

He cautioned, however, that “the therapeutic efficacy of these G12C inhibitors is currently limited by several things, including patient factors, intrinsic biology, and the emergence of complex resistance mechanisms.”

New approaches will be needed, he said, “to delay and overcome drug resistance to hopefully keep kicking cancer’s KRAS.”

At a media briefing where Dr. Dy presented the data prior to the oral abstract session, moderator Timothy A. Yap, MBBS, PhD, from the University of Texas MD Anderson Cancer Center, Houston, commented that the development of drug resistance is common in oncology.

“That is exactly why we’re now actively working on multiple different combinatorial approaches in the clinic. There have been pretty compelling data published from Mirati [Therapeutics] and from other companies, from Amgen, that really show the resistance mechanisms that actually come about upon monotherapy with KRASG12C inhibitors, including CDK4/6, including P13K-Akt pathways,” he said.

“The solution there really is, No. 1, we need to identify proactively the resistance mechanisms involved and driving each cancer’s resistance, and No. 2, then apply the combinatorial agent, to bring in a combination that’s a rational approach to match a patient’s molecular profile upon resistance,” he said.
 

Tarnished triumph

As previously reported, sotorasib was hailed as “a triumph of drug discovery” when early results of the trial were reported at the European Society of Medical Oncology annual meeting in 2020.

Sotorasib is a small-molecule, specific, and irreversible inhibitor of KRAS that interacts with a “pocket” on the gene’s surface that is present only in an inactive conformation of KRAS. The drug inhibits oncogenic signaling and tumorigenesis by preventing cycling of the oncogene into its active form.

But as Dr. Awad reported at the 2021 AACR annual meeting, the efficacy of sotorasib and other KRAS inhibitors in development has been threatened by the development of resistance caused by a wide range of genomic and histologic mechanisms.

Dr. Awad reported that among 30 patients with NSCLC or colorectal cancer bearing the KRASG12C mutation who had disease progression while being treated with the investigational inhibitor adagrasib in clinical trials, investigators found multiple on-target KRAS alterations and off-target bypass mechanisms of acquired resistance to the drug.

“Diverse mechanisms confer resistance to the KRASG12C inhibitors, including secondary KRAS mutations, MAP [mitogen-activated protein] kinase pathway alterations, acquired genomic rearrangements, and histologic transformation,” he said.
 

Long follow-up

The long-term data reported at the 2022 meeting by Dr. Dy and colleagues included data on 48 patients enrolled in phase 1 of the trial, which had a primary endpoint of safety and tolerability, and 126 patients enrolled in phase 2, with a primary endpoint of objective response rate by blinded independent review.

The trial was conducted in centers in the United States, Europe, Australia, Japan, and South Korea.

Nearly all patients were pretreated: 92.5% of patients had received prior platinum-based chemotherapy and 90.2% had received anti–PD-1/PD-L1 immunotherapy.

Patients received oral sotorasib 960 mg once daily and were followed with radiographic scans every 6 weeks for the first year and once every 12 weeks thereafter.

Of the 174 patients enrolled, two were not evaluable for response at 2 years because of a lack of measurable lesions at baseline.

At a median follow-up of 24.9 months, 5 patients (2.9%) had a complete response and 65 (37.8%) had a partial response, for an objective response rate of 40.7%. An additional 74 patients (43%) had stable disease, for a disease control rate of 83.7%. Of the remaining patients, 23 (13.4%) had disease progression, and 5 were either not evaluable or had missing scan data.

Median progression-free survival was 6.3 months. Median time to response was 6 weeks, and median duration of response was 12.3 months. Half of patients who had a response retained that response for at least 12 months.

Median OS was 12.5 months. The 1-year and 2-year OS rates were 50.8% and 32.5%, respectively.

Grade 3 or 4 treatment-related adverse events occurred in 21% of patients, and one patient had new-onset grade 3 hemolytic anemia 1 year after starting therapy. There were no treatment-related deaths and no treatment-related adverse events leading to discontinuation after the first year.

In exploratory analyses, the benefit of the drug was seen across tumors with varying levels of PD-L1 expression and the oncogenic STK11 comutation, and across KRASG12C variant allele frequency.

The investigators also reported that baseline circulating tumor DNA levels correlated with tumor burden, and that patients who had long-term benefits had lower baseline ctDNA. This finding is consistent with the documented role of ctDNA as a marker for poor prognosis regardless of therapy.

Dr. Dy reported receiving consulting fees from AstraZeneca, Eli Lilly, Mirati Therapeutics, and Takeda in the past 2 years. Dr. Yap disclosed receiving consulting fees from multiple companies. Dr. Awad disclosed consulting for multiple companies.

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

NEW ORLEANS – One third of patients with non–small cell lung cancers (NSCLC) bearing the KRASG12C mutation were alive 2 years after starting therapy with the first-in-class KRAS inhibitor sotorasib (Lumakras, Amgen).

The finding comes from an analysis of long-term follow-up data from the CodeBreaK100 trial, which showed a 2-year overall survival (OS) rate of 32.5% in pretreated patients with KRASG12C-mutant disease.

That rate compares favorably with historical data on NSCLC therapies, said Grace K. Dy, MD, from Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.

“We expect about half of that [survival rate] in patients who are treated with docetaxel,” she said in a plenary session at the annual meeting of the American Association for Cancer Research.

Sotorasib was approved by the Food and Drug Administration in May 2021 as the first drug for patients with NSCLC and KRAS mutations and was described as a “historic milestone.” 

In this most recent analysis, which combined data from patients enrolled in phases 1 and 2 of the trial, the “objective response rate of 41% of patients was achieved with sotorasib, with a durable [disease] control rate of 84% and a median duration of response of 12.3 months, with no new safety signals emerging,” she said.

Nearly one-fourth of patients saw long-term benefit, as defined by progression-free survival of at least 12 months, and this long-term benefit was seen across variant allele frequencies of KRASG12C, programmed death–ligand 1 (PD-L1) tumor proportion score, and other comutations, she noted.

“KRASG12C inhibitors represent a major advance in the treatment of KRAS-mutant lung cancers and other types as well,” said invited discussant Mark M. Awad, MD, PhD, director of clinical research at the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Center, Boston.

He cautioned, however, that “the therapeutic efficacy of these G12C inhibitors is currently limited by several things, including patient factors, intrinsic biology, and the emergence of complex resistance mechanisms.”

New approaches will be needed, he said, “to delay and overcome drug resistance to hopefully keep kicking cancer’s KRAS.”

At a media briefing where Dr. Dy presented the data prior to the oral abstract session, moderator Timothy A. Yap, MBBS, PhD, from the University of Texas MD Anderson Cancer Center, Houston, commented that the development of drug resistance is common in oncology.

“That is exactly why we’re now actively working on multiple different combinatorial approaches in the clinic. There have been pretty compelling data published from Mirati [Therapeutics] and from other companies, from Amgen, that really show the resistance mechanisms that actually come about upon monotherapy with KRASG12C inhibitors, including CDK4/6, including P13K-Akt pathways,” he said.

“The solution there really is, No. 1, we need to identify proactively the resistance mechanisms involved and driving each cancer’s resistance, and No. 2, then apply the combinatorial agent, to bring in a combination that’s a rational approach to match a patient’s molecular profile upon resistance,” he said.
 

Tarnished triumph

As previously reported, sotorasib was hailed as “a triumph of drug discovery” when early results of the trial were reported at the European Society of Medical Oncology annual meeting in 2020.

Sotorasib is a small-molecule, specific, and irreversible inhibitor of KRAS that interacts with a “pocket” on the gene’s surface that is present only in an inactive conformation of KRAS. The drug inhibits oncogenic signaling and tumorigenesis by preventing cycling of the oncogene into its active form.

But as Dr. Awad reported at the 2021 AACR annual meeting, the efficacy of sotorasib and other KRAS inhibitors in development has been threatened by the development of resistance caused by a wide range of genomic and histologic mechanisms.

Dr. Awad reported that among 30 patients with NSCLC or colorectal cancer bearing the KRASG12C mutation who had disease progression while being treated with the investigational inhibitor adagrasib in clinical trials, investigators found multiple on-target KRAS alterations and off-target bypass mechanisms of acquired resistance to the drug.

“Diverse mechanisms confer resistance to the KRASG12C inhibitors, including secondary KRAS mutations, MAP [mitogen-activated protein] kinase pathway alterations, acquired genomic rearrangements, and histologic transformation,” he said.
 

Long follow-up

The long-term data reported at the 2022 meeting by Dr. Dy and colleagues included data on 48 patients enrolled in phase 1 of the trial, which had a primary endpoint of safety and tolerability, and 126 patients enrolled in phase 2, with a primary endpoint of objective response rate by blinded independent review.

The trial was conducted in centers in the United States, Europe, Australia, Japan, and South Korea.

Nearly all patients were pretreated: 92.5% of patients had received prior platinum-based chemotherapy and 90.2% had received anti–PD-1/PD-L1 immunotherapy.

Patients received oral sotorasib 960 mg once daily and were followed with radiographic scans every 6 weeks for the first year and once every 12 weeks thereafter.

Of the 174 patients enrolled, two were not evaluable for response at 2 years because of a lack of measurable lesions at baseline.

At a median follow-up of 24.9 months, 5 patients (2.9%) had a complete response and 65 (37.8%) had a partial response, for an objective response rate of 40.7%. An additional 74 patients (43%) had stable disease, for a disease control rate of 83.7%. Of the remaining patients, 23 (13.4%) had disease progression, and 5 were either not evaluable or had missing scan data.

Median progression-free survival was 6.3 months. Median time to response was 6 weeks, and median duration of response was 12.3 months. Half of patients who had a response retained that response for at least 12 months.

Median OS was 12.5 months. The 1-year and 2-year OS rates were 50.8% and 32.5%, respectively.

Grade 3 or 4 treatment-related adverse events occurred in 21% of patients, and one patient had new-onset grade 3 hemolytic anemia 1 year after starting therapy. There were no treatment-related deaths and no treatment-related adverse events leading to discontinuation after the first year.

In exploratory analyses, the benefit of the drug was seen across tumors with varying levels of PD-L1 expression and the oncogenic STK11 comutation, and across KRASG12C variant allele frequency.

The investigators also reported that baseline circulating tumor DNA levels correlated with tumor burden, and that patients who had long-term benefits had lower baseline ctDNA. This finding is consistent with the documented role of ctDNA as a marker for poor prognosis regardless of therapy.

Dr. Dy reported receiving consulting fees from AstraZeneca, Eli Lilly, Mirati Therapeutics, and Takeda in the past 2 years. Dr. Yap disclosed receiving consulting fees from multiple companies. Dr. Awad disclosed consulting for multiple companies.

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

Women diagnosed with early breast cancer facing surgery often have a choice of having all of their breast or only a part of the breast removed.

A new study shows that a patient’s satisfaction with their breasts at 10 years after surgery is similar for both groups of women.

However, superior psychosocial and sexual well-being at 10 years after surgery was reported by women who underwent breast-conserving surgery and adjuvant radiation therapy (RT), compared with those who underwent mastectomy and reconstruction.

“These findings may inform preference-sensitive decision-making for women with early-stage breast cancer,” write the authors, led by Benjamin D. Smith, MD, department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.

The study was published online in JAMA Surgery.

These findings have important implications for patient decision-making, given that more women eligible for breast-conserving surgery are opting for a mastectomy, say Sudheer Vemuru, MD, from the University of Colorado at Denver, Aurora, and colleagues, writing in an accompanying editorial.

“Overall, the preponderance of evidence suggests superior short-term and long-term patient-reported outcomes in patients with early-stage breast cancer undergoing breast conserving surgery compared with mastectomy,” they comment.
 

Study details

For their study, Dr. Smith and colleagues conducted a comparative effectiveness research study using data from the Texas Cancer Registry and identified women diagnosed with stage 0-II breast cancer and treated with breast-conserving surgery or mastectomy and reconstruction between 2006 and 2008.

A total of 647 patients were included in their analysis (40%; 356 had undergone breast-conserving surgery; 291 had undergone mastectomy and reconstruction), 551 (85.2%) confirmed treatment with breast-conserving surgery with RT (n = 315) or mastectomy and reconstruction without RT (n = 236).

The median age of the cohort was 53 years and the median time from diagnosis to survey was 10.3 years. Mastectomy and reconstruction were more common among women who were White, younger, node positive, had larger tumors, had bilateral breast cancer, received chemotherapy, and had higher income.

The primary outcome was patient satisfaction with their breasts, as measured with the BREAST-Q patient-reported outcome measure. Secondary outcomes included physical well-being, psychosocial well-being, and sexual well-being. The EuroQol Health-Related Quality of Life 5-Dimension, 3-Level gaged health utility, and local therapy decisional regret was measured via the Decisional Regret Scale.

Using breast-conserving surgery plus RT as the referent, the authors did not find any significant differences in breast satisfaction, physical well-being, health utility, or decisional regret among the study cohorts: breast satisfaction: effect size, 2.71 (P = .30); physical well-being: effect size, –1.80 (P = .36); health utility: effect size, –0.003 (P = .83); and decisional regret: effect size, 1.32 (P = .61).

However, psychosocial well-being (effect size, –8.61; P < .001) and sexual well-being (effect size, –10.68; P < .001) were significantly worse among women who had undergone mastectomy and reconstruction without RT.

They noted that interactions of race and ethnicity and age by treatment group were not significant for reported satisfaction with breast outcomes. But the findings “indicated that the burden of poor long-term QOL outcomes was greater among younger individuals, those with lower educational attainment and income, and certain racial and ethnic minority populations,” they write. “These findings suggest that opportunities exist to enhance equity in the long-term QOL of individuals with breast cancer.”

The editorialists note that previous studies have also found diminished quality of life following mastectomy compared with breast-conserving surgery. However, most of these prior studies included patients undergoing breast-conserving surgery without RT, patients undergoing mastectomy without reconstruction, and patients undergoing mastectomy with RT.

In contrast, this latest study “directly compared breast-conserving surgery with RT vs. mastectomy and reconstruction without RT to avoid those potential confounders,” they point out.

The study was supported by grants from the National Cancer Institute and other bodies. Several of the study authors disclosed relationships with industry and/or with nonprofit organizations. The full list can be found with the original article. Editorialist Clara Lee, MD, reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study.

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

Women diagnosed with early breast cancer facing surgery often have a choice of having all of their breast or only a part of the breast removed.

A new study shows that a patient’s satisfaction with their breasts at 10 years after surgery is similar for both groups of women.

However, superior psychosocial and sexual well-being at 10 years after surgery was reported by women who underwent breast-conserving surgery and adjuvant radiation therapy (RT), compared with those who underwent mastectomy and reconstruction.

“These findings may inform preference-sensitive decision-making for women with early-stage breast cancer,” write the authors, led by Benjamin D. Smith, MD, department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.

The study was published online in JAMA Surgery.

These findings have important implications for patient decision-making, given that more women eligible for breast-conserving surgery are opting for a mastectomy, say Sudheer Vemuru, MD, from the University of Colorado at Denver, Aurora, and colleagues, writing in an accompanying editorial.

“Overall, the preponderance of evidence suggests superior short-term and long-term patient-reported outcomes in patients with early-stage breast cancer undergoing breast conserving surgery compared with mastectomy,” they comment.
 

Study details

For their study, Dr. Smith and colleagues conducted a comparative effectiveness research study using data from the Texas Cancer Registry and identified women diagnosed with stage 0-II breast cancer and treated with breast-conserving surgery or mastectomy and reconstruction between 2006 and 2008.

A total of 647 patients were included in their analysis (40%; 356 had undergone breast-conserving surgery; 291 had undergone mastectomy and reconstruction), 551 (85.2%) confirmed treatment with breast-conserving surgery with RT (n = 315) or mastectomy and reconstruction without RT (n = 236).

The median age of the cohort was 53 years and the median time from diagnosis to survey was 10.3 years. Mastectomy and reconstruction were more common among women who were White, younger, node positive, had larger tumors, had bilateral breast cancer, received chemotherapy, and had higher income.

The primary outcome was patient satisfaction with their breasts, as measured with the BREAST-Q patient-reported outcome measure. Secondary outcomes included physical well-being, psychosocial well-being, and sexual well-being. The EuroQol Health-Related Quality of Life 5-Dimension, 3-Level gaged health utility, and local therapy decisional regret was measured via the Decisional Regret Scale.

Using breast-conserving surgery plus RT as the referent, the authors did not find any significant differences in breast satisfaction, physical well-being, health utility, or decisional regret among the study cohorts: breast satisfaction: effect size, 2.71 (P = .30); physical well-being: effect size, –1.80 (P = .36); health utility: effect size, –0.003 (P = .83); and decisional regret: effect size, 1.32 (P = .61).

However, psychosocial well-being (effect size, –8.61; P < .001) and sexual well-being (effect size, –10.68; P < .001) were significantly worse among women who had undergone mastectomy and reconstruction without RT.

They noted that interactions of race and ethnicity and age by treatment group were not significant for reported satisfaction with breast outcomes. But the findings “indicated that the burden of poor long-term QOL outcomes was greater among younger individuals, those with lower educational attainment and income, and certain racial and ethnic minority populations,” they write. “These findings suggest that opportunities exist to enhance equity in the long-term QOL of individuals with breast cancer.”

The editorialists note that previous studies have also found diminished quality of life following mastectomy compared with breast-conserving surgery. However, most of these prior studies included patients undergoing breast-conserving surgery without RT, patients undergoing mastectomy without reconstruction, and patients undergoing mastectomy with RT.

In contrast, this latest study “directly compared breast-conserving surgery with RT vs. mastectomy and reconstruction without RT to avoid those potential confounders,” they point out.

The study was supported by grants from the National Cancer Institute and other bodies. Several of the study authors disclosed relationships with industry and/or with nonprofit organizations. The full list can be found with the original article. Editorialist Clara Lee, MD, reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study.

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

Women diagnosed with early breast cancer facing surgery often have a choice of having all of their breast or only a part of the breast removed.

A new study shows that a patient’s satisfaction with their breasts at 10 years after surgery is similar for both groups of women.

However, superior psychosocial and sexual well-being at 10 years after surgery was reported by women who underwent breast-conserving surgery and adjuvant radiation therapy (RT), compared with those who underwent mastectomy and reconstruction.

“These findings may inform preference-sensitive decision-making for women with early-stage breast cancer,” write the authors, led by Benjamin D. Smith, MD, department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.

The study was published online in JAMA Surgery.

These findings have important implications for patient decision-making, given that more women eligible for breast-conserving surgery are opting for a mastectomy, say Sudheer Vemuru, MD, from the University of Colorado at Denver, Aurora, and colleagues, writing in an accompanying editorial.

“Overall, the preponderance of evidence suggests superior short-term and long-term patient-reported outcomes in patients with early-stage breast cancer undergoing breast conserving surgery compared with mastectomy,” they comment.
 

Study details

For their study, Dr. Smith and colleagues conducted a comparative effectiveness research study using data from the Texas Cancer Registry and identified women diagnosed with stage 0-II breast cancer and treated with breast-conserving surgery or mastectomy and reconstruction between 2006 and 2008.

A total of 647 patients were included in their analysis (40%; 356 had undergone breast-conserving surgery; 291 had undergone mastectomy and reconstruction), 551 (85.2%) confirmed treatment with breast-conserving surgery with RT (n = 315) or mastectomy and reconstruction without RT (n = 236).

The median age of the cohort was 53 years and the median time from diagnosis to survey was 10.3 years. Mastectomy and reconstruction were more common among women who were White, younger, node positive, had larger tumors, had bilateral breast cancer, received chemotherapy, and had higher income.

The primary outcome was patient satisfaction with their breasts, as measured with the BREAST-Q patient-reported outcome measure. Secondary outcomes included physical well-being, psychosocial well-being, and sexual well-being. The EuroQol Health-Related Quality of Life 5-Dimension, 3-Level gaged health utility, and local therapy decisional regret was measured via the Decisional Regret Scale.

Using breast-conserving surgery plus RT as the referent, the authors did not find any significant differences in breast satisfaction, physical well-being, health utility, or decisional regret among the study cohorts: breast satisfaction: effect size, 2.71 (P = .30); physical well-being: effect size, –1.80 (P = .36); health utility: effect size, –0.003 (P = .83); and decisional regret: effect size, 1.32 (P = .61).

However, psychosocial well-being (effect size, –8.61; P < .001) and sexual well-being (effect size, –10.68; P < .001) were significantly worse among women who had undergone mastectomy and reconstruction without RT.

They noted that interactions of race and ethnicity and age by treatment group were not significant for reported satisfaction with breast outcomes. But the findings “indicated that the burden of poor long-term QOL outcomes was greater among younger individuals, those with lower educational attainment and income, and certain racial and ethnic minority populations,” they write. “These findings suggest that opportunities exist to enhance equity in the long-term QOL of individuals with breast cancer.”

The editorialists note that previous studies have also found diminished quality of life following mastectomy compared with breast-conserving surgery. However, most of these prior studies included patients undergoing breast-conserving surgery without RT, patients undergoing mastectomy without reconstruction, and patients undergoing mastectomy with RT.

In contrast, this latest study “directly compared breast-conserving surgery with RT vs. mastectomy and reconstruction without RT to avoid those potential confounders,” they point out.

The study was supported by grants from the National Cancer Institute and other bodies. Several of the study authors disclosed relationships with industry and/or with nonprofit organizations. The full list can be found with the original article. Editorialist Clara Lee, MD, reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study.

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

The International Cancer Benchmarking Partnership, a collaboration of physicians, clinicians, researchers, policy makers, and data experts, has reached a consensus on key actions designed to standardize and homogenize lung cancer care that includes early diagnosis and access to care for all patients.

This consensus, reported at the 2022 European Lung Cancer Congress, is an effort to address disparities in care recognized by the group’s in-house research team. The team identified significantly different survival rates in early stage lung cancer patients from a group of countries with similar health care metrics, such as health care expenditure and universal access to health care.

“This group of countries is very comparable, but we saw a 20% difference in survival in localized, stage I and II cancers. When you consider that lung cancer is a bigger killer than any other cancer –more than breast, prostate, and colon cancer combined – that’s thousands of people,” said the project’s lead clinician, Christian Finley, MD, a thoracic surgeon with St. Joseph’s Healthcare Hamilton (Ont.).

Founded in 2009, the ICBP includes about 500 experts in its core countries of Sweden, Norway, Denmark, Australia, the United Kingdom, and Canada; New Zealand and Ireland have also participated. The goal of the partnership is to benchmark survival and other outcomes in cancer and to research why disparities between countries exist.

“That’s why we keep the membership fairly small, so that we can actually make more meaningful research projects to get into depth in factors beyond benchmarking survival and mortality,” said study author Charlotte Lynch, MSc, a senior researcher with Cancer Research UK in London.

To help narrow the disparity gap, Ms. Lynch, Dr. Finley and colleagues brought together nine key informants from ICBP countries to discuss local clinical insights and best practices, and ultimately came up a list of five recommendations considered most crucial: implementing cost-effective, equitable, and effective screening; ensuring diagnoses of lung cancer within 30 days of referral; developing thoracic centers of excellence; launching an international audit of lung cancer care; and prioritizing the recognition of improvements in lung cancer care and outcomes.

They identified 13 best practice points to support the development and implementation of the calls to action.

“For example, points supporting the screening call to action focus on timely access to cross-sectional imaging and availability and development of patient and health care practitioner lung cancer awareness materials,” Ms. Lynch said.

Another example would be the point that describes the need for a minimum data set to evaluate lung cancer patients’ diagnosis, treatment, and aftercare.

“I think we all work in a very disrupted system right now. Screening programs really took a hit during the pandemic, and I think people coming out of those disruptions are trying to imagine a more effective system using tools like information technologies, mobile clinics and having a better understanding of equity,” Dr. Finley said.

Ms. Lynch said the ICBP intends to use the consensus to generate concrete actions. “We’re thinking about how we can get everyone in the room to share lessons learned and best practices to push things forward rather than saying, ‘this is what should be done,’ making sure we do the next steps, collaborative thinking, and moving forward.”

In a press release, Antonio Passaro, MD, a lung cancer expert from the European Institute of Oncology in Milan, said there is a need to prioritize primary and secondary prevention of lung cancer.

“Although a much-debated topic in recent years, a strong body of research has now shown that lung cancer screening through annual computed tomography scans in individuals with a history of smoking can improve detection rates. Targeting the right populations with these interventions will be crucial to implementing screening approaches that are both efficacious and cost effective,” he stated.

The authors declared no conflicts of interest and this study was not funded.

The International Cancer Benchmarking Partnership, a collaboration of physicians, clinicians, researchers, policy makers, and data experts, has reached a consensus on key actions designed to standardize and homogenize lung cancer care that includes early diagnosis and access to care for all patients.

This consensus, reported at the 2022 European Lung Cancer Congress, is an effort to address disparities in care recognized by the group’s in-house research team. The team identified significantly different survival rates in early stage lung cancer patients from a group of countries with similar health care metrics, such as health care expenditure and universal access to health care.

“This group of countries is very comparable, but we saw a 20% difference in survival in localized, stage I and II cancers. When you consider that lung cancer is a bigger killer than any other cancer –more than breast, prostate, and colon cancer combined – that’s thousands of people,” said the project’s lead clinician, Christian Finley, MD, a thoracic surgeon with St. Joseph’s Healthcare Hamilton (Ont.).

Founded in 2009, the ICBP includes about 500 experts in its core countries of Sweden, Norway, Denmark, Australia, the United Kingdom, and Canada; New Zealand and Ireland have also participated. The goal of the partnership is to benchmark survival and other outcomes in cancer and to research why disparities between countries exist.

“That’s why we keep the membership fairly small, so that we can actually make more meaningful research projects to get into depth in factors beyond benchmarking survival and mortality,” said study author Charlotte Lynch, MSc, a senior researcher with Cancer Research UK in London.

To help narrow the disparity gap, Ms. Lynch, Dr. Finley and colleagues brought together nine key informants from ICBP countries to discuss local clinical insights and best practices, and ultimately came up a list of five recommendations considered most crucial: implementing cost-effective, equitable, and effective screening; ensuring diagnoses of lung cancer within 30 days of referral; developing thoracic centers of excellence; launching an international audit of lung cancer care; and prioritizing the recognition of improvements in lung cancer care and outcomes.

They identified 13 best practice points to support the development and implementation of the calls to action.

“For example, points supporting the screening call to action focus on timely access to cross-sectional imaging and availability and development of patient and health care practitioner lung cancer awareness materials,” Ms. Lynch said.

Another example would be the point that describes the need for a minimum data set to evaluate lung cancer patients’ diagnosis, treatment, and aftercare.

“I think we all work in a very disrupted system right now. Screening programs really took a hit during the pandemic, and I think people coming out of those disruptions are trying to imagine a more effective system using tools like information technologies, mobile clinics and having a better understanding of equity,” Dr. Finley said.

Ms. Lynch said the ICBP intends to use the consensus to generate concrete actions. “We’re thinking about how we can get everyone in the room to share lessons learned and best practices to push things forward rather than saying, ‘this is what should be done,’ making sure we do the next steps, collaborative thinking, and moving forward.”

In a press release, Antonio Passaro, MD, a lung cancer expert from the European Institute of Oncology in Milan, said there is a need to prioritize primary and secondary prevention of lung cancer.

“Although a much-debated topic in recent years, a strong body of research has now shown that lung cancer screening through annual computed tomography scans in individuals with a history of smoking can improve detection rates. Targeting the right populations with these interventions will be crucial to implementing screening approaches that are both efficacious and cost effective,” he stated.

The authors declared no conflicts of interest and this study was not funded.

The International Cancer Benchmarking Partnership, a collaboration of physicians, clinicians, researchers, policy makers, and data experts, has reached a consensus on key actions designed to standardize and homogenize lung cancer care that includes early diagnosis and access to care for all patients.

This consensus, reported at the 2022 European Lung Cancer Congress, is an effort to address disparities in care recognized by the group’s in-house research team. The team identified significantly different survival rates in early stage lung cancer patients from a group of countries with similar health care metrics, such as health care expenditure and universal access to health care.

“This group of countries is very comparable, but we saw a 20% difference in survival in localized, stage I and II cancers. When you consider that lung cancer is a bigger killer than any other cancer –more than breast, prostate, and colon cancer combined – that’s thousands of people,” said the project’s lead clinician, Christian Finley, MD, a thoracic surgeon with St. Joseph’s Healthcare Hamilton (Ont.).

Founded in 2009, the ICBP includes about 500 experts in its core countries of Sweden, Norway, Denmark, Australia, the United Kingdom, and Canada; New Zealand and Ireland have also participated. The goal of the partnership is to benchmark survival and other outcomes in cancer and to research why disparities between countries exist.

“That’s why we keep the membership fairly small, so that we can actually make more meaningful research projects to get into depth in factors beyond benchmarking survival and mortality,” said study author Charlotte Lynch, MSc, a senior researcher with Cancer Research UK in London.

To help narrow the disparity gap, Ms. Lynch, Dr. Finley and colleagues brought together nine key informants from ICBP countries to discuss local clinical insights and best practices, and ultimately came up a list of five recommendations considered most crucial: implementing cost-effective, equitable, and effective screening; ensuring diagnoses of lung cancer within 30 days of referral; developing thoracic centers of excellence; launching an international audit of lung cancer care; and prioritizing the recognition of improvements in lung cancer care and outcomes.

They identified 13 best practice points to support the development and implementation of the calls to action.

“For example, points supporting the screening call to action focus on timely access to cross-sectional imaging and availability and development of patient and health care practitioner lung cancer awareness materials,” Ms. Lynch said.

Another example would be the point that describes the need for a minimum data set to evaluate lung cancer patients’ diagnosis, treatment, and aftercare.

“I think we all work in a very disrupted system right now. Screening programs really took a hit during the pandemic, and I think people coming out of those disruptions are trying to imagine a more effective system using tools like information technologies, mobile clinics and having a better understanding of equity,” Dr. Finley said.

Ms. Lynch said the ICBP intends to use the consensus to generate concrete actions. “We’re thinking about how we can get everyone in the room to share lessons learned and best practices to push things forward rather than saying, ‘this is what should be done,’ making sure we do the next steps, collaborative thinking, and moving forward.”

In a press release, Antonio Passaro, MD, a lung cancer expert from the European Institute of Oncology in Milan, said there is a need to prioritize primary and secondary prevention of lung cancer.

“Although a much-debated topic in recent years, a strong body of research has now shown that lung cancer screening through annual computed tomography scans in individuals with a history of smoking can improve detection rates. Targeting the right populations with these interventions will be crucial to implementing screening approaches that are both efficacious and cost effective,” he stated.

The authors declared no conflicts of interest and this study was not funded.

Despite Spain’s lack of a national project or standard protocol for biomarker testing, more than half of patients diagnosed with stage 4 non–small cell lung cancer (NSCLC) are tested for biomarkers, according to a Spanish national registry study reported at the 2022 European Lung Cancer Congress.

“In recent years we’ve developed drugs that target biomarkers, so it’s important to identify those biomarkers to guide treatment and have an impact on the survival of our patients,” said lead author Virginia Calvo, MD, a medical oncologist with the Puerta de Hierro Majadahonda University Hospital, Madrid.

“If we don’t know our patients’ biomarkers, we can’t treat them with targeted therapies,” she added, noting that the overall survival of lung cancer patients has increased by 15% in the last 10 years, largely because of better therapies such as targeted drugs for advanced stage disease and immunotherapies.

To assess the status of biomarker testing in Spain, Dr. Calvo and colleagues analyzed data from the country’s Thoracic Tumor Registry on 9,239 patients diagnosed with metastatic NSCLC from 2016 to the present, 7,467 (81%) with nonsquamous tumors and 1,772 (19%) with squamous tumors.

They found that 85% of patients with nonsquamous NSCLC and about 53% of those with squamous cancers had undergone biomarker testing. They discovered that 4,115 (44%) of patients tested positive for EGFR, ALK, KRAS, BRAF, ROS1, or PD-L1.

Dr. Calvo attributes the widespread use of biomarker testing and its significant increase in the last 5 years to the growing knowledge and understanding of the disease.

“We are learning more about NSCLC, and I think in the next few years the number of biomarkers are going to grow,” she said.

The study’s findings also highlight the importance of establishing and maintaining cancer registries, Dr. Calvo said, noting that 182 hospitals across Spain and more than 550 experts participate in the Thoracic Tumors Registry, which includes data on patients from every Spanish territory.

“It’s important to collect information on real-life cancer care so that we know what our real situation is and take steps to improve it,” she said.

She anticipates that treatment for NSCLC patients will become increasingly complex in the future with the growing number of different biomarkers and the proportion of patients who test positive for them. “We may need to establish national strategies to implement next generation sequencing so that we can identify different biomarkers and improve the survival of our patients.”

In a press release, Rolf Stahel, MD, president of the European Thoracic Oncology Platform, said that it would be helpful to look at how frequently molecular testing led to patients receiving appropriate targeted treatment.

In the United States, the National Comprehensive Cancer Network recommends biomarker testing for eligible patients with newly diagnosed stage 4 NSCLC, and it can be considered for patients with squamous histology because 5%-10% of these tumors have targetable mutations. “This is because numerous lines of evidence show that patients with stage 4 NSCLC and a targetable mutation, typically have improved overall survival when treated with a targeted therapy,” wrote the authors of the NCCN recommendations.

“For newly diagnosed stage 4 NSCLC, there is always a tension between the need to start therapy versus waiting for molecular results. This is because if a recommended targeted option is identified, it is the optimal first-line therapy. Targeted therapy cannot be given to everyone. Different biomarkers predict response to different agents. This has been well illustrated and it makes testing critically important for patients with NSCLC,” Dara Aisner, MD, PhD, associate professor of pathology with the University of Colorado at Denver, Aurora, wrote in the NCCN guideline.

The study presented at ELCC was funded by a grant from the European Union’s Horizon 2020 Research and Innovation Program. Dr. Calvo has received fees from Roche, Bristol-Myers Squibb, MSD and AstraZeneca.

Despite Spain’s lack of a national project or standard protocol for biomarker testing, more than half of patients diagnosed with stage 4 non–small cell lung cancer (NSCLC) are tested for biomarkers, according to a Spanish national registry study reported at the 2022 European Lung Cancer Congress.

“In recent years we’ve developed drugs that target biomarkers, so it’s important to identify those biomarkers to guide treatment and have an impact on the survival of our patients,” said lead author Virginia Calvo, MD, a medical oncologist with the Puerta de Hierro Majadahonda University Hospital, Madrid.

“If we don’t know our patients’ biomarkers, we can’t treat them with targeted therapies,” she added, noting that the overall survival of lung cancer patients has increased by 15% in the last 10 years, largely because of better therapies such as targeted drugs for advanced stage disease and immunotherapies.

To assess the status of biomarker testing in Spain, Dr. Calvo and colleagues analyzed data from the country’s Thoracic Tumor Registry on 9,239 patients diagnosed with metastatic NSCLC from 2016 to the present, 7,467 (81%) with nonsquamous tumors and 1,772 (19%) with squamous tumors.

They found that 85% of patients with nonsquamous NSCLC and about 53% of those with squamous cancers had undergone biomarker testing. They discovered that 4,115 (44%) of patients tested positive for EGFR, ALK, KRAS, BRAF, ROS1, or PD-L1.

Dr. Calvo attributes the widespread use of biomarker testing and its significant increase in the last 5 years to the growing knowledge and understanding of the disease.

“We are learning more about NSCLC, and I think in the next few years the number of biomarkers are going to grow,” she said.

The study’s findings also highlight the importance of establishing and maintaining cancer registries, Dr. Calvo said, noting that 182 hospitals across Spain and more than 550 experts participate in the Thoracic Tumors Registry, which includes data on patients from every Spanish territory.

“It’s important to collect information on real-life cancer care so that we know what our real situation is and take steps to improve it,” she said.

She anticipates that treatment for NSCLC patients will become increasingly complex in the future with the growing number of different biomarkers and the proportion of patients who test positive for them. “We may need to establish national strategies to implement next generation sequencing so that we can identify different biomarkers and improve the survival of our patients.”

In a press release, Rolf Stahel, MD, president of the European Thoracic Oncology Platform, said that it would be helpful to look at how frequently molecular testing led to patients receiving appropriate targeted treatment.

In the United States, the National Comprehensive Cancer Network recommends biomarker testing for eligible patients with newly diagnosed stage 4 NSCLC, and it can be considered for patients with squamous histology because 5%-10% of these tumors have targetable mutations. “This is because numerous lines of evidence show that patients with stage 4 NSCLC and a targetable mutation, typically have improved overall survival when treated with a targeted therapy,” wrote the authors of the NCCN recommendations.

“For newly diagnosed stage 4 NSCLC, there is always a tension between the need to start therapy versus waiting for molecular results. This is because if a recommended targeted option is identified, it is the optimal first-line therapy. Targeted therapy cannot be given to everyone. Different biomarkers predict response to different agents. This has been well illustrated and it makes testing critically important for patients with NSCLC,” Dara Aisner, MD, PhD, associate professor of pathology with the University of Colorado at Denver, Aurora, wrote in the NCCN guideline.

The study presented at ELCC was funded by a grant from the European Union’s Horizon 2020 Research and Innovation Program. Dr. Calvo has received fees from Roche, Bristol-Myers Squibb, MSD and AstraZeneca.

Despite Spain’s lack of a national project or standard protocol for biomarker testing, more than half of patients diagnosed with stage 4 non–small cell lung cancer (NSCLC) are tested for biomarkers, according to a Spanish national registry study reported at the 2022 European Lung Cancer Congress.

“In recent years we’ve developed drugs that target biomarkers, so it’s important to identify those biomarkers to guide treatment and have an impact on the survival of our patients,” said lead author Virginia Calvo, MD, a medical oncologist with the Puerta de Hierro Majadahonda University Hospital, Madrid.

“If we don’t know our patients’ biomarkers, we can’t treat them with targeted therapies,” she added, noting that the overall survival of lung cancer patients has increased by 15% in the last 10 years, largely because of better therapies such as targeted drugs for advanced stage disease and immunotherapies.

To assess the status of biomarker testing in Spain, Dr. Calvo and colleagues analyzed data from the country’s Thoracic Tumor Registry on 9,239 patients diagnosed with metastatic NSCLC from 2016 to the present, 7,467 (81%) with nonsquamous tumors and 1,772 (19%) with squamous tumors.

They found that 85% of patients with nonsquamous NSCLC and about 53% of those with squamous cancers had undergone biomarker testing. They discovered that 4,115 (44%) of patients tested positive for EGFR, ALK, KRAS, BRAF, ROS1, or PD-L1.

Dr. Calvo attributes the widespread use of biomarker testing and its significant increase in the last 5 years to the growing knowledge and understanding of the disease.

“We are learning more about NSCLC, and I think in the next few years the number of biomarkers are going to grow,” she said.

The study’s findings also highlight the importance of establishing and maintaining cancer registries, Dr. Calvo said, noting that 182 hospitals across Spain and more than 550 experts participate in the Thoracic Tumors Registry, which includes data on patients from every Spanish territory.

“It’s important to collect information on real-life cancer care so that we know what our real situation is and take steps to improve it,” she said.

She anticipates that treatment for NSCLC patients will become increasingly complex in the future with the growing number of different biomarkers and the proportion of patients who test positive for them. “We may need to establish national strategies to implement next generation sequencing so that we can identify different biomarkers and improve the survival of our patients.”

In a press release, Rolf Stahel, MD, president of the European Thoracic Oncology Platform, said that it would be helpful to look at how frequently molecular testing led to patients receiving appropriate targeted treatment.

In the United States, the National Comprehensive Cancer Network recommends biomarker testing for eligible patients with newly diagnosed stage 4 NSCLC, and it can be considered for patients with squamous histology because 5%-10% of these tumors have targetable mutations. “This is because numerous lines of evidence show that patients with stage 4 NSCLC and a targetable mutation, typically have improved overall survival when treated with a targeted therapy,” wrote the authors of the NCCN recommendations.

“For newly diagnosed stage 4 NSCLC, there is always a tension between the need to start therapy versus waiting for molecular results. This is because if a recommended targeted option is identified, it is the optimal first-line therapy. Targeted therapy cannot be given to everyone. Different biomarkers predict response to different agents. This has been well illustrated and it makes testing critically important for patients with NSCLC,” Dara Aisner, MD, PhD, associate professor of pathology with the University of Colorado at Denver, Aurora, wrote in the NCCN guideline.

The study presented at ELCC was funded by a grant from the European Union’s Horizon 2020 Research and Innovation Program. Dr. Calvo has received fees from Roche, Bristol-Myers Squibb, MSD and AstraZeneca.

A pair of new studies offers more evidence for the value of vegetables and the risk of red meat on the cancer prevention front. Researchers report that high consumption of vegetables – especially lettuce, legumes, and cruciferous varieties – appears to lower the risk of liver cancer/liver disease. A separate team suggests that high consumption of red meat, organ meats, and processed meats boosts the risk of gastric cancer.

The findings of the latter study “reinforce the idea that avoidance of red meat and processed meat is probably good beyond [the prevention of] colorectal cancer,” said corresponding author and epidemiologist Paolo Boffetta, MD, MPH, of Stony Brook University Cancer Center, New York, in an interview. “The possible carcinogenic effect may extend beyond the colon.”

Both studies were released at the annual meeting of the American Association for Cancer Research.

For the red meat study, researchers examined statistics from the Golestan cohort study, which is prospectively tracking 50,045 people aged 40-75 from northeastern Iran. The study focuses on esophageal cancer due to the region’s high rate of the disease.

Red meat consumption is fairly rare in the region, where residents typically prefer chicken, said study lead author Giulia Collatuzzo, MD, a resident physician in occupational medicine at the University of Bologna, Italy, in an interview. On average, participants reported eating 18.4 grams daily of red meat and 72.1 grams daily of white meat.

The researchers tracked study participants for a median 12-year follow-up, during which 369 developed esophageal cancer and 368 developed gastric cancer. Red meat was only linked to more esophageal cancer in women (hazard ratio, 1.13, 95% confidence interval, 1.00-1.18, for each quintile increase in consumption).

Overall red meat consumption (including red meat, organ meat, and processed meat) was linked to higher rates of gastric cancer (HR, 1.08, 95% CI, 1.00-1.17) for each quartile increase in consumption, as was consumption of the red meat subtype alone (HR, 1.09, 95% CI, 1.00-1.18).

According to Dr. Collatuzzo, the findings suggest that those in the highest quartile of overall red meat consumption may have around a 25% increase in risk, compared with the lowest quartile.

Overall, she said, the study findings aren’t surprising. The lack of a connection between red meat consumption and esophageal cancer may be due to the fact that meat only temporarily transits through the esophagus, she said.

For the liver cancer/liver disease study, researchers examined the medical records of 470,653 subjects in the NIH-AARP Diet and Health Study. They were recruited in 1995-1996 when they were 50-71 years old. Over a median follow-up of 15.5 years, 899 developed liver cancer, and 934 died of chronic liver disease.

The median intakes of vegetables in quintile 5 (highest) and quintile 1 (lowest) were 3.7 cups daily and 1.0 cups daily, respectively, said study lead author Long-Gang Zhao, MS, a graduate student at Harvard University.

After adjusting for possible cofounders, those in the highest quintile of vegetable consumption were a third less likely to develop liver cancer, compared with the lowest quintile (HR, 0.66, 95% CI, 0.53-0.82, P < 0.01). Several types of vegetables appeared to be the strongest cancer fighters: cruciferous (broccoli, cauliflower), lettuce, legumes, and carrots. These kinds of vegetables were also linked to lower rates of chronic liver disease mortality (all P < 0.01), as was total vegetable intake for the top quintile versus the lowest quintile (HR, 0.60, 95% CI, 0.49-0.74, P = < 0.01).

“A one-cup increase (8 oz or 225 g) in vegetable intake was associated with about 20% decreased risk of liver cancer incidence and chronic liver mortality,” Zhao said.

There was no statistically significant link between fruit consumption and liver cancer or chronic liver disease mortality.

The findings provide more insight into diet and liver disease, Zhao said. “Chronic liver disease, which predisposes to liver cancer, is the tenth cause of death worldwide, causing two million deaths each year. It shares some etiological processes with liver cancer. Therefore, examining both chronic liver disease mortality and liver cancer incidence in our study may provide a more general picture for the prevention of liver diseases.”

As for limitations, both studies are based on self-reports about food consumption, which can be unreliable, and the subjects in the fruit/vegetable analysis were mainly of European origin.

The authors of both studies report no relevant disclosures. No funding is reported for either study.

A pair of new studies offers more evidence for the value of vegetables and the risk of red meat on the cancer prevention front. Researchers report that high consumption of vegetables – especially lettuce, legumes, and cruciferous varieties – appears to lower the risk of liver cancer/liver disease. A separate team suggests that high consumption of red meat, organ meats, and processed meats boosts the risk of gastric cancer.

The findings of the latter study “reinforce the idea that avoidance of red meat and processed meat is probably good beyond [the prevention of] colorectal cancer,” said corresponding author and epidemiologist Paolo Boffetta, MD, MPH, of Stony Brook University Cancer Center, New York, in an interview. “The possible carcinogenic effect may extend beyond the colon.”

Both studies were released at the annual meeting of the American Association for Cancer Research.

For the red meat study, researchers examined statistics from the Golestan cohort study, which is prospectively tracking 50,045 people aged 40-75 from northeastern Iran. The study focuses on esophageal cancer due to the region’s high rate of the disease.

Red meat consumption is fairly rare in the region, where residents typically prefer chicken, said study lead author Giulia Collatuzzo, MD, a resident physician in occupational medicine at the University of Bologna, Italy, in an interview. On average, participants reported eating 18.4 grams daily of red meat and 72.1 grams daily of white meat.

The researchers tracked study participants for a median 12-year follow-up, during which 369 developed esophageal cancer and 368 developed gastric cancer. Red meat was only linked to more esophageal cancer in women (hazard ratio, 1.13, 95% confidence interval, 1.00-1.18, for each quintile increase in consumption).

Overall red meat consumption (including red meat, organ meat, and processed meat) was linked to higher rates of gastric cancer (HR, 1.08, 95% CI, 1.00-1.17) for each quartile increase in consumption, as was consumption of the red meat subtype alone (HR, 1.09, 95% CI, 1.00-1.18).

According to Dr. Collatuzzo, the findings suggest that those in the highest quartile of overall red meat consumption may have around a 25% increase in risk, compared with the lowest quartile.

Overall, she said, the study findings aren’t surprising. The lack of a connection between red meat consumption and esophageal cancer may be due to the fact that meat only temporarily transits through the esophagus, she said.

For the liver cancer/liver disease study, researchers examined the medical records of 470,653 subjects in the NIH-AARP Diet and Health Study. They were recruited in 1995-1996 when they were 50-71 years old. Over a median follow-up of 15.5 years, 899 developed liver cancer, and 934 died of chronic liver disease.

The median intakes of vegetables in quintile 5 (highest) and quintile 1 (lowest) were 3.7 cups daily and 1.0 cups daily, respectively, said study lead author Long-Gang Zhao, MS, a graduate student at Harvard University.

After adjusting for possible cofounders, those in the highest quintile of vegetable consumption were a third less likely to develop liver cancer, compared with the lowest quintile (HR, 0.66, 95% CI, 0.53-0.82, P < 0.01). Several types of vegetables appeared to be the strongest cancer fighters: cruciferous (broccoli, cauliflower), lettuce, legumes, and carrots. These kinds of vegetables were also linked to lower rates of chronic liver disease mortality (all P < 0.01), as was total vegetable intake for the top quintile versus the lowest quintile (HR, 0.60, 95% CI, 0.49-0.74, P = < 0.01).

“A one-cup increase (8 oz or 225 g) in vegetable intake was associated with about 20% decreased risk of liver cancer incidence and chronic liver mortality,” Zhao said.

There was no statistically significant link between fruit consumption and liver cancer or chronic liver disease mortality.

The findings provide more insight into diet and liver disease, Zhao said. “Chronic liver disease, which predisposes to liver cancer, is the tenth cause of death worldwide, causing two million deaths each year. It shares some etiological processes with liver cancer. Therefore, examining both chronic liver disease mortality and liver cancer incidence in our study may provide a more general picture for the prevention of liver diseases.”

As for limitations, both studies are based on self-reports about food consumption, which can be unreliable, and the subjects in the fruit/vegetable analysis were mainly of European origin.

The authors of both studies report no relevant disclosures. No funding is reported for either study.

A pair of new studies offers more evidence for the value of vegetables and the risk of red meat on the cancer prevention front. Researchers report that high consumption of vegetables – especially lettuce, legumes, and cruciferous varieties – appears to lower the risk of liver cancer/liver disease. A separate team suggests that high consumption of red meat, organ meats, and processed meats boosts the risk of gastric cancer.

The findings of the latter study “reinforce the idea that avoidance of red meat and processed meat is probably good beyond [the prevention of] colorectal cancer,” said corresponding author and epidemiologist Paolo Boffetta, MD, MPH, of Stony Brook University Cancer Center, New York, in an interview. “The possible carcinogenic effect may extend beyond the colon.”

Both studies were released at the annual meeting of the American Association for Cancer Research.

For the red meat study, researchers examined statistics from the Golestan cohort study, which is prospectively tracking 50,045 people aged 40-75 from northeastern Iran. The study focuses on esophageal cancer due to the region’s high rate of the disease.

Red meat consumption is fairly rare in the region, where residents typically prefer chicken, said study lead author Giulia Collatuzzo, MD, a resident physician in occupational medicine at the University of Bologna, Italy, in an interview. On average, participants reported eating 18.4 grams daily of red meat and 72.1 grams daily of white meat.

The researchers tracked study participants for a median 12-year follow-up, during which 369 developed esophageal cancer and 368 developed gastric cancer. Red meat was only linked to more esophageal cancer in women (hazard ratio, 1.13, 95% confidence interval, 1.00-1.18, for each quintile increase in consumption).

Overall red meat consumption (including red meat, organ meat, and processed meat) was linked to higher rates of gastric cancer (HR, 1.08, 95% CI, 1.00-1.17) for each quartile increase in consumption, as was consumption of the red meat subtype alone (HR, 1.09, 95% CI, 1.00-1.18).

According to Dr. Collatuzzo, the findings suggest that those in the highest quartile of overall red meat consumption may have around a 25% increase in risk, compared with the lowest quartile.

Overall, she said, the study findings aren’t surprising. The lack of a connection between red meat consumption and esophageal cancer may be due to the fact that meat only temporarily transits through the esophagus, she said.

For the liver cancer/liver disease study, researchers examined the medical records of 470,653 subjects in the NIH-AARP Diet and Health Study. They were recruited in 1995-1996 when they were 50-71 years old. Over a median follow-up of 15.5 years, 899 developed liver cancer, and 934 died of chronic liver disease.

The median intakes of vegetables in quintile 5 (highest) and quintile 1 (lowest) were 3.7 cups daily and 1.0 cups daily, respectively, said study lead author Long-Gang Zhao, MS, a graduate student at Harvard University.

After adjusting for possible cofounders, those in the highest quintile of vegetable consumption were a third less likely to develop liver cancer, compared with the lowest quintile (HR, 0.66, 95% CI, 0.53-0.82, P < 0.01). Several types of vegetables appeared to be the strongest cancer fighters: cruciferous (broccoli, cauliflower), lettuce, legumes, and carrots. These kinds of vegetables were also linked to lower rates of chronic liver disease mortality (all P < 0.01), as was total vegetable intake for the top quintile versus the lowest quintile (HR, 0.60, 95% CI, 0.49-0.74, P = < 0.01).

“A one-cup increase (8 oz or 225 g) in vegetable intake was associated with about 20% decreased risk of liver cancer incidence and chronic liver mortality,” Zhao said.

There was no statistically significant link between fruit consumption and liver cancer or chronic liver disease mortality.

The findings provide more insight into diet and liver disease, Zhao said. “Chronic liver disease, which predisposes to liver cancer, is the tenth cause of death worldwide, causing two million deaths each year. It shares some etiological processes with liver cancer. Therefore, examining both chronic liver disease mortality and liver cancer incidence in our study may provide a more general picture for the prevention of liver diseases.”

As for limitations, both studies are based on self-reports about food consumption, which can be unreliable, and the subjects in the fruit/vegetable analysis were mainly of European origin.

The authors of both studies report no relevant disclosures. No funding is reported for either study.

In patients with B-cell deficiencies, CoVac-1, a SARS-CoV-2 vaccine currently in clinical trials in Germany, induced T-cell immune responses in a large proportion of patients, according to study results presented at the annual meeting of the American Association for Cancer Research.

The phase 1/2 trial included 54 patients with a B-cell deficiency (mean age, 63 years; 28% female): 4 had congenital B-cell deficiency and 50 had a blood cancer (lymphocytic leukemia or lymphoma). T-cell immune responses were observed in 86% of patients 28 days after vaccination with a single CoVac-1 dose. The potency of CoVac-1–induced T-cell responses exceeded those seen typically with B cell–deficient patient responses after mRNA vaccine treatment and were comparable with those seen among nonimmunocompromised COVID-19 patients.

In the majority of individuals, currently approved SARS-CoV-2 vaccines induce a robust immune response, however, their efficacy, has been shown to be decreased among individuals who are immunocompromised. Patients treated for hematologic cancers, in particular, receive treatment regimens that damage healthy immune cells, particularly B cells, said Juliane Walz, MD, the study’s senior author and professor of medicine at University Hospital Tübingen (Germany).

“In the clinic, we see many cancer patients who do not mount sufficient humoral immune responses after vaccination with available SARS-CoV-2 vaccines,” Dr. Walz said. “These patients are at a high risk for a severe course of COVID-19.”

B-cell deficiency, she stated, can be compensated for by enhancing T-cell responses against SARS-CoV-2, which can then combat infections in the absence of neutralizing antibodies.

In a prior study of CoVac-1 among 36 adults without immune deficiency, the vaccine elicited T-cell responses that were still robust 3 months post vaccination, and that included responses against omicron and other key SARS-CoV-2 variants.

While mRNA-based or adenoviral vector-based vaccines are limited to the spike protein and are thus prone to loss of activity because of viral mutations, CoVac-1–induced T-cell immunity is far more intense and broader, Dr. Walz said.

CoVac-1 is a peptide vaccine that is injected directly rather than being encoded via mRNA and targets different viral components. It would not be given, however, to healthy, immunocompetent adults because it is important for them to have both B-cell antibody and T-cell response.

The patients with B-cell deficiency recruited for the study were given a single dose of CoVac-1 and assessed for safety and immunogenicity until day 56. Prior vaccinations with an approved SARS-CoV-2 vaccine had failed to elicit a humoral response in 87% of the subjects.

“Our vaccine does not induce antibody responses,” Dr. Walz said. “However, it could be used to induce broad T-cell responses as a complementary or additive vaccine for elderly adults. In the elderly, antibody responses decline very, very fast after vaccination.”

Dr. Walz said that CoVac-1 could find application in various syndromes associated with congenital B-cell deficiencies, in autoimmune diseases such as rheumatoid arthritis and multiple sclerosis, or diseases treated with rituximab or other B cell–depleting therapies (for example, ofatumumab, blinatumomab, or chimeric antigen receptor T cells), and in transplant patients.

A phase 3 study of CoVac-1 versus placebo is under discussion and would require about 300-500 subjects, Dr. Walz said.

“CoVac-1 is designed to induce broad and long-lasting SARS-CoV-2 T-cell immunity, even in individuals who have impaired ability to mount sufficient immunity from a currently approved vaccine, and thus protect these high-risk patients from a severe course of COVID-19,” Dr. Walz said.

“Having an option for these patients is just critical – so this is significant work,” said Ana Maria Lopez, MD, MPH, of the Sidney Kimmel Cancer Center–Jefferson Health, Philadelphia.

Limitations of this study included the small sample size with low racial and ethnic diversity, Dr. Walz stated.

Funding was provided by the Ministry of Science, Research and the Arts of the state of Baden-Württemberg; the Federal Ministry of Research and Education in Germany; the German Research Foundation under Germany’s Excellence Strategy; and the Clinical Cooperation Unit Translational Immunology at University Hospital Tübingen. Dr. Walz holds the CoVac-1 patent.

In patients with B-cell deficiencies, CoVac-1, a SARS-CoV-2 vaccine currently in clinical trials in Germany, induced T-cell immune responses in a large proportion of patients, according to study results presented at the annual meeting of the American Association for Cancer Research.

The phase 1/2 trial included 54 patients with a B-cell deficiency (mean age, 63 years; 28% female): 4 had congenital B-cell deficiency and 50 had a blood cancer (lymphocytic leukemia or lymphoma). T-cell immune responses were observed in 86% of patients 28 days after vaccination with a single CoVac-1 dose. The potency of CoVac-1–induced T-cell responses exceeded those seen typically with B cell–deficient patient responses after mRNA vaccine treatment and were comparable with those seen among nonimmunocompromised COVID-19 patients.

In the majority of individuals, currently approved SARS-CoV-2 vaccines induce a robust immune response, however, their efficacy, has been shown to be decreased among individuals who are immunocompromised. Patients treated for hematologic cancers, in particular, receive treatment regimens that damage healthy immune cells, particularly B cells, said Juliane Walz, MD, the study’s senior author and professor of medicine at University Hospital Tübingen (Germany).

“In the clinic, we see many cancer patients who do not mount sufficient humoral immune responses after vaccination with available SARS-CoV-2 vaccines,” Dr. Walz said. “These patients are at a high risk for a severe course of COVID-19.”

B-cell deficiency, she stated, can be compensated for by enhancing T-cell responses against SARS-CoV-2, which can then combat infections in the absence of neutralizing antibodies.

In a prior study of CoVac-1 among 36 adults without immune deficiency, the vaccine elicited T-cell responses that were still robust 3 months post vaccination, and that included responses against omicron and other key SARS-CoV-2 variants.

While mRNA-based or adenoviral vector-based vaccines are limited to the spike protein and are thus prone to loss of activity because of viral mutations, CoVac-1–induced T-cell immunity is far more intense and broader, Dr. Walz said.

CoVac-1 is a peptide vaccine that is injected directly rather than being encoded via mRNA and targets different viral components. It would not be given, however, to healthy, immunocompetent adults because it is important for them to have both B-cell antibody and T-cell response.

The patients with B-cell deficiency recruited for the study were given a single dose of CoVac-1 and assessed for safety and immunogenicity until day 56. Prior vaccinations with an approved SARS-CoV-2 vaccine had failed to elicit a humoral response in 87% of the subjects.

“Our vaccine does not induce antibody responses,” Dr. Walz said. “However, it could be used to induce broad T-cell responses as a complementary or additive vaccine for elderly adults. In the elderly, antibody responses decline very, very fast after vaccination.”

Dr. Walz said that CoVac-1 could find application in various syndromes associated with congenital B-cell deficiencies, in autoimmune diseases such as rheumatoid arthritis and multiple sclerosis, or diseases treated with rituximab or other B cell–depleting therapies (for example, ofatumumab, blinatumomab, or chimeric antigen receptor T cells), and in transplant patients.

A phase 3 study of CoVac-1 versus placebo is under discussion and would require about 300-500 subjects, Dr. Walz said.

“CoVac-1 is designed to induce broad and long-lasting SARS-CoV-2 T-cell immunity, even in individuals who have impaired ability to mount sufficient immunity from a currently approved vaccine, and thus protect these high-risk patients from a severe course of COVID-19,” Dr. Walz said.

“Having an option for these patients is just critical – so this is significant work,” said Ana Maria Lopez, MD, MPH, of the Sidney Kimmel Cancer Center–Jefferson Health, Philadelphia.

Limitations of this study included the small sample size with low racial and ethnic diversity, Dr. Walz stated.

Funding was provided by the Ministry of Science, Research and the Arts of the state of Baden-Württemberg; the Federal Ministry of Research and Education in Germany; the German Research Foundation under Germany’s Excellence Strategy; and the Clinical Cooperation Unit Translational Immunology at University Hospital Tübingen. Dr. Walz holds the CoVac-1 patent.

In patients with B-cell deficiencies, CoVac-1, a SARS-CoV-2 vaccine currently in clinical trials in Germany, induced T-cell immune responses in a large proportion of patients, according to study results presented at the annual meeting of the American Association for Cancer Research.

The phase 1/2 trial included 54 patients with a B-cell deficiency (mean age, 63 years; 28% female): 4 had congenital B-cell deficiency and 50 had a blood cancer (lymphocytic leukemia or lymphoma). T-cell immune responses were observed in 86% of patients 28 days after vaccination with a single CoVac-1 dose. The potency of CoVac-1–induced T-cell responses exceeded those seen typically with B cell–deficient patient responses after mRNA vaccine treatment and were comparable with those seen among nonimmunocompromised COVID-19 patients.

In the majority of individuals, currently approved SARS-CoV-2 vaccines induce a robust immune response, however, their efficacy, has been shown to be decreased among individuals who are immunocompromised. Patients treated for hematologic cancers, in particular, receive treatment regimens that damage healthy immune cells, particularly B cells, said Juliane Walz, MD, the study’s senior author and professor of medicine at University Hospital Tübingen (Germany).

“In the clinic, we see many cancer patients who do not mount sufficient humoral immune responses after vaccination with available SARS-CoV-2 vaccines,” Dr. Walz said. “These patients are at a high risk for a severe course of COVID-19.”

B-cell deficiency, she stated, can be compensated for by enhancing T-cell responses against SARS-CoV-2, which can then combat infections in the absence of neutralizing antibodies.

In a prior study of CoVac-1 among 36 adults without immune deficiency, the vaccine elicited T-cell responses that were still robust 3 months post vaccination, and that included responses against omicron and other key SARS-CoV-2 variants.

While mRNA-based or adenoviral vector-based vaccines are limited to the spike protein and are thus prone to loss of activity because of viral mutations, CoVac-1–induced T-cell immunity is far more intense and broader, Dr. Walz said.

CoVac-1 is a peptide vaccine that is injected directly rather than being encoded via mRNA and targets different viral components. It would not be given, however, to healthy, immunocompetent adults because it is important for them to have both B-cell antibody and T-cell response.

The patients with B-cell deficiency recruited for the study were given a single dose of CoVac-1 and assessed for safety and immunogenicity until day 56. Prior vaccinations with an approved SARS-CoV-2 vaccine had failed to elicit a humoral response in 87% of the subjects.

“Our vaccine does not induce antibody responses,” Dr. Walz said. “However, it could be used to induce broad T-cell responses as a complementary or additive vaccine for elderly adults. In the elderly, antibody responses decline very, very fast after vaccination.”

Dr. Walz said that CoVac-1 could find application in various syndromes associated with congenital B-cell deficiencies, in autoimmune diseases such as rheumatoid arthritis and multiple sclerosis, or diseases treated with rituximab or other B cell–depleting therapies (for example, ofatumumab, blinatumomab, or chimeric antigen receptor T cells), and in transplant patients.

A phase 3 study of CoVac-1 versus placebo is under discussion and would require about 300-500 subjects, Dr. Walz said.

“CoVac-1 is designed to induce broad and long-lasting SARS-CoV-2 T-cell immunity, even in individuals who have impaired ability to mount sufficient immunity from a currently approved vaccine, and thus protect these high-risk patients from a severe course of COVID-19,” Dr. Walz said.

“Having an option for these patients is just critical – so this is significant work,” said Ana Maria Lopez, MD, MPH, of the Sidney Kimmel Cancer Center–Jefferson Health, Philadelphia.

Limitations of this study included the small sample size with low racial and ethnic diversity, Dr. Walz stated.

Funding was provided by the Ministry of Science, Research and the Arts of the state of Baden-Württemberg; the Federal Ministry of Research and Education in Germany; the German Research Foundation under Germany’s Excellence Strategy; and the Clinical Cooperation Unit Translational Immunology at University Hospital Tübingen. Dr. Walz holds the CoVac-1 patent.

With New York nurse practitioners recently gaining full practice authority (FPA), half of the country’s NPs now have the ability to provide patients with easier access to care, according to leading national nurse organizations.

New York joins 24 other states, the District of Columbia, and two U.S. territories that have adopted FPA legislation, as reported by the American Association of Nurse Practitioners (AANP). Like other states, New York has been under an emergency order during the pandemic that allowed NPs to practice to their full authority because of staffing shortages. That order was extended multiple times and was expected to expire this month, AANP reports.

“This has been in the making for nurse practitioners in New York since 2014, trying to get full practice authority,” Michelle Jones, RN, MSN, ANP-C, director at large for the New York State Nurses Association, said in an interview.

NPs who were allowed to practice independently during the pandemic campaigned for that provision to become permanent once the emergency order expired, she said. Ms. Jones explained that the FPA law expands the scope of practice and “removes unnecessary barriers,” namely an agreement with doctors to oversee NPs’ actions.

FPA gives NPs the authority to evaluate patients; diagnose, order, and interpret diagnostic tests; and initiate and manage treatments – including prescribing medications – without oversight by a doctor or state medical board, according to AANP.

Before the pandemic, New York NPs had “reduced” practice authority with those who had more than 3,600 hours of experience required to maintain a collaborative practice agreement with doctors and those with less experience maintaining a written agreement. The change gives full practice authority to those with more than 3,600 hours of experience, Stephen A. Ferrara, DNP, FNP-BC, AANP regional director, said in an interview.

Ferrara, who practices in New York, said the state is the largest to change to FPA. He said the state and others that have moved to FPA have determined that there “has been no lapse in quality care” during the emergency order period and that the regulatory barriers kept NPs from providing access to care.

Jones said that the law also will allow NPs to open private practices and serve underserved patients in areas that lack access to health care. “This is a step to improve access to health care and health equity of the New York population.”

It’s been a while since another state passed FPA legislation, Massachusetts in January 2021 and Delaware in August 2021, according to AANP.

Earlier this month, AANP released new data showing a 9% increase in NPs licensed to practice in the United States, rising from 325,000 in May 2021 to 355,000.

The New York legislation “will help New York attract and retain nurse practitioners and provide New Yorkers better access to quality care,” AANP President April Kapu, DNP, APRN, said in a statement.

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

With New York nurse practitioners recently gaining full practice authority (FPA), half of the country’s NPs now have the ability to provide patients with easier access to care, according to leading national nurse organizations.

New York joins 24 other states, the District of Columbia, and two U.S. territories that have adopted FPA legislation, as reported by the American Association of Nurse Practitioners (AANP). Like other states, New York has been under an emergency order during the pandemic that allowed NPs to practice to their full authority because of staffing shortages. That order was extended multiple times and was expected to expire this month, AANP reports.

“This has been in the making for nurse practitioners in New York since 2014, trying to get full practice authority,” Michelle Jones, RN, MSN, ANP-C, director at large for the New York State Nurses Association, said in an interview.

NPs who were allowed to practice independently during the pandemic campaigned for that provision to become permanent once the emergency order expired, she said. Ms. Jones explained that the FPA law expands the scope of practice and “removes unnecessary barriers,” namely an agreement with doctors to oversee NPs’ actions.

FPA gives NPs the authority to evaluate patients; diagnose, order, and interpret diagnostic tests; and initiate and manage treatments – including prescribing medications – without oversight by a doctor or state medical board, according to AANP.

Before the pandemic, New York NPs had “reduced” practice authority with those who had more than 3,600 hours of experience required to maintain a collaborative practice agreement with doctors and those with less experience maintaining a written agreement. The change gives full practice authority to those with more than 3,600 hours of experience, Stephen A. Ferrara, DNP, FNP-BC, AANP regional director, said in an interview.

Ferrara, who practices in New York, said the state is the largest to change to FPA. He said the state and others that have moved to FPA have determined that there “has been no lapse in quality care” during the emergency order period and that the regulatory barriers kept NPs from providing access to care.

Jones said that the law also will allow NPs to open private practices and serve underserved patients in areas that lack access to health care. “This is a step to improve access to health care and health equity of the New York population.”

It’s been a while since another state passed FPA legislation, Massachusetts in January 2021 and Delaware in August 2021, according to AANP.

Earlier this month, AANP released new data showing a 9% increase in NPs licensed to practice in the United States, rising from 325,000 in May 2021 to 355,000.

The New York legislation “will help New York attract and retain nurse practitioners and provide New Yorkers better access to quality care,” AANP President April Kapu, DNP, APRN, said in a statement.

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

With New York nurse practitioners recently gaining full practice authority (FPA), half of the country’s NPs now have the ability to provide patients with easier access to care, according to leading national nurse organizations.

New York joins 24 other states, the District of Columbia, and two U.S. territories that have adopted FPA legislation, as reported by the American Association of Nurse Practitioners (AANP). Like other states, New York has been under an emergency order during the pandemic that allowed NPs to practice to their full authority because of staffing shortages. That order was extended multiple times and was expected to expire this month, AANP reports.

“This has been in the making for nurse practitioners in New York since 2014, trying to get full practice authority,” Michelle Jones, RN, MSN, ANP-C, director at large for the New York State Nurses Association, said in an interview.

NPs who were allowed to practice independently during the pandemic campaigned for that provision to become permanent once the emergency order expired, she said. Ms. Jones explained that the FPA law expands the scope of practice and “removes unnecessary barriers,” namely an agreement with doctors to oversee NPs’ actions.

FPA gives NPs the authority to evaluate patients; diagnose, order, and interpret diagnostic tests; and initiate and manage treatments – including prescribing medications – without oversight by a doctor or state medical board, according to AANP.

Before the pandemic, New York NPs had “reduced” practice authority with those who had more than 3,600 hours of experience required to maintain a collaborative practice agreement with doctors and those with less experience maintaining a written agreement. The change gives full practice authority to those with more than 3,600 hours of experience, Stephen A. Ferrara, DNP, FNP-BC, AANP regional director, said in an interview.

Ferrara, who practices in New York, said the state is the largest to change to FPA. He said the state and others that have moved to FPA have determined that there “has been no lapse in quality care” during the emergency order period and that the regulatory barriers kept NPs from providing access to care.

Jones said that the law also will allow NPs to open private practices and serve underserved patients in areas that lack access to health care. “This is a step to improve access to health care and health equity of the New York population.”

It’s been a while since another state passed FPA legislation, Massachusetts in January 2021 and Delaware in August 2021, according to AANP.

Earlier this month, AANP released new data showing a 9% increase in NPs licensed to practice in the United States, rising from 325,000 in May 2021 to 355,000.

The New York legislation “will help New York attract and retain nurse practitioners and provide New Yorkers better access to quality care,” AANP President April Kapu, DNP, APRN, said in a statement.

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

A simple, two-ingredient gel may boost the fighting power of a groundbreaking cancer treatment, say Stanford University engineers.

The gel – made from water and a plant-based polymer – delivers targeted T cells adjacent to a cancer growth, taking aim at solid tumors.

It’s the latest development in CAR T-cell therapy, a type of immunotherapy that involves collecting the patient’s T cells, reengineering them to be stronger, and returning them to the patient’s body.

Results have been promising in blood cancers, such as leukemia and lymphoma, but less so in solid tumors, such as brain, breast, or kidney cancer, according to the National Cancer Institute.

The gel “is a really exciting step forward,” says Abigail Grosskopf, a PhD candidate at Stanford (Calif.) University, who is the lead study author, “because it can change the delivery of these cells and expand this kind of treatment to other cancers.”
 

CAR T-cell therapy: Limits in solid tumors

Currently available CAR T-cell therapies are administered by intravenous infusion. But that doesn’t do much against tumors in specific locations because the cells enter the bloodstream and flow throughout the body. The cancer-fighting effort exhausts the T cells, weakening their ability to infiltrate dense tumors.

CAR T cells need cytokines to tell them when to attack, Ms. Grosskopf explains. If delivered through an IV drip, the number of cytokines required to destroy a solid tumor would be toxic to other, healthy parts of the body.

So Ms. Grosskopf and her colleagues created a hydrogel that can temporarily hold the T cells and cytokines and that can be injected near a tumor, bombarding the cancerous growth.

In their study, which was published in Science Advances, the injections wiped out mouse tumors in 12 days. The gel degraded harmlessly a few weeks later.
 

A “leaky pen” that fights cancer

The reason a gel works better than a liquid is because of its staying power, says Ms. Grosskopf, who compares the method to a leaky pen.

The gel acts as the “pen,” releasing activated CAR T cells at regular intervals to attack the cancerous growth. Whereas liquid dissipates quickly, the gel’s structure is strong enough to stay in place for weeks, Ms. Grosskopf says. Plus, it’s biocompatible and harmless within the body, she adds.

More preclinical studies are needed before human clinical trials can occur, Ms. Grosskopf says.

“Not only could this be a way to deliver T cells and cytokines,” Ms. Grosskopf says, “but it may be used for other targeted therapy cancer drugs that are in development. So we see this as running parallel to those efforts.”

Taking an even broader view, the gel could have applications across medical specialties, such as slow-release delivery of vaccines.

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

A simple, two-ingredient gel may boost the fighting power of a groundbreaking cancer treatment, say Stanford University engineers.

The gel – made from water and a plant-based polymer – delivers targeted T cells adjacent to a cancer growth, taking aim at solid tumors.

It’s the latest development in CAR T-cell therapy, a type of immunotherapy that involves collecting the patient’s T cells, reengineering them to be stronger, and returning them to the patient’s body.

Results have been promising in blood cancers, such as leukemia and lymphoma, but less so in solid tumors, such as brain, breast, or kidney cancer, according to the National Cancer Institute.

The gel “is a really exciting step forward,” says Abigail Grosskopf, a PhD candidate at Stanford (Calif.) University, who is the lead study author, “because it can change the delivery of these cells and expand this kind of treatment to other cancers.”
 

CAR T-cell therapy: Limits in solid tumors

Currently available CAR T-cell therapies are administered by intravenous infusion. But that doesn’t do much against tumors in specific locations because the cells enter the bloodstream and flow throughout the body. The cancer-fighting effort exhausts the T cells, weakening their ability to infiltrate dense tumors.

CAR T cells need cytokines to tell them when to attack, Ms. Grosskopf explains. If delivered through an IV drip, the number of cytokines required to destroy a solid tumor would be toxic to other, healthy parts of the body.

So Ms. Grosskopf and her colleagues created a hydrogel that can temporarily hold the T cells and cytokines and that can be injected near a tumor, bombarding the cancerous growth.

In their study, which was published in Science Advances, the injections wiped out mouse tumors in 12 days. The gel degraded harmlessly a few weeks later.
 

A “leaky pen” that fights cancer

The reason a gel works better than a liquid is because of its staying power, says Ms. Grosskopf, who compares the method to a leaky pen.

The gel acts as the “pen,” releasing activated CAR T cells at regular intervals to attack the cancerous growth. Whereas liquid dissipates quickly, the gel’s structure is strong enough to stay in place for weeks, Ms. Grosskopf says. Plus, it’s biocompatible and harmless within the body, she adds.

More preclinical studies are needed before human clinical trials can occur, Ms. Grosskopf says.

“Not only could this be a way to deliver T cells and cytokines,” Ms. Grosskopf says, “but it may be used for other targeted therapy cancer drugs that are in development. So we see this as running parallel to those efforts.”

Taking an even broader view, the gel could have applications across medical specialties, such as slow-release delivery of vaccines.

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

A simple, two-ingredient gel may boost the fighting power of a groundbreaking cancer treatment, say Stanford University engineers.

The gel – made from water and a plant-based polymer – delivers targeted T cells adjacent to a cancer growth, taking aim at solid tumors.

It’s the latest development in CAR T-cell therapy, a type of immunotherapy that involves collecting the patient’s T cells, reengineering them to be stronger, and returning them to the patient’s body.

Results have been promising in blood cancers, such as leukemia and lymphoma, but less so in solid tumors, such as brain, breast, or kidney cancer, according to the National Cancer Institute.

The gel “is a really exciting step forward,” says Abigail Grosskopf, a PhD candidate at Stanford (Calif.) University, who is the lead study author, “because it can change the delivery of these cells and expand this kind of treatment to other cancers.”
 

CAR T-cell therapy: Limits in solid tumors

Currently available CAR T-cell therapies are administered by intravenous infusion. But that doesn’t do much against tumors in specific locations because the cells enter the bloodstream and flow throughout the body. The cancer-fighting effort exhausts the T cells, weakening their ability to infiltrate dense tumors.

CAR T cells need cytokines to tell them when to attack, Ms. Grosskopf explains. If delivered through an IV drip, the number of cytokines required to destroy a solid tumor would be toxic to other, healthy parts of the body.

So Ms. Grosskopf and her colleagues created a hydrogel that can temporarily hold the T cells and cytokines and that can be injected near a tumor, bombarding the cancerous growth.

In their study, which was published in Science Advances, the injections wiped out mouse tumors in 12 days. The gel degraded harmlessly a few weeks later.
 

A “leaky pen” that fights cancer

The reason a gel works better than a liquid is because of its staying power, says Ms. Grosskopf, who compares the method to a leaky pen.

The gel acts as the “pen,” releasing activated CAR T cells at regular intervals to attack the cancerous growth. Whereas liquid dissipates quickly, the gel’s structure is strong enough to stay in place for weeks, Ms. Grosskopf says. Plus, it’s biocompatible and harmless within the body, she adds.

More preclinical studies are needed before human clinical trials can occur, Ms. Grosskopf says.

“Not only could this be a way to deliver T cells and cytokines,” Ms. Grosskopf says, “but it may be used for other targeted therapy cancer drugs that are in development. So we see this as running parallel to those efforts.”

Taking an even broader view, the gel could have applications across medical specialties, such as slow-release delivery of vaccines.

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

New research suggests that chemotherapy treatments for recurrent high-grade gliomas indicated by an assay-guided tool called ChemoID can boost median survival, compared with physician choice.

The randomized, phase 3 trial results were presented at the annual meeting of the American Association for Cancer Research.

Over a median follow-up of 9 months, median overall survival in the ChemoID group was 12.5 months (95% confidence interval, 10.2-14.7), compared with 9 months (95% CI, 4.2-13.8) in the group whose treatments were chosen by physicians (P = .010).

“While the prognosis is very dismal, we’re still providing a 3.5-month benefit in the guided arm versus physician choice,” said study coauthor Jagan Valluri, PhD, professor of cellular biology and integrative medicine at Marshall University, Huntington, W. Va.

As Dr. Valluri noted, patients with recurrent high-grade gliomas typically have failed radiation and are left with poor prognoses. Fewer than one in four patients respond to chemotherapy at this point, he said, and the response is inconsistent from patient to patient.

“We developed ChemoID since cancer is very unique,” he said, “and any kind of chemotherapy should be tailored to each individual patient on a case-by-case basis.”

The ChemoID tool, a proprietary assay, tests the response of patient cells to various chemotherapy treatments. A test costs $3,500, and some insurers cover it, Dr. Valluri said.

For the new study, researchers randomly assigned 50 patients with grade III/IV recurrent glioma to be treated with chemotherapy chosen by physicians or chemotherapy recommended by the ChemoID tool.

Risk of death in the ChemoID group was lower than in the physician-guided group (hazard ratio, 0.44; 95% CI, 0.24-0.81; P = .008), and median progression-free survival was higher in the ChemoID group (10.1 months vs. 3.5 months; 95% CI, 4.8-15.4 vs. 1.9-5.1; HR, 0.25; 95% CI, 0.14-0.44; P < .001).

“We want the treating physician to have actionable tools in front of them before they treat the patient,” Dr. Valluri said. “We want this assay to become mainstream and part of the standard care workup.”

The study is funded by Cordgenics, where Dr. Valluri serves as chief operating officer.

New research suggests that chemotherapy treatments for recurrent high-grade gliomas indicated by an assay-guided tool called ChemoID can boost median survival, compared with physician choice.

The randomized, phase 3 trial results were presented at the annual meeting of the American Association for Cancer Research.

Over a median follow-up of 9 months, median overall survival in the ChemoID group was 12.5 months (95% confidence interval, 10.2-14.7), compared with 9 months (95% CI, 4.2-13.8) in the group whose treatments were chosen by physicians (P = .010).

“While the prognosis is very dismal, we’re still providing a 3.5-month benefit in the guided arm versus physician choice,” said study coauthor Jagan Valluri, PhD, professor of cellular biology and integrative medicine at Marshall University, Huntington, W. Va.

As Dr. Valluri noted, patients with recurrent high-grade gliomas typically have failed radiation and are left with poor prognoses. Fewer than one in four patients respond to chemotherapy at this point, he said, and the response is inconsistent from patient to patient.

“We developed ChemoID since cancer is very unique,” he said, “and any kind of chemotherapy should be tailored to each individual patient on a case-by-case basis.”

The ChemoID tool, a proprietary assay, tests the response of patient cells to various chemotherapy treatments. A test costs $3,500, and some insurers cover it, Dr. Valluri said.

For the new study, researchers randomly assigned 50 patients with grade III/IV recurrent glioma to be treated with chemotherapy chosen by physicians or chemotherapy recommended by the ChemoID tool.

Risk of death in the ChemoID group was lower than in the physician-guided group (hazard ratio, 0.44; 95% CI, 0.24-0.81; P = .008), and median progression-free survival was higher in the ChemoID group (10.1 months vs. 3.5 months; 95% CI, 4.8-15.4 vs. 1.9-5.1; HR, 0.25; 95% CI, 0.14-0.44; P < .001).

“We want the treating physician to have actionable tools in front of them before they treat the patient,” Dr. Valluri said. “We want this assay to become mainstream and part of the standard care workup.”

The study is funded by Cordgenics, where Dr. Valluri serves as chief operating officer.

New research suggests that chemotherapy treatments for recurrent high-grade gliomas indicated by an assay-guided tool called ChemoID can boost median survival, compared with physician choice.

The randomized, phase 3 trial results were presented at the annual meeting of the American Association for Cancer Research.

Over a median follow-up of 9 months, median overall survival in the ChemoID group was 12.5 months (95% confidence interval, 10.2-14.7), compared with 9 months (95% CI, 4.2-13.8) in the group whose treatments were chosen by physicians (P = .010).

“While the prognosis is very dismal, we’re still providing a 3.5-month benefit in the guided arm versus physician choice,” said study coauthor Jagan Valluri, PhD, professor of cellular biology and integrative medicine at Marshall University, Huntington, W. Va.

As Dr. Valluri noted, patients with recurrent high-grade gliomas typically have failed radiation and are left with poor prognoses. Fewer than one in four patients respond to chemotherapy at this point, he said, and the response is inconsistent from patient to patient.

“We developed ChemoID since cancer is very unique,” he said, “and any kind of chemotherapy should be tailored to each individual patient on a case-by-case basis.”

The ChemoID tool, a proprietary assay, tests the response of patient cells to various chemotherapy treatments. A test costs $3,500, and some insurers cover it, Dr. Valluri said.

For the new study, researchers randomly assigned 50 patients with grade III/IV recurrent glioma to be treated with chemotherapy chosen by physicians or chemotherapy recommended by the ChemoID tool.

Risk of death in the ChemoID group was lower than in the physician-guided group (hazard ratio, 0.44; 95% CI, 0.24-0.81; P = .008), and median progression-free survival was higher in the ChemoID group (10.1 months vs. 3.5 months; 95% CI, 4.8-15.4 vs. 1.9-5.1; HR, 0.25; 95% CI, 0.14-0.44; P < .001).

“We want the treating physician to have actionable tools in front of them before they treat the patient,” Dr. Valluri said. “We want this assay to become mainstream and part of the standard care workup.”

The study is funded by Cordgenics, where Dr. Valluri serves as chief operating officer.

Clinicians are not following guidelines that recommend a de-escalation in surveillance for patients with low-risk non–muscle-invasive bladder cancer (NMIBC), a new study concludes.  

These cancers are associated with low rates of recurrence, progression, and bladder cancer–specific death, so current clinical practice guidelines recommend against frequent monitoring and testing.

However, the study authors found that patients with a low grade Ta NMIBC diagnosis underwent a median of three cystoscopies per year, and many also received a median of two imagine scans (CT or MRI) as well as 2-3 urine-based tests.

“These data suggest a need for ongoing efforts to limit overuse of treatment and surveillance, which may in turn mitigate associated increases in the costs of care,” write the authors, led by Kelly K. Bree, MD, from the department of urology, University of Texas MD Anderson Cancer Center, Houston. Bladder cancer has the highest lifetime treatment cost of all malignancies, they point out.

The study was published online in JAMA Network Open.
 

Higher value and more evidence-based

The impact of increased surveillance of this patient cohort has broad implications for patients and the health care system in general, say experts writing in an accompanying editorial.

“It has been well established that workup for NMIBC can have negative consequences for the physical and psychological health of patients,” note Grayden S. Cook, BS, and Jeffrey M. Howard, MD, PhD, both from University of Texas Southwestern Medical Center, Dallas.

“Many of these patients undergo frequent CT imaging of the urinary tract, which carries a high dose of radiation as well as the potential for financial toxic effects (that is, detrimental consequences to the patient because of health care costs),” they write.

Additionally, patient distress is a factor, as they may experience preprocedural anxiety, physical discomfort during procedures, and worry about disease progression, they point out.

“The impact of these patterns is substantial and may have negative consequences for both patients and the health care system,” they conclude. “Thus, it is imperative to move forward with initiatives that provide higher value and are more evidence-based and patient-centered.”
 

Study finds frequent surveillance

The American Urological Association (AUA)/Society of Urologic Oncologists (SUO), the European Association of Urology, and the International Bladder Cancer Group have made an effort to de-escalate surveillance and treatment for patients with low-grade Ta disease, while at the same time maintaining appropriate surveillance for high-grade aggressive disease.

However, the new study found that in practice, such patients undergo frequent testing.

The study involved 13,054 patients with low-grade Ta NMIBC. Most of the participants were male (73.5%), with a median age of 76 years, and had no or few comorbidities (71.2%).

Most patients had undergone cystoscopy, and rates increased over time: from 79.3% of patients in 2004 to 81.5% of patients in 2013 (P = .007). Patients underwent a median of 3.0 cystoscopies per year following their diagnosis, and upper-tract imaging was performed in most patients.

The use of kidney ultrasonography also rose from 19% of patients in 2004 to 23.2% in 2013, as did retrograde pyelography (20.9% in 2004 vs. 24.2% in 2013). Conversely, the use of intravenous pyelography declined (from 14.5% in 2004 to 1.7% in 2012), but there was an increase in CT and MRI in all years except 2010 (from 30.4% of patients in 2004 to 47% of patients in 2013; P < .001). The rate of urine-based testing also significantly increased during the study period (from 44.8% in 2004 to 54.9% in 2013; P < .001), with patients undergoing between two to three tests per year.

Adherence to current guidelines remained similar during the study time frame. For example, 55.2% of patients received two cystoscopies per year in 2004-2008, compared with 53.8% in 2009-2013 (P = .11), suggesting that there was an overuse of all surveillance testing modalities.

As for treatment, 17.2% received intravesical immunotherapy with bacillus Calmette-Guérin, 6.1% were treated with intravesical chemotherapy (excluding receipt of a single perioperative dose). Disease recurrence within this cohort was 1.7%, and only 0.4% experienced disease progression.

When looking at the cost, the total median expenditures at 1 year after diagnosis increased by 60% during the study period, from $34,792 in 2004 to $53,986 in 2013. Higher costs were seen among patients who experienced a recurrence versus no recurrence ($76,669 vs. $53,909).

The study was supported by a grant from the U.S. Department of Defense Peer Reviewed Cancer Research Program. Several of the authors have disclosed relationships with industry, as noted in the original article. Editorialists Mr. Cook and Dr. Howard have disclosed no relevant financial relationships.

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

Clinicians are not following guidelines that recommend a de-escalation in surveillance for patients with low-risk non–muscle-invasive bladder cancer (NMIBC), a new study concludes.  

These cancers are associated with low rates of recurrence, progression, and bladder cancer–specific death, so current clinical practice guidelines recommend against frequent monitoring and testing.

However, the study authors found that patients with a low grade Ta NMIBC diagnosis underwent a median of three cystoscopies per year, and many also received a median of two imagine scans (CT or MRI) as well as 2-3 urine-based tests.

“These data suggest a need for ongoing efforts to limit overuse of treatment and surveillance, which may in turn mitigate associated increases in the costs of care,” write the authors, led by Kelly K. Bree, MD, from the department of urology, University of Texas MD Anderson Cancer Center, Houston. Bladder cancer has the highest lifetime treatment cost of all malignancies, they point out.

The study was published online in JAMA Network Open.
 

Higher value and more evidence-based

The impact of increased surveillance of this patient cohort has broad implications for patients and the health care system in general, say experts writing in an accompanying editorial.

“It has been well established that workup for NMIBC can have negative consequences for the physical and psychological health of patients,” note Grayden S. Cook, BS, and Jeffrey M. Howard, MD, PhD, both from University of Texas Southwestern Medical Center, Dallas.

“Many of these patients undergo frequent CT imaging of the urinary tract, which carries a high dose of radiation as well as the potential for financial toxic effects (that is, detrimental consequences to the patient because of health care costs),” they write.

Additionally, patient distress is a factor, as they may experience preprocedural anxiety, physical discomfort during procedures, and worry about disease progression, they point out.

“The impact of these patterns is substantial and may have negative consequences for both patients and the health care system,” they conclude. “Thus, it is imperative to move forward with initiatives that provide higher value and are more evidence-based and patient-centered.”
 

Study finds frequent surveillance

The American Urological Association (AUA)/Society of Urologic Oncologists (SUO), the European Association of Urology, and the International Bladder Cancer Group have made an effort to de-escalate surveillance and treatment for patients with low-grade Ta disease, while at the same time maintaining appropriate surveillance for high-grade aggressive disease.

However, the new study found that in practice, such patients undergo frequent testing.

The study involved 13,054 patients with low-grade Ta NMIBC. Most of the participants were male (73.5%), with a median age of 76 years, and had no or few comorbidities (71.2%).

Most patients had undergone cystoscopy, and rates increased over time: from 79.3% of patients in 2004 to 81.5% of patients in 2013 (P = .007). Patients underwent a median of 3.0 cystoscopies per year following their diagnosis, and upper-tract imaging was performed in most patients.

The use of kidney ultrasonography also rose from 19% of patients in 2004 to 23.2% in 2013, as did retrograde pyelography (20.9% in 2004 vs. 24.2% in 2013). Conversely, the use of intravenous pyelography declined (from 14.5% in 2004 to 1.7% in 2012), but there was an increase in CT and MRI in all years except 2010 (from 30.4% of patients in 2004 to 47% of patients in 2013; P < .001). The rate of urine-based testing also significantly increased during the study period (from 44.8% in 2004 to 54.9% in 2013; P < .001), with patients undergoing between two to three tests per year.

Adherence to current guidelines remained similar during the study time frame. For example, 55.2% of patients received two cystoscopies per year in 2004-2008, compared with 53.8% in 2009-2013 (P = .11), suggesting that there was an overuse of all surveillance testing modalities.

As for treatment, 17.2% received intravesical immunotherapy with bacillus Calmette-Guérin, 6.1% were treated with intravesical chemotherapy (excluding receipt of a single perioperative dose). Disease recurrence within this cohort was 1.7%, and only 0.4% experienced disease progression.

When looking at the cost, the total median expenditures at 1 year after diagnosis increased by 60% during the study period, from $34,792 in 2004 to $53,986 in 2013. Higher costs were seen among patients who experienced a recurrence versus no recurrence ($76,669 vs. $53,909).

The study was supported by a grant from the U.S. Department of Defense Peer Reviewed Cancer Research Program. Several of the authors have disclosed relationships with industry, as noted in the original article. Editorialists Mr. Cook and Dr. Howard have disclosed no relevant financial relationships.

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

Clinicians are not following guidelines that recommend a de-escalation in surveillance for patients with low-risk non–muscle-invasive bladder cancer (NMIBC), a new study concludes.  

These cancers are associated with low rates of recurrence, progression, and bladder cancer–specific death, so current clinical practice guidelines recommend against frequent monitoring and testing.

However, the study authors found that patients with a low grade Ta NMIBC diagnosis underwent a median of three cystoscopies per year, and many also received a median of two imagine scans (CT or MRI) as well as 2-3 urine-based tests.

“These data suggest a need for ongoing efforts to limit overuse of treatment and surveillance, which may in turn mitigate associated increases in the costs of care,” write the authors, led by Kelly K. Bree, MD, from the department of urology, University of Texas MD Anderson Cancer Center, Houston. Bladder cancer has the highest lifetime treatment cost of all malignancies, they point out.

The study was published online in JAMA Network Open.
 

Higher value and more evidence-based

The impact of increased surveillance of this patient cohort has broad implications for patients and the health care system in general, say experts writing in an accompanying editorial.

“It has been well established that workup for NMIBC can have negative consequences for the physical and psychological health of patients,” note Grayden S. Cook, BS, and Jeffrey M. Howard, MD, PhD, both from University of Texas Southwestern Medical Center, Dallas.

“Many of these patients undergo frequent CT imaging of the urinary tract, which carries a high dose of radiation as well as the potential for financial toxic effects (that is, detrimental consequences to the patient because of health care costs),” they write.

Additionally, patient distress is a factor, as they may experience preprocedural anxiety, physical discomfort during procedures, and worry about disease progression, they point out.

“The impact of these patterns is substantial and may have negative consequences for both patients and the health care system,” they conclude. “Thus, it is imperative to move forward with initiatives that provide higher value and are more evidence-based and patient-centered.”
 

Study finds frequent surveillance

The American Urological Association (AUA)/Society of Urologic Oncologists (SUO), the European Association of Urology, and the International Bladder Cancer Group have made an effort to de-escalate surveillance and treatment for patients with low-grade Ta disease, while at the same time maintaining appropriate surveillance for high-grade aggressive disease.

However, the new study found that in practice, such patients undergo frequent testing.

The study involved 13,054 patients with low-grade Ta NMIBC. Most of the participants were male (73.5%), with a median age of 76 years, and had no or few comorbidities (71.2%).

Most patients had undergone cystoscopy, and rates increased over time: from 79.3% of patients in 2004 to 81.5% of patients in 2013 (P = .007). Patients underwent a median of 3.0 cystoscopies per year following their diagnosis, and upper-tract imaging was performed in most patients.

The use of kidney ultrasonography also rose from 19% of patients in 2004 to 23.2% in 2013, as did retrograde pyelography (20.9% in 2004 vs. 24.2% in 2013). Conversely, the use of intravenous pyelography declined (from 14.5% in 2004 to 1.7% in 2012), but there was an increase in CT and MRI in all years except 2010 (from 30.4% of patients in 2004 to 47% of patients in 2013; P < .001). The rate of urine-based testing also significantly increased during the study period (from 44.8% in 2004 to 54.9% in 2013; P < .001), with patients undergoing between two to three tests per year.

Adherence to current guidelines remained similar during the study time frame. For example, 55.2% of patients received two cystoscopies per year in 2004-2008, compared with 53.8% in 2009-2013 (P = .11), suggesting that there was an overuse of all surveillance testing modalities.

As for treatment, 17.2% received intravesical immunotherapy with bacillus Calmette-Guérin, 6.1% were treated with intravesical chemotherapy (excluding receipt of a single perioperative dose). Disease recurrence within this cohort was 1.7%, and only 0.4% experienced disease progression.

When looking at the cost, the total median expenditures at 1 year after diagnosis increased by 60% during the study period, from $34,792 in 2004 to $53,986 in 2013. Higher costs were seen among patients who experienced a recurrence versus no recurrence ($76,669 vs. $53,909).

The study was supported by a grant from the U.S. Department of Defense Peer Reviewed Cancer Research Program. Several of the authors have disclosed relationships with industry, as noted in the original article. Editorialists Mr. Cook and Dr. Howard have disclosed no relevant financial relationships.

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