User login
MDedge conference coverage features onsite reporting of the latest study results and expert perspectives from leading researchers.
Corticosteroid injections may worsen knee OA progression
Injecting hyaluronic acid (HA) instead, or managing the condition without injections, may better preserve knee structure and cartilage, according to results of two related studies presented at the annual meeting of the Radiological Society of North America.
The findings come nonrandomized, observational cohort studies, leading knee OA experts to call for further study in randomized trial settings. In the meantime, shared decision-making between patients and clinicians is advised on the use of these injections.
For knee OA, most patients seek a noninvasive treatment for symptomatic relief. “At least 10% of these patients undergo local treatment with injectable corticosteroids or hyaluronic acid,” the lead author of one of the studies, Upasana Upadhyay Bharadwaj, MD, research fellow in musculoskeletal radiology at the University of California, San Francisco, said in a video press release.
Researchers in both studies used data and images from the Osteoarthritis Initiative (OAI), a multicenter, longitudinal, observational study of 4,796 U.S. patients aged 45-79 years with knee OA. Participants were enrolled from February 2004 to May 2006.
The OAI maintains a natural history database of information regarding participants’ clinical evaluation data, x-rays, MRI scans, and a biospecimen repository. Data are available to researchers worldwide.
Two studies draw similar conclusions
In one study, Dr. Bharadwaj and colleagues found that HA injections appeared to show decreased knee OA progression in bone marrow lesions.
They investigated 8 patients who received one CS injection, 12 who received one HA injection, and 40 control persons who received neither treatment. Participants were propensity-score matched by age, sex, body mass index (BMI), Kellgren-Lawrence (KL) grade, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Physical Activity Scale for the Elderly (PASE).
The researchers semiquantitatively graded three Tesla MRI scans that had been obtained at baseline, 2 years before the injection, and 2 years after the injection, using whole-organ MRI score (WORMS) for the meniscus, bone marrow lesions, cartilage, joint effusion, and ligaments.
They quantified OA progression using the difference in WORMS between baseline and 2-year follow-up, and they used linear regression models, adjusted for age, sex, BMI, KL grade, WOMAC, and PASE, to identify the link between type of injection and progression of WORMS.
At 2 years, the authors found a significant association between CS injection and postinjection progression of WORMS over 2 years for the knee overall, the lateral meniscus, lateral cartilage, and medial cartilage. There was no significant link between HA injection and postinjection progression of WORMS or between either injection type and progression of pain, as quantified by WOMAC. There was also no significant difference in progression of WORMS over the 2 years prior to injection for CS and HA injections.
“Corticosteroid injections must be administered with caution with respect to long-term effects on osteoarthritis,” Dr. Bharadwaj advised. “Hyaluronic acid injections, on the other hand, may slow down progression of knee osteoarthritis and alleviate long-term effects while offering similar symptomatic relief to corticosteroid injections. Overall, they are perhaps a safer alternative when looking at medium- and long-term disease course of knee osteoarthritis.”
In the second study, lead author Azad Darbandi, MS, a fourth-year medical student at Chicago Medical School, North Chicago, and colleagues found that patients who received CS injections experienced significantly more medial joint space narrowing.
They identified 210 knees with imaging at baseline and at 48 months that received CS injections, and 59 that received HA injections; 6,827 knees served as controls. The investigators matched 50 patients per group on the basis of confounding factors, which included age, sex, BMI, comorbidities, surgery, and semiquantitative imaging outcomes at baseline. They performed ANCOVA testing using 48-month semiquantitative imaging outcomes as dependent variables and confounding variables as covariates.
The researchers analyzed joint space narrowing, KL grade, and tibia/femur medial/lateral compartment osteophyte formation and sclerosis.
At 4 years, the average KL grade in the CS group was 2.79, it was 2.11 in the HA group,;and it was 2.37 in the control group. Intergroup comparisons showed significant differences in KL grade between CS and HA groups and between CS and control groups. Medial compartment joint space narrowing was 1.56 in the CS group, 1.11 in the HA group, and 1.18 in controls. There was a significant difference between the CS and control groups. Other dependent variables were not significant.
“These preliminary results suggest that corticosteroid injections accelerated the radiographic progression of osteoarthritis, specifically medial joint space narrowing and Kellgren-Lawrence grading, whereas hyaluronic acid injections did not,” Mr. Darbandi said in an interview.
“OA radiographic progression does not always correlate with clinical progression, and further research is needed,” he added.
Proper matching of patients at baseline for confounding factors is a strength of the study, Mr. Darbandi said, while the retrospective study design is a weakness.
Experts share their perspectives on the preliminary results
Michael M. Kheir, MD, assistant professor of orthopedic surgery at the University of Michigan Health System, who was not involved in the studies, said he would like to see further related research.
“Perhaps steroid injections are not as benign as they once seemed,” he added. “They should be reserved for patients who already have significant arthritis and are seeking temporary relief prior to surgical reconstruction with a joint replacement, or for patients with recalcitrant pain after having already tried HA injections.”
William A. Jiranek, MD, professor and orthopedic surgeon at Duke Health in Morrisville, N.C., who also was not involved in the studies, was not surprised by the findings.
“It is important to do these studies to learn that steroid injections do not come with zero cost,” he said.
“I am pretty sure that a percentage of these patients had no cartilage loss at all,” he added. “We need to understand which OA phenotypes are not at risk of progressive cartilage loss from steroid injections.”
Annunziato (Ned) Amendola, MD, professor and sports medicine orthopedic surgeon at Duke Health in Durham, N.C., who was also not involved in the studies, said he would like to know how injection effectiveness and activity level are related.
“If the injections were effective at relieving pain, and the patients were more active, that may have predisposed to more joint wear,” he said. “It’s like tires that last longer if you don’t abuse them.”
Shared decision-making and further research recommended
Amanda E. Nelson, MD, associate professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, said: “The lack of randomization introduces potential biases around why certain therapies (CS injection, HA injection, or neither) were selected over others (such as disease severity, preference, comorbid conditions, other contraindications, etc), thus making interpretation of the findings challenging.
“The causal relationship remains in question, and questions around the efficacy of intra-articular HA in particular, and the ideal settings for intra-articular therapy in general, persist,” noted Dr. Nelson, who was also not involved in the studies. “Thus, shared decision-making between patients and their providers is essential when considering these options.”
C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona and director of the University of Arizona Arthritis Center, both in Tucson, said in an interview that these types of studies are important because CS injections are common treatments for knee OA, they are recommended in treatment guidelines, and other good options are lacking.
But he pointed out that the results of these two studies need to be interpreted with caution and should not be used to decide the course of treatment.
“These data are hypothesis generating. They suggest association, but they do not show causation,” said Dr. Kwoh, who was also not involved in the studies. “Both studies are secondary analyses of data collected from the OAI, which was not specifically designed to answer the questions these studies are posing.
“The OAI was not a treatment study, and participants were seen only once a year or so. They may have had joint injections anytime from only days to around 1 year before their visit, and their levels of activity or pain just prior to or just after their joint injections were not reported,” Dr. Kwoh explained.
The reasons why patients did or did not receive a specific joint injection – including their socioeconomic status, race, access to insurance, and other confounding factors – were not assessed and may have affected the results, he added.
The fact that both studies used the same data and came to the same conclusions gives the conclusions some strength, he said, but “the gold standard to understanding causation would be a randomized, controlled trial.”
Mr. Darbandi’s research received grant support from Boeing, His c-authors, as well as all experts not involved in the studies, reported no relevant financial relationshiips. Dr. Bharadwaj did not provide conflict-of-interest and funding details. Dr. Kwoh reported membership on panels that have developed guidelines for the management of knee OA.
A version of this article first appeared on Medscape.com.
Injecting hyaluronic acid (HA) instead, or managing the condition without injections, may better preserve knee structure and cartilage, according to results of two related studies presented at the annual meeting of the Radiological Society of North America.
The findings come nonrandomized, observational cohort studies, leading knee OA experts to call for further study in randomized trial settings. In the meantime, shared decision-making between patients and clinicians is advised on the use of these injections.
For knee OA, most patients seek a noninvasive treatment for symptomatic relief. “At least 10% of these patients undergo local treatment with injectable corticosteroids or hyaluronic acid,” the lead author of one of the studies, Upasana Upadhyay Bharadwaj, MD, research fellow in musculoskeletal radiology at the University of California, San Francisco, said in a video press release.
Researchers in both studies used data and images from the Osteoarthritis Initiative (OAI), a multicenter, longitudinal, observational study of 4,796 U.S. patients aged 45-79 years with knee OA. Participants were enrolled from February 2004 to May 2006.
The OAI maintains a natural history database of information regarding participants’ clinical evaluation data, x-rays, MRI scans, and a biospecimen repository. Data are available to researchers worldwide.
Two studies draw similar conclusions
In one study, Dr. Bharadwaj and colleagues found that HA injections appeared to show decreased knee OA progression in bone marrow lesions.
They investigated 8 patients who received one CS injection, 12 who received one HA injection, and 40 control persons who received neither treatment. Participants were propensity-score matched by age, sex, body mass index (BMI), Kellgren-Lawrence (KL) grade, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Physical Activity Scale for the Elderly (PASE).
The researchers semiquantitatively graded three Tesla MRI scans that had been obtained at baseline, 2 years before the injection, and 2 years after the injection, using whole-organ MRI score (WORMS) for the meniscus, bone marrow lesions, cartilage, joint effusion, and ligaments.
They quantified OA progression using the difference in WORMS between baseline and 2-year follow-up, and they used linear regression models, adjusted for age, sex, BMI, KL grade, WOMAC, and PASE, to identify the link between type of injection and progression of WORMS.
At 2 years, the authors found a significant association between CS injection and postinjection progression of WORMS over 2 years for the knee overall, the lateral meniscus, lateral cartilage, and medial cartilage. There was no significant link between HA injection and postinjection progression of WORMS or between either injection type and progression of pain, as quantified by WOMAC. There was also no significant difference in progression of WORMS over the 2 years prior to injection for CS and HA injections.
“Corticosteroid injections must be administered with caution with respect to long-term effects on osteoarthritis,” Dr. Bharadwaj advised. “Hyaluronic acid injections, on the other hand, may slow down progression of knee osteoarthritis and alleviate long-term effects while offering similar symptomatic relief to corticosteroid injections. Overall, they are perhaps a safer alternative when looking at medium- and long-term disease course of knee osteoarthritis.”
In the second study, lead author Azad Darbandi, MS, a fourth-year medical student at Chicago Medical School, North Chicago, and colleagues found that patients who received CS injections experienced significantly more medial joint space narrowing.
They identified 210 knees with imaging at baseline and at 48 months that received CS injections, and 59 that received HA injections; 6,827 knees served as controls. The investigators matched 50 patients per group on the basis of confounding factors, which included age, sex, BMI, comorbidities, surgery, and semiquantitative imaging outcomes at baseline. They performed ANCOVA testing using 48-month semiquantitative imaging outcomes as dependent variables and confounding variables as covariates.
The researchers analyzed joint space narrowing, KL grade, and tibia/femur medial/lateral compartment osteophyte formation and sclerosis.
At 4 years, the average KL grade in the CS group was 2.79, it was 2.11 in the HA group,;and it was 2.37 in the control group. Intergroup comparisons showed significant differences in KL grade between CS and HA groups and between CS and control groups. Medial compartment joint space narrowing was 1.56 in the CS group, 1.11 in the HA group, and 1.18 in controls. There was a significant difference between the CS and control groups. Other dependent variables were not significant.
“These preliminary results suggest that corticosteroid injections accelerated the radiographic progression of osteoarthritis, specifically medial joint space narrowing and Kellgren-Lawrence grading, whereas hyaluronic acid injections did not,” Mr. Darbandi said in an interview.
“OA radiographic progression does not always correlate with clinical progression, and further research is needed,” he added.
Proper matching of patients at baseline for confounding factors is a strength of the study, Mr. Darbandi said, while the retrospective study design is a weakness.
Experts share their perspectives on the preliminary results
Michael M. Kheir, MD, assistant professor of orthopedic surgery at the University of Michigan Health System, who was not involved in the studies, said he would like to see further related research.
“Perhaps steroid injections are not as benign as they once seemed,” he added. “They should be reserved for patients who already have significant arthritis and are seeking temporary relief prior to surgical reconstruction with a joint replacement, or for patients with recalcitrant pain after having already tried HA injections.”
William A. Jiranek, MD, professor and orthopedic surgeon at Duke Health in Morrisville, N.C., who also was not involved in the studies, was not surprised by the findings.
“It is important to do these studies to learn that steroid injections do not come with zero cost,” he said.
“I am pretty sure that a percentage of these patients had no cartilage loss at all,” he added. “We need to understand which OA phenotypes are not at risk of progressive cartilage loss from steroid injections.”
Annunziato (Ned) Amendola, MD, professor and sports medicine orthopedic surgeon at Duke Health in Durham, N.C., who was also not involved in the studies, said he would like to know how injection effectiveness and activity level are related.
“If the injections were effective at relieving pain, and the patients were more active, that may have predisposed to more joint wear,” he said. “It’s like tires that last longer if you don’t abuse them.”
Shared decision-making and further research recommended
Amanda E. Nelson, MD, associate professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, said: “The lack of randomization introduces potential biases around why certain therapies (CS injection, HA injection, or neither) were selected over others (such as disease severity, preference, comorbid conditions, other contraindications, etc), thus making interpretation of the findings challenging.
“The causal relationship remains in question, and questions around the efficacy of intra-articular HA in particular, and the ideal settings for intra-articular therapy in general, persist,” noted Dr. Nelson, who was also not involved in the studies. “Thus, shared decision-making between patients and their providers is essential when considering these options.”
C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona and director of the University of Arizona Arthritis Center, both in Tucson, said in an interview that these types of studies are important because CS injections are common treatments for knee OA, they are recommended in treatment guidelines, and other good options are lacking.
But he pointed out that the results of these two studies need to be interpreted with caution and should not be used to decide the course of treatment.
“These data are hypothesis generating. They suggest association, but they do not show causation,” said Dr. Kwoh, who was also not involved in the studies. “Both studies are secondary analyses of data collected from the OAI, which was not specifically designed to answer the questions these studies are posing.
“The OAI was not a treatment study, and participants were seen only once a year or so. They may have had joint injections anytime from only days to around 1 year before their visit, and their levels of activity or pain just prior to or just after their joint injections were not reported,” Dr. Kwoh explained.
The reasons why patients did or did not receive a specific joint injection – including their socioeconomic status, race, access to insurance, and other confounding factors – were not assessed and may have affected the results, he added.
The fact that both studies used the same data and came to the same conclusions gives the conclusions some strength, he said, but “the gold standard to understanding causation would be a randomized, controlled trial.”
Mr. Darbandi’s research received grant support from Boeing, His c-authors, as well as all experts not involved in the studies, reported no relevant financial relationshiips. Dr. Bharadwaj did not provide conflict-of-interest and funding details. Dr. Kwoh reported membership on panels that have developed guidelines for the management of knee OA.
A version of this article first appeared on Medscape.com.
Injecting hyaluronic acid (HA) instead, or managing the condition without injections, may better preserve knee structure and cartilage, according to results of two related studies presented at the annual meeting of the Radiological Society of North America.
The findings come nonrandomized, observational cohort studies, leading knee OA experts to call for further study in randomized trial settings. In the meantime, shared decision-making between patients and clinicians is advised on the use of these injections.
For knee OA, most patients seek a noninvasive treatment for symptomatic relief. “At least 10% of these patients undergo local treatment with injectable corticosteroids or hyaluronic acid,” the lead author of one of the studies, Upasana Upadhyay Bharadwaj, MD, research fellow in musculoskeletal radiology at the University of California, San Francisco, said in a video press release.
Researchers in both studies used data and images from the Osteoarthritis Initiative (OAI), a multicenter, longitudinal, observational study of 4,796 U.S. patients aged 45-79 years with knee OA. Participants were enrolled from February 2004 to May 2006.
The OAI maintains a natural history database of information regarding participants’ clinical evaluation data, x-rays, MRI scans, and a biospecimen repository. Data are available to researchers worldwide.
Two studies draw similar conclusions
In one study, Dr. Bharadwaj and colleagues found that HA injections appeared to show decreased knee OA progression in bone marrow lesions.
They investigated 8 patients who received one CS injection, 12 who received one HA injection, and 40 control persons who received neither treatment. Participants were propensity-score matched by age, sex, body mass index (BMI), Kellgren-Lawrence (KL) grade, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Physical Activity Scale for the Elderly (PASE).
The researchers semiquantitatively graded three Tesla MRI scans that had been obtained at baseline, 2 years before the injection, and 2 years after the injection, using whole-organ MRI score (WORMS) for the meniscus, bone marrow lesions, cartilage, joint effusion, and ligaments.
They quantified OA progression using the difference in WORMS between baseline and 2-year follow-up, and they used linear regression models, adjusted for age, sex, BMI, KL grade, WOMAC, and PASE, to identify the link between type of injection and progression of WORMS.
At 2 years, the authors found a significant association between CS injection and postinjection progression of WORMS over 2 years for the knee overall, the lateral meniscus, lateral cartilage, and medial cartilage. There was no significant link between HA injection and postinjection progression of WORMS or between either injection type and progression of pain, as quantified by WOMAC. There was also no significant difference in progression of WORMS over the 2 years prior to injection for CS and HA injections.
“Corticosteroid injections must be administered with caution with respect to long-term effects on osteoarthritis,” Dr. Bharadwaj advised. “Hyaluronic acid injections, on the other hand, may slow down progression of knee osteoarthritis and alleviate long-term effects while offering similar symptomatic relief to corticosteroid injections. Overall, they are perhaps a safer alternative when looking at medium- and long-term disease course of knee osteoarthritis.”
In the second study, lead author Azad Darbandi, MS, a fourth-year medical student at Chicago Medical School, North Chicago, and colleagues found that patients who received CS injections experienced significantly more medial joint space narrowing.
They identified 210 knees with imaging at baseline and at 48 months that received CS injections, and 59 that received HA injections; 6,827 knees served as controls. The investigators matched 50 patients per group on the basis of confounding factors, which included age, sex, BMI, comorbidities, surgery, and semiquantitative imaging outcomes at baseline. They performed ANCOVA testing using 48-month semiquantitative imaging outcomes as dependent variables and confounding variables as covariates.
The researchers analyzed joint space narrowing, KL grade, and tibia/femur medial/lateral compartment osteophyte formation and sclerosis.
At 4 years, the average KL grade in the CS group was 2.79, it was 2.11 in the HA group,;and it was 2.37 in the control group. Intergroup comparisons showed significant differences in KL grade between CS and HA groups and between CS and control groups. Medial compartment joint space narrowing was 1.56 in the CS group, 1.11 in the HA group, and 1.18 in controls. There was a significant difference between the CS and control groups. Other dependent variables were not significant.
“These preliminary results suggest that corticosteroid injections accelerated the radiographic progression of osteoarthritis, specifically medial joint space narrowing and Kellgren-Lawrence grading, whereas hyaluronic acid injections did not,” Mr. Darbandi said in an interview.
“OA radiographic progression does not always correlate with clinical progression, and further research is needed,” he added.
Proper matching of patients at baseline for confounding factors is a strength of the study, Mr. Darbandi said, while the retrospective study design is a weakness.
Experts share their perspectives on the preliminary results
Michael M. Kheir, MD, assistant professor of orthopedic surgery at the University of Michigan Health System, who was not involved in the studies, said he would like to see further related research.
“Perhaps steroid injections are not as benign as they once seemed,” he added. “They should be reserved for patients who already have significant arthritis and are seeking temporary relief prior to surgical reconstruction with a joint replacement, or for patients with recalcitrant pain after having already tried HA injections.”
William A. Jiranek, MD, professor and orthopedic surgeon at Duke Health in Morrisville, N.C., who also was not involved in the studies, was not surprised by the findings.
“It is important to do these studies to learn that steroid injections do not come with zero cost,” he said.
“I am pretty sure that a percentage of these patients had no cartilage loss at all,” he added. “We need to understand which OA phenotypes are not at risk of progressive cartilage loss from steroid injections.”
Annunziato (Ned) Amendola, MD, professor and sports medicine orthopedic surgeon at Duke Health in Durham, N.C., who was also not involved in the studies, said he would like to know how injection effectiveness and activity level are related.
“If the injections were effective at relieving pain, and the patients were more active, that may have predisposed to more joint wear,” he said. “It’s like tires that last longer if you don’t abuse them.”
Shared decision-making and further research recommended
Amanda E. Nelson, MD, associate professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, said: “The lack of randomization introduces potential biases around why certain therapies (CS injection, HA injection, or neither) were selected over others (such as disease severity, preference, comorbid conditions, other contraindications, etc), thus making interpretation of the findings challenging.
“The causal relationship remains in question, and questions around the efficacy of intra-articular HA in particular, and the ideal settings for intra-articular therapy in general, persist,” noted Dr. Nelson, who was also not involved in the studies. “Thus, shared decision-making between patients and their providers is essential when considering these options.”
C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona and director of the University of Arizona Arthritis Center, both in Tucson, said in an interview that these types of studies are important because CS injections are common treatments for knee OA, they are recommended in treatment guidelines, and other good options are lacking.
But he pointed out that the results of these two studies need to be interpreted with caution and should not be used to decide the course of treatment.
“These data are hypothesis generating. They suggest association, but they do not show causation,” said Dr. Kwoh, who was also not involved in the studies. “Both studies are secondary analyses of data collected from the OAI, which was not specifically designed to answer the questions these studies are posing.
“The OAI was not a treatment study, and participants were seen only once a year or so. They may have had joint injections anytime from only days to around 1 year before their visit, and their levels of activity or pain just prior to or just after their joint injections were not reported,” Dr. Kwoh explained.
The reasons why patients did or did not receive a specific joint injection – including their socioeconomic status, race, access to insurance, and other confounding factors – were not assessed and may have affected the results, he added.
The fact that both studies used the same data and came to the same conclusions gives the conclusions some strength, he said, but “the gold standard to understanding causation would be a randomized, controlled trial.”
Mr. Darbandi’s research received grant support from Boeing, His c-authors, as well as all experts not involved in the studies, reported no relevant financial relationshiips. Dr. Bharadwaj did not provide conflict-of-interest and funding details. Dr. Kwoh reported membership on panels that have developed guidelines for the management of knee OA.
A version of this article first appeared on Medscape.com.
FROM RSNA 2022
What length antibiotic course for prostatitis?
PARIS – To date, studies of antibiotic course length for treating urinary tract infections in men have been patchy and retrospective.
Through recent randomized trials, guidelines can now be based on more solid data.
In sum, to maximize clinical and microbiologic success, a nonfebrile urinary tract infection is treated for 7 days, and a febrile urinary tract infection is treated for a minimum of 14 days.
At the 116th conference of the French urology association, Matthieu Lafaurie, MD, of the Multidisciplinary Infectious Diseases Unit U21, Saint Louis Hospital, Paris, reviewed the literature on this subject.
Guidelines for men
The European Association of Urology made its position clear in a text updated in 2022. It stated: Therefore, treatment with antimicrobial drugs that penetrate the prostate tissue is needed in men presenting with symptoms of a urinary tract infection.” In its classification of prostatitis, the National Institutes of Health distinguishes between acute prostatitis (symptoms of a urinary tract infection; stage I) and chronic prostatitis (recurrent infection with the same microorganism; stage II).
Although the French-language Society of Infectious Diseases distinguishes between febrile and nonfebrile urinary tract infections in males, the academic body does not take into account whether the patient has a fever when determining which antibiotic should be given and how long the course should be: A minimum of 14 days’ treatment is recommended when opting for fluoroquinolones, trimethoprim-sulfamethoxazole (cotrimoxazole), or injectable beta-lactam antibiotics, and at least 21 days is recommended for other drugs or in cases in which there is an underlying urologic condition that has not been treated.
Yet the EAU recommends treating cystitis with antibiotics for at least 7 days, preferably with cotrimoxazole or fluoroquinolone, depending on the results of sensitivity testing. For acute prostatitis, the length of treatment with fluoroquinolones should be at least 14 days.
Nonfebrile infections
Participation of men in studies of the treatment of complicated cystitis is variable; at most only 10% of patients in such trials are men. There are few data specific to men with nonfebrile urinary tract infections, and most studies are retrospective and involve small cohorts. One of these is a community-based study that involved 422 men aged 18-104 years who presented with nonfebrile urinary tract infection (acute dysuria, frequency of urination and/or urgency of urination, temperature < 38° C, no general symptoms). Antibiotic treatment was prescribed in 60% of cases. In more than 55% of cases, the length of the course of treatment was 1–7 days. Treatment was with cotrimoxazole, quinolones, and nitrofurantoin.
Another observational retrospective study showed benefit with nitrofurantoin (50 mg/8 h in 94% of cases; 69 patients) and pivmecillinam (200 mg/8 h in 65% of cases; 200 mg/12 h in 30% of patients; 57 patients) in treating lower urinary tract infections in men. The median treatment duration was 7 days. The failure rate was 1.4% and 12%, respectively, for these treatments. Compared to the so-called gold-standard treatment, trimethoprim (10 days/800 mg/12 h; 45 patients), the recurrence rate was 11% and 26% for nitrofurantoin and pivmecillinam versus 7% for trimethoprim. The most significant relapse rate with pivmecillinam was when treatment was given for fewer than 7 days.
This is the only risk factor for further antibiotic treatment and/or recurrence. There was no significant difference between the three drugs with regard to other parameters (urinary tract infection symptoms, benign prostatic hypertrophy, prostate cancer, gram-positive bacteria, etc).
Another retrospective, European study of nitrofurantoin that was published in 2015 included 485 patients (100 mg twice daily in 71% of cases). Clinical cure was defined as an absence of signs or symptoms of a urinary tract infection for 14 days after stopping nitrofurantoin, without use of other antibiotics. The cure rate was 77%. Better efficacy was achieved for patients with gram-negative (vs. gram-positive) bacteria. The treatment duration did not differ significantly (clinical success was achieved when the treatment was taken for 8.6 ± 3.6 days; clinical failure occurred when the treatment was taken for 9.3 ± 6.9 days; P = .28).
Regarding pivmecillinam, a retrospective 2010-2016 study involved 21,864 adults and included 2,524 men who had been treated empirically with pivmecillinam (400 mg three times daily) for significant bacteriuria (Escherichia coli) and a lower urinary tract infection. The researchers concluded that for men, the success rate was identical whether the treatment lasted 5 or 7 days.
An American community-based (urologists, primary care physicians, general medicine services) retrospective cohort study involving 573 men with nonfebrile lower urinary tract infections was conducted from 2011 to 2015. The patients received antibiotic treatment with fluoroquinolones (69.7%), cotrimoxazole (21.2%), nitrofurantoin (5.3%), trimethoprim, beta-lactam antibiotics, or aminoglycosides. No clinical advantage was seen in treating men with urinary tract infections for longer than 7 days.
There are some data on the use of fosfomycin. In an observational retrospective study, 25 men of 52 male adults with leukocyturia and E. coli greater than 105, ESBL, were treated with fosfomycin trometamol 3 g on days 1, 3, 5. Clinical and microbiologic success was achieved for 94% and 78.5%, respectively. No distinction was made between the sexes.
These results were confirmed in a retrospective, observational study involving 18 men (of a total of 75 adults) with no fever or hyperleukocytosis who received the same fosfomycin trometamol regimen. The rate of clinical cure or sterile urine microscopy and culture was 69% at 13 days. The risk failure factor was, as expected, infection with Klebsiella pneumoniae, which was slightly susceptible to fosfomycin, unlike E. coli.
The most recent study in this field was published in 2021. It was also the first randomized, double-blind, placebo-controlled study. In all, 272 men older than 18 years were prescribed either ciprofloxacin or cotrimoxazole for 7-14 days to treat a nonfebrile urinary tract infection. To be eligible for the trial, patients were required to have disease of new onset with at least one of the following symptoms: dysuria, frequency of urination, urgency of urination, hematuria, costovertebral angle tenderness, or perineal, flank, or suprapubic pain. Urine microscopy and culture were not necessary; the approach was wholly symptomatic. Treatment was prescribed for 7 days. Patients were randomly allocated on day 8 to receive treatment for the following 7 days (molecule or placebo). The primary outcome was resolution of clinical symptoms of urinary tract infection by 14 days after completion of active antibiotic treatment. In an intention-to-treat or per-protocol analysis, the difference in efficacy between the two molecules was largely below the required 10%. The treatment duration noninferiority margin was 7 days, compared with 14 days.
“In 2022, with regard to the duration of treatment of nonfebrile urinary tract infections in men, the not completely irrefutable evidence does, however, stack up in favor of the possibility of a 7-day or even 5-day course,” pointed out Dr. Lafaurie. “Fluoroquinolones [such as] ofloxacin, levofloxacin, ciprofloxacin, as well as cotrimoxazole and other antibiotics, such as pivmecillinam, nitrofurantoin, or fosfomycin trometamol, can be used, despite the fact that they pass less easily into the prostate – a not-so-obvious benefit.”
Febrile infections
In terms of febrile urinary tract infections, a single-center, prospective, open-label study from 2003 involved 72 male inpatients who were randomly to receive treatment either for 2 weeks or 4 weeks. Treatment consisted of ciprofloxacin 500 mg twice daily. This study provided most of the evidence to justify the recommended 14-day antibiotic course.
Another noninferiority, randomized, placebo-controlled study published in 2017 compared 7- and 14-day treatment with ciprofloxacin 500 mg to placebo twice per week. In men, 7 days of antibiotic therapy was inferior to 14 days during a short-term follow-up but was not inferior during a longer follow-up.
A decisive study, which is currently in the submission phase, could silence debate. “In our noninferiority, multicenter, randomized, double-blind, placebo-controlled study, we have enrolled 240 men over the age of 18 years with a febrile infection documented by a fever of 38° C or more, clinical signs of infection, and leukocyturia at least above 10/mm3 and with symptoms lasting less than 3 months,” said Dr. Lafaurie, the trial coordinator.
The primary outcome for efficacy was microbiologic and clinical success after 6 weeks. Patients received either ofloxacin, ceftriaxone, or cefotaxime (two third-generation cephalosporins in the beta-lactam family).
“We clearly show that, for a 7-day course, the clinical success rate is 55.7%, and for a 14-day course, this goes up to 77.6%, with no difference in terms of adverse effects or selection of resistant bacteria. The predictive factors for success are a 14-day treatment and being under the age of 50 years,” said Dr. Lafaurie.
“Unlike nonfebrile urinary tract infections in men, a 7-day course is insufficient for patients with febrile urinary tract infections, and a minimum of 14 days is required to achieve clinical and microbiological success,” he concluded.
This article was translated from the Medscape French edition. A version appeared on Medscape.com.
PARIS – To date, studies of antibiotic course length for treating urinary tract infections in men have been patchy and retrospective.
Through recent randomized trials, guidelines can now be based on more solid data.
In sum, to maximize clinical and microbiologic success, a nonfebrile urinary tract infection is treated for 7 days, and a febrile urinary tract infection is treated for a minimum of 14 days.
At the 116th conference of the French urology association, Matthieu Lafaurie, MD, of the Multidisciplinary Infectious Diseases Unit U21, Saint Louis Hospital, Paris, reviewed the literature on this subject.
Guidelines for men
The European Association of Urology made its position clear in a text updated in 2022. It stated: Therefore, treatment with antimicrobial drugs that penetrate the prostate tissue is needed in men presenting with symptoms of a urinary tract infection.” In its classification of prostatitis, the National Institutes of Health distinguishes between acute prostatitis (symptoms of a urinary tract infection; stage I) and chronic prostatitis (recurrent infection with the same microorganism; stage II).
Although the French-language Society of Infectious Diseases distinguishes between febrile and nonfebrile urinary tract infections in males, the academic body does not take into account whether the patient has a fever when determining which antibiotic should be given and how long the course should be: A minimum of 14 days’ treatment is recommended when opting for fluoroquinolones, trimethoprim-sulfamethoxazole (cotrimoxazole), or injectable beta-lactam antibiotics, and at least 21 days is recommended for other drugs or in cases in which there is an underlying urologic condition that has not been treated.
Yet the EAU recommends treating cystitis with antibiotics for at least 7 days, preferably with cotrimoxazole or fluoroquinolone, depending on the results of sensitivity testing. For acute prostatitis, the length of treatment with fluoroquinolones should be at least 14 days.
Nonfebrile infections
Participation of men in studies of the treatment of complicated cystitis is variable; at most only 10% of patients in such trials are men. There are few data specific to men with nonfebrile urinary tract infections, and most studies are retrospective and involve small cohorts. One of these is a community-based study that involved 422 men aged 18-104 years who presented with nonfebrile urinary tract infection (acute dysuria, frequency of urination and/or urgency of urination, temperature < 38° C, no general symptoms). Antibiotic treatment was prescribed in 60% of cases. In more than 55% of cases, the length of the course of treatment was 1–7 days. Treatment was with cotrimoxazole, quinolones, and nitrofurantoin.
Another observational retrospective study showed benefit with nitrofurantoin (50 mg/8 h in 94% of cases; 69 patients) and pivmecillinam (200 mg/8 h in 65% of cases; 200 mg/12 h in 30% of patients; 57 patients) in treating lower urinary tract infections in men. The median treatment duration was 7 days. The failure rate was 1.4% and 12%, respectively, for these treatments. Compared to the so-called gold-standard treatment, trimethoprim (10 days/800 mg/12 h; 45 patients), the recurrence rate was 11% and 26% for nitrofurantoin and pivmecillinam versus 7% for trimethoprim. The most significant relapse rate with pivmecillinam was when treatment was given for fewer than 7 days.
This is the only risk factor for further antibiotic treatment and/or recurrence. There was no significant difference between the three drugs with regard to other parameters (urinary tract infection symptoms, benign prostatic hypertrophy, prostate cancer, gram-positive bacteria, etc).
Another retrospective, European study of nitrofurantoin that was published in 2015 included 485 patients (100 mg twice daily in 71% of cases). Clinical cure was defined as an absence of signs or symptoms of a urinary tract infection for 14 days after stopping nitrofurantoin, without use of other antibiotics. The cure rate was 77%. Better efficacy was achieved for patients with gram-negative (vs. gram-positive) bacteria. The treatment duration did not differ significantly (clinical success was achieved when the treatment was taken for 8.6 ± 3.6 days; clinical failure occurred when the treatment was taken for 9.3 ± 6.9 days; P = .28).
Regarding pivmecillinam, a retrospective 2010-2016 study involved 21,864 adults and included 2,524 men who had been treated empirically with pivmecillinam (400 mg three times daily) for significant bacteriuria (Escherichia coli) and a lower urinary tract infection. The researchers concluded that for men, the success rate was identical whether the treatment lasted 5 or 7 days.
An American community-based (urologists, primary care physicians, general medicine services) retrospective cohort study involving 573 men with nonfebrile lower urinary tract infections was conducted from 2011 to 2015. The patients received antibiotic treatment with fluoroquinolones (69.7%), cotrimoxazole (21.2%), nitrofurantoin (5.3%), trimethoprim, beta-lactam antibiotics, or aminoglycosides. No clinical advantage was seen in treating men with urinary tract infections for longer than 7 days.
There are some data on the use of fosfomycin. In an observational retrospective study, 25 men of 52 male adults with leukocyturia and E. coli greater than 105, ESBL, were treated with fosfomycin trometamol 3 g on days 1, 3, 5. Clinical and microbiologic success was achieved for 94% and 78.5%, respectively. No distinction was made between the sexes.
These results were confirmed in a retrospective, observational study involving 18 men (of a total of 75 adults) with no fever or hyperleukocytosis who received the same fosfomycin trometamol regimen. The rate of clinical cure or sterile urine microscopy and culture was 69% at 13 days. The risk failure factor was, as expected, infection with Klebsiella pneumoniae, which was slightly susceptible to fosfomycin, unlike E. coli.
The most recent study in this field was published in 2021. It was also the first randomized, double-blind, placebo-controlled study. In all, 272 men older than 18 years were prescribed either ciprofloxacin or cotrimoxazole for 7-14 days to treat a nonfebrile urinary tract infection. To be eligible for the trial, patients were required to have disease of new onset with at least one of the following symptoms: dysuria, frequency of urination, urgency of urination, hematuria, costovertebral angle tenderness, or perineal, flank, or suprapubic pain. Urine microscopy and culture were not necessary; the approach was wholly symptomatic. Treatment was prescribed for 7 days. Patients were randomly allocated on day 8 to receive treatment for the following 7 days (molecule or placebo). The primary outcome was resolution of clinical symptoms of urinary tract infection by 14 days after completion of active antibiotic treatment. In an intention-to-treat or per-protocol analysis, the difference in efficacy between the two molecules was largely below the required 10%. The treatment duration noninferiority margin was 7 days, compared with 14 days.
“In 2022, with regard to the duration of treatment of nonfebrile urinary tract infections in men, the not completely irrefutable evidence does, however, stack up in favor of the possibility of a 7-day or even 5-day course,” pointed out Dr. Lafaurie. “Fluoroquinolones [such as] ofloxacin, levofloxacin, ciprofloxacin, as well as cotrimoxazole and other antibiotics, such as pivmecillinam, nitrofurantoin, or fosfomycin trometamol, can be used, despite the fact that they pass less easily into the prostate – a not-so-obvious benefit.”
Febrile infections
In terms of febrile urinary tract infections, a single-center, prospective, open-label study from 2003 involved 72 male inpatients who were randomly to receive treatment either for 2 weeks or 4 weeks. Treatment consisted of ciprofloxacin 500 mg twice daily. This study provided most of the evidence to justify the recommended 14-day antibiotic course.
Another noninferiority, randomized, placebo-controlled study published in 2017 compared 7- and 14-day treatment with ciprofloxacin 500 mg to placebo twice per week. In men, 7 days of antibiotic therapy was inferior to 14 days during a short-term follow-up but was not inferior during a longer follow-up.
A decisive study, which is currently in the submission phase, could silence debate. “In our noninferiority, multicenter, randomized, double-blind, placebo-controlled study, we have enrolled 240 men over the age of 18 years with a febrile infection documented by a fever of 38° C or more, clinical signs of infection, and leukocyturia at least above 10/mm3 and with symptoms lasting less than 3 months,” said Dr. Lafaurie, the trial coordinator.
The primary outcome for efficacy was microbiologic and clinical success after 6 weeks. Patients received either ofloxacin, ceftriaxone, or cefotaxime (two third-generation cephalosporins in the beta-lactam family).
“We clearly show that, for a 7-day course, the clinical success rate is 55.7%, and for a 14-day course, this goes up to 77.6%, with no difference in terms of adverse effects or selection of resistant bacteria. The predictive factors for success are a 14-day treatment and being under the age of 50 years,” said Dr. Lafaurie.
“Unlike nonfebrile urinary tract infections in men, a 7-day course is insufficient for patients with febrile urinary tract infections, and a minimum of 14 days is required to achieve clinical and microbiological success,” he concluded.
This article was translated from the Medscape French edition. A version appeared on Medscape.com.
PARIS – To date, studies of antibiotic course length for treating urinary tract infections in men have been patchy and retrospective.
Through recent randomized trials, guidelines can now be based on more solid data.
In sum, to maximize clinical and microbiologic success, a nonfebrile urinary tract infection is treated for 7 days, and a febrile urinary tract infection is treated for a minimum of 14 days.
At the 116th conference of the French urology association, Matthieu Lafaurie, MD, of the Multidisciplinary Infectious Diseases Unit U21, Saint Louis Hospital, Paris, reviewed the literature on this subject.
Guidelines for men
The European Association of Urology made its position clear in a text updated in 2022. It stated: Therefore, treatment with antimicrobial drugs that penetrate the prostate tissue is needed in men presenting with symptoms of a urinary tract infection.” In its classification of prostatitis, the National Institutes of Health distinguishes between acute prostatitis (symptoms of a urinary tract infection; stage I) and chronic prostatitis (recurrent infection with the same microorganism; stage II).
Although the French-language Society of Infectious Diseases distinguishes between febrile and nonfebrile urinary tract infections in males, the academic body does not take into account whether the patient has a fever when determining which antibiotic should be given and how long the course should be: A minimum of 14 days’ treatment is recommended when opting for fluoroquinolones, trimethoprim-sulfamethoxazole (cotrimoxazole), or injectable beta-lactam antibiotics, and at least 21 days is recommended for other drugs or in cases in which there is an underlying urologic condition that has not been treated.
Yet the EAU recommends treating cystitis with antibiotics for at least 7 days, preferably with cotrimoxazole or fluoroquinolone, depending on the results of sensitivity testing. For acute prostatitis, the length of treatment with fluoroquinolones should be at least 14 days.
Nonfebrile infections
Participation of men in studies of the treatment of complicated cystitis is variable; at most only 10% of patients in such trials are men. There are few data specific to men with nonfebrile urinary tract infections, and most studies are retrospective and involve small cohorts. One of these is a community-based study that involved 422 men aged 18-104 years who presented with nonfebrile urinary tract infection (acute dysuria, frequency of urination and/or urgency of urination, temperature < 38° C, no general symptoms). Antibiotic treatment was prescribed in 60% of cases. In more than 55% of cases, the length of the course of treatment was 1–7 days. Treatment was with cotrimoxazole, quinolones, and nitrofurantoin.
Another observational retrospective study showed benefit with nitrofurantoin (50 mg/8 h in 94% of cases; 69 patients) and pivmecillinam (200 mg/8 h in 65% of cases; 200 mg/12 h in 30% of patients; 57 patients) in treating lower urinary tract infections in men. The median treatment duration was 7 days. The failure rate was 1.4% and 12%, respectively, for these treatments. Compared to the so-called gold-standard treatment, trimethoprim (10 days/800 mg/12 h; 45 patients), the recurrence rate was 11% and 26% for nitrofurantoin and pivmecillinam versus 7% for trimethoprim. The most significant relapse rate with pivmecillinam was when treatment was given for fewer than 7 days.
This is the only risk factor for further antibiotic treatment and/or recurrence. There was no significant difference between the three drugs with regard to other parameters (urinary tract infection symptoms, benign prostatic hypertrophy, prostate cancer, gram-positive bacteria, etc).
Another retrospective, European study of nitrofurantoin that was published in 2015 included 485 patients (100 mg twice daily in 71% of cases). Clinical cure was defined as an absence of signs or symptoms of a urinary tract infection for 14 days after stopping nitrofurantoin, without use of other antibiotics. The cure rate was 77%. Better efficacy was achieved for patients with gram-negative (vs. gram-positive) bacteria. The treatment duration did not differ significantly (clinical success was achieved when the treatment was taken for 8.6 ± 3.6 days; clinical failure occurred when the treatment was taken for 9.3 ± 6.9 days; P = .28).
Regarding pivmecillinam, a retrospective 2010-2016 study involved 21,864 adults and included 2,524 men who had been treated empirically with pivmecillinam (400 mg three times daily) for significant bacteriuria (Escherichia coli) and a lower urinary tract infection. The researchers concluded that for men, the success rate was identical whether the treatment lasted 5 or 7 days.
An American community-based (urologists, primary care physicians, general medicine services) retrospective cohort study involving 573 men with nonfebrile lower urinary tract infections was conducted from 2011 to 2015. The patients received antibiotic treatment with fluoroquinolones (69.7%), cotrimoxazole (21.2%), nitrofurantoin (5.3%), trimethoprim, beta-lactam antibiotics, or aminoglycosides. No clinical advantage was seen in treating men with urinary tract infections for longer than 7 days.
There are some data on the use of fosfomycin. In an observational retrospective study, 25 men of 52 male adults with leukocyturia and E. coli greater than 105, ESBL, were treated with fosfomycin trometamol 3 g on days 1, 3, 5. Clinical and microbiologic success was achieved for 94% and 78.5%, respectively. No distinction was made between the sexes.
These results were confirmed in a retrospective, observational study involving 18 men (of a total of 75 adults) with no fever or hyperleukocytosis who received the same fosfomycin trometamol regimen. The rate of clinical cure or sterile urine microscopy and culture was 69% at 13 days. The risk failure factor was, as expected, infection with Klebsiella pneumoniae, which was slightly susceptible to fosfomycin, unlike E. coli.
The most recent study in this field was published in 2021. It was also the first randomized, double-blind, placebo-controlled study. In all, 272 men older than 18 years were prescribed either ciprofloxacin or cotrimoxazole for 7-14 days to treat a nonfebrile urinary tract infection. To be eligible for the trial, patients were required to have disease of new onset with at least one of the following symptoms: dysuria, frequency of urination, urgency of urination, hematuria, costovertebral angle tenderness, or perineal, flank, or suprapubic pain. Urine microscopy and culture were not necessary; the approach was wholly symptomatic. Treatment was prescribed for 7 days. Patients were randomly allocated on day 8 to receive treatment for the following 7 days (molecule or placebo). The primary outcome was resolution of clinical symptoms of urinary tract infection by 14 days after completion of active antibiotic treatment. In an intention-to-treat or per-protocol analysis, the difference in efficacy between the two molecules was largely below the required 10%. The treatment duration noninferiority margin was 7 days, compared with 14 days.
“In 2022, with regard to the duration of treatment of nonfebrile urinary tract infections in men, the not completely irrefutable evidence does, however, stack up in favor of the possibility of a 7-day or even 5-day course,” pointed out Dr. Lafaurie. “Fluoroquinolones [such as] ofloxacin, levofloxacin, ciprofloxacin, as well as cotrimoxazole and other antibiotics, such as pivmecillinam, nitrofurantoin, or fosfomycin trometamol, can be used, despite the fact that they pass less easily into the prostate – a not-so-obvious benefit.”
Febrile infections
In terms of febrile urinary tract infections, a single-center, prospective, open-label study from 2003 involved 72 male inpatients who were randomly to receive treatment either for 2 weeks or 4 weeks. Treatment consisted of ciprofloxacin 500 mg twice daily. This study provided most of the evidence to justify the recommended 14-day antibiotic course.
Another noninferiority, randomized, placebo-controlled study published in 2017 compared 7- and 14-day treatment with ciprofloxacin 500 mg to placebo twice per week. In men, 7 days of antibiotic therapy was inferior to 14 days during a short-term follow-up but was not inferior during a longer follow-up.
A decisive study, which is currently in the submission phase, could silence debate. “In our noninferiority, multicenter, randomized, double-blind, placebo-controlled study, we have enrolled 240 men over the age of 18 years with a febrile infection documented by a fever of 38° C or more, clinical signs of infection, and leukocyturia at least above 10/mm3 and with symptoms lasting less than 3 months,” said Dr. Lafaurie, the trial coordinator.
The primary outcome for efficacy was microbiologic and clinical success after 6 weeks. Patients received either ofloxacin, ceftriaxone, or cefotaxime (two third-generation cephalosporins in the beta-lactam family).
“We clearly show that, for a 7-day course, the clinical success rate is 55.7%, and for a 14-day course, this goes up to 77.6%, with no difference in terms of adverse effects or selection of resistant bacteria. The predictive factors for success are a 14-day treatment and being under the age of 50 years,” said Dr. Lafaurie.
“Unlike nonfebrile urinary tract infections in men, a 7-day course is insufficient for patients with febrile urinary tract infections, and a minimum of 14 days is required to achieve clinical and microbiological success,” he concluded.
This article was translated from the Medscape French edition. A version appeared on Medscape.com.
Antipsychotic shows benefit for Alzheimer’s agitation
SAN FRANCISCO – In a widely anticipated report,
Members of a panel of dementia specialists here at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference said that the results were encouraging. But they also noted that the available data make it difficult to understand the impact of the drug on the day-to-day life on patients.
“I’d like to be able to translate that into something else to understand the risk benefit calculus,” said neurologist and neuroscientist Alireza Atri, MD, PhD, of Banner Sun Health Research Institute in Phoenix. “How does it affect the patients themselves, their quality of life, and the family members and their burden?”
Currently, there’s no Food and Drug Administration–approved treatment for agitation in AD.
In 2015, the FDA approved brexpiprazole, an oral medication, as a treatment for schizophrenia and an adjunctive treatment for major depressive disorder (MDD). It is an expensive drug with an average retail price per GoodRx of $1,582 per month, and no generic is available.
Researchers released the results of a trio of phase 3 clinical trials at CTAD that examined various doses of brexpiprazole. The results of the first two trials had been released earlier in 2018.
Three trials
All trials were multicenter, 12-week, randomized, double-blind and placebo-controlled.
Study participants were aged 55-90 years, had probable AD diagnoses, and had agitation per various scales. The average age in the groups was 74 years, 56.0%-61.7% were women, and 94.3%-98.1% were White.
The first trial examined two fixed doses (1 mg/d, n = 137; and 2 mg/d, n = 140) or placebo (n = 136). “The study initially included a 0.5 mg/day arm,” the researchers reported, “which was removed in a protocol amendment, and patients randomized to that arm were not included in efficacy analyses.”
The second trial looked at a flexible dose (0.5-2 mg/d, n = 133) or placebo (n = 137).
In a CTAD presentation, Nanco Hefting of Lundbeck, a codeveloper of the drug, said that the researchers learned from the first two trials that 2 mg/d might be an appropriate dose, and the FDA recommended they also examine 3 mg/day. As a result, the third trial examined two fixed doses (2 mg/d, n = 75; 3 mg/d, n = 153; or placebo, n = 117).
In the third trial, both the placebo and drug groups improved per a measurement of agitation; those in the drug group improved somewhat more.
The mean change in baseline on the Cohen-Mansfield Agitation Inventory scale – the primary endpoint – was –5.32 for the 2-mg/d and 3-mg/d groups vs. placebo (P = .0026); the score in the placebo group fell by about 18 and by about 22 in the drug group.
The key secondary endpoint was an improvement from baseline to week 12 in the Clinical Global Impression–Severity (CGI-S) score related to agitation. Compared with the placebo group, this score was –0.27 in the drug group (P = .0078). Both scores hovered around –1.0.
Safety data show the percentage of treatment-emergent events ranged from 45.9% in the placebo group to 49.0%-56.8% for brexpiprazole in the three trials. The percentage of these events leading to discontinuation was 6.3% among those receiving the drug and 3.4% in the placebo group.
University of Exeter dementia researcher Clive Ballard, MD, MB ChB, one of the panelists who discussed the research after the CTAD presentation, praised the trials as “well-conducted” and said that he was pleased that subjects in institutions were included. “It’s not an easy environment to do trials in. They should be really commended for doing for doing that.”
But he echoed fellow panelist Dr. Atri by noting that more data are needed to understand how well the drug works. “I would like to see the effect sizes and a little bit more detail to understand the clinical meaningfulness of that level of benefit.”
What’s next? A spokeswoman for Otsuka, a codeveloper of brexpiprazole, said that it hopes to hear in 2023 about a supplemental new drug application that was filed in November 2022.
Otsuka and Lundbeck funded the research. Mr. Hefting is an employee of Lundbeck, and several other authors work for Lundbeck or Otsuka. The single non-employee author reports various disclosures. Disclosures for Dr. Atri and Dr. Ballard were not provided.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO – In a widely anticipated report,
Members of a panel of dementia specialists here at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference said that the results were encouraging. But they also noted that the available data make it difficult to understand the impact of the drug on the day-to-day life on patients.
“I’d like to be able to translate that into something else to understand the risk benefit calculus,” said neurologist and neuroscientist Alireza Atri, MD, PhD, of Banner Sun Health Research Institute in Phoenix. “How does it affect the patients themselves, their quality of life, and the family members and their burden?”
Currently, there’s no Food and Drug Administration–approved treatment for agitation in AD.
In 2015, the FDA approved brexpiprazole, an oral medication, as a treatment for schizophrenia and an adjunctive treatment for major depressive disorder (MDD). It is an expensive drug with an average retail price per GoodRx of $1,582 per month, and no generic is available.
Researchers released the results of a trio of phase 3 clinical trials at CTAD that examined various doses of brexpiprazole. The results of the first two trials had been released earlier in 2018.
Three trials
All trials were multicenter, 12-week, randomized, double-blind and placebo-controlled.
Study participants were aged 55-90 years, had probable AD diagnoses, and had agitation per various scales. The average age in the groups was 74 years, 56.0%-61.7% were women, and 94.3%-98.1% were White.
The first trial examined two fixed doses (1 mg/d, n = 137; and 2 mg/d, n = 140) or placebo (n = 136). “The study initially included a 0.5 mg/day arm,” the researchers reported, “which was removed in a protocol amendment, and patients randomized to that arm were not included in efficacy analyses.”
The second trial looked at a flexible dose (0.5-2 mg/d, n = 133) or placebo (n = 137).
In a CTAD presentation, Nanco Hefting of Lundbeck, a codeveloper of the drug, said that the researchers learned from the first two trials that 2 mg/d might be an appropriate dose, and the FDA recommended they also examine 3 mg/day. As a result, the third trial examined two fixed doses (2 mg/d, n = 75; 3 mg/d, n = 153; or placebo, n = 117).
In the third trial, both the placebo and drug groups improved per a measurement of agitation; those in the drug group improved somewhat more.
The mean change in baseline on the Cohen-Mansfield Agitation Inventory scale – the primary endpoint – was –5.32 for the 2-mg/d and 3-mg/d groups vs. placebo (P = .0026); the score in the placebo group fell by about 18 and by about 22 in the drug group.
The key secondary endpoint was an improvement from baseline to week 12 in the Clinical Global Impression–Severity (CGI-S) score related to agitation. Compared with the placebo group, this score was –0.27 in the drug group (P = .0078). Both scores hovered around –1.0.
Safety data show the percentage of treatment-emergent events ranged from 45.9% in the placebo group to 49.0%-56.8% for brexpiprazole in the three trials. The percentage of these events leading to discontinuation was 6.3% among those receiving the drug and 3.4% in the placebo group.
University of Exeter dementia researcher Clive Ballard, MD, MB ChB, one of the panelists who discussed the research after the CTAD presentation, praised the trials as “well-conducted” and said that he was pleased that subjects in institutions were included. “It’s not an easy environment to do trials in. They should be really commended for doing for doing that.”
But he echoed fellow panelist Dr. Atri by noting that more data are needed to understand how well the drug works. “I would like to see the effect sizes and a little bit more detail to understand the clinical meaningfulness of that level of benefit.”
What’s next? A spokeswoman for Otsuka, a codeveloper of brexpiprazole, said that it hopes to hear in 2023 about a supplemental new drug application that was filed in November 2022.
Otsuka and Lundbeck funded the research. Mr. Hefting is an employee of Lundbeck, and several other authors work for Lundbeck or Otsuka. The single non-employee author reports various disclosures. Disclosures for Dr. Atri and Dr. Ballard were not provided.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO – In a widely anticipated report,
Members of a panel of dementia specialists here at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference said that the results were encouraging. But they also noted that the available data make it difficult to understand the impact of the drug on the day-to-day life on patients.
“I’d like to be able to translate that into something else to understand the risk benefit calculus,” said neurologist and neuroscientist Alireza Atri, MD, PhD, of Banner Sun Health Research Institute in Phoenix. “How does it affect the patients themselves, their quality of life, and the family members and their burden?”
Currently, there’s no Food and Drug Administration–approved treatment for agitation in AD.
In 2015, the FDA approved brexpiprazole, an oral medication, as a treatment for schizophrenia and an adjunctive treatment for major depressive disorder (MDD). It is an expensive drug with an average retail price per GoodRx of $1,582 per month, and no generic is available.
Researchers released the results of a trio of phase 3 clinical trials at CTAD that examined various doses of brexpiprazole. The results of the first two trials had been released earlier in 2018.
Three trials
All trials were multicenter, 12-week, randomized, double-blind and placebo-controlled.
Study participants were aged 55-90 years, had probable AD diagnoses, and had agitation per various scales. The average age in the groups was 74 years, 56.0%-61.7% were women, and 94.3%-98.1% were White.
The first trial examined two fixed doses (1 mg/d, n = 137; and 2 mg/d, n = 140) or placebo (n = 136). “The study initially included a 0.5 mg/day arm,” the researchers reported, “which was removed in a protocol amendment, and patients randomized to that arm were not included in efficacy analyses.”
The second trial looked at a flexible dose (0.5-2 mg/d, n = 133) or placebo (n = 137).
In a CTAD presentation, Nanco Hefting of Lundbeck, a codeveloper of the drug, said that the researchers learned from the first two trials that 2 mg/d might be an appropriate dose, and the FDA recommended they also examine 3 mg/day. As a result, the third trial examined two fixed doses (2 mg/d, n = 75; 3 mg/d, n = 153; or placebo, n = 117).
In the third trial, both the placebo and drug groups improved per a measurement of agitation; those in the drug group improved somewhat more.
The mean change in baseline on the Cohen-Mansfield Agitation Inventory scale – the primary endpoint – was –5.32 for the 2-mg/d and 3-mg/d groups vs. placebo (P = .0026); the score in the placebo group fell by about 18 and by about 22 in the drug group.
The key secondary endpoint was an improvement from baseline to week 12 in the Clinical Global Impression–Severity (CGI-S) score related to agitation. Compared with the placebo group, this score was –0.27 in the drug group (P = .0078). Both scores hovered around –1.0.
Safety data show the percentage of treatment-emergent events ranged from 45.9% in the placebo group to 49.0%-56.8% for brexpiprazole in the three trials. The percentage of these events leading to discontinuation was 6.3% among those receiving the drug and 3.4% in the placebo group.
University of Exeter dementia researcher Clive Ballard, MD, MB ChB, one of the panelists who discussed the research after the CTAD presentation, praised the trials as “well-conducted” and said that he was pleased that subjects in institutions were included. “It’s not an easy environment to do trials in. They should be really commended for doing for doing that.”
But he echoed fellow panelist Dr. Atri by noting that more data are needed to understand how well the drug works. “I would like to see the effect sizes and a little bit more detail to understand the clinical meaningfulness of that level of benefit.”
What’s next? A spokeswoman for Otsuka, a codeveloper of brexpiprazole, said that it hopes to hear in 2023 about a supplemental new drug application that was filed in November 2022.
Otsuka and Lundbeck funded the research. Mr. Hefting is an employee of Lundbeck, and several other authors work for Lundbeck or Otsuka. The single non-employee author reports various disclosures. Disclosures for Dr. Atri and Dr. Ballard were not provided.
A version of this article first appeared on Medscape.com.
AT CTAD 2022
Most women with breast cancer elude serious COVID-19 vaccine side effects
Findings from the LymphVAX study recently presented at the San Antonio Breast Cancer Symposium show that relatively
Lymph node swelling can be a particularly troubling side effect, since it could be mistaken for breast cancer progression. In this study, of 621 women who received the first dose of an mRNA COVID-19 vaccine, 9.8% developed lymph node swelling as compared with 12.9% of 621 women who received the second dose, and 11.3% of 469 women who received the third dose. The findings were comparable to those of studies conducted of the general population, said study author Brooke C. Juhel, BS, a clinical research coordinator in the lymphedema research program at Massachusetts General Hospital and a student at Harvard Medical School, both in Boston. In the general population, 10.2% experienced lymph node swelling after the first dose and 14% after the second dose, according to the Centers for Disease Control and studies of the Pfizer and Moderna vaccines.
“This is consistent with the hypothesis that, after repeated vaccine doses, the immune system already has the antigens ready to fight the virus, thus the side effects may worsen as the immune response has increased,” she said. “Having screened over 6,500 women for breast cancer–related lymphedema, and with our patients reaching out with concerns about vaccine side effects, we were in a unique position to conduct this study.”
The study also confirmed that the most common side effects of receiving mRNA COVID-19 vaccines for women treated for breast cancer included injection site soreness, fatigue, muscle soreness, headache and chills lasting an average of 48 hours, which are symptoms comparable with those experienced by the general population.
“The side-effect profiles reported in this study for a cohort of women treated for breast cancer can be used to provide evidence-based patient education regarding future COVID-19 vaccine administration. The effect of the COVID-19 vaccines on breast cancer–related lymphedema risk is currently unknown and more research is required. In the interim, we would recommend vaccination away from the side of lymph node removal, either in the contralateral arm or in the thigh,” Ms. Juhel said.
The median duration of lymph node swelling was less than 1 week. In cases where lymph node swelling occurred after the first dose, 54.1% had swelling in ipsilateral axillary lymph nodes, and 45.9% in contralateral axillary lymph nodes. About 29.5% experienced swelling in ipsilateral supraclavicular lymph nodes, and 18.0% in contralateral supraclavicular lymph nodes.
Injection-site soreness, fatigue, GMS, headache, and chills occurred less often among older individuals (P < .001), and fatigue, muscle soreness, headache, and chills occurred more frequently after the second dose than the first (P < .001). The median duration of all side effects was 48 hours or less.
“The informed education that can be produced based on these results will hopefully ease the fears of women treated for breast cancer and empower them to make informed decisions regarding future vaccine doses,” Ms. Juhel said.
Ms. Juhel has no relevant financial disclosures.
Findings from the LymphVAX study recently presented at the San Antonio Breast Cancer Symposium show that relatively
Lymph node swelling can be a particularly troubling side effect, since it could be mistaken for breast cancer progression. In this study, of 621 women who received the first dose of an mRNA COVID-19 vaccine, 9.8% developed lymph node swelling as compared with 12.9% of 621 women who received the second dose, and 11.3% of 469 women who received the third dose. The findings were comparable to those of studies conducted of the general population, said study author Brooke C. Juhel, BS, a clinical research coordinator in the lymphedema research program at Massachusetts General Hospital and a student at Harvard Medical School, both in Boston. In the general population, 10.2% experienced lymph node swelling after the first dose and 14% after the second dose, according to the Centers for Disease Control and studies of the Pfizer and Moderna vaccines.
“This is consistent with the hypothesis that, after repeated vaccine doses, the immune system already has the antigens ready to fight the virus, thus the side effects may worsen as the immune response has increased,” she said. “Having screened over 6,500 women for breast cancer–related lymphedema, and with our patients reaching out with concerns about vaccine side effects, we were in a unique position to conduct this study.”
The study also confirmed that the most common side effects of receiving mRNA COVID-19 vaccines for women treated for breast cancer included injection site soreness, fatigue, muscle soreness, headache and chills lasting an average of 48 hours, which are symptoms comparable with those experienced by the general population.
“The side-effect profiles reported in this study for a cohort of women treated for breast cancer can be used to provide evidence-based patient education regarding future COVID-19 vaccine administration. The effect of the COVID-19 vaccines on breast cancer–related lymphedema risk is currently unknown and more research is required. In the interim, we would recommend vaccination away from the side of lymph node removal, either in the contralateral arm or in the thigh,” Ms. Juhel said.
The median duration of lymph node swelling was less than 1 week. In cases where lymph node swelling occurred after the first dose, 54.1% had swelling in ipsilateral axillary lymph nodes, and 45.9% in contralateral axillary lymph nodes. About 29.5% experienced swelling in ipsilateral supraclavicular lymph nodes, and 18.0% in contralateral supraclavicular lymph nodes.
Injection-site soreness, fatigue, GMS, headache, and chills occurred less often among older individuals (P < .001), and fatigue, muscle soreness, headache, and chills occurred more frequently after the second dose than the first (P < .001). The median duration of all side effects was 48 hours or less.
“The informed education that can be produced based on these results will hopefully ease the fears of women treated for breast cancer and empower them to make informed decisions regarding future vaccine doses,” Ms. Juhel said.
Ms. Juhel has no relevant financial disclosures.
Findings from the LymphVAX study recently presented at the San Antonio Breast Cancer Symposium show that relatively
Lymph node swelling can be a particularly troubling side effect, since it could be mistaken for breast cancer progression. In this study, of 621 women who received the first dose of an mRNA COVID-19 vaccine, 9.8% developed lymph node swelling as compared with 12.9% of 621 women who received the second dose, and 11.3% of 469 women who received the third dose. The findings were comparable to those of studies conducted of the general population, said study author Brooke C. Juhel, BS, a clinical research coordinator in the lymphedema research program at Massachusetts General Hospital and a student at Harvard Medical School, both in Boston. In the general population, 10.2% experienced lymph node swelling after the first dose and 14% after the second dose, according to the Centers for Disease Control and studies of the Pfizer and Moderna vaccines.
“This is consistent with the hypothesis that, after repeated vaccine doses, the immune system already has the antigens ready to fight the virus, thus the side effects may worsen as the immune response has increased,” she said. “Having screened over 6,500 women for breast cancer–related lymphedema, and with our patients reaching out with concerns about vaccine side effects, we were in a unique position to conduct this study.”
The study also confirmed that the most common side effects of receiving mRNA COVID-19 vaccines for women treated for breast cancer included injection site soreness, fatigue, muscle soreness, headache and chills lasting an average of 48 hours, which are symptoms comparable with those experienced by the general population.
“The side-effect profiles reported in this study for a cohort of women treated for breast cancer can be used to provide evidence-based patient education regarding future COVID-19 vaccine administration. The effect of the COVID-19 vaccines on breast cancer–related lymphedema risk is currently unknown and more research is required. In the interim, we would recommend vaccination away from the side of lymph node removal, either in the contralateral arm or in the thigh,” Ms. Juhel said.
The median duration of lymph node swelling was less than 1 week. In cases where lymph node swelling occurred after the first dose, 54.1% had swelling in ipsilateral axillary lymph nodes, and 45.9% in contralateral axillary lymph nodes. About 29.5% experienced swelling in ipsilateral supraclavicular lymph nodes, and 18.0% in contralateral supraclavicular lymph nodes.
Injection-site soreness, fatigue, GMS, headache, and chills occurred less often among older individuals (P < .001), and fatigue, muscle soreness, headache, and chills occurred more frequently after the second dose than the first (P < .001). The median duration of all side effects was 48 hours or less.
“The informed education that can be produced based on these results will hopefully ease the fears of women treated for breast cancer and empower them to make informed decisions regarding future vaccine doses,” Ms. Juhel said.
Ms. Juhel has no relevant financial disclosures.
FROM SABCS 2022
Breast cancer diagnoses worse among Hispanics during COVID-19 pandemic
In a series of studies recently presented at the San Antonio Breast Cancer Symposium that examine the effects of the COVID-19 pandemic on women with breast cancer, researchers report that ethnicity played a role in later diagnoses, Hispanics presented with more advanced and aggressive disease, and a focus on a single hospital in San Antonio finds a statistical difference between stage at diagnosis prior to the pandemic, compared with the postvaccine era.
Patients treated at the Mays Cancer Center, a cancer hospital of University of Texas Health and MD Anderson Cancer Center in San Antonio, during the pandemic were found to more likely present with advanced disease between March and December 2020, according to Marcela Mazo, MD, an oncologist with UT Health, San Antonio, and an author of each of three studies.
“We learned that Hispanic patients were presenting with more aggressive histologies such as HER2-positive and triple-negative disease. We also confirmed what we were suspecting, which is that Latina women had less access to medical coverage. We had a higher proportion of Hispanic patients presenting to us without medical coverage, which of course made the treatment extremely challenging,” said Dr. Mazo.
Hispanics are one of the fastest-growing minority groups in the United States, and understanding the factors that affect their healthcare is critical to formulating health policies.
And I’m sad to say that, even after everything opened up and people could get vaccinated, I still saw some patients who, for whatever reason, did not get a mammogram – which led to [more] clinical presentations of advanced cancer by the time they were seen by us,” she said.
Dr. Mazo said that underscreened women could also be considered victims of the pandemic. “I tell my patients to get their vaccines so they’re protected and they can feel more comfortable going to the doctor where there is a higher proportion of people who could potentially have COVID.”
Other studies have shown that patients in general, regardless of race or ethnicity, have been diagnosed with later-stage breast cancer diagnoses during the pandemic.
The three studies are based on an analysis of 696 patients treated at Mays Cancer Center. Of these, 264 were diagnosed before the pandemic (cohort A), 171 during the lockdown (Apr. 1 to Dec. 31, 2020, cohort B) and 261 after vaccines were introduced (Jan. 1 to Dec. 31, 2021, cohort C). Overall, there was a slight trend toward a higher incidence of HER2-positive disease during the lockdown period (odds ratio, 1.45) and in the postvaccine period (OR, 1.40), though neither relationship was statistically significant (P = .2). No relationships were seen between time period and incidence of triple-negative breast cancer.
The researchers found that Hispanic patients were more likely to be diagnosed with advanced disease in the pandemic years, compared with pre-COVID times. For example, the likelihood of being diagnosed with carcinoma in situ (Tis) versus T1 disease was lower in the postvaccine era than the pre-COVID era (OR, 0.38; P < .001), although there was no significant difference in Tis versus T1 during the lockdown period, compared with the pre-COVID era. The researchers concluded the difference was likely caused by the latency period of breast cancer.
The postvaccine era saw a 15% increase in patients diagnosed with HER2-positive disease, compared with the pre-COVID era. Patients diagnosed in the COVID era (cohorts B and C) were more likely to require neoadjuvant therapy than patients diagnosed in the pre-COVID era (OR, 1.78; P = .009).
They also found significant disparities in health insurance coverage. 91% of non-Hispanic patients were covered by insurance, compared with 70% of Hispanic patients.
Overall, the findings hint at the depth of health care inequities faced by Hispanic women in the region, and should be a call for action, Dr. Mazo said. “I wish that we as physicians would take the lead to do the best we can to support legislative changes that could help all of our patients get treated – independent of where they come from.”
Dr. Mazo has no relevant financial disclosures.
In a series of studies recently presented at the San Antonio Breast Cancer Symposium that examine the effects of the COVID-19 pandemic on women with breast cancer, researchers report that ethnicity played a role in later diagnoses, Hispanics presented with more advanced and aggressive disease, and a focus on a single hospital in San Antonio finds a statistical difference between stage at diagnosis prior to the pandemic, compared with the postvaccine era.
Patients treated at the Mays Cancer Center, a cancer hospital of University of Texas Health and MD Anderson Cancer Center in San Antonio, during the pandemic were found to more likely present with advanced disease between March and December 2020, according to Marcela Mazo, MD, an oncologist with UT Health, San Antonio, and an author of each of three studies.
“We learned that Hispanic patients were presenting with more aggressive histologies such as HER2-positive and triple-negative disease. We also confirmed what we were suspecting, which is that Latina women had less access to medical coverage. We had a higher proportion of Hispanic patients presenting to us without medical coverage, which of course made the treatment extremely challenging,” said Dr. Mazo.
Hispanics are one of the fastest-growing minority groups in the United States, and understanding the factors that affect their healthcare is critical to formulating health policies.
And I’m sad to say that, even after everything opened up and people could get vaccinated, I still saw some patients who, for whatever reason, did not get a mammogram – which led to [more] clinical presentations of advanced cancer by the time they were seen by us,” she said.
Dr. Mazo said that underscreened women could also be considered victims of the pandemic. “I tell my patients to get their vaccines so they’re protected and they can feel more comfortable going to the doctor where there is a higher proportion of people who could potentially have COVID.”
Other studies have shown that patients in general, regardless of race or ethnicity, have been diagnosed with later-stage breast cancer diagnoses during the pandemic.
The three studies are based on an analysis of 696 patients treated at Mays Cancer Center. Of these, 264 were diagnosed before the pandemic (cohort A), 171 during the lockdown (Apr. 1 to Dec. 31, 2020, cohort B) and 261 after vaccines were introduced (Jan. 1 to Dec. 31, 2021, cohort C). Overall, there was a slight trend toward a higher incidence of HER2-positive disease during the lockdown period (odds ratio, 1.45) and in the postvaccine period (OR, 1.40), though neither relationship was statistically significant (P = .2). No relationships were seen between time period and incidence of triple-negative breast cancer.
The researchers found that Hispanic patients were more likely to be diagnosed with advanced disease in the pandemic years, compared with pre-COVID times. For example, the likelihood of being diagnosed with carcinoma in situ (Tis) versus T1 disease was lower in the postvaccine era than the pre-COVID era (OR, 0.38; P < .001), although there was no significant difference in Tis versus T1 during the lockdown period, compared with the pre-COVID era. The researchers concluded the difference was likely caused by the latency period of breast cancer.
The postvaccine era saw a 15% increase in patients diagnosed with HER2-positive disease, compared with the pre-COVID era. Patients diagnosed in the COVID era (cohorts B and C) were more likely to require neoadjuvant therapy than patients diagnosed in the pre-COVID era (OR, 1.78; P = .009).
They also found significant disparities in health insurance coverage. 91% of non-Hispanic patients were covered by insurance, compared with 70% of Hispanic patients.
Overall, the findings hint at the depth of health care inequities faced by Hispanic women in the region, and should be a call for action, Dr. Mazo said. “I wish that we as physicians would take the lead to do the best we can to support legislative changes that could help all of our patients get treated – independent of where they come from.”
Dr. Mazo has no relevant financial disclosures.
In a series of studies recently presented at the San Antonio Breast Cancer Symposium that examine the effects of the COVID-19 pandemic on women with breast cancer, researchers report that ethnicity played a role in later diagnoses, Hispanics presented with more advanced and aggressive disease, and a focus on a single hospital in San Antonio finds a statistical difference between stage at diagnosis prior to the pandemic, compared with the postvaccine era.
Patients treated at the Mays Cancer Center, a cancer hospital of University of Texas Health and MD Anderson Cancer Center in San Antonio, during the pandemic were found to more likely present with advanced disease between March and December 2020, according to Marcela Mazo, MD, an oncologist with UT Health, San Antonio, and an author of each of three studies.
“We learned that Hispanic patients were presenting with more aggressive histologies such as HER2-positive and triple-negative disease. We also confirmed what we were suspecting, which is that Latina women had less access to medical coverage. We had a higher proportion of Hispanic patients presenting to us without medical coverage, which of course made the treatment extremely challenging,” said Dr. Mazo.
Hispanics are one of the fastest-growing minority groups in the United States, and understanding the factors that affect their healthcare is critical to formulating health policies.
And I’m sad to say that, even after everything opened up and people could get vaccinated, I still saw some patients who, for whatever reason, did not get a mammogram – which led to [more] clinical presentations of advanced cancer by the time they were seen by us,” she said.
Dr. Mazo said that underscreened women could also be considered victims of the pandemic. “I tell my patients to get their vaccines so they’re protected and they can feel more comfortable going to the doctor where there is a higher proportion of people who could potentially have COVID.”
Other studies have shown that patients in general, regardless of race or ethnicity, have been diagnosed with later-stage breast cancer diagnoses during the pandemic.
The three studies are based on an analysis of 696 patients treated at Mays Cancer Center. Of these, 264 were diagnosed before the pandemic (cohort A), 171 during the lockdown (Apr. 1 to Dec. 31, 2020, cohort B) and 261 after vaccines were introduced (Jan. 1 to Dec. 31, 2021, cohort C). Overall, there was a slight trend toward a higher incidence of HER2-positive disease during the lockdown period (odds ratio, 1.45) and in the postvaccine period (OR, 1.40), though neither relationship was statistically significant (P = .2). No relationships were seen between time period and incidence of triple-negative breast cancer.
The researchers found that Hispanic patients were more likely to be diagnosed with advanced disease in the pandemic years, compared with pre-COVID times. For example, the likelihood of being diagnosed with carcinoma in situ (Tis) versus T1 disease was lower in the postvaccine era than the pre-COVID era (OR, 0.38; P < .001), although there was no significant difference in Tis versus T1 during the lockdown period, compared with the pre-COVID era. The researchers concluded the difference was likely caused by the latency period of breast cancer.
The postvaccine era saw a 15% increase in patients diagnosed with HER2-positive disease, compared with the pre-COVID era. Patients diagnosed in the COVID era (cohorts B and C) were more likely to require neoadjuvant therapy than patients diagnosed in the pre-COVID era (OR, 1.78; P = .009).
They also found significant disparities in health insurance coverage. 91% of non-Hispanic patients were covered by insurance, compared with 70% of Hispanic patients.
Overall, the findings hint at the depth of health care inequities faced by Hispanic women in the region, and should be a call for action, Dr. Mazo said. “I wish that we as physicians would take the lead to do the best we can to support legislative changes that could help all of our patients get treated – independent of where they come from.”
Dr. Mazo has no relevant financial disclosures.
FROM SABCS 2022
Structural racism tied to later-stage breast cancer diagnoses
A new study recently presented at the San Antonio Breast Cancer Symposium found that patients in economically and racially/ethnically marginalized neighborhoods are more likely to present with breast cancer at later stages of the disease.
“ through several mechanisms, such as access to health care, particularly through limited breast cancer mammographic screening,” said the study’s author, Neha Goel, MD, an assistant professor of surgery at the University of Miami.
The findings are based on an analysis of data from the neighborhood indicator called the Index of Concentration at the Extremes, a database that focuses on the distribution of concentrations of privilege and deprivation, rather than comparing individual or household levels. This is important because growing concentrations of extreme wealth and extreme poverty are becoming increasingly common, and these are not properties discernible by measures by individuals or households. The indicator considers concentration of privilege and deprivation independently, unlike typical models that combine these factors. Doing so reduces bias that can occur in statistical models where these two factors can influence one another. “It brings subtle social inequalities and polarization to the forefront and maps a critical dimension of social inequality,” Dr. Goel said.
Researchers defined structural racism based on its effects, such as separation of marginalized economic and racial/ethnic groups, as well as classism that occurs as a result of discriminatory housing policies over decades. The American Medical Association defines structural racism as the “totality of ways in which societies foster racial discrimination through mutually reinforcing systems of housing, education, employment, earnings, benefits, credit, media, health care and criminal justice.” It considers racism, structural racism, and unconscious biases within medical research and health care delivery to be public health threats. The AMA calls for educational and continuing medical education programs to promote an understanding of all forms of racism, and methods for preventing or reducing the health effects of racism.
The final analysis included 6,145 patients (52.6% Hispanic, 26.3 White, and 17.2% Black) who were treated for breast cancer between 2005 and 2017. At 45.2%, nearly half of participants were privately insured.
Five models were created comparing the likelihood of being diagnosed with a more advance stage tumor (stage 3-4 vs. stage 1-2) between the most disadvantage quartile and the most advantaged group quartile. They found significant relationships for low versus high economic segregation for both the most disadvantaged quartile (odds ratio, 1.36; P < .05) and the second-most disadvantaged quartile (OR, 1.43; P < .05); low-income Black versus high-income White patients in both the most disadvantage quartile (OR, 1.55; P < .05) and the second-most disadvantaged quartile (OR, 1.44; P < .05); Hispanic versus non-Hispanic ethnicity in the most disadvantaged quartile (OR, 1.32; P < .05), and low-income Hispanics versus high-income Whites in both the most disadvantaged quartile (OR, 1.43; P < .05) and the second-most disadvantaged quartile (OR, 1.56; P < .05).
Black patients were more likely to be diagnosed with triple-negative breast cancer than White patients (25.1% vs. 12.5%; P < .001).
The findings suggest that both economically disadvantaged patients and those in racially or ethnically marginalized neighborhoods had a greater probability of having later-stage disease at diagnosis. The researchers controlled for age, insurance status, tumor subtype, and comorbidities like diabetes, coronary artery disease, and hyperlipidemia.
“This study adds insight to a growing body of literature that demonstrate how the ecological effects of structural racism – expressed through poverty and residential segregation – shape cancer outcomes across patients of all races [and] ethnicities,” Dr. Goel said.
Dr. Goel has no relevant financial disclosures.
A new study recently presented at the San Antonio Breast Cancer Symposium found that patients in economically and racially/ethnically marginalized neighborhoods are more likely to present with breast cancer at later stages of the disease.
“ through several mechanisms, such as access to health care, particularly through limited breast cancer mammographic screening,” said the study’s author, Neha Goel, MD, an assistant professor of surgery at the University of Miami.
The findings are based on an analysis of data from the neighborhood indicator called the Index of Concentration at the Extremes, a database that focuses on the distribution of concentrations of privilege and deprivation, rather than comparing individual or household levels. This is important because growing concentrations of extreme wealth and extreme poverty are becoming increasingly common, and these are not properties discernible by measures by individuals or households. The indicator considers concentration of privilege and deprivation independently, unlike typical models that combine these factors. Doing so reduces bias that can occur in statistical models where these two factors can influence one another. “It brings subtle social inequalities and polarization to the forefront and maps a critical dimension of social inequality,” Dr. Goel said.
Researchers defined structural racism based on its effects, such as separation of marginalized economic and racial/ethnic groups, as well as classism that occurs as a result of discriminatory housing policies over decades. The American Medical Association defines structural racism as the “totality of ways in which societies foster racial discrimination through mutually reinforcing systems of housing, education, employment, earnings, benefits, credit, media, health care and criminal justice.” It considers racism, structural racism, and unconscious biases within medical research and health care delivery to be public health threats. The AMA calls for educational and continuing medical education programs to promote an understanding of all forms of racism, and methods for preventing or reducing the health effects of racism.
The final analysis included 6,145 patients (52.6% Hispanic, 26.3 White, and 17.2% Black) who were treated for breast cancer between 2005 and 2017. At 45.2%, nearly half of participants were privately insured.
Five models were created comparing the likelihood of being diagnosed with a more advance stage tumor (stage 3-4 vs. stage 1-2) between the most disadvantage quartile and the most advantaged group quartile. They found significant relationships for low versus high economic segregation for both the most disadvantaged quartile (odds ratio, 1.36; P < .05) and the second-most disadvantaged quartile (OR, 1.43; P < .05); low-income Black versus high-income White patients in both the most disadvantage quartile (OR, 1.55; P < .05) and the second-most disadvantaged quartile (OR, 1.44; P < .05); Hispanic versus non-Hispanic ethnicity in the most disadvantaged quartile (OR, 1.32; P < .05), and low-income Hispanics versus high-income Whites in both the most disadvantaged quartile (OR, 1.43; P < .05) and the second-most disadvantaged quartile (OR, 1.56; P < .05).
Black patients were more likely to be diagnosed with triple-negative breast cancer than White patients (25.1% vs. 12.5%; P < .001).
The findings suggest that both economically disadvantaged patients and those in racially or ethnically marginalized neighborhoods had a greater probability of having later-stage disease at diagnosis. The researchers controlled for age, insurance status, tumor subtype, and comorbidities like diabetes, coronary artery disease, and hyperlipidemia.
“This study adds insight to a growing body of literature that demonstrate how the ecological effects of structural racism – expressed through poverty and residential segregation – shape cancer outcomes across patients of all races [and] ethnicities,” Dr. Goel said.
Dr. Goel has no relevant financial disclosures.
A new study recently presented at the San Antonio Breast Cancer Symposium found that patients in economically and racially/ethnically marginalized neighborhoods are more likely to present with breast cancer at later stages of the disease.
“ through several mechanisms, such as access to health care, particularly through limited breast cancer mammographic screening,” said the study’s author, Neha Goel, MD, an assistant professor of surgery at the University of Miami.
The findings are based on an analysis of data from the neighborhood indicator called the Index of Concentration at the Extremes, a database that focuses on the distribution of concentrations of privilege and deprivation, rather than comparing individual or household levels. This is important because growing concentrations of extreme wealth and extreme poverty are becoming increasingly common, and these are not properties discernible by measures by individuals or households. The indicator considers concentration of privilege and deprivation independently, unlike typical models that combine these factors. Doing so reduces bias that can occur in statistical models where these two factors can influence one another. “It brings subtle social inequalities and polarization to the forefront and maps a critical dimension of social inequality,” Dr. Goel said.
Researchers defined structural racism based on its effects, such as separation of marginalized economic and racial/ethnic groups, as well as classism that occurs as a result of discriminatory housing policies over decades. The American Medical Association defines structural racism as the “totality of ways in which societies foster racial discrimination through mutually reinforcing systems of housing, education, employment, earnings, benefits, credit, media, health care and criminal justice.” It considers racism, structural racism, and unconscious biases within medical research and health care delivery to be public health threats. The AMA calls for educational and continuing medical education programs to promote an understanding of all forms of racism, and methods for preventing or reducing the health effects of racism.
The final analysis included 6,145 patients (52.6% Hispanic, 26.3 White, and 17.2% Black) who were treated for breast cancer between 2005 and 2017. At 45.2%, nearly half of participants were privately insured.
Five models were created comparing the likelihood of being diagnosed with a more advance stage tumor (stage 3-4 vs. stage 1-2) between the most disadvantage quartile and the most advantaged group quartile. They found significant relationships for low versus high economic segregation for both the most disadvantaged quartile (odds ratio, 1.36; P < .05) and the second-most disadvantaged quartile (OR, 1.43; P < .05); low-income Black versus high-income White patients in both the most disadvantage quartile (OR, 1.55; P < .05) and the second-most disadvantaged quartile (OR, 1.44; P < .05); Hispanic versus non-Hispanic ethnicity in the most disadvantaged quartile (OR, 1.32; P < .05), and low-income Hispanics versus high-income Whites in both the most disadvantaged quartile (OR, 1.43; P < .05) and the second-most disadvantaged quartile (OR, 1.56; P < .05).
Black patients were more likely to be diagnosed with triple-negative breast cancer than White patients (25.1% vs. 12.5%; P < .001).
The findings suggest that both economically disadvantaged patients and those in racially or ethnically marginalized neighborhoods had a greater probability of having later-stage disease at diagnosis. The researchers controlled for age, insurance status, tumor subtype, and comorbidities like diabetes, coronary artery disease, and hyperlipidemia.
“This study adds insight to a growing body of literature that demonstrate how the ecological effects of structural racism – expressed through poverty and residential segregation – shape cancer outcomes across patients of all races [and] ethnicities,” Dr. Goel said.
Dr. Goel has no relevant financial disclosures.
FROM SABCS 2022
Adjuvant chemo tied to better survival in low-risk node-positive breast cancer
A retrospective analysis of the National Cancer Database suggests an overall survival benefit to adjuvant chemotherapy among breast cancer patients with an OncotypeDX score of 25 or less. The findings reinforce the positive results from the RxPONDER study, which showed benefits to invasive disease–free and distant relapse–free survival.
OncotypeDX is a prognostic assay for hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative and axillary lymph-node–negative breast cancer. It measures expression of 21 different genes and assigns each patient a score between 0 and 100, with higher scores representing a greater risk of recurrence and a worse prognosis. The 2018 TAILORx study validated Oncotype DX and found no benefit of adjuvant chemotherapy added to endocrine therapy in women over 50 with an OncotypeDX score of 11-25, but it did find a benefit in women under 50 years old with a score of 16 or higher.
RxPONDER was a prospective study that randomized women with Oncotype DX scores of 25 or lower and 1-3 positive lymph nodes to adjuvant endocrine therapy with or without chemotherapy. Among premenopausal women, 5-year invasive disease–free survival was 93.9% with chemotherapy and 89.0% with endocrine therapy only (hazard ratio, 0.60; P = .002), while distant relapse–free survival was 96.1% and 92.8%, respectively (HR, 0.58; P = .009).
Overall survival data from RxPONDER has yet to be reported. In the meantime, “We decided to use the National Cancer database to see if this group of patients have an overall survival benefit,” said Prashanth Ashok Kumar, MBBS, who presented the results of the new study at a poster session this month during the 2022 San Antonio Breast Cancer Symposium.
“Our research further supports the findings of the RxPONDER trial showing that this subgroup of patients may also have an overall survival benefit with adjuvant chemotherapy. We can give physicians a little bit more confidence to recommend the findings of the RxPONDER study to their patients and could recommend chemotherapy in this group,” said Dr. Kumar, who is a second-year oncology fellow at Upstate University Hospital. Syracuse, N.Y.
The study is limited by its retrospective nature, but Dr. Kumar said that the researchers used propensity score matching to reduce confounding. “This would need to be confirmed with further prospective clinical trials and also the mature data from the RxPONDER trial is something that we have to look forward to,” he said.
Adjuvant therapy might be particularly beneficial to patients with more high-risk features, such as T4 or N2 or N3 disease. “We have to go with each individual patient’s features, and also the patient’s personal preference and what they want from their quality of life,” Dr. Kumar said.
The study included 8,628 patients from the 2004-2018 National Cancer Database participant user file. They were 18-50 years old with N1-N3 lymph node status, no metastasis, and any T stage. All had an OncotypeDX score of 25 or less and were hormone receptor–positive and HER2-negative while 40.8% underwent adjuvant chemotherapy.
Unadjusted Kaplan-Meier scores showed a slightly higher 10-year survival with adjuvant chemotherapy (93% versus 91%; HR, 0.602; 95% confidence interval, 0.482-0.751). Multivariate subanalyses showed that adjuvant chemotherapy was associated with better survival among White patients (HR, 0.512; 95% CI, 0.348-0.752) between 18 and 40 years old (HR, 0.429; 95% CI, 0.217-0.847), and for patients between 40 and 50 years old (HR, 0.585; 95% CI, 0.394-0.869); among patients with poorly differentiated tumors (HR, 0.404; 95% CI, 0.186-0.874); among patients with well-differentiated tumors (HR, 0.386; 95% CI, 0.165-0.903); and for those with Oncotype DX scores between 12 and 25 (HR, 0.549; 95% CI, 0.379-0.795).
Dr. Kumar has no relevant financial disclosures.
A retrospective analysis of the National Cancer Database suggests an overall survival benefit to adjuvant chemotherapy among breast cancer patients with an OncotypeDX score of 25 or less. The findings reinforce the positive results from the RxPONDER study, which showed benefits to invasive disease–free and distant relapse–free survival.
OncotypeDX is a prognostic assay for hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative and axillary lymph-node–negative breast cancer. It measures expression of 21 different genes and assigns each patient a score between 0 and 100, with higher scores representing a greater risk of recurrence and a worse prognosis. The 2018 TAILORx study validated Oncotype DX and found no benefit of adjuvant chemotherapy added to endocrine therapy in women over 50 with an OncotypeDX score of 11-25, but it did find a benefit in women under 50 years old with a score of 16 or higher.
RxPONDER was a prospective study that randomized women with Oncotype DX scores of 25 or lower and 1-3 positive lymph nodes to adjuvant endocrine therapy with or without chemotherapy. Among premenopausal women, 5-year invasive disease–free survival was 93.9% with chemotherapy and 89.0% with endocrine therapy only (hazard ratio, 0.60; P = .002), while distant relapse–free survival was 96.1% and 92.8%, respectively (HR, 0.58; P = .009).
Overall survival data from RxPONDER has yet to be reported. In the meantime, “We decided to use the National Cancer database to see if this group of patients have an overall survival benefit,” said Prashanth Ashok Kumar, MBBS, who presented the results of the new study at a poster session this month during the 2022 San Antonio Breast Cancer Symposium.
“Our research further supports the findings of the RxPONDER trial showing that this subgroup of patients may also have an overall survival benefit with adjuvant chemotherapy. We can give physicians a little bit more confidence to recommend the findings of the RxPONDER study to their patients and could recommend chemotherapy in this group,” said Dr. Kumar, who is a second-year oncology fellow at Upstate University Hospital. Syracuse, N.Y.
The study is limited by its retrospective nature, but Dr. Kumar said that the researchers used propensity score matching to reduce confounding. “This would need to be confirmed with further prospective clinical trials and also the mature data from the RxPONDER trial is something that we have to look forward to,” he said.
Adjuvant therapy might be particularly beneficial to patients with more high-risk features, such as T4 or N2 or N3 disease. “We have to go with each individual patient’s features, and also the patient’s personal preference and what they want from their quality of life,” Dr. Kumar said.
The study included 8,628 patients from the 2004-2018 National Cancer Database participant user file. They were 18-50 years old with N1-N3 lymph node status, no metastasis, and any T stage. All had an OncotypeDX score of 25 or less and were hormone receptor–positive and HER2-negative while 40.8% underwent adjuvant chemotherapy.
Unadjusted Kaplan-Meier scores showed a slightly higher 10-year survival with adjuvant chemotherapy (93% versus 91%; HR, 0.602; 95% confidence interval, 0.482-0.751). Multivariate subanalyses showed that adjuvant chemotherapy was associated with better survival among White patients (HR, 0.512; 95% CI, 0.348-0.752) between 18 and 40 years old (HR, 0.429; 95% CI, 0.217-0.847), and for patients between 40 and 50 years old (HR, 0.585; 95% CI, 0.394-0.869); among patients with poorly differentiated tumors (HR, 0.404; 95% CI, 0.186-0.874); among patients with well-differentiated tumors (HR, 0.386; 95% CI, 0.165-0.903); and for those with Oncotype DX scores between 12 and 25 (HR, 0.549; 95% CI, 0.379-0.795).
Dr. Kumar has no relevant financial disclosures.
A retrospective analysis of the National Cancer Database suggests an overall survival benefit to adjuvant chemotherapy among breast cancer patients with an OncotypeDX score of 25 or less. The findings reinforce the positive results from the RxPONDER study, which showed benefits to invasive disease–free and distant relapse–free survival.
OncotypeDX is a prognostic assay for hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative and axillary lymph-node–negative breast cancer. It measures expression of 21 different genes and assigns each patient a score between 0 and 100, with higher scores representing a greater risk of recurrence and a worse prognosis. The 2018 TAILORx study validated Oncotype DX and found no benefit of adjuvant chemotherapy added to endocrine therapy in women over 50 with an OncotypeDX score of 11-25, but it did find a benefit in women under 50 years old with a score of 16 or higher.
RxPONDER was a prospective study that randomized women with Oncotype DX scores of 25 or lower and 1-3 positive lymph nodes to adjuvant endocrine therapy with or without chemotherapy. Among premenopausal women, 5-year invasive disease–free survival was 93.9% with chemotherapy and 89.0% with endocrine therapy only (hazard ratio, 0.60; P = .002), while distant relapse–free survival was 96.1% and 92.8%, respectively (HR, 0.58; P = .009).
Overall survival data from RxPONDER has yet to be reported. In the meantime, “We decided to use the National Cancer database to see if this group of patients have an overall survival benefit,” said Prashanth Ashok Kumar, MBBS, who presented the results of the new study at a poster session this month during the 2022 San Antonio Breast Cancer Symposium.
“Our research further supports the findings of the RxPONDER trial showing that this subgroup of patients may also have an overall survival benefit with adjuvant chemotherapy. We can give physicians a little bit more confidence to recommend the findings of the RxPONDER study to their patients and could recommend chemotherapy in this group,” said Dr. Kumar, who is a second-year oncology fellow at Upstate University Hospital. Syracuse, N.Y.
The study is limited by its retrospective nature, but Dr. Kumar said that the researchers used propensity score matching to reduce confounding. “This would need to be confirmed with further prospective clinical trials and also the mature data from the RxPONDER trial is something that we have to look forward to,” he said.
Adjuvant therapy might be particularly beneficial to patients with more high-risk features, such as T4 or N2 or N3 disease. “We have to go with each individual patient’s features, and also the patient’s personal preference and what they want from their quality of life,” Dr. Kumar said.
The study included 8,628 patients from the 2004-2018 National Cancer Database participant user file. They were 18-50 years old with N1-N3 lymph node status, no metastasis, and any T stage. All had an OncotypeDX score of 25 or less and were hormone receptor–positive and HER2-negative while 40.8% underwent adjuvant chemotherapy.
Unadjusted Kaplan-Meier scores showed a slightly higher 10-year survival with adjuvant chemotherapy (93% versus 91%; HR, 0.602; 95% confidence interval, 0.482-0.751). Multivariate subanalyses showed that adjuvant chemotherapy was associated with better survival among White patients (HR, 0.512; 95% CI, 0.348-0.752) between 18 and 40 years old (HR, 0.429; 95% CI, 0.217-0.847), and for patients between 40 and 50 years old (HR, 0.585; 95% CI, 0.394-0.869); among patients with poorly differentiated tumors (HR, 0.404; 95% CI, 0.186-0.874); among patients with well-differentiated tumors (HR, 0.386; 95% CI, 0.165-0.903); and for those with Oncotype DX scores between 12 and 25 (HR, 0.549; 95% CI, 0.379-0.795).
Dr. Kumar has no relevant financial disclosures.
FROM SABCS 2022
‘Dr. Pimple Popper’ offers tips for building a social media presence
SAN DIEGO – In the fall of 2014, Sandra Lee, MD, posted a blackhead extraction video on her Instagram account, a decision that changed her professional life forever.
“I got these crazy comments,” Dr. Lee, a dermatologist who practices in Upland, Calif., recalled at the annual Masters of Aesthetics Symposium. “Either people loved it – they were obsessed – or they thought it was the most disgusting thing they’d ever seen. It created a strong reaction. Either way, they shared it with their friends.”
Soon after she started posting videos, she discovered Reddit, which has a subreddit for “popping addicts” and the “pop-curious.” “I thought, ‘These videos are so amateur. They’re culling them from the Internet. Or, they’re pinning down their son at the beach and trying to squeeze out a blackhead,’ ” Dr. Lee said. “I thought, ‘I could give them pristine videos,’ ” and that is exactly what she did.
Turning to YouTube as a platform, she began to post videos showing everything from Mohs surgery and Botox injections to keloid removals and ear lobe repair surgeries. With this, . She also grew 16.2 million subscribers on TikTok, 4.5 million followers on Instagram, 2.9 million on Facebook, and 136,700 on Twitter.
About 80% of her followers are women who range between 18 and 40 years of age. “I have over 5 billion views on YouTube, which is mind-blowing,” she said. “That tells you something about the content. It’s not something people watch once. They watch it over and over again.” These include videos compiled as a “bedtime story.”
Dr. Lee offered the following pearls of advice for dermatologists looking to build and maintain a presence on social media:
Use it to showcase what makes you unique. Post what you do on social media, and people will find you. “It’s an opportunity to freely advertise,” Dr. Lee said. “I’m super nitpicky about posting good before-and-after photos. You can also show off how nice and warm and inviting your office is. People come to see me because they know my voice. They know how I interact with patients. That is reason for them enough to travel from far away to see me. It doesn’t mean that I’m the person who is best at treating whatever condition they have.”
Make it interesting. “I say that the special sauce is entertainment and education,” said Dr. Lee, who is in the fifth season of “Dr. Pimple Popper,” her TV show that airs internationally. “The only way you can draw people in is by entertaining them, catching their interest. But I try to trick them into educating them. Five-year-old kids come up to me now and know what a lipoma is. I’m proud of that.”
Be authentic. You may be using social media to promote your dermatology practice, but it’s important for followers to get a glimpse of your nonwork personality as well. Maybe that means posting a photo of yourself at a concert, baseball game, or dinner with family and friends. “Show that you have a sense of humor, because you want them to like you,” Dr. Lee added. “That’s why someone follows you, because they want to be your friend. They enjoy spending time with you on the Internet. It’s like gambling. In order to win, you have to play. So, you have to post.”
Avoid hot-button topics. “I don’t post about my kids, and I try to choose sponsorships wisely,” she said. “I do very few branding deals. Be careful about your brand and how you present yourself. Present yourself in an authentic way, but not in a way that hurts yourself or the dermatology profession.”
Be mindful of the time investment. “It’s like running a whole other business,” Dr. Lee said. “There are also trolls out there, so you have to have thick skin.”
Don’t sweat it if you don’t want to engage. “Not everybody wants to do it, and not everybody will be good at it, but that’s okay,” she said.
Dr. Lee reported having no relevant disclosures.
SAN DIEGO – In the fall of 2014, Sandra Lee, MD, posted a blackhead extraction video on her Instagram account, a decision that changed her professional life forever.
“I got these crazy comments,” Dr. Lee, a dermatologist who practices in Upland, Calif., recalled at the annual Masters of Aesthetics Symposium. “Either people loved it – they were obsessed – or they thought it was the most disgusting thing they’d ever seen. It created a strong reaction. Either way, they shared it with their friends.”
Soon after she started posting videos, she discovered Reddit, which has a subreddit for “popping addicts” and the “pop-curious.” “I thought, ‘These videos are so amateur. They’re culling them from the Internet. Or, they’re pinning down their son at the beach and trying to squeeze out a blackhead,’ ” Dr. Lee said. “I thought, ‘I could give them pristine videos,’ ” and that is exactly what she did.
Turning to YouTube as a platform, she began to post videos showing everything from Mohs surgery and Botox injections to keloid removals and ear lobe repair surgeries. With this, . She also grew 16.2 million subscribers on TikTok, 4.5 million followers on Instagram, 2.9 million on Facebook, and 136,700 on Twitter.
About 80% of her followers are women who range between 18 and 40 years of age. “I have over 5 billion views on YouTube, which is mind-blowing,” she said. “That tells you something about the content. It’s not something people watch once. They watch it over and over again.” These include videos compiled as a “bedtime story.”
Dr. Lee offered the following pearls of advice for dermatologists looking to build and maintain a presence on social media:
Use it to showcase what makes you unique. Post what you do on social media, and people will find you. “It’s an opportunity to freely advertise,” Dr. Lee said. “I’m super nitpicky about posting good before-and-after photos. You can also show off how nice and warm and inviting your office is. People come to see me because they know my voice. They know how I interact with patients. That is reason for them enough to travel from far away to see me. It doesn’t mean that I’m the person who is best at treating whatever condition they have.”
Make it interesting. “I say that the special sauce is entertainment and education,” said Dr. Lee, who is in the fifth season of “Dr. Pimple Popper,” her TV show that airs internationally. “The only way you can draw people in is by entertaining them, catching their interest. But I try to trick them into educating them. Five-year-old kids come up to me now and know what a lipoma is. I’m proud of that.”
Be authentic. You may be using social media to promote your dermatology practice, but it’s important for followers to get a glimpse of your nonwork personality as well. Maybe that means posting a photo of yourself at a concert, baseball game, or dinner with family and friends. “Show that you have a sense of humor, because you want them to like you,” Dr. Lee added. “That’s why someone follows you, because they want to be your friend. They enjoy spending time with you on the Internet. It’s like gambling. In order to win, you have to play. So, you have to post.”
Avoid hot-button topics. “I don’t post about my kids, and I try to choose sponsorships wisely,” she said. “I do very few branding deals. Be careful about your brand and how you present yourself. Present yourself in an authentic way, but not in a way that hurts yourself or the dermatology profession.”
Be mindful of the time investment. “It’s like running a whole other business,” Dr. Lee said. “There are also trolls out there, so you have to have thick skin.”
Don’t sweat it if you don’t want to engage. “Not everybody wants to do it, and not everybody will be good at it, but that’s okay,” she said.
Dr. Lee reported having no relevant disclosures.
SAN DIEGO – In the fall of 2014, Sandra Lee, MD, posted a blackhead extraction video on her Instagram account, a decision that changed her professional life forever.
“I got these crazy comments,” Dr. Lee, a dermatologist who practices in Upland, Calif., recalled at the annual Masters of Aesthetics Symposium. “Either people loved it – they were obsessed – or they thought it was the most disgusting thing they’d ever seen. It created a strong reaction. Either way, they shared it with their friends.”
Soon after she started posting videos, she discovered Reddit, which has a subreddit for “popping addicts” and the “pop-curious.” “I thought, ‘These videos are so amateur. They’re culling them from the Internet. Or, they’re pinning down their son at the beach and trying to squeeze out a blackhead,’ ” Dr. Lee said. “I thought, ‘I could give them pristine videos,’ ” and that is exactly what she did.
Turning to YouTube as a platform, she began to post videos showing everything from Mohs surgery and Botox injections to keloid removals and ear lobe repair surgeries. With this, . She also grew 16.2 million subscribers on TikTok, 4.5 million followers on Instagram, 2.9 million on Facebook, and 136,700 on Twitter.
About 80% of her followers are women who range between 18 and 40 years of age. “I have over 5 billion views on YouTube, which is mind-blowing,” she said. “That tells you something about the content. It’s not something people watch once. They watch it over and over again.” These include videos compiled as a “bedtime story.”
Dr. Lee offered the following pearls of advice for dermatologists looking to build and maintain a presence on social media:
Use it to showcase what makes you unique. Post what you do on social media, and people will find you. “It’s an opportunity to freely advertise,” Dr. Lee said. “I’m super nitpicky about posting good before-and-after photos. You can also show off how nice and warm and inviting your office is. People come to see me because they know my voice. They know how I interact with patients. That is reason for them enough to travel from far away to see me. It doesn’t mean that I’m the person who is best at treating whatever condition they have.”
Make it interesting. “I say that the special sauce is entertainment and education,” said Dr. Lee, who is in the fifth season of “Dr. Pimple Popper,” her TV show that airs internationally. “The only way you can draw people in is by entertaining them, catching their interest. But I try to trick them into educating them. Five-year-old kids come up to me now and know what a lipoma is. I’m proud of that.”
Be authentic. You may be using social media to promote your dermatology practice, but it’s important for followers to get a glimpse of your nonwork personality as well. Maybe that means posting a photo of yourself at a concert, baseball game, or dinner with family and friends. “Show that you have a sense of humor, because you want them to like you,” Dr. Lee added. “That’s why someone follows you, because they want to be your friend. They enjoy spending time with you on the Internet. It’s like gambling. In order to win, you have to play. So, you have to post.”
Avoid hot-button topics. “I don’t post about my kids, and I try to choose sponsorships wisely,” she said. “I do very few branding deals. Be careful about your brand and how you present yourself. Present yourself in an authentic way, but not in a way that hurts yourself or the dermatology profession.”
Be mindful of the time investment. “It’s like running a whole other business,” Dr. Lee said. “There are also trolls out there, so you have to have thick skin.”
Don’t sweat it if you don’t want to engage. “Not everybody wants to do it, and not everybody will be good at it, but that’s okay,” she said.
Dr. Lee reported having no relevant disclosures.
AT MOAS 2022
Exciting advances in HR-positive breast cancer: Top five picks from SABCS
SAN ANTONIO –
This news organization spoke with SABCS program director Virginia Kaklamani, MD, leader of the Breast Cancer Program at UT Health, San Antonio, and Jason A. Mouabbi, MD, of the University of Texas MD Anderson Cancer Center, Houston, about their top five picks on HR-positive disease – the research they were most excited about and what the findings could mean for clinical practice and patient outcomes.
1. Addressing an unmet need
Data from the phase 3 CAPItello-291 clinical trial showed that the addition of the investigational AKT inhibitor capivasertib to fulvestrant resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) among 708 patients with HR-positive, HER2-negative advanced breast cancer, compared with those who received placebo plus fulvestrant (GS3-04).
For patients treated with capivasertib plus fulvestrant, median PFS was 7.2 months, compared with 3.6 months for those who received placebo plus fulvestrant (hazard ratio, 0.60). Among patients assigned to the capivasertib group, 41% had tumors with AKT pathway mutations. In this group, the median PFS was 7.3 months vs. 3.1 months in the placebo cohort. The objective response rate among patients with measurable disease was 23% overall in the capivasertib group, compared with 12.2% in the placebo arm; it was 28.8% vs. 9.7% among the patients with AKT alterations.
Dr. Mouabbi noted that the study “met its primary endpoint” and that, importantly, it “addresses an area of unmet need.”
“The study’s treatment targets the PI3K/AKT/mTOR pathway, which is a very active pathway in hormone-positive metastatic breast cancer,” Dr. Mouabbi explained. He noted, “We’ve always wanted to tackle that pathway effectively, and it looks like this drug can do that.”
2. Next-generation SERD
Data from the phase 2 SERENA-2 trial offers evidence that camizestrant, a next-generation selective estrogen-receptor degrader (SERD), improved PFS compared with fulvestrant for patients with HR-positive, HER2-negative breast cancer (GS3-02).
Overall, 240 patients were randomly assigned to receive camizestrant monotherapy at various doses or fulvestrant at 500 mg. Among patients who received camizestrant 75 mg, median PFS was 7.2 months; among those who received camizestrant 150 mg, PFS was slightly longer, at 7.7 months vs. 3.7 months for patients treated with fulvestrant. Compared with fulvestrant, camizestrant reduced the risk of disease progression by 42% at 75 mg (HR, 0.58) and by 33% at 150 mg (HR, 0.67). In a subgroup of patients with ESR1 mutations, camizestrant reduced the risk of disease progression by 67% in the group that received 75 mg and by 45% in the group that received 150 mg, compared with fulvestrant (median PFS, 6.3, 9.2, and 2.2 months, respectively).
“In this trial, camizestrant looks like a more beneficial treatment in the target group,” said Dr. Kaklamani. “This is significant because it means that camizestrant could be used in the future in HR-positive metastatic breast cancer instead of fulvestrant.” In addition, “camizestrant is taken orally and is much more convenient for patients, unlike fulvestrant, which is taken intramuscularly.”
3. Pregnancy risks
Can endocrine therapy be safely interrupted for women with breast cancer who wish to become pregnant? That’s what researchers tried to glean in a recent prospective trial presented at the meeting (GS4-09).
The study enrolled over 500 women for whom endocrine therapy had been stopped in the hopes of their becoming pregnant. Almost all (93.4%) had stage I/II HR-positive breast cancer. The primary objective was to determine the risk of breast cancer relapse associated with interrupting therapy for about 2 years. The authors defined no more than 46 breast cancer–free interval (BCFI) events as the safety threshold. A BCFI event was defined as local, regional, or distant recurrence or a new invasive contralateral breast cancer.
Among 497 women, 368 (74%) had at least one pregnancy and 317 (64%) had at least one live birth, for a total of 365 babies born. At a median follow-up of 41 months, 44 participants experienced a BCFI event, in line with the safety threshold. The 3-year BCFI failure rate was 8.9%, similar to the 9.2% rate in an external control cohort from the SOFT/TEXT trials. In addition, 76.3% of patients resumed endocrine therapy; 15.4% had not yet resumed therapy.
“This trial is more confirmatory but an extremely important step for young women who want to get pregnant after diagnosis and recovery from HR-positive breast cancer,” Dr. Kaklamani said. “It seems that stopping endocrine therapy to become pregnant did not cause any adverse outcomes or increase the risk of reoccurrence of cancer in the women in the study.”
Dr. Mouabbi agreed, noting, “Many of our patients are afraid that they will miss the window to get pregnant because they have to be on treatment for so long. This is the first study that let us know pregnancy and safety outcomes in patients who took a break from endocrine therapy to get pregnant. The results are promising and will be exciting for many of our patients.”
4. Assay identifies OFS benefit
A genomic assay was able to distinguish premenopausal patients with early-stage HR-positive breast cancer who benefited from the addition of ovarian function suppression (OFS) to adjuvant endocrine therapy, according to new data presented at the meeting (GS1-06).
In the study, investigators analyzed 1,717 patient tumor samples from the landmark Suppression of Ovarian Function Trial (SOFT) trial. The Breast Cancer Index identified 58% of women who benefited from the addition of ovarian function suppression to tamoxifen or exemestane therapy. They experienced an absolute benefit of 11.6% (42% did not benefit), compared with those with received tamoxifen alone. The predictive benefit was observed regardless of age, lymph node involvement, and receipt of chemotherapy.
Dr. Kaklamani highlighted this study’s importance, saying, “Ovarian suppression is associated with severe adverse events for patients. Obviously, the women who will get a benefit should continue, but this research is important because it will hopefully show us who to recommend ovarian suppression to while not exposing patients who are likely to get little benefit to unneeded toxicity.”
5. Optimizing elacestrant PFS
Last year, data from the Emerald trial showed that elacestrant is superior to standard-of-care therapy for HR-positive metastatic breast cancer. An update that Dr. Kaklamani presented at SABCS (GS3-01) explored whether the duration of a prior CDK4/6 inhibitor affects PFS.
The study was a randomized, open-label, phase 3 trial in which 478 patients with ER-positive/HER2-negative metastatic breast cancer received either elacestrant or standard of care. These patients had previously received one or two lines of endocrine therapy, a CDK4/6 inhibitor, and ≤ 1 line of chemotherapy.
Overall, the duration of prior CDK4/6 inhibitor in the metastatic setting was positively associated with PFS – the longer the duration of prior CDK4/6 inhibitor therapy, the longer the PFS with elacestrant. PFS outcomes were even stronger among patients with ESR1 mutations.
“What we found was that the women who benefit most from elacestrant had previously received a CDK4/6 inhibitor for at least 6 months,” Dr. Kaklamani said. These data can help us determine who may do best on the drug, she added.
A version of this article first appeared on Medscape.com.
SAN ANTONIO –
This news organization spoke with SABCS program director Virginia Kaklamani, MD, leader of the Breast Cancer Program at UT Health, San Antonio, and Jason A. Mouabbi, MD, of the University of Texas MD Anderson Cancer Center, Houston, about their top five picks on HR-positive disease – the research they were most excited about and what the findings could mean for clinical practice and patient outcomes.
1. Addressing an unmet need
Data from the phase 3 CAPItello-291 clinical trial showed that the addition of the investigational AKT inhibitor capivasertib to fulvestrant resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) among 708 patients with HR-positive, HER2-negative advanced breast cancer, compared with those who received placebo plus fulvestrant (GS3-04).
For patients treated with capivasertib plus fulvestrant, median PFS was 7.2 months, compared with 3.6 months for those who received placebo plus fulvestrant (hazard ratio, 0.60). Among patients assigned to the capivasertib group, 41% had tumors with AKT pathway mutations. In this group, the median PFS was 7.3 months vs. 3.1 months in the placebo cohort. The objective response rate among patients with measurable disease was 23% overall in the capivasertib group, compared with 12.2% in the placebo arm; it was 28.8% vs. 9.7% among the patients with AKT alterations.
Dr. Mouabbi noted that the study “met its primary endpoint” and that, importantly, it “addresses an area of unmet need.”
“The study’s treatment targets the PI3K/AKT/mTOR pathway, which is a very active pathway in hormone-positive metastatic breast cancer,” Dr. Mouabbi explained. He noted, “We’ve always wanted to tackle that pathway effectively, and it looks like this drug can do that.”
2. Next-generation SERD
Data from the phase 2 SERENA-2 trial offers evidence that camizestrant, a next-generation selective estrogen-receptor degrader (SERD), improved PFS compared with fulvestrant for patients with HR-positive, HER2-negative breast cancer (GS3-02).
Overall, 240 patients were randomly assigned to receive camizestrant monotherapy at various doses or fulvestrant at 500 mg. Among patients who received camizestrant 75 mg, median PFS was 7.2 months; among those who received camizestrant 150 mg, PFS was slightly longer, at 7.7 months vs. 3.7 months for patients treated with fulvestrant. Compared with fulvestrant, camizestrant reduced the risk of disease progression by 42% at 75 mg (HR, 0.58) and by 33% at 150 mg (HR, 0.67). In a subgroup of patients with ESR1 mutations, camizestrant reduced the risk of disease progression by 67% in the group that received 75 mg and by 45% in the group that received 150 mg, compared with fulvestrant (median PFS, 6.3, 9.2, and 2.2 months, respectively).
“In this trial, camizestrant looks like a more beneficial treatment in the target group,” said Dr. Kaklamani. “This is significant because it means that camizestrant could be used in the future in HR-positive metastatic breast cancer instead of fulvestrant.” In addition, “camizestrant is taken orally and is much more convenient for patients, unlike fulvestrant, which is taken intramuscularly.”
3. Pregnancy risks
Can endocrine therapy be safely interrupted for women with breast cancer who wish to become pregnant? That’s what researchers tried to glean in a recent prospective trial presented at the meeting (GS4-09).
The study enrolled over 500 women for whom endocrine therapy had been stopped in the hopes of their becoming pregnant. Almost all (93.4%) had stage I/II HR-positive breast cancer. The primary objective was to determine the risk of breast cancer relapse associated with interrupting therapy for about 2 years. The authors defined no more than 46 breast cancer–free interval (BCFI) events as the safety threshold. A BCFI event was defined as local, regional, or distant recurrence or a new invasive contralateral breast cancer.
Among 497 women, 368 (74%) had at least one pregnancy and 317 (64%) had at least one live birth, for a total of 365 babies born. At a median follow-up of 41 months, 44 participants experienced a BCFI event, in line with the safety threshold. The 3-year BCFI failure rate was 8.9%, similar to the 9.2% rate in an external control cohort from the SOFT/TEXT trials. In addition, 76.3% of patients resumed endocrine therapy; 15.4% had not yet resumed therapy.
“This trial is more confirmatory but an extremely important step for young women who want to get pregnant after diagnosis and recovery from HR-positive breast cancer,” Dr. Kaklamani said. “It seems that stopping endocrine therapy to become pregnant did not cause any adverse outcomes or increase the risk of reoccurrence of cancer in the women in the study.”
Dr. Mouabbi agreed, noting, “Many of our patients are afraid that they will miss the window to get pregnant because they have to be on treatment for so long. This is the first study that let us know pregnancy and safety outcomes in patients who took a break from endocrine therapy to get pregnant. The results are promising and will be exciting for many of our patients.”
4. Assay identifies OFS benefit
A genomic assay was able to distinguish premenopausal patients with early-stage HR-positive breast cancer who benefited from the addition of ovarian function suppression (OFS) to adjuvant endocrine therapy, according to new data presented at the meeting (GS1-06).
In the study, investigators analyzed 1,717 patient tumor samples from the landmark Suppression of Ovarian Function Trial (SOFT) trial. The Breast Cancer Index identified 58% of women who benefited from the addition of ovarian function suppression to tamoxifen or exemestane therapy. They experienced an absolute benefit of 11.6% (42% did not benefit), compared with those with received tamoxifen alone. The predictive benefit was observed regardless of age, lymph node involvement, and receipt of chemotherapy.
Dr. Kaklamani highlighted this study’s importance, saying, “Ovarian suppression is associated with severe adverse events for patients. Obviously, the women who will get a benefit should continue, but this research is important because it will hopefully show us who to recommend ovarian suppression to while not exposing patients who are likely to get little benefit to unneeded toxicity.”
5. Optimizing elacestrant PFS
Last year, data from the Emerald trial showed that elacestrant is superior to standard-of-care therapy for HR-positive metastatic breast cancer. An update that Dr. Kaklamani presented at SABCS (GS3-01) explored whether the duration of a prior CDK4/6 inhibitor affects PFS.
The study was a randomized, open-label, phase 3 trial in which 478 patients with ER-positive/HER2-negative metastatic breast cancer received either elacestrant or standard of care. These patients had previously received one or two lines of endocrine therapy, a CDK4/6 inhibitor, and ≤ 1 line of chemotherapy.
Overall, the duration of prior CDK4/6 inhibitor in the metastatic setting was positively associated with PFS – the longer the duration of prior CDK4/6 inhibitor therapy, the longer the PFS with elacestrant. PFS outcomes were even stronger among patients with ESR1 mutations.
“What we found was that the women who benefit most from elacestrant had previously received a CDK4/6 inhibitor for at least 6 months,” Dr. Kaklamani said. These data can help us determine who may do best on the drug, she added.
A version of this article first appeared on Medscape.com.
SAN ANTONIO –
This news organization spoke with SABCS program director Virginia Kaklamani, MD, leader of the Breast Cancer Program at UT Health, San Antonio, and Jason A. Mouabbi, MD, of the University of Texas MD Anderson Cancer Center, Houston, about their top five picks on HR-positive disease – the research they were most excited about and what the findings could mean for clinical practice and patient outcomes.
1. Addressing an unmet need
Data from the phase 3 CAPItello-291 clinical trial showed that the addition of the investigational AKT inhibitor capivasertib to fulvestrant resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) among 708 patients with HR-positive, HER2-negative advanced breast cancer, compared with those who received placebo plus fulvestrant (GS3-04).
For patients treated with capivasertib plus fulvestrant, median PFS was 7.2 months, compared with 3.6 months for those who received placebo plus fulvestrant (hazard ratio, 0.60). Among patients assigned to the capivasertib group, 41% had tumors with AKT pathway mutations. In this group, the median PFS was 7.3 months vs. 3.1 months in the placebo cohort. The objective response rate among patients with measurable disease was 23% overall in the capivasertib group, compared with 12.2% in the placebo arm; it was 28.8% vs. 9.7% among the patients with AKT alterations.
Dr. Mouabbi noted that the study “met its primary endpoint” and that, importantly, it “addresses an area of unmet need.”
“The study’s treatment targets the PI3K/AKT/mTOR pathway, which is a very active pathway in hormone-positive metastatic breast cancer,” Dr. Mouabbi explained. He noted, “We’ve always wanted to tackle that pathway effectively, and it looks like this drug can do that.”
2. Next-generation SERD
Data from the phase 2 SERENA-2 trial offers evidence that camizestrant, a next-generation selective estrogen-receptor degrader (SERD), improved PFS compared with fulvestrant for patients with HR-positive, HER2-negative breast cancer (GS3-02).
Overall, 240 patients were randomly assigned to receive camizestrant monotherapy at various doses or fulvestrant at 500 mg. Among patients who received camizestrant 75 mg, median PFS was 7.2 months; among those who received camizestrant 150 mg, PFS was slightly longer, at 7.7 months vs. 3.7 months for patients treated with fulvestrant. Compared with fulvestrant, camizestrant reduced the risk of disease progression by 42% at 75 mg (HR, 0.58) and by 33% at 150 mg (HR, 0.67). In a subgroup of patients with ESR1 mutations, camizestrant reduced the risk of disease progression by 67% in the group that received 75 mg and by 45% in the group that received 150 mg, compared with fulvestrant (median PFS, 6.3, 9.2, and 2.2 months, respectively).
“In this trial, camizestrant looks like a more beneficial treatment in the target group,” said Dr. Kaklamani. “This is significant because it means that camizestrant could be used in the future in HR-positive metastatic breast cancer instead of fulvestrant.” In addition, “camizestrant is taken orally and is much more convenient for patients, unlike fulvestrant, which is taken intramuscularly.”
3. Pregnancy risks
Can endocrine therapy be safely interrupted for women with breast cancer who wish to become pregnant? That’s what researchers tried to glean in a recent prospective trial presented at the meeting (GS4-09).
The study enrolled over 500 women for whom endocrine therapy had been stopped in the hopes of their becoming pregnant. Almost all (93.4%) had stage I/II HR-positive breast cancer. The primary objective was to determine the risk of breast cancer relapse associated with interrupting therapy for about 2 years. The authors defined no more than 46 breast cancer–free interval (BCFI) events as the safety threshold. A BCFI event was defined as local, regional, or distant recurrence or a new invasive contralateral breast cancer.
Among 497 women, 368 (74%) had at least one pregnancy and 317 (64%) had at least one live birth, for a total of 365 babies born. At a median follow-up of 41 months, 44 participants experienced a BCFI event, in line with the safety threshold. The 3-year BCFI failure rate was 8.9%, similar to the 9.2% rate in an external control cohort from the SOFT/TEXT trials. In addition, 76.3% of patients resumed endocrine therapy; 15.4% had not yet resumed therapy.
“This trial is more confirmatory but an extremely important step for young women who want to get pregnant after diagnosis and recovery from HR-positive breast cancer,” Dr. Kaklamani said. “It seems that stopping endocrine therapy to become pregnant did not cause any adverse outcomes or increase the risk of reoccurrence of cancer in the women in the study.”
Dr. Mouabbi agreed, noting, “Many of our patients are afraid that they will miss the window to get pregnant because they have to be on treatment for so long. This is the first study that let us know pregnancy and safety outcomes in patients who took a break from endocrine therapy to get pregnant. The results are promising and will be exciting for many of our patients.”
4. Assay identifies OFS benefit
A genomic assay was able to distinguish premenopausal patients with early-stage HR-positive breast cancer who benefited from the addition of ovarian function suppression (OFS) to adjuvant endocrine therapy, according to new data presented at the meeting (GS1-06).
In the study, investigators analyzed 1,717 patient tumor samples from the landmark Suppression of Ovarian Function Trial (SOFT) trial. The Breast Cancer Index identified 58% of women who benefited from the addition of ovarian function suppression to tamoxifen or exemestane therapy. They experienced an absolute benefit of 11.6% (42% did not benefit), compared with those with received tamoxifen alone. The predictive benefit was observed regardless of age, lymph node involvement, and receipt of chemotherapy.
Dr. Kaklamani highlighted this study’s importance, saying, “Ovarian suppression is associated with severe adverse events for patients. Obviously, the women who will get a benefit should continue, but this research is important because it will hopefully show us who to recommend ovarian suppression to while not exposing patients who are likely to get little benefit to unneeded toxicity.”
5. Optimizing elacestrant PFS
Last year, data from the Emerald trial showed that elacestrant is superior to standard-of-care therapy for HR-positive metastatic breast cancer. An update that Dr. Kaklamani presented at SABCS (GS3-01) explored whether the duration of a prior CDK4/6 inhibitor affects PFS.
The study was a randomized, open-label, phase 3 trial in which 478 patients with ER-positive/HER2-negative metastatic breast cancer received either elacestrant or standard of care. These patients had previously received one or two lines of endocrine therapy, a CDK4/6 inhibitor, and ≤ 1 line of chemotherapy.
Overall, the duration of prior CDK4/6 inhibitor in the metastatic setting was positively associated with PFS – the longer the duration of prior CDK4/6 inhibitor therapy, the longer the PFS with elacestrant. PFS outcomes were even stronger among patients with ESR1 mutations.
“What we found was that the women who benefit most from elacestrant had previously received a CDK4/6 inhibitor for at least 6 months,” Dr. Kaklamani said. These data can help us determine who may do best on the drug, she added.
A version of this article first appeared on Medscape.com.
AT SABCS 2022
Study: Formula-fed extreme preemies need more iron
NEW ORLEANS –
“We were surprised that, despite actually receiving more iron in total each day on average, the formula-fed infants were significantly more iron deficient than breast-fed babies. This is the opposite of what one would expect,” study lead author Grace Power, a medical student at Dalhousie University, Halifax, N.S., said in an interview. She presented the results at the annual meeting of the American Society of Hematology.
According to Ms. Power, there’s limited research into how breastfeeding and formula feeding affect iron levels in preterm infants – especially those born extremely early, between 23 and 30 weeks’ gestation.
“This kind of research is important because preterm infants are highly susceptible to iron deficiency for a number of reasons,” she said. “Iron deficiency early in life is associated with developmental and behavioral problems later on in life. That association still stands, even if the iron deficiency is corrected, so prevention is key in this population. Knowing more about how feeding type affects iron status can help us learn about ways to prevent iron deficiency in these infants in the future.”
For the study, researchers retrospectively analyzed data about all preterm infants (< 31 weeks gestation) in Nova Scotia from 2005 to 2018. Of the 392 infants in this group (55.75% male; average age, about 5 months), 285 were fed with iron-rich formula (mean intake, 1.66 mg/kg per day), and 107 were fully or partially breast fed. The two groups were similar in terms of traits such as mean birth weight and gestational age.
The formula-fed infants were more likely to develop iron deficiency (ID, 36.8%) than the breast-fed infants (20.6%; P = .002). “Mean gestational age and birth weight were both lower in the ID group. The ID group also had a higher percentage of infants born less than 1,100 g (P = .01). More babies in the ID group received at least one blood transfusion,” the researchers reported. “ID infants had a higher daily formula intake, daily iron intake from formula, and total daily iron intake combined from formula and supplements.”
Why is there such a gap between formula-fed infants and breast-fed infants? The researchers speculated that infants absorb less iron from formula versus breast milk, possibly because of the presence of lactoferrin in breast milk.
The researchers also wondered whether physicians may pull back on iron supplementation in infants who undergo blood transfusions out of fear of the risk of iron overload, which Ms. Power said can cause infection and poor growth. By doing so, they may inadvertently deprive the babies of their need for iron.
“We don’t want clinicians to assume an infant doesn’t need iron supplementation just because they’ve received a blood transfusion,” she said.
As for an overall message from the research, Ms. Power said clinicians “should be aware that formula feeding can put infants at risk for iron deficiency and consider this when making decisions about supplementation.” And she noted that guidelines from the American Academy of Pediatrics and Canadian Pediatric Society don’t highlight the importance of iron supplementation in formula-fed, very preterm infants.
In an interview, University of Michigan pediatrician Michael K. Georgieff, MD, who has studied iron supplementation, said the study’s primary findings are surprising, although it makes sense that infants with lower gestational age and birth weight would suffer from more ID. Blood transfusion can indeed raise iron levels, but it’s important to consider that these infants may already have low levels of iron.
Dr. Georgieff advised colleagues to understand the potential for various nutritional deficiencies in preterm infants well beyond the first few weeks. When the babies are handed off to other clinicians such as pediatricians, they should undergo nutritional screening at 6 months, not at a year.
Dalhousie University funded the study. The study authors and Dr. Georgieff have no disclosures.
NEW ORLEANS –
“We were surprised that, despite actually receiving more iron in total each day on average, the formula-fed infants were significantly more iron deficient than breast-fed babies. This is the opposite of what one would expect,” study lead author Grace Power, a medical student at Dalhousie University, Halifax, N.S., said in an interview. She presented the results at the annual meeting of the American Society of Hematology.
According to Ms. Power, there’s limited research into how breastfeeding and formula feeding affect iron levels in preterm infants – especially those born extremely early, between 23 and 30 weeks’ gestation.
“This kind of research is important because preterm infants are highly susceptible to iron deficiency for a number of reasons,” she said. “Iron deficiency early in life is associated with developmental and behavioral problems later on in life. That association still stands, even if the iron deficiency is corrected, so prevention is key in this population. Knowing more about how feeding type affects iron status can help us learn about ways to prevent iron deficiency in these infants in the future.”
For the study, researchers retrospectively analyzed data about all preterm infants (< 31 weeks gestation) in Nova Scotia from 2005 to 2018. Of the 392 infants in this group (55.75% male; average age, about 5 months), 285 were fed with iron-rich formula (mean intake, 1.66 mg/kg per day), and 107 were fully or partially breast fed. The two groups were similar in terms of traits such as mean birth weight and gestational age.
The formula-fed infants were more likely to develop iron deficiency (ID, 36.8%) than the breast-fed infants (20.6%; P = .002). “Mean gestational age and birth weight were both lower in the ID group. The ID group also had a higher percentage of infants born less than 1,100 g (P = .01). More babies in the ID group received at least one blood transfusion,” the researchers reported. “ID infants had a higher daily formula intake, daily iron intake from formula, and total daily iron intake combined from formula and supplements.”
Why is there such a gap between formula-fed infants and breast-fed infants? The researchers speculated that infants absorb less iron from formula versus breast milk, possibly because of the presence of lactoferrin in breast milk.
The researchers also wondered whether physicians may pull back on iron supplementation in infants who undergo blood transfusions out of fear of the risk of iron overload, which Ms. Power said can cause infection and poor growth. By doing so, they may inadvertently deprive the babies of their need for iron.
“We don’t want clinicians to assume an infant doesn’t need iron supplementation just because they’ve received a blood transfusion,” she said.
As for an overall message from the research, Ms. Power said clinicians “should be aware that formula feeding can put infants at risk for iron deficiency and consider this when making decisions about supplementation.” And she noted that guidelines from the American Academy of Pediatrics and Canadian Pediatric Society don’t highlight the importance of iron supplementation in formula-fed, very preterm infants.
In an interview, University of Michigan pediatrician Michael K. Georgieff, MD, who has studied iron supplementation, said the study’s primary findings are surprising, although it makes sense that infants with lower gestational age and birth weight would suffer from more ID. Blood transfusion can indeed raise iron levels, but it’s important to consider that these infants may already have low levels of iron.
Dr. Georgieff advised colleagues to understand the potential for various nutritional deficiencies in preterm infants well beyond the first few weeks. When the babies are handed off to other clinicians such as pediatricians, they should undergo nutritional screening at 6 months, not at a year.
Dalhousie University funded the study. The study authors and Dr. Georgieff have no disclosures.
NEW ORLEANS –
“We were surprised that, despite actually receiving more iron in total each day on average, the formula-fed infants were significantly more iron deficient than breast-fed babies. This is the opposite of what one would expect,” study lead author Grace Power, a medical student at Dalhousie University, Halifax, N.S., said in an interview. She presented the results at the annual meeting of the American Society of Hematology.
According to Ms. Power, there’s limited research into how breastfeeding and formula feeding affect iron levels in preterm infants – especially those born extremely early, between 23 and 30 weeks’ gestation.
“This kind of research is important because preterm infants are highly susceptible to iron deficiency for a number of reasons,” she said. “Iron deficiency early in life is associated with developmental and behavioral problems later on in life. That association still stands, even if the iron deficiency is corrected, so prevention is key in this population. Knowing more about how feeding type affects iron status can help us learn about ways to prevent iron deficiency in these infants in the future.”
For the study, researchers retrospectively analyzed data about all preterm infants (< 31 weeks gestation) in Nova Scotia from 2005 to 2018. Of the 392 infants in this group (55.75% male; average age, about 5 months), 285 were fed with iron-rich formula (mean intake, 1.66 mg/kg per day), and 107 were fully or partially breast fed. The two groups were similar in terms of traits such as mean birth weight and gestational age.
The formula-fed infants were more likely to develop iron deficiency (ID, 36.8%) than the breast-fed infants (20.6%; P = .002). “Mean gestational age and birth weight were both lower in the ID group. The ID group also had a higher percentage of infants born less than 1,100 g (P = .01). More babies in the ID group received at least one blood transfusion,” the researchers reported. “ID infants had a higher daily formula intake, daily iron intake from formula, and total daily iron intake combined from formula and supplements.”
Why is there such a gap between formula-fed infants and breast-fed infants? The researchers speculated that infants absorb less iron from formula versus breast milk, possibly because of the presence of lactoferrin in breast milk.
The researchers also wondered whether physicians may pull back on iron supplementation in infants who undergo blood transfusions out of fear of the risk of iron overload, which Ms. Power said can cause infection and poor growth. By doing so, they may inadvertently deprive the babies of their need for iron.
“We don’t want clinicians to assume an infant doesn’t need iron supplementation just because they’ve received a blood transfusion,” she said.
As for an overall message from the research, Ms. Power said clinicians “should be aware that formula feeding can put infants at risk for iron deficiency and consider this when making decisions about supplementation.” And she noted that guidelines from the American Academy of Pediatrics and Canadian Pediatric Society don’t highlight the importance of iron supplementation in formula-fed, very preterm infants.
In an interview, University of Michigan pediatrician Michael K. Georgieff, MD, who has studied iron supplementation, said the study’s primary findings are surprising, although it makes sense that infants with lower gestational age and birth weight would suffer from more ID. Blood transfusion can indeed raise iron levels, but it’s important to consider that these infants may already have low levels of iron.
Dr. Georgieff advised colleagues to understand the potential for various nutritional deficiencies in preterm infants well beyond the first few weeks. When the babies are handed off to other clinicians such as pediatricians, they should undergo nutritional screening at 6 months, not at a year.
Dalhousie University funded the study. The study authors and Dr. Georgieff have no disclosures.
AT ASH 2022