Deepa Varma

TOPLINE:

Bariatric surgery may lower the risk for breast cancer in women with obesity, particularly in premenopausal women and in women with high insulin levels at baseline.

METHODOLOGY:

• Previous research suggests that bariatric surgery is associated with a lower risk for cancer in people with obesity, as well as female-specific cancers in women with obesity, especially those with higher baseline insulin levels. But there is a need for large prospective studies with more detailed patient information.
• The current secondary analysis included 2867 matched women (mean age, 48 years) from a prospective nonrandomized Swedish trial, which recruited men and women who had obesity between 1987 and 2001.
• Overall, 1420 women underwent bariatric surgery, and 1447 received usual care.
• Median baseline insulin levels were 15.8 μIU/L. In the surgery group, 68.3% of patients had vertical banded gastroplasty, 18.3% underwent gastric banding, and 13.4% underwent gastric bypass.
• The main outcome was breast cancer incidence, as identified from Swedish National Cancer Registry.

TAKEAWAY:

• Over a median follow-up of 23.9 years, 66 breast cancer events occurred in the surgery group and 88 in the usual care group (P = .02).
• Bariatric surgery was associated with a 33% lower risk for breast cancer (adjusted hazard ratio [aHR], 0.67), after excluding cases that occurred within the first 3 years (to account for any undiagnosed breast cancer at baseline) and adjusting for age, body mass index, alcohol, and smoking status.
• Looking at the menopausal status at baseline, bariatric surgery was associated with a reduced risk for breast cancer in premenopausal women (aHR, 0.64) but not postmenopausal women (aHR, 0.84; 95% CI, 0.49-1.45; P = .54).
• Bariatric surgery was also associated with a lower risk for breast cancer in women with baseline insulin levels above the median (aHR, 0.55) than in those with baseline insulin levels below the median (aHR, 1.01).

IN PRACTICE:

“The surgical treatment benefit was predominantly seen in women with hyperinsulinemia, suggesting insulin may be used as a predictor of treatment effect,” the authors wrote. Authors of an accompanying editorial, however, cautioned that “it is not known if insulin levels or insulin resistance are true biomarkers of breast cancer risk in patients with obesity undergoing bariatric surgery” and urged further research into underlying biological mechanisms.

SOURCE:

This study, led by Felipe M. Kristensson, MD, from Institute of Medicine, Department of Molecular and Clinical Medicine, the Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden, was published online in JAMA Surgery. The accompanying editorial was led by Swati A. Kulkarni, MD, of the Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago.

LIMITATIONS:

The study was not randomized. Breast cancer was not a predefined outcome of the main trial. Most patients underwent vertical banded gastroplasty, which is rarely used and could limit applicability of the results; however, vertical banded gastroplasty results in weight loss similar to that observed after sleeve gastrectomy. Follow-up values for insulin and insulin resistance were not available. The researchers noted significant differences in 12 out of 17 baseline characteristics between the two groups, including a larger proportion of postmenopausal women in the usual care group.

DISCLOSURES:

This study was supported by the Swedish state, Swedish Research Council, the Health & Medical Care Committee of the Region Västra Götaland, and the Adlerbert Research Foundation. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Bariatric surgery may lower the risk for breast cancer in women with obesity, particularly in premenopausal women and in women with high insulin levels at baseline.

METHODOLOGY:

• Previous research suggests that bariatric surgery is associated with a lower risk for cancer in people with obesity, as well as female-specific cancers in women with obesity, especially those with higher baseline insulin levels. But there is a need for large prospective studies with more detailed patient information.
• The current secondary analysis included 2867 matched women (mean age, 48 years) from a prospective nonrandomized Swedish trial, which recruited men and women who had obesity between 1987 and 2001.
• Overall, 1420 women underwent bariatric surgery, and 1447 received usual care.
• Median baseline insulin levels were 15.8 μIU/L. In the surgery group, 68.3% of patients had vertical banded gastroplasty, 18.3% underwent gastric banding, and 13.4% underwent gastric bypass.
• The main outcome was breast cancer incidence, as identified from Swedish National Cancer Registry.

TAKEAWAY:

• Over a median follow-up of 23.9 years, 66 breast cancer events occurred in the surgery group and 88 in the usual care group (P = .02).
• Bariatric surgery was associated with a 33% lower risk for breast cancer (adjusted hazard ratio [aHR], 0.67), after excluding cases that occurred within the first 3 years (to account for any undiagnosed breast cancer at baseline) and adjusting for age, body mass index, alcohol, and smoking status.
• Looking at the menopausal status at baseline, bariatric surgery was associated with a reduced risk for breast cancer in premenopausal women (aHR, 0.64) but not postmenopausal women (aHR, 0.84; 95% CI, 0.49-1.45; P = .54).
• Bariatric surgery was also associated with a lower risk for breast cancer in women with baseline insulin levels above the median (aHR, 0.55) than in those with baseline insulin levels below the median (aHR, 1.01).

IN PRACTICE:

“The surgical treatment benefit was predominantly seen in women with hyperinsulinemia, suggesting insulin may be used as a predictor of treatment effect,” the authors wrote. Authors of an accompanying editorial, however, cautioned that “it is not known if insulin levels or insulin resistance are true biomarkers of breast cancer risk in patients with obesity undergoing bariatric surgery” and urged further research into underlying biological mechanisms.

SOURCE:

This study, led by Felipe M. Kristensson, MD, from Institute of Medicine, Department of Molecular and Clinical Medicine, the Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden, was published online in JAMA Surgery. The accompanying editorial was led by Swati A. Kulkarni, MD, of the Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago.

LIMITATIONS:

The study was not randomized. Breast cancer was not a predefined outcome of the main trial. Most patients underwent vertical banded gastroplasty, which is rarely used and could limit applicability of the results; however, vertical banded gastroplasty results in weight loss similar to that observed after sleeve gastrectomy. Follow-up values for insulin and insulin resistance were not available. The researchers noted significant differences in 12 out of 17 baseline characteristics between the two groups, including a larger proportion of postmenopausal women in the usual care group.

DISCLOSURES:

This study was supported by the Swedish state, Swedish Research Council, the Health & Medical Care Committee of the Region Västra Götaland, and the Adlerbert Research Foundation. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Bariatric surgery may lower the risk for breast cancer in women with obesity, particularly in premenopausal women and in women with high insulin levels at baseline.

METHODOLOGY:

• Previous research suggests that bariatric surgery is associated with a lower risk for cancer in people with obesity, as well as female-specific cancers in women with obesity, especially those with higher baseline insulin levels. But there is a need for large prospective studies with more detailed patient information.
• The current secondary analysis included 2867 matched women (mean age, 48 years) from a prospective nonrandomized Swedish trial, which recruited men and women who had obesity between 1987 and 2001.
• Overall, 1420 women underwent bariatric surgery, and 1447 received usual care.
• Median baseline insulin levels were 15.8 μIU/L. In the surgery group, 68.3% of patients had vertical banded gastroplasty, 18.3% underwent gastric banding, and 13.4% underwent gastric bypass.
• The main outcome was breast cancer incidence, as identified from Swedish National Cancer Registry.

TAKEAWAY:

• Over a median follow-up of 23.9 years, 66 breast cancer events occurred in the surgery group and 88 in the usual care group (P = .02).
• Bariatric surgery was associated with a 33% lower risk for breast cancer (adjusted hazard ratio [aHR], 0.67), after excluding cases that occurred within the first 3 years (to account for any undiagnosed breast cancer at baseline) and adjusting for age, body mass index, alcohol, and smoking status.
• Looking at the menopausal status at baseline, bariatric surgery was associated with a reduced risk for breast cancer in premenopausal women (aHR, 0.64) but not postmenopausal women (aHR, 0.84; 95% CI, 0.49-1.45; P = .54).
• Bariatric surgery was also associated with a lower risk for breast cancer in women with baseline insulin levels above the median (aHR, 0.55) than in those with baseline insulin levels below the median (aHR, 1.01).

IN PRACTICE:

“The surgical treatment benefit was predominantly seen in women with hyperinsulinemia, suggesting insulin may be used as a predictor of treatment effect,” the authors wrote. Authors of an accompanying editorial, however, cautioned that “it is not known if insulin levels or insulin resistance are true biomarkers of breast cancer risk in patients with obesity undergoing bariatric surgery” and urged further research into underlying biological mechanisms.

SOURCE:

This study, led by Felipe M. Kristensson, MD, from Institute of Medicine, Department of Molecular and Clinical Medicine, the Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden, was published online in JAMA Surgery. The accompanying editorial was led by Swati A. Kulkarni, MD, of the Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago.

LIMITATIONS:

The study was not randomized. Breast cancer was not a predefined outcome of the main trial. Most patients underwent vertical banded gastroplasty, which is rarely used and could limit applicability of the results; however, vertical banded gastroplasty results in weight loss similar to that observed after sleeve gastrectomy. Follow-up values for insulin and insulin resistance were not available. The researchers noted significant differences in 12 out of 17 baseline characteristics between the two groups, including a larger proportion of postmenopausal women in the usual care group.

DISCLOSURES:

This study was supported by the Swedish state, Swedish Research Council, the Health & Medical Care Committee of the Region Västra Götaland, and the Adlerbert Research Foundation. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Cutaneous manifestations of cystic fibrosis (CF) include palmar wrinkling, nutrient deficiency dermatitis, vascular disorders, and reactions to CF treatments.

METHODOLOGY:

• Patients with CF, caused by a mutation in the CF Transmembrane Conductance Regulator (CFTR) gene, can develop diverse dermatologic manifestations.
• Researchers reviewed the literature and provided their own clinical experience regarding dermatologic manifestations of CF.
• They also reviewed the cutaneous side effects of CFTR modulators and antibiotics used to treat CF.

TAKEAWAY:

• Aquagenic wrinkling of the palm is common in individuals with CF, affecting up to 80% of patients (and 25% of CF gene carriers), and can be an early manifestation of CF. Treatments include topical medications (such as aluminum chloride, corticosteroids, and salicylic acid), botulinum toxin injections, and recently, CFTR-modulating treatments.
• CF nutrient deficiency dermatitis, often in a diaper distribution, usually appears in infancy and, before newborn screening was available, was sometimes the first sign of CF in some cases. It usually resolves with an adequate diet, pancreatic enzymes, and/or nutritional supplements. Zinc and essential fatty acid deficiencies can lead to acrodermatitis enteropathica–like symptoms and psoriasiform rashes, respectively.
• CF is also associated with vascular disorders, including cutaneous and, rarely, systemic vasculitis. Treatment includes topical and oral steroids and immune-modulating therapies.
• CFTR modulators, now the most common and highly effective treatment for CF, are associated with several skin reactions, which can be managed with treatments that include topical steroids and oral antihistamines. Frequent antibiotic treatment can also trigger skin reactions.

IN PRACTICE:

“Recognition and familiarity with dermatologic clinical manifestations of CF are important for multidisciplinary care” for patients with CF, the authors wrote, adding that “dermatology providers may play a significant role in the diagnosis and management of CF cutaneous comorbidities.”

SOURCE:

Aaron D. Smith, BS, from the University of Virginia (UVA) School of Medicine, Charlottesville, and coauthors were from the departments of dermatology and pulmonology/critical care medicine at UVA. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The authors did not make a comment about the limitations of their review.

DISCLOSURES:

No funding was received for the review. The authors had no disclosures.

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

TOPLINE:

Cutaneous manifestations of cystic fibrosis (CF) include palmar wrinkling, nutrient deficiency dermatitis, vascular disorders, and reactions to CF treatments.

METHODOLOGY:

• Patients with CF, caused by a mutation in the CF Transmembrane Conductance Regulator (CFTR) gene, can develop diverse dermatologic manifestations.
• Researchers reviewed the literature and provided their own clinical experience regarding dermatologic manifestations of CF.
• They also reviewed the cutaneous side effects of CFTR modulators and antibiotics used to treat CF.

TAKEAWAY:

• Aquagenic wrinkling of the palm is common in individuals with CF, affecting up to 80% of patients (and 25% of CF gene carriers), and can be an early manifestation of CF. Treatments include topical medications (such as aluminum chloride, corticosteroids, and salicylic acid), botulinum toxin injections, and recently, CFTR-modulating treatments.
• CF nutrient deficiency dermatitis, often in a diaper distribution, usually appears in infancy and, before newborn screening was available, was sometimes the first sign of CF in some cases. It usually resolves with an adequate diet, pancreatic enzymes, and/or nutritional supplements. Zinc and essential fatty acid deficiencies can lead to acrodermatitis enteropathica–like symptoms and psoriasiform rashes, respectively.
• CF is also associated with vascular disorders, including cutaneous and, rarely, systemic vasculitis. Treatment includes topical and oral steroids and immune-modulating therapies.
• CFTR modulators, now the most common and highly effective treatment for CF, are associated with several skin reactions, which can be managed with treatments that include topical steroids and oral antihistamines. Frequent antibiotic treatment can also trigger skin reactions.

IN PRACTICE:

“Recognition and familiarity with dermatologic clinical manifestations of CF are important for multidisciplinary care” for patients with CF, the authors wrote, adding that “dermatology providers may play a significant role in the diagnosis and management of CF cutaneous comorbidities.”

SOURCE:

Aaron D. Smith, BS, from the University of Virginia (UVA) School of Medicine, Charlottesville, and coauthors were from the departments of dermatology and pulmonology/critical care medicine at UVA. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The authors did not make a comment about the limitations of their review.

DISCLOSURES:

No funding was received for the review. The authors had no disclosures.

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

TOPLINE:

Cutaneous manifestations of cystic fibrosis (CF) include palmar wrinkling, nutrient deficiency dermatitis, vascular disorders, and reactions to CF treatments.

METHODOLOGY:

• Patients with CF, caused by a mutation in the CF Transmembrane Conductance Regulator (CFTR) gene, can develop diverse dermatologic manifestations.
• Researchers reviewed the literature and provided their own clinical experience regarding dermatologic manifestations of CF.
• They also reviewed the cutaneous side effects of CFTR modulators and antibiotics used to treat CF.

TAKEAWAY:

• Aquagenic wrinkling of the palm is common in individuals with CF, affecting up to 80% of patients (and 25% of CF gene carriers), and can be an early manifestation of CF. Treatments include topical medications (such as aluminum chloride, corticosteroids, and salicylic acid), botulinum toxin injections, and recently, CFTR-modulating treatments.
• CF nutrient deficiency dermatitis, often in a diaper distribution, usually appears in infancy and, before newborn screening was available, was sometimes the first sign of CF in some cases. It usually resolves with an adequate diet, pancreatic enzymes, and/or nutritional supplements. Zinc and essential fatty acid deficiencies can lead to acrodermatitis enteropathica–like symptoms and psoriasiform rashes, respectively.
• CF is also associated with vascular disorders, including cutaneous and, rarely, systemic vasculitis. Treatment includes topical and oral steroids and immune-modulating therapies.
• CFTR modulators, now the most common and highly effective treatment for CF, are associated with several skin reactions, which can be managed with treatments that include topical steroids and oral antihistamines. Frequent antibiotic treatment can also trigger skin reactions.

IN PRACTICE:

“Recognition and familiarity with dermatologic clinical manifestations of CF are important for multidisciplinary care” for patients with CF, the authors wrote, adding that “dermatology providers may play a significant role in the diagnosis and management of CF cutaneous comorbidities.”

SOURCE:

Aaron D. Smith, BS, from the University of Virginia (UVA) School of Medicine, Charlottesville, and coauthors were from the departments of dermatology and pulmonology/critical care medicine at UVA. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The authors did not make a comment about the limitations of their review.

DISCLOSURES:

No funding was received for the review. The authors had no disclosures.

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

TOPLINE:

A large international cohort study identified a higher risk for cardiovascular diseases and mortality in patients with prurigo nodularis (PN), particularly among women and White patients.

METHODOLOGY:

• Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
• In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
• Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.

TAKEAWAY:

• Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
• PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
• White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
• Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.

IN PRACTICE:

“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.

LIMITATIONS:

Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.

SOURCE:

This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.

DISCLOSURES:

The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A large international cohort study identified a higher risk for cardiovascular diseases and mortality in patients with prurigo nodularis (PN), particularly among women and White patients.

METHODOLOGY:

• Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
• In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
• Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.

TAKEAWAY:

• Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
• PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
• White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
• Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.

IN PRACTICE:

“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.

LIMITATIONS:

Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.

SOURCE:

This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.

DISCLOSURES:

The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A large international cohort study identified a higher risk for cardiovascular diseases and mortality in patients with prurigo nodularis (PN), particularly among women and White patients.

METHODOLOGY:

• Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
• In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
• Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.

TAKEAWAY:

• Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
• PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
• White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
• Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.

IN PRACTICE:

“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.

LIMITATIONS:

Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.

SOURCE:

This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.

DISCLOSURES:

The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Overall, patients with solid tumors who receive an investigational cancer drug experience small progression-free survival (PFS) and overall survival benefits but much higher toxicity than those who receive a control intervention.

METHODOLOGY:

• The view that patients with cancer benefit from access to investigational drugs in the clinical trial setting is widely held but does necessarily align with trial findings, which often show limited evidence of a clinical benefit. First, most investigational treatments assessed in clinical trials fail to gain regulatory approval, and the minority that are approved tend to offer minimal clinical benefit, experts explained.
• To estimate the survival benefit and toxicities associated with receiving experimental treatments, researchers conducted a meta-analysis of 128 trials comprising 141 comparisons of an investigational drug and a control treatment, which included immunotherapies and targeted therapies.
• The analysis included 42 trials in non–small cell lung cancer (NSCLC), 37 in breast cancer, 15 in hepatobiliary cancer, 13 in pancreatic cancer, 12 in colorectal cancer, and 10 in prostate cancer, involving a total of 47,050 patients.
• The primary outcome was PFS and secondary outcomes were overall survival and grades 3-5 serious adverse events.

TAKEAWAY:

• Overall, the experimental treatment was associated with a 20% improvement in PFS (pooled hazard ratio [HR], 0.80), corresponding to a median 1.25-month PFS advantage. The PFS benefit was seen across all cancer types, except pancreatic cancer.
• Overall survival improved by 8% with experimental agents (HR, 0.92), corresponding to 1.18 additional months. A significant overall survival benefit was seen across NSCLC, breast cancer, and hepatobiliary cancer trials but not pancreatic, prostate, colorectal cancer trials.
• Patients in the experimental intervention group, however, experienced much higher risk for grade 3-5 serious adverse events (risk ratio [RR], 1.27), corresponding to 7.40% increase in absolute risk. The greater risk for serious adverse events was significant for all indications except prostate cancer (RR, 1.13; 95% CI, 0.91-1.40).

IN PRACTICE:

“We believe our findings are best interpreted as suggesting that access to experimental interventions that have not yet received full FDA approval is associated with a marginal but nonzero clinical benefit,” the authors wrote. 

“Although our findings seem to reflect poorly on trials as a vehicle for extending survival for participants, they have reassuring implications for clinical investigators, policymakers, and institutional review boards,” the researchers said, explaining that this “scenario allows clinical trials to continue to pursue promising new treatments — supporting incremental advances that sum to large gains over extended periods of research — without disadvantaging patients in comparator groups.”

SOURCE: 

Renata Iskander, MSc, of McGill University, Montreal, Quebec, Canada, led this work, which was published online on April 29, 2024, in Annals of Internal Medicine.

LIMITATIONS:

There was high heterogeneity across studies due to variations in drugs tested, comparators used, and populations involved. The use of comparators below standard care could have inflated survival benefits. Additionally, data collected from ClinicalTrials.gov might be biased due to some trials not being reported. 

DISCLOSURES:

Canadian Institutes of Health Research supported this work. The authors received grants for this work from McGill University, Rossy Cancer Network, and National Science Foundation. One author received consulting fees outside this work. The other authors declared no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

Overall, patients with solid tumors who receive an investigational cancer drug experience small progression-free survival (PFS) and overall survival benefits but much higher toxicity than those who receive a control intervention.

METHODOLOGY:

• The view that patients with cancer benefit from access to investigational drugs in the clinical trial setting is widely held but does necessarily align with trial findings, which often show limited evidence of a clinical benefit. First, most investigational treatments assessed in clinical trials fail to gain regulatory approval, and the minority that are approved tend to offer minimal clinical benefit, experts explained.
• To estimate the survival benefit and toxicities associated with receiving experimental treatments, researchers conducted a meta-analysis of 128 trials comprising 141 comparisons of an investigational drug and a control treatment, which included immunotherapies and targeted therapies.
• The analysis included 42 trials in non–small cell lung cancer (NSCLC), 37 in breast cancer, 15 in hepatobiliary cancer, 13 in pancreatic cancer, 12 in colorectal cancer, and 10 in prostate cancer, involving a total of 47,050 patients.
• The primary outcome was PFS and secondary outcomes were overall survival and grades 3-5 serious adverse events.

TAKEAWAY:

• Overall, the experimental treatment was associated with a 20% improvement in PFS (pooled hazard ratio [HR], 0.80), corresponding to a median 1.25-month PFS advantage. The PFS benefit was seen across all cancer types, except pancreatic cancer.
• Overall survival improved by 8% with experimental agents (HR, 0.92), corresponding to 1.18 additional months. A significant overall survival benefit was seen across NSCLC, breast cancer, and hepatobiliary cancer trials but not pancreatic, prostate, colorectal cancer trials.
• Patients in the experimental intervention group, however, experienced much higher risk for grade 3-5 serious adverse events (risk ratio [RR], 1.27), corresponding to 7.40% increase in absolute risk. The greater risk for serious adverse events was significant for all indications except prostate cancer (RR, 1.13; 95% CI, 0.91-1.40).

IN PRACTICE:

“We believe our findings are best interpreted as suggesting that access to experimental interventions that have not yet received full FDA approval is associated with a marginal but nonzero clinical benefit,” the authors wrote. 

“Although our findings seem to reflect poorly on trials as a vehicle for extending survival for participants, they have reassuring implications for clinical investigators, policymakers, and institutional review boards,” the researchers said, explaining that this “scenario allows clinical trials to continue to pursue promising new treatments — supporting incremental advances that sum to large gains over extended periods of research — without disadvantaging patients in comparator groups.”

SOURCE: 

Renata Iskander, MSc, of McGill University, Montreal, Quebec, Canada, led this work, which was published online on April 29, 2024, in Annals of Internal Medicine.

LIMITATIONS:

There was high heterogeneity across studies due to variations in drugs tested, comparators used, and populations involved. The use of comparators below standard care could have inflated survival benefits. Additionally, data collected from ClinicalTrials.gov might be biased due to some trials not being reported. 

DISCLOSURES:

Canadian Institutes of Health Research supported this work. The authors received grants for this work from McGill University, Rossy Cancer Network, and National Science Foundation. One author received consulting fees outside this work. The other authors declared no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

Overall, patients with solid tumors who receive an investigational cancer drug experience small progression-free survival (PFS) and overall survival benefits but much higher toxicity than those who receive a control intervention.

METHODOLOGY:

• The view that patients with cancer benefit from access to investigational drugs in the clinical trial setting is widely held but does necessarily align with trial findings, which often show limited evidence of a clinical benefit. First, most investigational treatments assessed in clinical trials fail to gain regulatory approval, and the minority that are approved tend to offer minimal clinical benefit, experts explained.
• To estimate the survival benefit and toxicities associated with receiving experimental treatments, researchers conducted a meta-analysis of 128 trials comprising 141 comparisons of an investigational drug and a control treatment, which included immunotherapies and targeted therapies.
• The analysis included 42 trials in non–small cell lung cancer (NSCLC), 37 in breast cancer, 15 in hepatobiliary cancer, 13 in pancreatic cancer, 12 in colorectal cancer, and 10 in prostate cancer, involving a total of 47,050 patients.
• The primary outcome was PFS and secondary outcomes were overall survival and grades 3-5 serious adverse events.

TAKEAWAY:

• Overall, the experimental treatment was associated with a 20% improvement in PFS (pooled hazard ratio [HR], 0.80), corresponding to a median 1.25-month PFS advantage. The PFS benefit was seen across all cancer types, except pancreatic cancer.
• Overall survival improved by 8% with experimental agents (HR, 0.92), corresponding to 1.18 additional months. A significant overall survival benefit was seen across NSCLC, breast cancer, and hepatobiliary cancer trials but not pancreatic, prostate, colorectal cancer trials.
• Patients in the experimental intervention group, however, experienced much higher risk for grade 3-5 serious adverse events (risk ratio [RR], 1.27), corresponding to 7.40% increase in absolute risk. The greater risk for serious adverse events was significant for all indications except prostate cancer (RR, 1.13; 95% CI, 0.91-1.40).

IN PRACTICE:

“We believe our findings are best interpreted as suggesting that access to experimental interventions that have not yet received full FDA approval is associated with a marginal but nonzero clinical benefit,” the authors wrote. 

“Although our findings seem to reflect poorly on trials as a vehicle for extending survival for participants, they have reassuring implications for clinical investigators, policymakers, and institutional review boards,” the researchers said, explaining that this “scenario allows clinical trials to continue to pursue promising new treatments — supporting incremental advances that sum to large gains over extended periods of research — without disadvantaging patients in comparator groups.”

SOURCE: 

Renata Iskander, MSc, of McGill University, Montreal, Quebec, Canada, led this work, which was published online on April 29, 2024, in Annals of Internal Medicine.

LIMITATIONS:

There was high heterogeneity across studies due to variations in drugs tested, comparators used, and populations involved. The use of comparators below standard care could have inflated survival benefits. Additionally, data collected from ClinicalTrials.gov might be biased due to some trials not being reported. 

DISCLOSURES:

Canadian Institutes of Health Research supported this work. The authors received grants for this work from McGill University, Rossy Cancer Network, and National Science Foundation. One author received consulting fees outside this work. The other authors declared no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

A recent survey-based study found that only 4% of cancer survivors reported adhering to all four American Cancer Society (ACS) nutrition and physical activity guidelines, which include maintaining a healthy weight and diet, avoiding alcohol, and exercising regularly.

METHODOLOGY:

• The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
• Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
• The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
• Overall, 9,121 survivors (91%) completed questionnaires for all four domains.

TAKEAWAY:

Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.

When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.

Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.

The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).

IN PRACTICE:

This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”

SOURCE:

This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.

LIMITATIONS:

The authors reported several study limitations, most notably that self-reported data may introduce biases.

DISCLOSURES:

The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

A recent survey-based study found that only 4% of cancer survivors reported adhering to all four American Cancer Society (ACS) nutrition and physical activity guidelines, which include maintaining a healthy weight and diet, avoiding alcohol, and exercising regularly.

METHODOLOGY:

• The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
• Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
• The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
• Overall, 9,121 survivors (91%) completed questionnaires for all four domains.

TAKEAWAY:

Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.

When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.

Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.

The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).

IN PRACTICE:

This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”

SOURCE:

This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.

LIMITATIONS:

The authors reported several study limitations, most notably that self-reported data may introduce biases.

DISCLOSURES:

The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

A recent survey-based study found that only 4% of cancer survivors reported adhering to all four American Cancer Society (ACS) nutrition and physical activity guidelines, which include maintaining a healthy weight and diet, avoiding alcohol, and exercising regularly.

METHODOLOGY:

• The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
• Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
• The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
• Overall, 9,121 survivors (91%) completed questionnaires for all four domains.

TAKEAWAY:

Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.

When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.

Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.

The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).

IN PRACTICE:

This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”

SOURCE:

This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.

LIMITATIONS:

The authors reported several study limitations, most notably that self-reported data may introduce biases.

DISCLOSURES:

The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

The time interval between onset of interstitial lung disease (ILD) and diagnosis of anti–melanoma differentiation-associated gene 5 (MDA5) antibody-positive dermatomyositis (DM) “has not been well described,” the authors say.

METHODOLOGY:

• MDA5 antibody-positive DM is a rare DM subtype associated with ILD, which is categorized into rapidly progressive ILD (RPILD) and chronic ILD, with the former having a particularly high mortality rate.
• In this retrospective cohort study using electronic medical records, researchers evaluated 774 patients with DM between 2008 and 2023 to learn more about the time interval between ILD and the time of an MDA5 antibody-positive DM diagnosis, which has not been well described.
• The primary outcome was ILD diagnosis and time in days between documented ILD and MDA5 antibody-positive DM diagnoses.

TAKEAWAY:

• Overall, 14 patients with DM (1.8%) were diagnosed with MDA5 antibody-positive DM in dermatology, rheumatology, or pulmonology departments (nine women and five men; age, 24-77 years; 79% were White and 7% were Black).
• ILD was diagnosed in 9 of the 14 patients (64%); 6 of the 14 (43%) met the criteria for RPILD. Two cases were diagnosed concurrently and two prior to MDA5 antibody-positive DM diagnosis.
• The median time between ILD and MDA5 antibody-positive DM diagnoses was 163 days.
• Gottron papules/sign and midfacial erythema were the most common dermatologic findings, and no association was seen between cutaneous signs and type of ILD.

IN PRACTICE:

“Establishing an accurate timeline between MDA5 antibody-positive DM and ILD can promote urgency among dermatologists to evaluate extracutaneous manifestations in their management of patients with DM for more accurate risk stratification and appropriate treatment,” the authors wrote.

SOURCE:

This study, led by Rachel R. Lin, from the University of Miami, Miami, Florida, was published online as a research letter in JAMA Dermatology.

LIMITATIONS:

Study limitations were the study’s retrospective design and small sample size.

DISCLOSURES:

No information on study funding was provided. One author reported personal fees from argenX outside this submitted work. Other authors did not disclose any competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

The time interval between onset of interstitial lung disease (ILD) and diagnosis of anti–melanoma differentiation-associated gene 5 (MDA5) antibody-positive dermatomyositis (DM) “has not been well described,” the authors say.

METHODOLOGY:

• MDA5 antibody-positive DM is a rare DM subtype associated with ILD, which is categorized into rapidly progressive ILD (RPILD) and chronic ILD, with the former having a particularly high mortality rate.
• In this retrospective cohort study using electronic medical records, researchers evaluated 774 patients with DM between 2008 and 2023 to learn more about the time interval between ILD and the time of an MDA5 antibody-positive DM diagnosis, which has not been well described.
• The primary outcome was ILD diagnosis and time in days between documented ILD and MDA5 antibody-positive DM diagnoses.

TAKEAWAY:

• Overall, 14 patients with DM (1.8%) were diagnosed with MDA5 antibody-positive DM in dermatology, rheumatology, or pulmonology departments (nine women and five men; age, 24-77 years; 79% were White and 7% were Black).
• ILD was diagnosed in 9 of the 14 patients (64%); 6 of the 14 (43%) met the criteria for RPILD. Two cases were diagnosed concurrently and two prior to MDA5 antibody-positive DM diagnosis.
• The median time between ILD and MDA5 antibody-positive DM diagnoses was 163 days.
• Gottron papules/sign and midfacial erythema were the most common dermatologic findings, and no association was seen between cutaneous signs and type of ILD.

IN PRACTICE:

“Establishing an accurate timeline between MDA5 antibody-positive DM and ILD can promote urgency among dermatologists to evaluate extracutaneous manifestations in their management of patients with DM for more accurate risk stratification and appropriate treatment,” the authors wrote.

SOURCE:

This study, led by Rachel R. Lin, from the University of Miami, Miami, Florida, was published online as a research letter in JAMA Dermatology.

LIMITATIONS:

Study limitations were the study’s retrospective design and small sample size.

DISCLOSURES:

No information on study funding was provided. One author reported personal fees from argenX outside this submitted work. Other authors did not disclose any competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

The time interval between onset of interstitial lung disease (ILD) and diagnosis of anti–melanoma differentiation-associated gene 5 (MDA5) antibody-positive dermatomyositis (DM) “has not been well described,” the authors say.

METHODOLOGY:

• MDA5 antibody-positive DM is a rare DM subtype associated with ILD, which is categorized into rapidly progressive ILD (RPILD) and chronic ILD, with the former having a particularly high mortality rate.
• In this retrospective cohort study using electronic medical records, researchers evaluated 774 patients with DM between 2008 and 2023 to learn more about the time interval between ILD and the time of an MDA5 antibody-positive DM diagnosis, which has not been well described.
• The primary outcome was ILD diagnosis and time in days between documented ILD and MDA5 antibody-positive DM diagnoses.

TAKEAWAY:

• Overall, 14 patients with DM (1.8%) were diagnosed with MDA5 antibody-positive DM in dermatology, rheumatology, or pulmonology departments (nine women and five men; age, 24-77 years; 79% were White and 7% were Black).
• ILD was diagnosed in 9 of the 14 patients (64%); 6 of the 14 (43%) met the criteria for RPILD. Two cases were diagnosed concurrently and two prior to MDA5 antibody-positive DM diagnosis.
• The median time between ILD and MDA5 antibody-positive DM diagnoses was 163 days.
• Gottron papules/sign and midfacial erythema were the most common dermatologic findings, and no association was seen between cutaneous signs and type of ILD.

IN PRACTICE:

“Establishing an accurate timeline between MDA5 antibody-positive DM and ILD can promote urgency among dermatologists to evaluate extracutaneous manifestations in their management of patients with DM for more accurate risk stratification and appropriate treatment,” the authors wrote.

SOURCE:

This study, led by Rachel R. Lin, from the University of Miami, Miami, Florida, was published online as a research letter in JAMA Dermatology.

LIMITATIONS:

Study limitations were the study’s retrospective design and small sample size.

DISCLOSURES:

No information on study funding was provided. One author reported personal fees from argenX outside this submitted work. Other authors did not disclose any competing interests.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.

Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.

Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.

It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.

This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.

Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.

Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.

It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.

This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.

Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.

Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.

It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.

This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.

A version of this article appeared on Medscape.com.

TOPLINE:

A recent study suggests that younger breast cancer survivors with a germline pathogenic variant or those with an initial diagnosis of in situ vs invasive primary breast cancer have a significantly higher risk for a second primary breast cancer.

METHODOLOGY:

• Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
• However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
• To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
• The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
• The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.

TAKEAWAY:

• Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
• Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
• Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
• The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.

IN PRACTICE:

Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”

SOURCE:

This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.

LIMITATIONS:

A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.

DISCLOSURES:

This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

A recent study suggests that younger breast cancer survivors with a germline pathogenic variant or those with an initial diagnosis of in situ vs invasive primary breast cancer have a significantly higher risk for a second primary breast cancer.

METHODOLOGY:

• Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
• However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
• To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
• The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
• The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.

TAKEAWAY:

• Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
• Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
• Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
• The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.

IN PRACTICE:

Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”

SOURCE:

This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.

LIMITATIONS:

A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.

DISCLOSURES:

This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

A recent study suggests that younger breast cancer survivors with a germline pathogenic variant or those with an initial diagnosis of in situ vs invasive primary breast cancer have a significantly higher risk for a second primary breast cancer.

METHODOLOGY:

• Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
• However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
• To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
• The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
• The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.

TAKEAWAY:

• Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
• Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
• Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
• The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.

IN PRACTICE:

Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”

SOURCE:

This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.

LIMITATIONS:

A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.

DISCLOSURES:

This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

Omitting axillary lymph node dissection does not increase the risk for recurrence or compromise 5-year overall survival outcomes in patients with early-stage, node-negative breast cancer with sentinel-node metastases undergoing surgery and radiation therapy.

METHODOLOGY:

• A growing body of evidence has indicated that patients with one or two positive sentinel nodes undergoing breast-conserving surgery and radiation therapy can skip axillary lymph node dissection and achieve similar outcomes compared with patients receiving axillary dissection.
• However, these earlier studies had notable limitations, such as limited statistical power, uncertain nodal radiotherapy target volumes, and minimal data on relevant clinical subgroups.
• To fill the gaps in the literature, the researchers conducted a trial with a large, inclusive cohort of patients with node-negative stage T1-T3 breast cancer who had one or two sentinel-node macrometastases and had undergone a mastectomy or breast-conserving surgery.
• The trial randomized 2540 patients to either completion axillary lymph node dissection (n = 1205) or sentinel-node biopsy only (n = 1335). Nearly 90% of patients received adjuvant radiation therapy, and the majority also received systematic therapy.
• Earlier recurrence-free survival findings and patient-reported outcomes were reported last December. The researchers now reported overall survival findings as well as secondary endpoints of breast cancer-specific survival.

TAKEAWAY:

• The researchers reported 191 recurrences or deaths over a median follow-up of 46.8 months; 62 patients (4.6%) in the sentinel-node biopsy–only group died, and 69 patients (5.7%) in the dissection group died.
• The biopsy-only group had an estimated 5-year overall survival of 92.9% compared with 92.0% in the dissection group and an estimated 5-year breast cancer-specific survival of 97.1% vs 96.6% in the dissection group.
• The estimated 5-year recurrence-free survival was 89.7% in the biopsy-only group vs 88.7% in the dissection group (hazard ratio [HR], 0.89; 95% CI, 0.66-1.19).
• This non-inferior difference held across all prespecified patient subgroups, except in patients with estrogen receptor-positive, human epidermal growth factor receptor 2–positive disease, in which sentinel biopsy alone appeared to be better (HR, 0.26).

IN PRACTICE:

“This trial provides robust evidence that the omission of completion axillary-lymph-node dissection was safe in patients with clinically node-negative T1, T2, or T3 breast cancer and one or two sentinel-node macrometastases who received adjuvant systemic treatment and radiation therapy according to national guidelines,” the authors concluded.

“It is clear that the role of axillary dissection is rapidly disappearing,” Kandace P. McGuire, MD, of Virginia Commonwealth University, Richmond, wrote in an accompanying editorial. “However, axillary staging continues to be vital with regard to decisions about appropriate breast cancer therapy.”

SOURCE:

This work, led by Jana de Boniface, MD, PhD, from Karolinska Institute, Stockholm, was published online in The New England Journal of Medicine, alongside the accompanying editorial by Dr. McGuire.

LIMITATIONS:

The study limitations include unavailable radiation therapy details for comparison, low male recruitment hindering sex-based analysis, short follow-up for luminal subtype breast cancer, unmet enrollment targets, and higher withdrawal rates in the dissection group.

DISCLOSURES:

This study was supported by the Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, and Swedish Breast Cancer Association. One coauthor reported receiving consultancy fees from various pharmaceutical companies outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Omitting axillary lymph node dissection does not increase the risk for recurrence or compromise 5-year overall survival outcomes in patients with early-stage, node-negative breast cancer with sentinel-node metastases undergoing surgery and radiation therapy.

METHODOLOGY:

• A growing body of evidence has indicated that patients with one or two positive sentinel nodes undergoing breast-conserving surgery and radiation therapy can skip axillary lymph node dissection and achieve similar outcomes compared with patients receiving axillary dissection.
• However, these earlier studies had notable limitations, such as limited statistical power, uncertain nodal radiotherapy target volumes, and minimal data on relevant clinical subgroups.
• To fill the gaps in the literature, the researchers conducted a trial with a large, inclusive cohort of patients with node-negative stage T1-T3 breast cancer who had one or two sentinel-node macrometastases and had undergone a mastectomy or breast-conserving surgery.
• The trial randomized 2540 patients to either completion axillary lymph node dissection (n = 1205) or sentinel-node biopsy only (n = 1335). Nearly 90% of patients received adjuvant radiation therapy, and the majority also received systematic therapy.
• Earlier recurrence-free survival findings and patient-reported outcomes were reported last December. The researchers now reported overall survival findings as well as secondary endpoints of breast cancer-specific survival.

TAKEAWAY:

• The researchers reported 191 recurrences or deaths over a median follow-up of 46.8 months; 62 patients (4.6%) in the sentinel-node biopsy–only group died, and 69 patients (5.7%) in the dissection group died.
• The biopsy-only group had an estimated 5-year overall survival of 92.9% compared with 92.0% in the dissection group and an estimated 5-year breast cancer-specific survival of 97.1% vs 96.6% in the dissection group.
• The estimated 5-year recurrence-free survival was 89.7% in the biopsy-only group vs 88.7% in the dissection group (hazard ratio [HR], 0.89; 95% CI, 0.66-1.19).
• This non-inferior difference held across all prespecified patient subgroups, except in patients with estrogen receptor-positive, human epidermal growth factor receptor 2–positive disease, in which sentinel biopsy alone appeared to be better (HR, 0.26).

IN PRACTICE:

“This trial provides robust evidence that the omission of completion axillary-lymph-node dissection was safe in patients with clinically node-negative T1, T2, or T3 breast cancer and one or two sentinel-node macrometastases who received adjuvant systemic treatment and radiation therapy according to national guidelines,” the authors concluded.

“It is clear that the role of axillary dissection is rapidly disappearing,” Kandace P. McGuire, MD, of Virginia Commonwealth University, Richmond, wrote in an accompanying editorial. “However, axillary staging continues to be vital with regard to decisions about appropriate breast cancer therapy.”

SOURCE:

This work, led by Jana de Boniface, MD, PhD, from Karolinska Institute, Stockholm, was published online in The New England Journal of Medicine, alongside the accompanying editorial by Dr. McGuire.

LIMITATIONS:

The study limitations include unavailable radiation therapy details for comparison, low male recruitment hindering sex-based analysis, short follow-up for luminal subtype breast cancer, unmet enrollment targets, and higher withdrawal rates in the dissection group.

DISCLOSURES:

This study was supported by the Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, and Swedish Breast Cancer Association. One coauthor reported receiving consultancy fees from various pharmaceutical companies outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Omitting axillary lymph node dissection does not increase the risk for recurrence or compromise 5-year overall survival outcomes in patients with early-stage, node-negative breast cancer with sentinel-node metastases undergoing surgery and radiation therapy.

METHODOLOGY:

• A growing body of evidence has indicated that patients with one or two positive sentinel nodes undergoing breast-conserving surgery and radiation therapy can skip axillary lymph node dissection and achieve similar outcomes compared with patients receiving axillary dissection.
• However, these earlier studies had notable limitations, such as limited statistical power, uncertain nodal radiotherapy target volumes, and minimal data on relevant clinical subgroups.
• To fill the gaps in the literature, the researchers conducted a trial with a large, inclusive cohort of patients with node-negative stage T1-T3 breast cancer who had one or two sentinel-node macrometastases and had undergone a mastectomy or breast-conserving surgery.
• The trial randomized 2540 patients to either completion axillary lymph node dissection (n = 1205) or sentinel-node biopsy only (n = 1335). Nearly 90% of patients received adjuvant radiation therapy, and the majority also received systematic therapy.
• Earlier recurrence-free survival findings and patient-reported outcomes were reported last December. The researchers now reported overall survival findings as well as secondary endpoints of breast cancer-specific survival.

TAKEAWAY:

• The researchers reported 191 recurrences or deaths over a median follow-up of 46.8 months; 62 patients (4.6%) in the sentinel-node biopsy–only group died, and 69 patients (5.7%) in the dissection group died.
• The biopsy-only group had an estimated 5-year overall survival of 92.9% compared with 92.0% in the dissection group and an estimated 5-year breast cancer-specific survival of 97.1% vs 96.6% in the dissection group.
• The estimated 5-year recurrence-free survival was 89.7% in the biopsy-only group vs 88.7% in the dissection group (hazard ratio [HR], 0.89; 95% CI, 0.66-1.19).
• This non-inferior difference held across all prespecified patient subgroups, except in patients with estrogen receptor-positive, human epidermal growth factor receptor 2–positive disease, in which sentinel biopsy alone appeared to be better (HR, 0.26).

IN PRACTICE:

“This trial provides robust evidence that the omission of completion axillary-lymph-node dissection was safe in patients with clinically node-negative T1, T2, or T3 breast cancer and one or two sentinel-node macrometastases who received adjuvant systemic treatment and radiation therapy according to national guidelines,” the authors concluded.

“It is clear that the role of axillary dissection is rapidly disappearing,” Kandace P. McGuire, MD, of Virginia Commonwealth University, Richmond, wrote in an accompanying editorial. “However, axillary staging continues to be vital with regard to decisions about appropriate breast cancer therapy.”

SOURCE:

This work, led by Jana de Boniface, MD, PhD, from Karolinska Institute, Stockholm, was published online in The New England Journal of Medicine, alongside the accompanying editorial by Dr. McGuire.

LIMITATIONS:

The study limitations include unavailable radiation therapy details for comparison, low male recruitment hindering sex-based analysis, short follow-up for luminal subtype breast cancer, unmet enrollment targets, and higher withdrawal rates in the dissection group.

DISCLOSURES:

This study was supported by the Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, and Swedish Breast Cancer Association. One coauthor reported receiving consultancy fees from various pharmaceutical companies outside this work.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.