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Australia Registry Study: Melanoma-Related Deaths Increase at 0.8-mm Breslow Thickness
TOPLINE:
in an Australian study that used registry data.
METHODOLOGY:
- The study analyzed 144,447 individuals (median age, 56 years, 54% men) diagnosed with thin (T1) primary invasive melanomas (Breslow thickness, ≤ 1.0 mm) between 1982 and 2014 from all eight Australian state and territory population-based cancer registries.
- The researchers evaluated the associations between Breslow thickness (< 0.8 mm vs 0.8-1.0 mm) and incidences of melanoma-related and nonmelanoma-related deaths.
- The primary endpoint was time to death attributable to a melanoma-related cause, with death by a nonmelanoma-related cause as a competing event.
TAKEAWAY:
- The 20-year cumulative incidence of melanoma-related deaths was 6.3% for the whole cohort. The incidence was higher for tumors with a thickness of 0.8-1.0 mm (11%) than for those with a thickness < 0.8 mm (5.6%).
- The overall 20-year melanoma-specific survival rate was 95.9%, with rates of 94.2% for tumors < 0.8 mm and 87.8% for tumors measuring 0.8-1.0 mm in thickness. Each 0.1-mm increase in Breslow thickness was associated with worse prognosis.
- A multivariable analysis revealed that a tumor thickness of 0.8-1.0 mm was associated with both a greater absolute risk for melanoma-related deaths (subdistribution hazard ratio, 2.92) and a higher rate of melanoma-related deaths (hazard ratio, 2.98) than a tumor thickness < 0.8 mm.
- The 20-year incidence of death from nonmelanoma-related causes was 23.4%, but the risk for death from these causes showed no significant association with Breslow thickness categories.
IN PRACTICE:
“The findings of this large-scale population–based analysis suggest the separation of risk for patients with melanomas with a Breslow thickness above and below 0.8 mm,” the authors wrote, adding: “These results suggest that a change of the T1 threshold from 1.0 mm to 0.8 mm should be considered when the AJCC [American Joint Committee on Cancer] staging system is next reviewed.”
SOURCE:
The study was led by Serigne N. Lo, PhD, Melanoma Institute Australia, the University of Sydney. It was published online on December 11, 2024, in JAMA Dermatology.
LIMITATIONS:
The study was registry-based and did not capture details such as tumor characteristics and treatment modalities. Inaccuracies in reporting the cause of death may have led to an underestimation of melanoma-specific mortality risks across all thickness groups and an overestimation of nonmelanoma mortality risks.
DISCLOSURES:
The study received funding support from Melanoma Institute Australia and two grants from the Australian National Health and Medical Research Council (NHMRC). Several authors reported receiving grants or personal fees from or having ties with various sources, including NHMRC.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
in an Australian study that used registry data.
METHODOLOGY:
- The study analyzed 144,447 individuals (median age, 56 years, 54% men) diagnosed with thin (T1) primary invasive melanomas (Breslow thickness, ≤ 1.0 mm) between 1982 and 2014 from all eight Australian state and territory population-based cancer registries.
- The researchers evaluated the associations between Breslow thickness (< 0.8 mm vs 0.8-1.0 mm) and incidences of melanoma-related and nonmelanoma-related deaths.
- The primary endpoint was time to death attributable to a melanoma-related cause, with death by a nonmelanoma-related cause as a competing event.
TAKEAWAY:
- The 20-year cumulative incidence of melanoma-related deaths was 6.3% for the whole cohort. The incidence was higher for tumors with a thickness of 0.8-1.0 mm (11%) than for those with a thickness < 0.8 mm (5.6%).
- The overall 20-year melanoma-specific survival rate was 95.9%, with rates of 94.2% for tumors < 0.8 mm and 87.8% for tumors measuring 0.8-1.0 mm in thickness. Each 0.1-mm increase in Breslow thickness was associated with worse prognosis.
- A multivariable analysis revealed that a tumor thickness of 0.8-1.0 mm was associated with both a greater absolute risk for melanoma-related deaths (subdistribution hazard ratio, 2.92) and a higher rate of melanoma-related deaths (hazard ratio, 2.98) than a tumor thickness < 0.8 mm.
- The 20-year incidence of death from nonmelanoma-related causes was 23.4%, but the risk for death from these causes showed no significant association with Breslow thickness categories.
IN PRACTICE:
“The findings of this large-scale population–based analysis suggest the separation of risk for patients with melanomas with a Breslow thickness above and below 0.8 mm,” the authors wrote, adding: “These results suggest that a change of the T1 threshold from 1.0 mm to 0.8 mm should be considered when the AJCC [American Joint Committee on Cancer] staging system is next reviewed.”
SOURCE:
The study was led by Serigne N. Lo, PhD, Melanoma Institute Australia, the University of Sydney. It was published online on December 11, 2024, in JAMA Dermatology.
LIMITATIONS:
The study was registry-based and did not capture details such as tumor characteristics and treatment modalities. Inaccuracies in reporting the cause of death may have led to an underestimation of melanoma-specific mortality risks across all thickness groups and an overestimation of nonmelanoma mortality risks.
DISCLOSURES:
The study received funding support from Melanoma Institute Australia and two grants from the Australian National Health and Medical Research Council (NHMRC). Several authors reported receiving grants or personal fees from or having ties with various sources, including NHMRC.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
in an Australian study that used registry data.
METHODOLOGY:
- The study analyzed 144,447 individuals (median age, 56 years, 54% men) diagnosed with thin (T1) primary invasive melanomas (Breslow thickness, ≤ 1.0 mm) between 1982 and 2014 from all eight Australian state and territory population-based cancer registries.
- The researchers evaluated the associations between Breslow thickness (< 0.8 mm vs 0.8-1.0 mm) and incidences of melanoma-related and nonmelanoma-related deaths.
- The primary endpoint was time to death attributable to a melanoma-related cause, with death by a nonmelanoma-related cause as a competing event.
TAKEAWAY:
- The 20-year cumulative incidence of melanoma-related deaths was 6.3% for the whole cohort. The incidence was higher for tumors with a thickness of 0.8-1.0 mm (11%) than for those with a thickness < 0.8 mm (5.6%).
- The overall 20-year melanoma-specific survival rate was 95.9%, with rates of 94.2% for tumors < 0.8 mm and 87.8% for tumors measuring 0.8-1.0 mm in thickness. Each 0.1-mm increase in Breslow thickness was associated with worse prognosis.
- A multivariable analysis revealed that a tumor thickness of 0.8-1.0 mm was associated with both a greater absolute risk for melanoma-related deaths (subdistribution hazard ratio, 2.92) and a higher rate of melanoma-related deaths (hazard ratio, 2.98) than a tumor thickness < 0.8 mm.
- The 20-year incidence of death from nonmelanoma-related causes was 23.4%, but the risk for death from these causes showed no significant association with Breslow thickness categories.
IN PRACTICE:
“The findings of this large-scale population–based analysis suggest the separation of risk for patients with melanomas with a Breslow thickness above and below 0.8 mm,” the authors wrote, adding: “These results suggest that a change of the T1 threshold from 1.0 mm to 0.8 mm should be considered when the AJCC [American Joint Committee on Cancer] staging system is next reviewed.”
SOURCE:
The study was led by Serigne N. Lo, PhD, Melanoma Institute Australia, the University of Sydney. It was published online on December 11, 2024, in JAMA Dermatology.
LIMITATIONS:
The study was registry-based and did not capture details such as tumor characteristics and treatment modalities. Inaccuracies in reporting the cause of death may have led to an underestimation of melanoma-specific mortality risks across all thickness groups and an overestimation of nonmelanoma mortality risks.
DISCLOSURES:
The study received funding support from Melanoma Institute Australia and two grants from the Australian National Health and Medical Research Council (NHMRC). Several authors reported receiving grants or personal fees from or having ties with various sources, including NHMRC.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Cutaneous Lupus Associated with Greater Risk for Atherosclerotic Cardiovascular Disease
TOPLINE:
than with psoriasis.
METHODOLOGY:
- A retrospective matched longitudinal study compared the incidence and prevalence of ASCVD of 8138 individuals with CLE; 24,675 with SLE; 192,577 with psoriasis; and 81,380 control individuals.
- The disease-free control population was matched in a 10:1 ratio to the CLE population on the basis of age, sex, insurance type, and enrollment duration.
- Prevalent ASCVD was defined as coronary artery disease, prior myocardial infarction, or cerebrovascular accident, with ASCVD incidence assessed by number of hospitalizations over 3 years.
TAKEAWAY:
- Persons with CLE had higher ASCVD risk than control individuals (odds ratio [OR], 1.72; P < .001), similar to those with SLE (OR, 2.41; P < .001) but unlike those with psoriasis (OR, 1.03; P = .48).
- ASCVD incidence at 3 years was 24.8 per 1000 person-years for SLE, 15.2 per 1000 person-years for CLE, 14.0 per 1000 person-years for psoriasis, and 10.3 per 1000 person-years for controls.
- Multivariable Cox proportional regression modeling showed ASCVD risk was highest in those with SLE (hazard ratio [HR], 2.23; P < .001) vs CLE (HR, 1.32; P < .001) and psoriasis (HR, 1.06; P = .09).
- ASCVD prevalence was higher in individuals with CLE receiving systemic therapy (2.7%) than in those receiving no therapy (1.6%), suggesting a potential link between disease severity and CVD risk.
IN PRACTICE:
“Persons with CLE are at higher risk for ASCVD, and guidelines for the evaluation and management of ASCVD may improve their quality of care,” the authors wrote.
SOURCE:
The study was led by Henry W. Chen, MD, Department of Dermatology, University of Texas Southwestern Medical Center, Dallas. It was published online on December 4, 2024, in JAMA Dermatology.
LIMITATIONS:
The study was limited by its relatively young population (median age, 49 years) and the exclusion of adults aged > 65 years on Medicare insurance plans. The database lacked race and ethnicity data, and the analysis was restricted to a shorter 3-year period. The study could not fully evaluate detailed risk factors such as blood pressure levels, cholesterol measurements, or glycemic control, nor could it accurately assess smoking status.
DISCLOSURES:
The research was supported by the Department of Dermatology at the University of Texas Southwestern Medical Center and a grant from the National Institutes of Health. Several authors reported receiving grants or personal fees from various pharmaceutical companies. One author reported being a deputy editor for diversity, equity, and inclusion at JAMA Cardiology. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
than with psoriasis.
METHODOLOGY:
- A retrospective matched longitudinal study compared the incidence and prevalence of ASCVD of 8138 individuals with CLE; 24,675 with SLE; 192,577 with psoriasis; and 81,380 control individuals.
- The disease-free control population was matched in a 10:1 ratio to the CLE population on the basis of age, sex, insurance type, and enrollment duration.
- Prevalent ASCVD was defined as coronary artery disease, prior myocardial infarction, or cerebrovascular accident, with ASCVD incidence assessed by number of hospitalizations over 3 years.
TAKEAWAY:
- Persons with CLE had higher ASCVD risk than control individuals (odds ratio [OR], 1.72; P < .001), similar to those with SLE (OR, 2.41; P < .001) but unlike those with psoriasis (OR, 1.03; P = .48).
- ASCVD incidence at 3 years was 24.8 per 1000 person-years for SLE, 15.2 per 1000 person-years for CLE, 14.0 per 1000 person-years for psoriasis, and 10.3 per 1000 person-years for controls.
- Multivariable Cox proportional regression modeling showed ASCVD risk was highest in those with SLE (hazard ratio [HR], 2.23; P < .001) vs CLE (HR, 1.32; P < .001) and psoriasis (HR, 1.06; P = .09).
- ASCVD prevalence was higher in individuals with CLE receiving systemic therapy (2.7%) than in those receiving no therapy (1.6%), suggesting a potential link between disease severity and CVD risk.
IN PRACTICE:
“Persons with CLE are at higher risk for ASCVD, and guidelines for the evaluation and management of ASCVD may improve their quality of care,” the authors wrote.
SOURCE:
The study was led by Henry W. Chen, MD, Department of Dermatology, University of Texas Southwestern Medical Center, Dallas. It was published online on December 4, 2024, in JAMA Dermatology.
LIMITATIONS:
The study was limited by its relatively young population (median age, 49 years) and the exclusion of adults aged > 65 years on Medicare insurance plans. The database lacked race and ethnicity data, and the analysis was restricted to a shorter 3-year period. The study could not fully evaluate detailed risk factors such as blood pressure levels, cholesterol measurements, or glycemic control, nor could it accurately assess smoking status.
DISCLOSURES:
The research was supported by the Department of Dermatology at the University of Texas Southwestern Medical Center and a grant from the National Institutes of Health. Several authors reported receiving grants or personal fees from various pharmaceutical companies. One author reported being a deputy editor for diversity, equity, and inclusion at JAMA Cardiology. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
than with psoriasis.
METHODOLOGY:
- A retrospective matched longitudinal study compared the incidence and prevalence of ASCVD of 8138 individuals with CLE; 24,675 with SLE; 192,577 with psoriasis; and 81,380 control individuals.
- The disease-free control population was matched in a 10:1 ratio to the CLE population on the basis of age, sex, insurance type, and enrollment duration.
- Prevalent ASCVD was defined as coronary artery disease, prior myocardial infarction, or cerebrovascular accident, with ASCVD incidence assessed by number of hospitalizations over 3 years.
TAKEAWAY:
- Persons with CLE had higher ASCVD risk than control individuals (odds ratio [OR], 1.72; P < .001), similar to those with SLE (OR, 2.41; P < .001) but unlike those with psoriasis (OR, 1.03; P = .48).
- ASCVD incidence at 3 years was 24.8 per 1000 person-years for SLE, 15.2 per 1000 person-years for CLE, 14.0 per 1000 person-years for psoriasis, and 10.3 per 1000 person-years for controls.
- Multivariable Cox proportional regression modeling showed ASCVD risk was highest in those with SLE (hazard ratio [HR], 2.23; P < .001) vs CLE (HR, 1.32; P < .001) and psoriasis (HR, 1.06; P = .09).
- ASCVD prevalence was higher in individuals with CLE receiving systemic therapy (2.7%) than in those receiving no therapy (1.6%), suggesting a potential link between disease severity and CVD risk.
IN PRACTICE:
“Persons with CLE are at higher risk for ASCVD, and guidelines for the evaluation and management of ASCVD may improve their quality of care,” the authors wrote.
SOURCE:
The study was led by Henry W. Chen, MD, Department of Dermatology, University of Texas Southwestern Medical Center, Dallas. It was published online on December 4, 2024, in JAMA Dermatology.
LIMITATIONS:
The study was limited by its relatively young population (median age, 49 years) and the exclusion of adults aged > 65 years on Medicare insurance plans. The database lacked race and ethnicity data, and the analysis was restricted to a shorter 3-year period. The study could not fully evaluate detailed risk factors such as blood pressure levels, cholesterol measurements, or glycemic control, nor could it accurately assess smoking status.
DISCLOSURES:
The research was supported by the Department of Dermatology at the University of Texas Southwestern Medical Center and a grant from the National Institutes of Health. Several authors reported receiving grants or personal fees from various pharmaceutical companies. One author reported being a deputy editor for diversity, equity, and inclusion at JAMA Cardiology. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
US Study Pinpoints Merkel Cell Risk Factors
TOPLINE:
in the United States.
METHODOLOGY:
- Researchers evaluated 38,020 MCC cases (38% women; 93% non-Hispanic White, 4% Hispanic, 1% non-Hispanic Black) diagnosed in the United States from 2001 to 2019 to estimate the contribution of potentially modifiable risk factors to the burden of MCC.
- Population-based cancer registries and linkages with HIV and transplant registries were utilized to identify MCC cases in patients with HIV, solid organ transplant recipients, and patients with chronic lymphocytic leukemia (CLL).
- Data on cloud-adjusted daily ambient UVR irradiance were merged with cancer registry information on the county of residence at diagnosis to assess UVR exposure. Studies reporting the prevalence of MCPyV in MCC specimens collected in the United States were combined via a meta-analysis.
- The study assessed population attributable fractions of MCC cases that were attributable to major immunosuppressive conditions (HIV, solid organ transplant, and chronic CLL), ambient UVR exposure, and MCPyV.
TAKEAWAY:
- The incidence of MCC was higher in people with HIV (standardized incidence ratio [SIR], 2.78), organ transplant recipients (SIR, 13.1), and patients with CLL (SIR, 5.75) than in the general US population. However, only 2.5% of MCC cases were attributable to these immunosuppressive conditions.
- Non-Hispanic White individuals showed elevated MCC incidence at both lower and higher ambient UVR exposure levels, with incidence rate ratios of 4.05 and 4.91, respectively, for MCC on the head and neck.
- A meta-analysis of 19 case series revealed that 63.8% of MCC cases were attributable to MCPyV, with a similar prevalence observed between immunocompromised and immunocompetent patients.
- Overall, 65.1% of MCC cases were attributable to ambient UVR exposure, with higher attribution for cases diagnosed on the head and neck than those diagnosed on other sites (72.1% vs 60.2%).
IN PRACTICE:
“The results of this study suggest that most MCC cases in the US are attributable to MCPyV and/or ambient UVR [UV radiation] exposure, with a smaller fraction attributable to three major immunosuppressive conditions,” the authors wrote. “Future studies should investigate UVR mutational signature, TMB [tumor mutational burden], and MCPyV prevalence according to race and ethnicity and patient immune status to help clarify the overlap between MCC risk factors.”
SOURCE:
The study was led by Jacob T. Tribble, BA, Division of Cancer Epidemiology and Genetics, National Cancer Institute (NCI), Rockville, Maryland. It was published online on November 27, 2024, in JAMA Dermatology.
LIMITATIONS:
Incidences of MCC may have been inflated because of increased medical surveillance in immunosuppressed populations. The analysis assumed that only cases among non-Hispanic White individuals were associated with UVR. Additionally, the meta-analysis of MCPyV prevalence primarily included studies from large academic institutions, which may not be representative of the entire US population.
DISCLOSURES:
This study was supported in part by the Intramural Research Program of the NCI and the National Institutes of Health Medical Research Scholars Program. Additional funding was provided through a public-private partnership with contributions from the American Association for Dental Research and the Colgate-Palmolive Company to the Foundation for the National Institutes of Health. The authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
in the United States.
METHODOLOGY:
- Researchers evaluated 38,020 MCC cases (38% women; 93% non-Hispanic White, 4% Hispanic, 1% non-Hispanic Black) diagnosed in the United States from 2001 to 2019 to estimate the contribution of potentially modifiable risk factors to the burden of MCC.
- Population-based cancer registries and linkages with HIV and transplant registries were utilized to identify MCC cases in patients with HIV, solid organ transplant recipients, and patients with chronic lymphocytic leukemia (CLL).
- Data on cloud-adjusted daily ambient UVR irradiance were merged with cancer registry information on the county of residence at diagnosis to assess UVR exposure. Studies reporting the prevalence of MCPyV in MCC specimens collected in the United States were combined via a meta-analysis.
- The study assessed population attributable fractions of MCC cases that were attributable to major immunosuppressive conditions (HIV, solid organ transplant, and chronic CLL), ambient UVR exposure, and MCPyV.
TAKEAWAY:
- The incidence of MCC was higher in people with HIV (standardized incidence ratio [SIR], 2.78), organ transplant recipients (SIR, 13.1), and patients with CLL (SIR, 5.75) than in the general US population. However, only 2.5% of MCC cases were attributable to these immunosuppressive conditions.
- Non-Hispanic White individuals showed elevated MCC incidence at both lower and higher ambient UVR exposure levels, with incidence rate ratios of 4.05 and 4.91, respectively, for MCC on the head and neck.
- A meta-analysis of 19 case series revealed that 63.8% of MCC cases were attributable to MCPyV, with a similar prevalence observed between immunocompromised and immunocompetent patients.
- Overall, 65.1% of MCC cases were attributable to ambient UVR exposure, with higher attribution for cases diagnosed on the head and neck than those diagnosed on other sites (72.1% vs 60.2%).
IN PRACTICE:
“The results of this study suggest that most MCC cases in the US are attributable to MCPyV and/or ambient UVR [UV radiation] exposure, with a smaller fraction attributable to three major immunosuppressive conditions,” the authors wrote. “Future studies should investigate UVR mutational signature, TMB [tumor mutational burden], and MCPyV prevalence according to race and ethnicity and patient immune status to help clarify the overlap between MCC risk factors.”
SOURCE:
The study was led by Jacob T. Tribble, BA, Division of Cancer Epidemiology and Genetics, National Cancer Institute (NCI), Rockville, Maryland. It was published online on November 27, 2024, in JAMA Dermatology.
LIMITATIONS:
Incidences of MCC may have been inflated because of increased medical surveillance in immunosuppressed populations. The analysis assumed that only cases among non-Hispanic White individuals were associated with UVR. Additionally, the meta-analysis of MCPyV prevalence primarily included studies from large academic institutions, which may not be representative of the entire US population.
DISCLOSURES:
This study was supported in part by the Intramural Research Program of the NCI and the National Institutes of Health Medical Research Scholars Program. Additional funding was provided through a public-private partnership with contributions from the American Association for Dental Research and the Colgate-Palmolive Company to the Foundation for the National Institutes of Health. The authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
in the United States.
METHODOLOGY:
- Researchers evaluated 38,020 MCC cases (38% women; 93% non-Hispanic White, 4% Hispanic, 1% non-Hispanic Black) diagnosed in the United States from 2001 to 2019 to estimate the contribution of potentially modifiable risk factors to the burden of MCC.
- Population-based cancer registries and linkages with HIV and transplant registries were utilized to identify MCC cases in patients with HIV, solid organ transplant recipients, and patients with chronic lymphocytic leukemia (CLL).
- Data on cloud-adjusted daily ambient UVR irradiance were merged with cancer registry information on the county of residence at diagnosis to assess UVR exposure. Studies reporting the prevalence of MCPyV in MCC specimens collected in the United States were combined via a meta-analysis.
- The study assessed population attributable fractions of MCC cases that were attributable to major immunosuppressive conditions (HIV, solid organ transplant, and chronic CLL), ambient UVR exposure, and MCPyV.
TAKEAWAY:
- The incidence of MCC was higher in people with HIV (standardized incidence ratio [SIR], 2.78), organ transplant recipients (SIR, 13.1), and patients with CLL (SIR, 5.75) than in the general US population. However, only 2.5% of MCC cases were attributable to these immunosuppressive conditions.
- Non-Hispanic White individuals showed elevated MCC incidence at both lower and higher ambient UVR exposure levels, with incidence rate ratios of 4.05 and 4.91, respectively, for MCC on the head and neck.
- A meta-analysis of 19 case series revealed that 63.8% of MCC cases were attributable to MCPyV, with a similar prevalence observed between immunocompromised and immunocompetent patients.
- Overall, 65.1% of MCC cases were attributable to ambient UVR exposure, with higher attribution for cases diagnosed on the head and neck than those diagnosed on other sites (72.1% vs 60.2%).
IN PRACTICE:
“The results of this study suggest that most MCC cases in the US are attributable to MCPyV and/or ambient UVR [UV radiation] exposure, with a smaller fraction attributable to three major immunosuppressive conditions,” the authors wrote. “Future studies should investigate UVR mutational signature, TMB [tumor mutational burden], and MCPyV prevalence according to race and ethnicity and patient immune status to help clarify the overlap between MCC risk factors.”
SOURCE:
The study was led by Jacob T. Tribble, BA, Division of Cancer Epidemiology and Genetics, National Cancer Institute (NCI), Rockville, Maryland. It was published online on November 27, 2024, in JAMA Dermatology.
LIMITATIONS:
Incidences of MCC may have been inflated because of increased medical surveillance in immunosuppressed populations. The analysis assumed that only cases among non-Hispanic White individuals were associated with UVR. Additionally, the meta-analysis of MCPyV prevalence primarily included studies from large academic institutions, which may not be representative of the entire US population.
DISCLOSURES:
This study was supported in part by the Intramural Research Program of the NCI and the National Institutes of Health Medical Research Scholars Program. Additional funding was provided through a public-private partnership with contributions from the American Association for Dental Research and the Colgate-Palmolive Company to the Foundation for the National Institutes of Health. The authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Is 1-Week Radiotherapy Safe for Breast Cancer?
TOPLINE:
Most patients also reported that the reduced treatment time was a major benefit of the 1-week radiotherapy schedule.
METHODOLOGY:
- In March 2020, during the COVID-19 pandemic, international and national guidelines recommended adopting a 1-week ultrahypofractionated radiotherapy schedule for patients with node-negative breast cancer. Subsequently, a phase 3 trial demonstrated that a 1-week regimen of 26 Gy in five fractions led to similar breast cancer outcomes compared with a standard moderately hypofractionated regimen.
- In this study, researchers wanted to assess real world toxicities following ultrahypofractionated radiotherapy and enrolled 135 consecutive patients who received 1-week ultrahypofractionated adjuvant radiation of 26 Gy in five fractions from March to August 2020 at three centers in Ireland, with 33 patients (25%) receiving a sequential boost.
- Researchers recorded patient-reported outcomes on breast pain, swelling, firmness, and hypersensitivity at baseline, 3, 6, and 12 months. Virtual consultations without video occurred at baseline, 3 months, 6 months, and video consultations were offered at 1 year for a physician-led breast evaluation.
- Researchers assessed patient perspectives on this new schedule and telehealth workflows using questionnaires.
- Overall, 90% of patients completed the 1-year assessment plus another assessment. The primary endpoint was the worst toxicity reported at each time point.
TAKEAWAY:
- Overall, 76% of patients reported no or mild toxicities at 3 and 6 months, and 82% reported no or mild toxicities 12 months.
- At 1 year, 20 patients (17%) reported moderate toxicity, most commonly breast pain, and only two patients (2%) reported marked toxicities, including breast firmness and skin changes.
- Researchers found no difference in toxicities between patients who received only 26 Gy in five fractions and those who received an additional sequential boost.
- Most patients reported reduced treatment time (78.6%) and infection control (59%) as major benefits of the 1-week radiotherapy regimen. Patients also reported high satisfaction with the use of telehealth, with 97.3% feeling well-informed about their diagnosis, 88% feeling well-informed about treatment side effects, and 94% feeling supported by the medical team. However, only 27% agreed to video consultations for breast inspections at 1 year.
IN PRACTICE:
“Ultrahypofractionated whole breast radiotherapy leads to acceptable late toxicity rates at 1 year even when followed by a hypofractionated tumour bed boost,” the authors wrote. “Patient satisfaction with ultrahypofractionated treatment and virtual consultations without video was high.”
SOURCE:
The study, led by Jill Nicholson, MBBS, MRCP, FFFRRCSI, St Luke’s Radiation Oncology Network, St. Luke’s Hospital, Dublin, Ireland, was published online in Advances in Radiation Oncology.
LIMITATIONS:
The short follow-up period might not capture all late toxicities. Variability in patient-reported outcomes could affect consistency. The range in boost received (four to eight fractions) could have influenced patients’ experiences.
DISCLOSURES:
Nicholson received funding from the St. Luke’s Institute of Cancer Research, Dublin, Ireland. No other relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Most patients also reported that the reduced treatment time was a major benefit of the 1-week radiotherapy schedule.
METHODOLOGY:
- In March 2020, during the COVID-19 pandemic, international and national guidelines recommended adopting a 1-week ultrahypofractionated radiotherapy schedule for patients with node-negative breast cancer. Subsequently, a phase 3 trial demonstrated that a 1-week regimen of 26 Gy in five fractions led to similar breast cancer outcomes compared with a standard moderately hypofractionated regimen.
- In this study, researchers wanted to assess real world toxicities following ultrahypofractionated radiotherapy and enrolled 135 consecutive patients who received 1-week ultrahypofractionated adjuvant radiation of 26 Gy in five fractions from March to August 2020 at three centers in Ireland, with 33 patients (25%) receiving a sequential boost.
- Researchers recorded patient-reported outcomes on breast pain, swelling, firmness, and hypersensitivity at baseline, 3, 6, and 12 months. Virtual consultations without video occurred at baseline, 3 months, 6 months, and video consultations were offered at 1 year for a physician-led breast evaluation.
- Researchers assessed patient perspectives on this new schedule and telehealth workflows using questionnaires.
- Overall, 90% of patients completed the 1-year assessment plus another assessment. The primary endpoint was the worst toxicity reported at each time point.
TAKEAWAY:
- Overall, 76% of patients reported no or mild toxicities at 3 and 6 months, and 82% reported no or mild toxicities 12 months.
- At 1 year, 20 patients (17%) reported moderate toxicity, most commonly breast pain, and only two patients (2%) reported marked toxicities, including breast firmness and skin changes.
- Researchers found no difference in toxicities between patients who received only 26 Gy in five fractions and those who received an additional sequential boost.
- Most patients reported reduced treatment time (78.6%) and infection control (59%) as major benefits of the 1-week radiotherapy regimen. Patients also reported high satisfaction with the use of telehealth, with 97.3% feeling well-informed about their diagnosis, 88% feeling well-informed about treatment side effects, and 94% feeling supported by the medical team. However, only 27% agreed to video consultations for breast inspections at 1 year.
IN PRACTICE:
“Ultrahypofractionated whole breast radiotherapy leads to acceptable late toxicity rates at 1 year even when followed by a hypofractionated tumour bed boost,” the authors wrote. “Patient satisfaction with ultrahypofractionated treatment and virtual consultations without video was high.”
SOURCE:
The study, led by Jill Nicholson, MBBS, MRCP, FFFRRCSI, St Luke’s Radiation Oncology Network, St. Luke’s Hospital, Dublin, Ireland, was published online in Advances in Radiation Oncology.
LIMITATIONS:
The short follow-up period might not capture all late toxicities. Variability in patient-reported outcomes could affect consistency. The range in boost received (four to eight fractions) could have influenced patients’ experiences.
DISCLOSURES:
Nicholson received funding from the St. Luke’s Institute of Cancer Research, Dublin, Ireland. No other relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Most patients also reported that the reduced treatment time was a major benefit of the 1-week radiotherapy schedule.
METHODOLOGY:
- In March 2020, during the COVID-19 pandemic, international and national guidelines recommended adopting a 1-week ultrahypofractionated radiotherapy schedule for patients with node-negative breast cancer. Subsequently, a phase 3 trial demonstrated that a 1-week regimen of 26 Gy in five fractions led to similar breast cancer outcomes compared with a standard moderately hypofractionated regimen.
- In this study, researchers wanted to assess real world toxicities following ultrahypofractionated radiotherapy and enrolled 135 consecutive patients who received 1-week ultrahypofractionated adjuvant radiation of 26 Gy in five fractions from March to August 2020 at three centers in Ireland, with 33 patients (25%) receiving a sequential boost.
- Researchers recorded patient-reported outcomes on breast pain, swelling, firmness, and hypersensitivity at baseline, 3, 6, and 12 months. Virtual consultations without video occurred at baseline, 3 months, 6 months, and video consultations were offered at 1 year for a physician-led breast evaluation.
- Researchers assessed patient perspectives on this new schedule and telehealth workflows using questionnaires.
- Overall, 90% of patients completed the 1-year assessment plus another assessment. The primary endpoint was the worst toxicity reported at each time point.
TAKEAWAY:
- Overall, 76% of patients reported no or mild toxicities at 3 and 6 months, and 82% reported no or mild toxicities 12 months.
- At 1 year, 20 patients (17%) reported moderate toxicity, most commonly breast pain, and only two patients (2%) reported marked toxicities, including breast firmness and skin changes.
- Researchers found no difference in toxicities between patients who received only 26 Gy in five fractions and those who received an additional sequential boost.
- Most patients reported reduced treatment time (78.6%) and infection control (59%) as major benefits of the 1-week radiotherapy regimen. Patients also reported high satisfaction with the use of telehealth, with 97.3% feeling well-informed about their diagnosis, 88% feeling well-informed about treatment side effects, and 94% feeling supported by the medical team. However, only 27% agreed to video consultations for breast inspections at 1 year.
IN PRACTICE:
“Ultrahypofractionated whole breast radiotherapy leads to acceptable late toxicity rates at 1 year even when followed by a hypofractionated tumour bed boost,” the authors wrote. “Patient satisfaction with ultrahypofractionated treatment and virtual consultations without video was high.”
SOURCE:
The study, led by Jill Nicholson, MBBS, MRCP, FFFRRCSI, St Luke’s Radiation Oncology Network, St. Luke’s Hospital, Dublin, Ireland, was published online in Advances in Radiation Oncology.
LIMITATIONS:
The short follow-up period might not capture all late toxicities. Variability in patient-reported outcomes could affect consistency. The range in boost received (four to eight fractions) could have influenced patients’ experiences.
DISCLOSURES:
Nicholson received funding from the St. Luke’s Institute of Cancer Research, Dublin, Ireland. No other relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Spinal Cord Stimulation Promising for Chronic Back, Leg Pain
TOPLINE:
Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.
METHODOLOGY:
- Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
- More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
- Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
- Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
- The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.
TAKEAWAY:
- Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
- Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
- Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
- Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.
IN PRACTICE:
“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.
SOURCE:
The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.
LIMITATIONS:
The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.
DISCLOSURES:
This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.
METHODOLOGY:
- Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
- More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
- Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
- Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
- The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.
TAKEAWAY:
- Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
- Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
- Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
- Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.
IN PRACTICE:
“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.
SOURCE:
The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.
LIMITATIONS:
The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.
DISCLOSURES:
This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.
METHODOLOGY:
- Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
- More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
- Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
- Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
- The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.
TAKEAWAY:
- Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
- Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
- Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
- Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.
IN PRACTICE:
“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.
SOURCE:
The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.
LIMITATIONS:
The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.
DISCLOSURES:
This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Which Breast Cancer Patients Can Skip Postop Radiotherapy?
TOPLINE:
Overall, patients with a high POLAR score derived a significant benefit from adjuvant radiotherapy, while those with a low score did not and might consider forgoing radiotherapy.
METHODOLOGY:
- Radiation therapy after breast-conserving surgery has been shown to reduce the risk for locoregional recurrence and is a standard approach to manage early breast cancer. However, certain patients with low locoregional recurrence risks may not necessarily benefit from adjuvant radiation, but there has not been a commercially available molecular test to help identify which patients that might be.
- In the current analysis, researchers assessed whether the POLAR biomarker test could reliably predict locoregional recurrence as well as identify patients who would not benefit from radiotherapy.
- The meta-analysis used data from three randomized trials — Scottish Conservation Trial, SweBCG91-RT, and Princess Margaret RT trial — to validate the POLAR biomarker test in patients with low-risk, HR-positive, HER2-negative, node-negative breast cancer.
- The analysis included 623 patients (ages 50-76), of whom 429 (69%) had high POLAR scores and 194 (31%) had low POLAR scores.
- The primary endpoint was the time to locoregional recurrence, and secondary endpoints included evaluating POLAR as a prognostic factor for locoregional recurrence in patients without radiotherapy and effect of radiotherapy in patients with low and high POLAR scores.
TAKEAWAY:
- Patients with high POLAR scores demonstrated a significant benefit from radiotherapy. The 10-year locoregional recurrence rate was 7% with radiotherapy vs 20% without radiotherapy (hazard ratio [HR], 0.37; P < .001).
- Patients with low POLAR scores, however, did not experience a significant benefit from radiotherapy. In this group, the 10-year locoregional recurrence rates were similar with and without radiotherapy (7% vs 5%, respectively; HR, 0.92; P = .832), indicating that radiotherapy could potentially be omitted for these patients.
- Among patients who did not receive radiotherapy (n = 309), higher POLAR scores predicted a greater risk for recurrence, suggesting the genomic signature has prognostic value. There is no evidence, however, that POLAR predicts radiotherapy benefit or predicts patients’ risk for distant metastases or mortality.
IN PRACTICE:
“This meta-analysis from three randomized controlled trials clearly demonstrates the clinical potential for POLAR to be used in smaller estrogen receptor positive node negative breast cancer patients to identify those women who do not appear to benefit from the use of post-operative adjuvant radiotherapy,” the authors wrote. “ This classifier is an important step towards molecularly-stratified targeting of the use of radiotherapy.”
SOURCE:
The study, led by Per Karlsson, MD, PhD, University of Gothenburg, Sweden, was published online in the Journal of the National Cancer Institute.
LIMITATIONS:
One cohort (SweBCG) had limited use of adjuvant systemic therapy, which could affect generalizability. Additionally, low numbers of patients with low POLAR scores in two trials could affect the observed benefit of radiotherapy.
DISCLOSURES:
This study was supported by the Breast Cancer Institute Fund (Edinburgh and Lothians Health Foundation), Canadian Institutes of Health Research, Exact Sciences Corporation, PFS Genomics, Swedish Cancer Society, and Swedish Research Council. One author reported being an employee and owning stock or stock options or patents with Exact Sciences. Several authors reported having various ties with various sources including Exact Sciences.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Overall, patients with a high POLAR score derived a significant benefit from adjuvant radiotherapy, while those with a low score did not and might consider forgoing radiotherapy.
METHODOLOGY:
- Radiation therapy after breast-conserving surgery has been shown to reduce the risk for locoregional recurrence and is a standard approach to manage early breast cancer. However, certain patients with low locoregional recurrence risks may not necessarily benefit from adjuvant radiation, but there has not been a commercially available molecular test to help identify which patients that might be.
- In the current analysis, researchers assessed whether the POLAR biomarker test could reliably predict locoregional recurrence as well as identify patients who would not benefit from radiotherapy.
- The meta-analysis used data from three randomized trials — Scottish Conservation Trial, SweBCG91-RT, and Princess Margaret RT trial — to validate the POLAR biomarker test in patients with low-risk, HR-positive, HER2-negative, node-negative breast cancer.
- The analysis included 623 patients (ages 50-76), of whom 429 (69%) had high POLAR scores and 194 (31%) had low POLAR scores.
- The primary endpoint was the time to locoregional recurrence, and secondary endpoints included evaluating POLAR as a prognostic factor for locoregional recurrence in patients without radiotherapy and effect of radiotherapy in patients with low and high POLAR scores.
TAKEAWAY:
- Patients with high POLAR scores demonstrated a significant benefit from radiotherapy. The 10-year locoregional recurrence rate was 7% with radiotherapy vs 20% without radiotherapy (hazard ratio [HR], 0.37; P < .001).
- Patients with low POLAR scores, however, did not experience a significant benefit from radiotherapy. In this group, the 10-year locoregional recurrence rates were similar with and without radiotherapy (7% vs 5%, respectively; HR, 0.92; P = .832), indicating that radiotherapy could potentially be omitted for these patients.
- Among patients who did not receive radiotherapy (n = 309), higher POLAR scores predicted a greater risk for recurrence, suggesting the genomic signature has prognostic value. There is no evidence, however, that POLAR predicts radiotherapy benefit or predicts patients’ risk for distant metastases or mortality.
IN PRACTICE:
“This meta-analysis from three randomized controlled trials clearly demonstrates the clinical potential for POLAR to be used in smaller estrogen receptor positive node negative breast cancer patients to identify those women who do not appear to benefit from the use of post-operative adjuvant radiotherapy,” the authors wrote. “ This classifier is an important step towards molecularly-stratified targeting of the use of radiotherapy.”
SOURCE:
The study, led by Per Karlsson, MD, PhD, University of Gothenburg, Sweden, was published online in the Journal of the National Cancer Institute.
LIMITATIONS:
One cohort (SweBCG) had limited use of adjuvant systemic therapy, which could affect generalizability. Additionally, low numbers of patients with low POLAR scores in two trials could affect the observed benefit of radiotherapy.
DISCLOSURES:
This study was supported by the Breast Cancer Institute Fund (Edinburgh and Lothians Health Foundation), Canadian Institutes of Health Research, Exact Sciences Corporation, PFS Genomics, Swedish Cancer Society, and Swedish Research Council. One author reported being an employee and owning stock or stock options or patents with Exact Sciences. Several authors reported having various ties with various sources including Exact Sciences.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Overall, patients with a high POLAR score derived a significant benefit from adjuvant radiotherapy, while those with a low score did not and might consider forgoing radiotherapy.
METHODOLOGY:
- Radiation therapy after breast-conserving surgery has been shown to reduce the risk for locoregional recurrence and is a standard approach to manage early breast cancer. However, certain patients with low locoregional recurrence risks may not necessarily benefit from adjuvant radiation, but there has not been a commercially available molecular test to help identify which patients that might be.
- In the current analysis, researchers assessed whether the POLAR biomarker test could reliably predict locoregional recurrence as well as identify patients who would not benefit from radiotherapy.
- The meta-analysis used data from three randomized trials — Scottish Conservation Trial, SweBCG91-RT, and Princess Margaret RT trial — to validate the POLAR biomarker test in patients with low-risk, HR-positive, HER2-negative, node-negative breast cancer.
- The analysis included 623 patients (ages 50-76), of whom 429 (69%) had high POLAR scores and 194 (31%) had low POLAR scores.
- The primary endpoint was the time to locoregional recurrence, and secondary endpoints included evaluating POLAR as a prognostic factor for locoregional recurrence in patients without radiotherapy and effect of radiotherapy in patients with low and high POLAR scores.
TAKEAWAY:
- Patients with high POLAR scores demonstrated a significant benefit from radiotherapy. The 10-year locoregional recurrence rate was 7% with radiotherapy vs 20% without radiotherapy (hazard ratio [HR], 0.37; P < .001).
- Patients with low POLAR scores, however, did not experience a significant benefit from radiotherapy. In this group, the 10-year locoregional recurrence rates were similar with and without radiotherapy (7% vs 5%, respectively; HR, 0.92; P = .832), indicating that radiotherapy could potentially be omitted for these patients.
- Among patients who did not receive radiotherapy (n = 309), higher POLAR scores predicted a greater risk for recurrence, suggesting the genomic signature has prognostic value. There is no evidence, however, that POLAR predicts radiotherapy benefit or predicts patients’ risk for distant metastases or mortality.
IN PRACTICE:
“This meta-analysis from three randomized controlled trials clearly demonstrates the clinical potential for POLAR to be used in smaller estrogen receptor positive node negative breast cancer patients to identify those women who do not appear to benefit from the use of post-operative adjuvant radiotherapy,” the authors wrote. “ This classifier is an important step towards molecularly-stratified targeting of the use of radiotherapy.”
SOURCE:
The study, led by Per Karlsson, MD, PhD, University of Gothenburg, Sweden, was published online in the Journal of the National Cancer Institute.
LIMITATIONS:
One cohort (SweBCG) had limited use of adjuvant systemic therapy, which could affect generalizability. Additionally, low numbers of patients with low POLAR scores in two trials could affect the observed benefit of radiotherapy.
DISCLOSURES:
This study was supported by the Breast Cancer Institute Fund (Edinburgh and Lothians Health Foundation), Canadian Institutes of Health Research, Exact Sciences Corporation, PFS Genomics, Swedish Cancer Society, and Swedish Research Council. One author reported being an employee and owning stock or stock options or patents with Exact Sciences. Several authors reported having various ties with various sources including Exact Sciences.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Two Brain Stim Methods Better Than One for Depression?
TOPLINE:
a new study showed.
METHODOLOGY:
- Researchers conducted a double-blind, sham-controlled randomized clinical trial from 2021 to 2023 at three hospitals in China with 240 participants with MDD (mean age, 32.5 years; 58% women).
- Participants received active tDCS + active rTMS, sham tDCS + active rTMS, active tDCS + sham rTMS, or sham tDCS + sham rTMS with treatments administered five times per week for 2 weeks.
- tDCS was administered in 20-minute sessions using a 2-mA direct current stimulator, whereas rTMS involved 1600 pulses of 10-Hz stimulation targeting the left dorsolateral prefrontal cortex. Sham treatments used a pseudostimulation coil and only emitted sound.
- The primary outcome was change in the 24-item Hamilton Depression Rating Scale (HDRS-24) total score from baseline to week 2.
- Secondary outcomes included HDRS-24 total score change at week 4, remission rate (HDRS-24 total score ≤ 9), response rate (≥ 50% reduction in HDRS-24 total score), and adverse events.
TAKEAWAY:
- The active tDCS + active rTMS group demonstrated the greatest reduction in mean HDRS-24 score (18.33 ± 5.39) at week 2 compared with sham tDCS + active rTMS, active tDCS + sham rTMS, and sham tDCS + sham rTMS (P < .001).
- Response rates at week 2 were notably higher in the active tDCS + active rTMS group (85%) than in the active tDCS + sham rTMS (30%) and sham tDCS + sham rTMS groups (32%).
- The remission rate at week 4 reached 83% in the active tDCS + active rTMS group, which was significantly higher than the remission rates with the other interventions (P < .001).
- The treatments were well tolerated, with no serious adverse events, seizures, or manic symptoms reported across all intervention groups.
IN PRACTICE:
This trial “was the first to evaluate the safety, feasibility, and efficacy of combining tDCS and rTMS in treating depression. Future studies should focus on investigating the mechanism of this synergistic effect and improving the stimulation parameters to optimize the therapeutic effect,” the investigators wrote.
SOURCE:
This study was led by Dongsheng Zhou, MD, Ningbo Kangning Hospital, Ningbo, China. It was published online in JAMA Network Open.
LIMITATIONS:
The brief treatment duration involving 10 sessions may have been insufficient for tDCS and rTMS to demonstrate their full antidepressant potential. The inability to regulate participants’ antidepressant medications throughout the study period presented another limitation. Additionally, the lack of stratified randomization and adjustment for center effects may have introduced variability in the results.
DISCLOSURES:
This study received support from multiple grants, including from the Natural Science Foundation of Zhejiang Province, Basic Public Welfare Research Project of Zhejiang Province, Ningbo Medical and Health Brand Discipline, Ningbo Clinical Medical Research Centre for Mental Health, Ningbo Top Medical and Health Research Program, and the Zhejiang Medical and Health Science and Technology Plan Project. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
a new study showed.
METHODOLOGY:
- Researchers conducted a double-blind, sham-controlled randomized clinical trial from 2021 to 2023 at three hospitals in China with 240 participants with MDD (mean age, 32.5 years; 58% women).
- Participants received active tDCS + active rTMS, sham tDCS + active rTMS, active tDCS + sham rTMS, or sham tDCS + sham rTMS with treatments administered five times per week for 2 weeks.
- tDCS was administered in 20-minute sessions using a 2-mA direct current stimulator, whereas rTMS involved 1600 pulses of 10-Hz stimulation targeting the left dorsolateral prefrontal cortex. Sham treatments used a pseudostimulation coil and only emitted sound.
- The primary outcome was change in the 24-item Hamilton Depression Rating Scale (HDRS-24) total score from baseline to week 2.
- Secondary outcomes included HDRS-24 total score change at week 4, remission rate (HDRS-24 total score ≤ 9), response rate (≥ 50% reduction in HDRS-24 total score), and adverse events.
TAKEAWAY:
- The active tDCS + active rTMS group demonstrated the greatest reduction in mean HDRS-24 score (18.33 ± 5.39) at week 2 compared with sham tDCS + active rTMS, active tDCS + sham rTMS, and sham tDCS + sham rTMS (P < .001).
- Response rates at week 2 were notably higher in the active tDCS + active rTMS group (85%) than in the active tDCS + sham rTMS (30%) and sham tDCS + sham rTMS groups (32%).
- The remission rate at week 4 reached 83% in the active tDCS + active rTMS group, which was significantly higher than the remission rates with the other interventions (P < .001).
- The treatments were well tolerated, with no serious adverse events, seizures, or manic symptoms reported across all intervention groups.
IN PRACTICE:
This trial “was the first to evaluate the safety, feasibility, and efficacy of combining tDCS and rTMS in treating depression. Future studies should focus on investigating the mechanism of this synergistic effect and improving the stimulation parameters to optimize the therapeutic effect,” the investigators wrote.
SOURCE:
This study was led by Dongsheng Zhou, MD, Ningbo Kangning Hospital, Ningbo, China. It was published online in JAMA Network Open.
LIMITATIONS:
The brief treatment duration involving 10 sessions may have been insufficient for tDCS and rTMS to demonstrate their full antidepressant potential. The inability to regulate participants’ antidepressant medications throughout the study period presented another limitation. Additionally, the lack of stratified randomization and adjustment for center effects may have introduced variability in the results.
DISCLOSURES:
This study received support from multiple grants, including from the Natural Science Foundation of Zhejiang Province, Basic Public Welfare Research Project of Zhejiang Province, Ningbo Medical and Health Brand Discipline, Ningbo Clinical Medical Research Centre for Mental Health, Ningbo Top Medical and Health Research Program, and the Zhejiang Medical and Health Science and Technology Plan Project. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
a new study showed.
METHODOLOGY:
- Researchers conducted a double-blind, sham-controlled randomized clinical trial from 2021 to 2023 at three hospitals in China with 240 participants with MDD (mean age, 32.5 years; 58% women).
- Participants received active tDCS + active rTMS, sham tDCS + active rTMS, active tDCS + sham rTMS, or sham tDCS + sham rTMS with treatments administered five times per week for 2 weeks.
- tDCS was administered in 20-minute sessions using a 2-mA direct current stimulator, whereas rTMS involved 1600 pulses of 10-Hz stimulation targeting the left dorsolateral prefrontal cortex. Sham treatments used a pseudostimulation coil and only emitted sound.
- The primary outcome was change in the 24-item Hamilton Depression Rating Scale (HDRS-24) total score from baseline to week 2.
- Secondary outcomes included HDRS-24 total score change at week 4, remission rate (HDRS-24 total score ≤ 9), response rate (≥ 50% reduction in HDRS-24 total score), and adverse events.
TAKEAWAY:
- The active tDCS + active rTMS group demonstrated the greatest reduction in mean HDRS-24 score (18.33 ± 5.39) at week 2 compared with sham tDCS + active rTMS, active tDCS + sham rTMS, and sham tDCS + sham rTMS (P < .001).
- Response rates at week 2 were notably higher in the active tDCS + active rTMS group (85%) than in the active tDCS + sham rTMS (30%) and sham tDCS + sham rTMS groups (32%).
- The remission rate at week 4 reached 83% in the active tDCS + active rTMS group, which was significantly higher than the remission rates with the other interventions (P < .001).
- The treatments were well tolerated, with no serious adverse events, seizures, or manic symptoms reported across all intervention groups.
IN PRACTICE:
This trial “was the first to evaluate the safety, feasibility, and efficacy of combining tDCS and rTMS in treating depression. Future studies should focus on investigating the mechanism of this synergistic effect and improving the stimulation parameters to optimize the therapeutic effect,” the investigators wrote.
SOURCE:
This study was led by Dongsheng Zhou, MD, Ningbo Kangning Hospital, Ningbo, China. It was published online in JAMA Network Open.
LIMITATIONS:
The brief treatment duration involving 10 sessions may have been insufficient for tDCS and rTMS to demonstrate their full antidepressant potential. The inability to regulate participants’ antidepressant medications throughout the study period presented another limitation. Additionally, the lack of stratified randomization and adjustment for center effects may have introduced variability in the results.
DISCLOSURES:
This study received support from multiple grants, including from the Natural Science Foundation of Zhejiang Province, Basic Public Welfare Research Project of Zhejiang Province, Ningbo Medical and Health Brand Discipline, Ningbo Clinical Medical Research Centre for Mental Health, Ningbo Top Medical and Health Research Program, and the Zhejiang Medical and Health Science and Technology Plan Project. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Does Radiation Timing Affect QOL After Prostate Surgery?
TOPLINE:
METHODOLOGY:
- Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
- Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
- Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
- Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
- The median follow-up duration was 85.6 months.
TAKEAWAY:
- Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
- Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
- In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
- Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.
IN PRACTICE:
“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”
SOURCE:
The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.
LIMITATIONS:
The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.
DISCLOSURES:
This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
- Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
- Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
- Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
- The median follow-up duration was 85.6 months.
TAKEAWAY:
- Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
- Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
- In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
- Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.
IN PRACTICE:
“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”
SOURCE:
The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.
LIMITATIONS:
The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.
DISCLOSURES:
This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
- Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
- Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
- Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
- The median follow-up duration was 85.6 months.
TAKEAWAY:
- Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
- Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
- In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
- Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.
IN PRACTICE:
“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”
SOURCE:
The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.
LIMITATIONS:
The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.
DISCLOSURES:
This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
Novel Treatment Promising for Cutaneous Lupus in Phase 2 Trial
TOPLINE:
particularly in subacute and chronic cases.
METHODOLOGY:
- Researchers conducted a randomized phase 2 trial to evaluate the efficacy and safety of iberdomide in 288 patients with CLE (mean age, 45 years; 97% women). Iberdomide is a cereblon modulator, which results in degradation of two transcription factors of immune cell development and homeostasis — Ikaros and Aiolos — that have been implicated in the genetic predisposition of systemic lupus.
- CLE Disease Area and Severity Index Activity (CLASI-A) endpoints included mean percent change from baseline and ≥ 50% reduction from baseline (CLASI-50), which were evaluated in all patients with baseline CLASI-A scores ≥ 8 and by CLE subtypes (acute, subacute, and chronic).
- At baseline, 56% of patients had acute CLE, 29% had chronic CLE, and 16% had subacute CLE; 28% of patients had a baseline CLASI-A score ≥ 8.
- Patients were randomly assigned to receive oral iberdomide (0.45 mg, 0.30 mg, 0.15 mg, or placebo daily) for 24 weeks while continuing standard lupus medications. At week 24, patients on placebo were rerandomized to iberdomide 0.45 mg or 0.30 mg once a day, while those on iberdomide continued their assigned dose through week 52.
TAKEAWAY:
- Among patients with baseline CLASI-A ≥ 8, the mean change in CLASI-A score from baseline at week 24 was −66.7% for those on iberdomide 0.45 mg vs −54.2% for placebo (P = .295).
- At week 24, patients with subacute CLE showed a significantly greater mean percent change from baseline in CLASI-A with iberdomide 0.45 mg vs placebo (−90.5% vs −51.2%; P = .007), while no significant differences were observed with the 0.45-mg dose vs placebo in patients with chronic or acute CLE.
- Overall, CLASI-50 responses were not significantly different among those on 0.45 mg vs placebo (55.6% vs 44.6%). The proportions of patients achieving CLASI-50 at week 24 were significantly greater for iberdomide 0.45 mg vs placebo for those with subacute CLE (91.7% vs 52.9%; P = .035) and chronic CLE (62.1% vs 27.8%; P = .029), but not for those with baseline CLASI-A ≥ 8 (66.7% vs 50%).
- More than 80% of patients had treatment-emergent adverse events (TEAEs), which were mostly mild to moderate. Over 2 years, the most common were urinary tract infections, upper respiratory tract infections, neutropenia, and nasopharyngitis. TEAEs leading to iberdomide discontinuation in one or more patients were neutropenia (n = 7), rash (n = 7), increased hepatic enzymes (n = 4), and deep vein thrombosis (n = 3).
IN PRACTICE:
“Data from this phase 2 trial of iberdomide in patients with SLE suggest that a greater proportion of patients with subacute or chronic CLE who received the higher dose of 0.45 mg iberdomide achieved CLASI-50 vs placebo. For the overall population, CLASI-50 response was not significantly different between treatment groups at week 24, partly due to a high placebo response that may have been driven by patients with acute CLE,” the authors wrote.
SOURCE:
The study was led by Victoria P. Werth, MD, of the University of Pennsylvania and the Veteran’s Administration Medical Center, both in Philadelphia, and was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The study included small patient subgroups for different CLE subtypes, which may affect the generalizability of the findings. CLE subtype was determined by the investigator without additional photographic adjudication. Additionally, the use of background lupus medications could have influenced the placebo group’s response, limiting the ability to observe the treatment effect of iberdomide monotherapy.
DISCLOSURES:
The study was funded by Bristol-Myers Squibb. Six authors reported being employed by Bristol-Myers Squibb, and several others reported consultancy and research support from various sources including Bristol-Myers Squibb.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
particularly in subacute and chronic cases.
METHODOLOGY:
- Researchers conducted a randomized phase 2 trial to evaluate the efficacy and safety of iberdomide in 288 patients with CLE (mean age, 45 years; 97% women). Iberdomide is a cereblon modulator, which results in degradation of two transcription factors of immune cell development and homeostasis — Ikaros and Aiolos — that have been implicated in the genetic predisposition of systemic lupus.
- CLE Disease Area and Severity Index Activity (CLASI-A) endpoints included mean percent change from baseline and ≥ 50% reduction from baseline (CLASI-50), which were evaluated in all patients with baseline CLASI-A scores ≥ 8 and by CLE subtypes (acute, subacute, and chronic).
- At baseline, 56% of patients had acute CLE, 29% had chronic CLE, and 16% had subacute CLE; 28% of patients had a baseline CLASI-A score ≥ 8.
- Patients were randomly assigned to receive oral iberdomide (0.45 mg, 0.30 mg, 0.15 mg, or placebo daily) for 24 weeks while continuing standard lupus medications. At week 24, patients on placebo were rerandomized to iberdomide 0.45 mg or 0.30 mg once a day, while those on iberdomide continued their assigned dose through week 52.
TAKEAWAY:
- Among patients with baseline CLASI-A ≥ 8, the mean change in CLASI-A score from baseline at week 24 was −66.7% for those on iberdomide 0.45 mg vs −54.2% for placebo (P = .295).
- At week 24, patients with subacute CLE showed a significantly greater mean percent change from baseline in CLASI-A with iberdomide 0.45 mg vs placebo (−90.5% vs −51.2%; P = .007), while no significant differences were observed with the 0.45-mg dose vs placebo in patients with chronic or acute CLE.
- Overall, CLASI-50 responses were not significantly different among those on 0.45 mg vs placebo (55.6% vs 44.6%). The proportions of patients achieving CLASI-50 at week 24 were significantly greater for iberdomide 0.45 mg vs placebo for those with subacute CLE (91.7% vs 52.9%; P = .035) and chronic CLE (62.1% vs 27.8%; P = .029), but not for those with baseline CLASI-A ≥ 8 (66.7% vs 50%).
- More than 80% of patients had treatment-emergent adverse events (TEAEs), which were mostly mild to moderate. Over 2 years, the most common were urinary tract infections, upper respiratory tract infections, neutropenia, and nasopharyngitis. TEAEs leading to iberdomide discontinuation in one or more patients were neutropenia (n = 7), rash (n = 7), increased hepatic enzymes (n = 4), and deep vein thrombosis (n = 3).
IN PRACTICE:
“Data from this phase 2 trial of iberdomide in patients with SLE suggest that a greater proportion of patients with subacute or chronic CLE who received the higher dose of 0.45 mg iberdomide achieved CLASI-50 vs placebo. For the overall population, CLASI-50 response was not significantly different between treatment groups at week 24, partly due to a high placebo response that may have been driven by patients with acute CLE,” the authors wrote.
SOURCE:
The study was led by Victoria P. Werth, MD, of the University of Pennsylvania and the Veteran’s Administration Medical Center, both in Philadelphia, and was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The study included small patient subgroups for different CLE subtypes, which may affect the generalizability of the findings. CLE subtype was determined by the investigator without additional photographic adjudication. Additionally, the use of background lupus medications could have influenced the placebo group’s response, limiting the ability to observe the treatment effect of iberdomide monotherapy.
DISCLOSURES:
The study was funded by Bristol-Myers Squibb. Six authors reported being employed by Bristol-Myers Squibb, and several others reported consultancy and research support from various sources including Bristol-Myers Squibb.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
particularly in subacute and chronic cases.
METHODOLOGY:
- Researchers conducted a randomized phase 2 trial to evaluate the efficacy and safety of iberdomide in 288 patients with CLE (mean age, 45 years; 97% women). Iberdomide is a cereblon modulator, which results in degradation of two transcription factors of immune cell development and homeostasis — Ikaros and Aiolos — that have been implicated in the genetic predisposition of systemic lupus.
- CLE Disease Area and Severity Index Activity (CLASI-A) endpoints included mean percent change from baseline and ≥ 50% reduction from baseline (CLASI-50), which were evaluated in all patients with baseline CLASI-A scores ≥ 8 and by CLE subtypes (acute, subacute, and chronic).
- At baseline, 56% of patients had acute CLE, 29% had chronic CLE, and 16% had subacute CLE; 28% of patients had a baseline CLASI-A score ≥ 8.
- Patients were randomly assigned to receive oral iberdomide (0.45 mg, 0.30 mg, 0.15 mg, or placebo daily) for 24 weeks while continuing standard lupus medications. At week 24, patients on placebo were rerandomized to iberdomide 0.45 mg or 0.30 mg once a day, while those on iberdomide continued their assigned dose through week 52.
TAKEAWAY:
- Among patients with baseline CLASI-A ≥ 8, the mean change in CLASI-A score from baseline at week 24 was −66.7% for those on iberdomide 0.45 mg vs −54.2% for placebo (P = .295).
- At week 24, patients with subacute CLE showed a significantly greater mean percent change from baseline in CLASI-A with iberdomide 0.45 mg vs placebo (−90.5% vs −51.2%; P = .007), while no significant differences were observed with the 0.45-mg dose vs placebo in patients with chronic or acute CLE.
- Overall, CLASI-50 responses were not significantly different among those on 0.45 mg vs placebo (55.6% vs 44.6%). The proportions of patients achieving CLASI-50 at week 24 were significantly greater for iberdomide 0.45 mg vs placebo for those with subacute CLE (91.7% vs 52.9%; P = .035) and chronic CLE (62.1% vs 27.8%; P = .029), but not for those with baseline CLASI-A ≥ 8 (66.7% vs 50%).
- More than 80% of patients had treatment-emergent adverse events (TEAEs), which were mostly mild to moderate. Over 2 years, the most common were urinary tract infections, upper respiratory tract infections, neutropenia, and nasopharyngitis. TEAEs leading to iberdomide discontinuation in one or more patients were neutropenia (n = 7), rash (n = 7), increased hepatic enzymes (n = 4), and deep vein thrombosis (n = 3).
IN PRACTICE:
“Data from this phase 2 trial of iberdomide in patients with SLE suggest that a greater proportion of patients with subacute or chronic CLE who received the higher dose of 0.45 mg iberdomide achieved CLASI-50 vs placebo. For the overall population, CLASI-50 response was not significantly different between treatment groups at week 24, partly due to a high placebo response that may have been driven by patients with acute CLE,” the authors wrote.
SOURCE:
The study was led by Victoria P. Werth, MD, of the University of Pennsylvania and the Veteran’s Administration Medical Center, both in Philadelphia, and was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The study included small patient subgroups for different CLE subtypes, which may affect the generalizability of the findings. CLE subtype was determined by the investigator without additional photographic adjudication. Additionally, the use of background lupus medications could have influenced the placebo group’s response, limiting the ability to observe the treatment effect of iberdomide monotherapy.
DISCLOSURES:
The study was funded by Bristol-Myers Squibb. Six authors reported being employed by Bristol-Myers Squibb, and several others reported consultancy and research support from various sources including Bristol-Myers Squibb.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Air Pollution Exposure Linked to Higher Breast Cancer Risk
TOPLINE:
A recent study found that long-term exposure to fine particulate matter ≤ 2.5 μm (PM2.5) is associated with an increased risk for breast cancer, with the highest risk observed among White women.
METHODOLOGY:
- Studies have suggested that exposure to air pollution — specifically PM2.5 — may increase the risk for breast cancer, but data are largely in populations of White women.
- The current analysis explored the potential risk among a more racially and ethnically diverse group.
- The study included 58,358 women (median age, 60.4 years at enrollment) from the California Cancer Registry, followed over an average of 19.3 years. Overall, 35% were African American, 39% were Latino, 15% were White, and 10% were Japanese American.
- Researchers measured PM2.5 exposure using satellite-based data and geocoded addresses. Other pollutants, such as PM10, NO2, NOX, and CO, were also tracked using Environmental Protection Agency data.
TAKEAWAY:
- A total of 3524 invasive breast cancer cases were diagnosed over an average follow-up period of 19.3 years. PM2.5 exposure was associated with a 28% increased risk for breast cancer overall (hazard ratio [HR], 1.28; 95% CI, 1.08-1.51).
- When looking at risk by racial/ethnic group, the association between PM2.5 exposure and breast cancer risk was strongest among White women (HR, 1.67). PM2.5 exposure was also associated with a higher risk for breast cancer among African American women (HR, 1.14; 95% CI, 0.89-1.46) and Latino women (HR, 1.34; 95% CI, 0.94-1.92), but the associations were not significant.
- Overall breast cancer incidence was also positively associated with exposure to NO2, NOX, and CO (HRs, 1.09-1.11), but the associations were not significant. A meta-analysis of this study and ten other cohorts estimated a 5% increased breast cancer incidence per 10-unit increase in PM2.5 (HR, 1.05).
IN PRACTICE:
“Collective findings suggest that PM2.5 exposure should be considered a risk factor for breast cancer, and curtailing air pollution exposures at the population level using regulatory strategies should be a priority,” the authors concluded.
SOURCE:
The study, led by Anna H. Wu, PhD, MPH, Keck School of Medicine, University of Southern California, Los Angeles, was published online in the Journal of Clinical Oncology.
LIMITATIONS:
The study did not include data on nonresidential exposures or residential history before cohort entry, which limited the assessment of earlier exposures. The study also lacked information on specific sources of PM emissions, as well as an explanation for why White women had the highest breast cancer risk compared with other racial/ethnic groups.
DISCLOSURES:
The study was supported by grants from the Health Effects Air Pollution Foundation, the National Cancer Institute, USC Environmental Exposures, Host Factors, and Human Disease, and the California Air Resource Board. One author disclosed being an associate editor for the Journal of Clinical Oncology. No other potential conflicts of interest were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
A recent study found that long-term exposure to fine particulate matter ≤ 2.5 μm (PM2.5) is associated with an increased risk for breast cancer, with the highest risk observed among White women.
METHODOLOGY:
- Studies have suggested that exposure to air pollution — specifically PM2.5 — may increase the risk for breast cancer, but data are largely in populations of White women.
- The current analysis explored the potential risk among a more racially and ethnically diverse group.
- The study included 58,358 women (median age, 60.4 years at enrollment) from the California Cancer Registry, followed over an average of 19.3 years. Overall, 35% were African American, 39% were Latino, 15% were White, and 10% were Japanese American.
- Researchers measured PM2.5 exposure using satellite-based data and geocoded addresses. Other pollutants, such as PM10, NO2, NOX, and CO, were also tracked using Environmental Protection Agency data.
TAKEAWAY:
- A total of 3524 invasive breast cancer cases were diagnosed over an average follow-up period of 19.3 years. PM2.5 exposure was associated with a 28% increased risk for breast cancer overall (hazard ratio [HR], 1.28; 95% CI, 1.08-1.51).
- When looking at risk by racial/ethnic group, the association between PM2.5 exposure and breast cancer risk was strongest among White women (HR, 1.67). PM2.5 exposure was also associated with a higher risk for breast cancer among African American women (HR, 1.14; 95% CI, 0.89-1.46) and Latino women (HR, 1.34; 95% CI, 0.94-1.92), but the associations were not significant.
- Overall breast cancer incidence was also positively associated with exposure to NO2, NOX, and CO (HRs, 1.09-1.11), but the associations were not significant. A meta-analysis of this study and ten other cohorts estimated a 5% increased breast cancer incidence per 10-unit increase in PM2.5 (HR, 1.05).
IN PRACTICE:
“Collective findings suggest that PM2.5 exposure should be considered a risk factor for breast cancer, and curtailing air pollution exposures at the population level using regulatory strategies should be a priority,” the authors concluded.
SOURCE:
The study, led by Anna H. Wu, PhD, MPH, Keck School of Medicine, University of Southern California, Los Angeles, was published online in the Journal of Clinical Oncology.
LIMITATIONS:
The study did not include data on nonresidential exposures or residential history before cohort entry, which limited the assessment of earlier exposures. The study also lacked information on specific sources of PM emissions, as well as an explanation for why White women had the highest breast cancer risk compared with other racial/ethnic groups.
DISCLOSURES:
The study was supported by grants from the Health Effects Air Pollution Foundation, the National Cancer Institute, USC Environmental Exposures, Host Factors, and Human Disease, and the California Air Resource Board. One author disclosed being an associate editor for the Journal of Clinical Oncology. No other potential conflicts of interest were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
A recent study found that long-term exposure to fine particulate matter ≤ 2.5 μm (PM2.5) is associated with an increased risk for breast cancer, with the highest risk observed among White women.
METHODOLOGY:
- Studies have suggested that exposure to air pollution — specifically PM2.5 — may increase the risk for breast cancer, but data are largely in populations of White women.
- The current analysis explored the potential risk among a more racially and ethnically diverse group.
- The study included 58,358 women (median age, 60.4 years at enrollment) from the California Cancer Registry, followed over an average of 19.3 years. Overall, 35% were African American, 39% were Latino, 15% were White, and 10% were Japanese American.
- Researchers measured PM2.5 exposure using satellite-based data and geocoded addresses. Other pollutants, such as PM10, NO2, NOX, and CO, were also tracked using Environmental Protection Agency data.
TAKEAWAY:
- A total of 3524 invasive breast cancer cases were diagnosed over an average follow-up period of 19.3 years. PM2.5 exposure was associated with a 28% increased risk for breast cancer overall (hazard ratio [HR], 1.28; 95% CI, 1.08-1.51).
- When looking at risk by racial/ethnic group, the association between PM2.5 exposure and breast cancer risk was strongest among White women (HR, 1.67). PM2.5 exposure was also associated with a higher risk for breast cancer among African American women (HR, 1.14; 95% CI, 0.89-1.46) and Latino women (HR, 1.34; 95% CI, 0.94-1.92), but the associations were not significant.
- Overall breast cancer incidence was also positively associated with exposure to NO2, NOX, and CO (HRs, 1.09-1.11), but the associations were not significant. A meta-analysis of this study and ten other cohorts estimated a 5% increased breast cancer incidence per 10-unit increase in PM2.5 (HR, 1.05).
IN PRACTICE:
“Collective findings suggest that PM2.5 exposure should be considered a risk factor for breast cancer, and curtailing air pollution exposures at the population level using regulatory strategies should be a priority,” the authors concluded.
SOURCE:
The study, led by Anna H. Wu, PhD, MPH, Keck School of Medicine, University of Southern California, Los Angeles, was published online in the Journal of Clinical Oncology.
LIMITATIONS:
The study did not include data on nonresidential exposures or residential history before cohort entry, which limited the assessment of earlier exposures. The study also lacked information on specific sources of PM emissions, as well as an explanation for why White women had the highest breast cancer risk compared with other racial/ethnic groups.
DISCLOSURES:
The study was supported by grants from the Health Effects Air Pollution Foundation, the National Cancer Institute, USC Environmental Exposures, Host Factors, and Human Disease, and the California Air Resource Board. One author disclosed being an associate editor for the Journal of Clinical Oncology. No other potential conflicts of interest were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.