Edited by Gargi Mukherjee

TOPLINE:

Among patients with overweight or obesity, frontline immunotherapy for advanced non–small cell lung cancer (NSCLC) was not associated with a survival benefit compared with conventional chemotherapy. Overall, however, compared with low body mass index (BMI), overweight or obesity was associated with a lower risk for mortality among patients receiving either therapy.

METHODOLOGY:

• The association between BMI and overall survival in patients with cancer who receive immunotherapy or conventional chemotherapy in the frontline remains unclear. Patients with cancer and obesity are generally considered to have a worse prognosis, but some data suggest an obesity paradox, where patients with cancer and a higher BMI demonstrate better overall survival following immunotherapy or chemotherapy.
• To clarify whether (or how) BMI affects overall survival outcomes and the optimal frontline treatment choice, researchers evaluated 31,257 patients with advanced NSCLC from Japan who received immune checkpoint inhibitors (n = 12,816) or conventional chemotherapy (n = 18,441).
• Patient outcomes were assessed according to weight categories and frontline therapy type (immune checkpoint inhibitors or conventional chemotherapy), with overall survival as the primary outcome.
• A BMI < 18.5 was considered underweight, 18.5-24.9 was considered normal weight, 25.0-29.9 was considered overweight, and ≥ 30.0 was considered obese.

TAKEAWAY:

• In the overall population, regardless of weight, patients who received chemotherapy had a higher mortality rate than those who received immunotherapy — 35.9% vs 28.0%, respectively — over a follow-up of 3 years.
• However, overweight or obesity was associated with a lower risk for mortality compared with a lower BMI among patients with advanced NSCLC, regardless of whether they received immune checkpoint inhibitor therapy or conventional chemotherapy.
• Among patients who received immunotherapy, the risk for mortality decreased steadily as BMI increased from 15 to 24 and then increased at higher BMIs, indicating a U-shaped association.
• Immunotherapy was associated with a significant improvement in overall survival compared with conventional chemotherapy among patients with a BMI < 28; however, researchers observed no difference in overall survival between the two therapies in those with a BMI ≥ 28.

IN PRACTICE:

Overall, “these results support the presence of the obesity paradox in patients with [advanced] NSCLC who underwent either therapy,” the authors concluded.

But when focused on patients in the higher BMI group, there was no overall survival benefit with the frontline immunotherapy vs the conventional chemotherapy. “Immunotherapy therapy may not necessarily be the optimal first-line therapy for patients with overweight or obesity,” the authors wrote, adding that “the use of conventional chemotherapy should also be considered.”

SOURCE:

The study, led by Yasutaka Ihara, PharmD, Osaka Metropolitan University, Osaka, Japan, was published online in JAMA Network Open.

LIMITATIONS: 

Retrospective design has inherent bias. PD-L1 status was not known, and the inclusion of Japanese population may have limited the generalizability of the findings. 

DISCLOSURES:

This study received funding from the Graduate School of Medicine, Osaka Metropolitan University. Several authors reported receiving personal fees from various pharmaceutical sources.

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:

Among patients with overweight or obesity, frontline immunotherapy for advanced non–small cell lung cancer (NSCLC) was not associated with a survival benefit compared with conventional chemotherapy. Overall, however, compared with low body mass index (BMI), overweight or obesity was associated with a lower risk for mortality among patients receiving either therapy.

METHODOLOGY:

• The association between BMI and overall survival in patients with cancer who receive immunotherapy or conventional chemotherapy in the frontline remains unclear. Patients with cancer and obesity are generally considered to have a worse prognosis, but some data suggest an obesity paradox, where patients with cancer and a higher BMI demonstrate better overall survival following immunotherapy or chemotherapy.
• To clarify whether (or how) BMI affects overall survival outcomes and the optimal frontline treatment choice, researchers evaluated 31,257 patients with advanced NSCLC from Japan who received immune checkpoint inhibitors (n = 12,816) or conventional chemotherapy (n = 18,441).
• Patient outcomes were assessed according to weight categories and frontline therapy type (immune checkpoint inhibitors or conventional chemotherapy), with overall survival as the primary outcome.
• A BMI < 18.5 was considered underweight, 18.5-24.9 was considered normal weight, 25.0-29.9 was considered overweight, and ≥ 30.0 was considered obese.

TAKEAWAY:

• In the overall population, regardless of weight, patients who received chemotherapy had a higher mortality rate than those who received immunotherapy — 35.9% vs 28.0%, respectively — over a follow-up of 3 years.
• However, overweight or obesity was associated with a lower risk for mortality compared with a lower BMI among patients with advanced NSCLC, regardless of whether they received immune checkpoint inhibitor therapy or conventional chemotherapy.
• Among patients who received immunotherapy, the risk for mortality decreased steadily as BMI increased from 15 to 24 and then increased at higher BMIs, indicating a U-shaped association.
• Immunotherapy was associated with a significant improvement in overall survival compared with conventional chemotherapy among patients with a BMI < 28; however, researchers observed no difference in overall survival between the two therapies in those with a BMI ≥ 28.

IN PRACTICE:

Overall, “these results support the presence of the obesity paradox in patients with [advanced] NSCLC who underwent either therapy,” the authors concluded.

But when focused on patients in the higher BMI group, there was no overall survival benefit with the frontline immunotherapy vs the conventional chemotherapy. “Immunotherapy therapy may not necessarily be the optimal first-line therapy for patients with overweight or obesity,” the authors wrote, adding that “the use of conventional chemotherapy should also be considered.”

SOURCE:

The study, led by Yasutaka Ihara, PharmD, Osaka Metropolitan University, Osaka, Japan, was published online in JAMA Network Open.

LIMITATIONS: 

Retrospective design has inherent bias. PD-L1 status was not known, and the inclusion of Japanese population may have limited the generalizability of the findings. 

DISCLOSURES:

This study received funding from the Graduate School of Medicine, Osaka Metropolitan University. Several authors reported receiving personal fees from various pharmaceutical sources.

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:

Among patients with overweight or obesity, frontline immunotherapy for advanced non–small cell lung cancer (NSCLC) was not associated with a survival benefit compared with conventional chemotherapy. Overall, however, compared with low body mass index (BMI), overweight or obesity was associated with a lower risk for mortality among patients receiving either therapy.

METHODOLOGY:

• The association between BMI and overall survival in patients with cancer who receive immunotherapy or conventional chemotherapy in the frontline remains unclear. Patients with cancer and obesity are generally considered to have a worse prognosis, but some data suggest an obesity paradox, where patients with cancer and a higher BMI demonstrate better overall survival following immunotherapy or chemotherapy.
• To clarify whether (or how) BMI affects overall survival outcomes and the optimal frontline treatment choice, researchers evaluated 31,257 patients with advanced NSCLC from Japan who received immune checkpoint inhibitors (n = 12,816) or conventional chemotherapy (n = 18,441).
• Patient outcomes were assessed according to weight categories and frontline therapy type (immune checkpoint inhibitors or conventional chemotherapy), with overall survival as the primary outcome.
• A BMI < 18.5 was considered underweight, 18.5-24.9 was considered normal weight, 25.0-29.9 was considered overweight, and ≥ 30.0 was considered obese.

TAKEAWAY:

• In the overall population, regardless of weight, patients who received chemotherapy had a higher mortality rate than those who received immunotherapy — 35.9% vs 28.0%, respectively — over a follow-up of 3 years.
• However, overweight or obesity was associated with a lower risk for mortality compared with a lower BMI among patients with advanced NSCLC, regardless of whether they received immune checkpoint inhibitor therapy or conventional chemotherapy.
• Among patients who received immunotherapy, the risk for mortality decreased steadily as BMI increased from 15 to 24 and then increased at higher BMIs, indicating a U-shaped association.
• Immunotherapy was associated with a significant improvement in overall survival compared with conventional chemotherapy among patients with a BMI < 28; however, researchers observed no difference in overall survival between the two therapies in those with a BMI ≥ 28.

IN PRACTICE:

Overall, “these results support the presence of the obesity paradox in patients with [advanced] NSCLC who underwent either therapy,” the authors concluded.

But when focused on patients in the higher BMI group, there was no overall survival benefit with the frontline immunotherapy vs the conventional chemotherapy. “Immunotherapy therapy may not necessarily be the optimal first-line therapy for patients with overweight or obesity,” the authors wrote, adding that “the use of conventional chemotherapy should also be considered.”

SOURCE:

The study, led by Yasutaka Ihara, PharmD, Osaka Metropolitan University, Osaka, Japan, was published online in JAMA Network Open.

LIMITATIONS: 

Retrospective design has inherent bias. PD-L1 status was not known, and the inclusion of Japanese population may have limited the generalizability of the findings. 

DISCLOSURES:

This study received funding from the Graduate School of Medicine, Osaka Metropolitan University. Several authors reported receiving personal fees from various pharmaceutical sources.

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:

Breast cancer immunotherapy trials yield modest clinical impact, with a quarter of trials failing to report their outcomes, particularly among single-center studies which are more likely to go unreported, and many phase 2 studies failing to translate into successful phase 3 trials.

METHODOLOGY:

• Few immunotherapy agents — only pembrolizumab in the United States, as of December 2023, and atezolizumab in Europe — have received approvals for use in patients with breast cancer, indicating low returns on the large number of breast cancer immunotherapy trials launched in the early 2010s.
• In this cross-sectional study, researchers evaluated 331 immunotherapy trials, initiated between January 2004 and April 2023, that enrolled 48,844 patients with breast cancer.
• Of these, 47 were phase 1 trials, 242 were phase 2 trials, and 42 were phase 3 trials.
• A trial was considered reported if the results were posted on ClinicalTrial.gov or reported as an abstract or a manuscript.
• Overall, 120 trials met their completion date up to November 2022; of these, 30 (25%) failed to report outcomes, which included two phase 3 trials.

TAKEAWAY:

• Phase 1 trials had the highest rate of nonreporting (31.8%), followed by phase 2 (23.6%) and phase 3 (22.2%) trials.
• Single-center studies were more likely to be unreported than multicenter studies (35.2% vs 15.0%; P = .02).
• Of 90 reported trials, 47 (52.2%) met their primary endpoints and 43 (47.8%) did not.
• The majority, 17 out of 19 (89.5%), of the reported randomized trials had negative results.

IN PRACTICE:

“The findings of this study suggest that the large number of immunotherapy trials being run have yielded modest clinical impact,” the authors wrote. “More selective initiation of phase 2 trials, grounded in preclinical and biomarker observations and with optimal statistical designs for early efficacy assessment, is needed to increase trial efficiency.” 

SOURCE:

The study, led by Marco Mariani, MD, Università Vita-Salute San Raffaele, Milan, Italy, was published online in JAMA Network Open. 

LIMITATIONS:

The study’s reliance on ClinicalTrials.gov as the primary source of trial data might have resulted in some trials being overlooked. In addition, manual data extraction could cause inaccuracies and potentially introduced biases in the interpretation of trial results. Primary study completion date cutoff of December 2022 could have excluded significant data from more recent trials.

DISCLOSURES:

This study received support via Susan Komen Leadership Grant and the Fondazione AIRC per la Ricerca sul Cancro. Several authors reported receiving grants and personal fees and having other ties with various sources.

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:

Breast cancer immunotherapy trials yield modest clinical impact, with a quarter of trials failing to report their outcomes, particularly among single-center studies which are more likely to go unreported, and many phase 2 studies failing to translate into successful phase 3 trials.

METHODOLOGY:

• Few immunotherapy agents — only pembrolizumab in the United States, as of December 2023, and atezolizumab in Europe — have received approvals for use in patients with breast cancer, indicating low returns on the large number of breast cancer immunotherapy trials launched in the early 2010s.
• In this cross-sectional study, researchers evaluated 331 immunotherapy trials, initiated between January 2004 and April 2023, that enrolled 48,844 patients with breast cancer.
• Of these, 47 were phase 1 trials, 242 were phase 2 trials, and 42 were phase 3 trials.
• A trial was considered reported if the results were posted on ClinicalTrial.gov or reported as an abstract or a manuscript.
• Overall, 120 trials met their completion date up to November 2022; of these, 30 (25%) failed to report outcomes, which included two phase 3 trials.

TAKEAWAY:

• Phase 1 trials had the highest rate of nonreporting (31.8%), followed by phase 2 (23.6%) and phase 3 (22.2%) trials.
• Single-center studies were more likely to be unreported than multicenter studies (35.2% vs 15.0%; P = .02).
• Of 90 reported trials, 47 (52.2%) met their primary endpoints and 43 (47.8%) did not.
• The majority, 17 out of 19 (89.5%), of the reported randomized trials had negative results.

IN PRACTICE:

“The findings of this study suggest that the large number of immunotherapy trials being run have yielded modest clinical impact,” the authors wrote. “More selective initiation of phase 2 trials, grounded in preclinical and biomarker observations and with optimal statistical designs for early efficacy assessment, is needed to increase trial efficiency.” 

SOURCE:

The study, led by Marco Mariani, MD, Università Vita-Salute San Raffaele, Milan, Italy, was published online in JAMA Network Open. 

LIMITATIONS:

The study’s reliance on ClinicalTrials.gov as the primary source of trial data might have resulted in some trials being overlooked. In addition, manual data extraction could cause inaccuracies and potentially introduced biases in the interpretation of trial results. Primary study completion date cutoff of December 2022 could have excluded significant data from more recent trials.

DISCLOSURES:

This study received support via Susan Komen Leadership Grant and the Fondazione AIRC per la Ricerca sul Cancro. Several authors reported receiving grants and personal fees and having other ties with various sources.

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:

Breast cancer immunotherapy trials yield modest clinical impact, with a quarter of trials failing to report their outcomes, particularly among single-center studies which are more likely to go unreported, and many phase 2 studies failing to translate into successful phase 3 trials.

METHODOLOGY:

• Few immunotherapy agents — only pembrolizumab in the United States, as of December 2023, and atezolizumab in Europe — have received approvals for use in patients with breast cancer, indicating low returns on the large number of breast cancer immunotherapy trials launched in the early 2010s.
• In this cross-sectional study, researchers evaluated 331 immunotherapy trials, initiated between January 2004 and April 2023, that enrolled 48,844 patients with breast cancer.
• Of these, 47 were phase 1 trials, 242 were phase 2 trials, and 42 were phase 3 trials.
• A trial was considered reported if the results were posted on ClinicalTrial.gov or reported as an abstract or a manuscript.
• Overall, 120 trials met their completion date up to November 2022; of these, 30 (25%) failed to report outcomes, which included two phase 3 trials.

TAKEAWAY:

• Phase 1 trials had the highest rate of nonreporting (31.8%), followed by phase 2 (23.6%) and phase 3 (22.2%) trials.
• Single-center studies were more likely to be unreported than multicenter studies (35.2% vs 15.0%; P = .02).
• Of 90 reported trials, 47 (52.2%) met their primary endpoints and 43 (47.8%) did not.
• The majority, 17 out of 19 (89.5%), of the reported randomized trials had negative results.

IN PRACTICE:

“The findings of this study suggest that the large number of immunotherapy trials being run have yielded modest clinical impact,” the authors wrote. “More selective initiation of phase 2 trials, grounded in preclinical and biomarker observations and with optimal statistical designs for early efficacy assessment, is needed to increase trial efficiency.” 

SOURCE:

The study, led by Marco Mariani, MD, Università Vita-Salute San Raffaele, Milan, Italy, was published online in JAMA Network Open. 

LIMITATIONS:

The study’s reliance on ClinicalTrials.gov as the primary source of trial data might have resulted in some trials being overlooked. In addition, manual data extraction could cause inaccuracies and potentially introduced biases in the interpretation of trial results. Primary study completion date cutoff of December 2022 could have excluded significant data from more recent trials.

DISCLOSURES:

This study received support via Susan Komen Leadership Grant and the Fondazione AIRC per la Ricerca sul Cancro. Several authors reported receiving grants and personal fees and having other ties with various sources.

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:

Tirbanibulin ointment 1% shows good safety and tolerability in the treatment of actinic keratosis (AK) in fields of up to 100 cm2 on the face and scalp.

METHODOLOGY:

• This phase 3 multicenter, single-arm trial evaluated the safety and tolerability of tirbanibulin ointment 1% in 105 adults with 4-12 clinically typical, visible, and discrete AKs on the face or balding scalp from June to December 2022 in the United States. (In June 2024, the Food and Drug Administration approved a supplemental new drug application for tirbanibulin 1%, a microtubule inhibitor, allowing the expansion of the surface area treated for AKs of the face or scalp from 25 cm² to 100 cm².)
• Participants applied tirbanibulin ointment 1% once daily for 5 days over a treatment field of about 100 cm² on the face or balding scalp. A total of 102 patients completed the study.
• Safety and tolerability were evaluated with reports of treatment-emergent adverse events (TEAEs) and a composite score of six local tolerability signs on days 5, 8, 15, and 29, and on completion of the evaluation period on day 57.

TAKEAWAY:

• The most common local effects of treatment were erythema (96.1% of patients) and flaking or scaling (84.4%), with severe cases reported in 5.8% and 8.7% of the patients, respectively.
• The mean maximum local tolerability composite score was 4.1 out of 18, which peaked around day 8 and returned to baseline by day 29.
• TEAEs considered related to the treatment were reported in 18.1% of patients; the most frequent were application site pruritus (10.5%) and application site pain (8.6%). No adverse events led to the discontinuation of treatment.
• The mean percent reduction in the lesion count from baseline was 77.8% at day 57, with a mean lesion count of 1.8 at the end of the study.

IN PRACTICE:

In this study, “local tolerability and safety profiles were well characterized in patients with 4-12 clinically typical, visible, and discrete AK lesions in a field of 100 cm² and were consistent with those previously reported in patients with AK treated in pivotal trials with tirbanibulin over a smaller field (25 cm²),” the authors wrote.

SOURCE:

The study, led by Neal Bhatia, MD, of Therapeutics Clinical Research, San Diego, was published online in JAAD International.

LIMITATIONS:

The study was limited by the lack of a placebo group and the absence of long-term follow-up. 

DISCLOSURES:

This study was funded by Almirall. Five authors reported being employees of Almirall. Other authors declared having ties with various other sources, including Almirall.

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:

Tirbanibulin ointment 1% shows good safety and tolerability in the treatment of actinic keratosis (AK) in fields of up to 100 cm2 on the face and scalp.

METHODOLOGY:

• This phase 3 multicenter, single-arm trial evaluated the safety and tolerability of tirbanibulin ointment 1% in 105 adults with 4-12 clinically typical, visible, and discrete AKs on the face or balding scalp from June to December 2022 in the United States. (In June 2024, the Food and Drug Administration approved a supplemental new drug application for tirbanibulin 1%, a microtubule inhibitor, allowing the expansion of the surface area treated for AKs of the face or scalp from 25 cm² to 100 cm².)
• Participants applied tirbanibulin ointment 1% once daily for 5 days over a treatment field of about 100 cm² on the face or balding scalp. A total of 102 patients completed the study.
• Safety and tolerability were evaluated with reports of treatment-emergent adverse events (TEAEs) and a composite score of six local tolerability signs on days 5, 8, 15, and 29, and on completion of the evaluation period on day 57.

TAKEAWAY:

• The most common local effects of treatment were erythema (96.1% of patients) and flaking or scaling (84.4%), with severe cases reported in 5.8% and 8.7% of the patients, respectively.
• The mean maximum local tolerability composite score was 4.1 out of 18, which peaked around day 8 and returned to baseline by day 29.
• TEAEs considered related to the treatment were reported in 18.1% of patients; the most frequent were application site pruritus (10.5%) and application site pain (8.6%). No adverse events led to the discontinuation of treatment.
• The mean percent reduction in the lesion count from baseline was 77.8% at day 57, with a mean lesion count of 1.8 at the end of the study.

IN PRACTICE:

In this study, “local tolerability and safety profiles were well characterized in patients with 4-12 clinically typical, visible, and discrete AK lesions in a field of 100 cm² and were consistent with those previously reported in patients with AK treated in pivotal trials with tirbanibulin over a smaller field (25 cm²),” the authors wrote.

SOURCE:

The study, led by Neal Bhatia, MD, of Therapeutics Clinical Research, San Diego, was published online in JAAD International.

LIMITATIONS:

The study was limited by the lack of a placebo group and the absence of long-term follow-up. 

DISCLOSURES:

This study was funded by Almirall. Five authors reported being employees of Almirall. Other authors declared having ties with various other sources, including Almirall.

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:

Tirbanibulin ointment 1% shows good safety and tolerability in the treatment of actinic keratosis (AK) in fields of up to 100 cm2 on the face and scalp.

METHODOLOGY:

• This phase 3 multicenter, single-arm trial evaluated the safety and tolerability of tirbanibulin ointment 1% in 105 adults with 4-12 clinically typical, visible, and discrete AKs on the face or balding scalp from June to December 2022 in the United States. (In June 2024, the Food and Drug Administration approved a supplemental new drug application for tirbanibulin 1%, a microtubule inhibitor, allowing the expansion of the surface area treated for AKs of the face or scalp from 25 cm² to 100 cm².)
• Participants applied tirbanibulin ointment 1% once daily for 5 days over a treatment field of about 100 cm² on the face or balding scalp. A total of 102 patients completed the study.
• Safety and tolerability were evaluated with reports of treatment-emergent adverse events (TEAEs) and a composite score of six local tolerability signs on days 5, 8, 15, and 29, and on completion of the evaluation period on day 57.

TAKEAWAY:

• The most common local effects of treatment were erythema (96.1% of patients) and flaking or scaling (84.4%), with severe cases reported in 5.8% and 8.7% of the patients, respectively.
• The mean maximum local tolerability composite score was 4.1 out of 18, which peaked around day 8 and returned to baseline by day 29.
• TEAEs considered related to the treatment were reported in 18.1% of patients; the most frequent were application site pruritus (10.5%) and application site pain (8.6%). No adverse events led to the discontinuation of treatment.
• The mean percent reduction in the lesion count from baseline was 77.8% at day 57, with a mean lesion count of 1.8 at the end of the study.

IN PRACTICE:

In this study, “local tolerability and safety profiles were well characterized in patients with 4-12 clinically typical, visible, and discrete AK lesions in a field of 100 cm² and were consistent with those previously reported in patients with AK treated in pivotal trials with tirbanibulin over a smaller field (25 cm²),” the authors wrote.

SOURCE:

The study, led by Neal Bhatia, MD, of Therapeutics Clinical Research, San Diego, was published online in JAAD International.

LIMITATIONS:

The study was limited by the lack of a placebo group and the absence of long-term follow-up. 

DISCLOSURES:

This study was funded by Almirall. Five authors reported being employees of Almirall. Other authors declared having ties with various other sources, including Almirall.

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:

Patients with metastatic hormone-sensitive prostate cancer and baseline bone pain at diagnosis have worse overall survival compared to those without bone pain, a post hoc study found.

METHODOLOGY:

• Prostate cancer often metastasizes to the bones, leading to pain and a reduced quality of life. While the relationship between bone pain and overall survival in metastatic, castration-resistant prostate cancer is well-documented, its impact in metastatic hormone-sensitive prostate cancer is less clear.
• Researchers conducted a post hoc secondary analysis using data from the SWOG-1216 phase 3 randomized clinical trial, which included 1279 men diagnosed with metastatic hormone-sensitive prostate cancer from 248 centers across the United States. Patients had received androgen deprivation therapy either with orteronel or bicalutamide.
• Among the 1197 patients (median age, 67.6 years) with data on bone pain included in the secondary analysis, 301 (23.5%) reported bone pain at baseline.
• The primary outcome was overall survival; secondary outcomes included progression-free survival and prostate-specific antigen response.

TAKEAWAY:

• The median overall survival for patients with baseline bone pain was 3.9 years compared with not reached (95% CI, 6.6 years to not reached) for those without bone pain at a median follow-up of 4 years (adjusted hazard ratio [aHR], 1.66; P < .001).
• Similarly, patients with bone pain had a shorter progression-free survival vs those without bone pain (median, 1.3 years vs 3.7 years; aHR, 1.46; P < .001).
• The complete prostate-specific antigen response rate at 7 months was also lower for patients with baseline bone pain (46.3% vs 66.3%; P < .001).

IN PRACTICE:

Patients with metastatic hormone-sensitive prostate cancer “with baseline bone pain had worse survival outcomes than those without baseline bone pain,” the authors wrote. “These results highlight the need to consider bone pain in prognostic modeling, treatment selection, patient monitoring, and follow-up and suggest prioritizing these patients for clinical trials and immediate systemic treatment initiation.”

SOURCE:

The study, led by Georges Gebrael, MD, Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, was published online in JAMA Network Open.

LIMITATIONS:

The post hoc design may introduce bias. Orteronel failed to receive regulatory approval, which may affect the generalizability of the findings. In addition, the study did not account for synchronous vs metachronous disease status, a known established prognostic factor.

DISCLOSURES:

The study was funded by the National Institutes of Health/National Cancer Institute and Millennium Pharmaceuticals (Takeda Oncology Company). Several authors declared ties with various sources.

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:

Patients with metastatic hormone-sensitive prostate cancer and baseline bone pain at diagnosis have worse overall survival compared to those without bone pain, a post hoc study found.

METHODOLOGY:

• Prostate cancer often metastasizes to the bones, leading to pain and a reduced quality of life. While the relationship between bone pain and overall survival in metastatic, castration-resistant prostate cancer is well-documented, its impact in metastatic hormone-sensitive prostate cancer is less clear.
• Researchers conducted a post hoc secondary analysis using data from the SWOG-1216 phase 3 randomized clinical trial, which included 1279 men diagnosed with metastatic hormone-sensitive prostate cancer from 248 centers across the United States. Patients had received androgen deprivation therapy either with orteronel or bicalutamide.
• Among the 1197 patients (median age, 67.6 years) with data on bone pain included in the secondary analysis, 301 (23.5%) reported bone pain at baseline.
• The primary outcome was overall survival; secondary outcomes included progression-free survival and prostate-specific antigen response.

TAKEAWAY:

• The median overall survival for patients with baseline bone pain was 3.9 years compared with not reached (95% CI, 6.6 years to not reached) for those without bone pain at a median follow-up of 4 years (adjusted hazard ratio [aHR], 1.66; P < .001).
• Similarly, patients with bone pain had a shorter progression-free survival vs those without bone pain (median, 1.3 years vs 3.7 years; aHR, 1.46; P < .001).
• The complete prostate-specific antigen response rate at 7 months was also lower for patients with baseline bone pain (46.3% vs 66.3%; P < .001).

IN PRACTICE:

Patients with metastatic hormone-sensitive prostate cancer “with baseline bone pain had worse survival outcomes than those without baseline bone pain,” the authors wrote. “These results highlight the need to consider bone pain in prognostic modeling, treatment selection, patient monitoring, and follow-up and suggest prioritizing these patients for clinical trials and immediate systemic treatment initiation.”

SOURCE:

The study, led by Georges Gebrael, MD, Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, was published online in JAMA Network Open.

LIMITATIONS:

The post hoc design may introduce bias. Orteronel failed to receive regulatory approval, which may affect the generalizability of the findings. In addition, the study did not account for synchronous vs metachronous disease status, a known established prognostic factor.

DISCLOSURES:

The study was funded by the National Institutes of Health/National Cancer Institute and Millennium Pharmaceuticals (Takeda Oncology Company). Several authors declared ties with various sources.

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:

Patients with metastatic hormone-sensitive prostate cancer and baseline bone pain at diagnosis have worse overall survival compared to those without bone pain, a post hoc study found.

METHODOLOGY:

• Prostate cancer often metastasizes to the bones, leading to pain and a reduced quality of life. While the relationship between bone pain and overall survival in metastatic, castration-resistant prostate cancer is well-documented, its impact in metastatic hormone-sensitive prostate cancer is less clear.
• Researchers conducted a post hoc secondary analysis using data from the SWOG-1216 phase 3 randomized clinical trial, which included 1279 men diagnosed with metastatic hormone-sensitive prostate cancer from 248 centers across the United States. Patients had received androgen deprivation therapy either with orteronel or bicalutamide.
• Among the 1197 patients (median age, 67.6 years) with data on bone pain included in the secondary analysis, 301 (23.5%) reported bone pain at baseline.
• The primary outcome was overall survival; secondary outcomes included progression-free survival and prostate-specific antigen response.

TAKEAWAY:

• The median overall survival for patients with baseline bone pain was 3.9 years compared with not reached (95% CI, 6.6 years to not reached) for those without bone pain at a median follow-up of 4 years (adjusted hazard ratio [aHR], 1.66; P < .001).
• Similarly, patients with bone pain had a shorter progression-free survival vs those without bone pain (median, 1.3 years vs 3.7 years; aHR, 1.46; P < .001).
• The complete prostate-specific antigen response rate at 7 months was also lower for patients with baseline bone pain (46.3% vs 66.3%; P < .001).

IN PRACTICE:

Patients with metastatic hormone-sensitive prostate cancer “with baseline bone pain had worse survival outcomes than those without baseline bone pain,” the authors wrote. “These results highlight the need to consider bone pain in prognostic modeling, treatment selection, patient monitoring, and follow-up and suggest prioritizing these patients for clinical trials and immediate systemic treatment initiation.”

SOURCE:

The study, led by Georges Gebrael, MD, Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, was published online in JAMA Network Open.

LIMITATIONS:

The post hoc design may introduce bias. Orteronel failed to receive regulatory approval, which may affect the generalizability of the findings. In addition, the study did not account for synchronous vs metachronous disease status, a known established prognostic factor.

DISCLOSURES:

The study was funded by the National Institutes of Health/National Cancer Institute and Millennium Pharmaceuticals (Takeda Oncology Company). Several authors declared ties with various sources.

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: 

Spironolactone may benefit women of childbearing age with mild hidradenitis suppurativa (HS), especially if initiated early, according to the results of a single-center retrospective study.

METHODOLOGY:

• This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
• The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
• Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.

TAKEAWAY:

• Overall, 31 patients (20%) showed improvements with spironolactone treatment.
• A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
• Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
• Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).

IN PRACTICE:

Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”

SOURCE:

The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.

LIMITATIONS:

Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.

DISCLOSURES:

This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared 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 first appeared on Medscape.com.

TOPLINE: 

Spironolactone may benefit women of childbearing age with mild hidradenitis suppurativa (HS), especially if initiated early, according to the results of a single-center retrospective study.

METHODOLOGY:

• This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
• The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
• Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.

TAKEAWAY:

• Overall, 31 patients (20%) showed improvements with spironolactone treatment.
• A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
• Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
• Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).

IN PRACTICE:

Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”

SOURCE:

The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.

LIMITATIONS:

Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.

DISCLOSURES:

This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared 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 first appeared on Medscape.com.

TOPLINE: 

Spironolactone may benefit women of childbearing age with mild hidradenitis suppurativa (HS), especially if initiated early, according to the results of a single-center retrospective study.

METHODOLOGY:

• This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
• The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
• Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.

TAKEAWAY:

• Overall, 31 patients (20%) showed improvements with spironolactone treatment.
• A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
• Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
• Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).

IN PRACTICE:

Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”

SOURCE:

The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.

LIMITATIONS:

Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.

DISCLOSURES:

This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared 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 first appeared on Medscape.com.

TOPLINE:

Seborrheic dermatitis affects an estimated 4% of the global population, with significant variations across age groups, settings, and regions, according to a meta-analysis that also found a higher prevalence in adults than in children.

METHODOLOGY:

• Researchers conducted a meta-analysis of 121 studies, which included 1,260,163 people with clinician-diagnosed seborrheic dermatitis.
• The included studies represented nine countries; most were from India (n = 18), Turkey (n = 13), and the United States (n = 8).
• The primary outcome was the pooled prevalence of seborrheic dermatitis.

TAKEAWAY:

• The overall pooled prevalence of seborrheic dermatitis was 4.38%, 4.08% in clinical settings, and 4.71% in the studies conducted in the general population.
• The prevalence of seborrheic dermatitis was higher among adults (5.64%) than in children (3.7%) and neonates (0.23%).
• A significant variation was observed across countries, with South Africa having the highest prevalence at 8.82%, followed by the United States at 5.86% and Turkey at 3.74%, while India had the lowest prevalence at 2.62%.

IN PRACTICE:

The global prevalence in this meta-analysis was “higher than previous large-scale global estimates, with notable geographic and sociodemographic variability, highlighting the potential impact of environmental factors and cultural practices,” the authors wrote.

SOURCE:

The study was led by Meredith Tyree Polaskey, MS, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, and was published online on July 3, 2024, in the JAMA Dermatology.

LIMITATIONS:

Interpretation of the findings is limited by research gaps in Central Asia, much of Sub-Saharan Africa, Eastern Europe, Southeast Asia, Latin America (excluding Brazil), and the Caribbean, along with potential underreporting in regions with restricted healthcare access and significant heterogeneity across studies.

DISCLOSURES:

Funding information was not available. One author reported serving as an advisor, consultant, speaker, and/or investigator for multiple pharmaceutical companies, including AbbVie, Amgen, and Pfizer.

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:

Seborrheic dermatitis affects an estimated 4% of the global population, with significant variations across age groups, settings, and regions, according to a meta-analysis that also found a higher prevalence in adults than in children.

METHODOLOGY:

• Researchers conducted a meta-analysis of 121 studies, which included 1,260,163 people with clinician-diagnosed seborrheic dermatitis.
• The included studies represented nine countries; most were from India (n = 18), Turkey (n = 13), and the United States (n = 8).
• The primary outcome was the pooled prevalence of seborrheic dermatitis.

TAKEAWAY:

• The overall pooled prevalence of seborrheic dermatitis was 4.38%, 4.08% in clinical settings, and 4.71% in the studies conducted in the general population.
• The prevalence of seborrheic dermatitis was higher among adults (5.64%) than in children (3.7%) and neonates (0.23%).
• A significant variation was observed across countries, with South Africa having the highest prevalence at 8.82%, followed by the United States at 5.86% and Turkey at 3.74%, while India had the lowest prevalence at 2.62%.

IN PRACTICE:

The global prevalence in this meta-analysis was “higher than previous large-scale global estimates, with notable geographic and sociodemographic variability, highlighting the potential impact of environmental factors and cultural practices,” the authors wrote.

SOURCE:

The study was led by Meredith Tyree Polaskey, MS, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, and was published online on July 3, 2024, in the JAMA Dermatology.

LIMITATIONS:

Interpretation of the findings is limited by research gaps in Central Asia, much of Sub-Saharan Africa, Eastern Europe, Southeast Asia, Latin America (excluding Brazil), and the Caribbean, along with potential underreporting in regions with restricted healthcare access and significant heterogeneity across studies.

DISCLOSURES:

Funding information was not available. One author reported serving as an advisor, consultant, speaker, and/or investigator for multiple pharmaceutical companies, including AbbVie, Amgen, and Pfizer.

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:

Seborrheic dermatitis affects an estimated 4% of the global population, with significant variations across age groups, settings, and regions, according to a meta-analysis that also found a higher prevalence in adults than in children.

METHODOLOGY:

• Researchers conducted a meta-analysis of 121 studies, which included 1,260,163 people with clinician-diagnosed seborrheic dermatitis.
• The included studies represented nine countries; most were from India (n = 18), Turkey (n = 13), and the United States (n = 8).
• The primary outcome was the pooled prevalence of seborrheic dermatitis.

TAKEAWAY:

• The overall pooled prevalence of seborrheic dermatitis was 4.38%, 4.08% in clinical settings, and 4.71% in the studies conducted in the general population.
• The prevalence of seborrheic dermatitis was higher among adults (5.64%) than in children (3.7%) and neonates (0.23%).
• A significant variation was observed across countries, with South Africa having the highest prevalence at 8.82%, followed by the United States at 5.86% and Turkey at 3.74%, while India had the lowest prevalence at 2.62%.

IN PRACTICE:

The global prevalence in this meta-analysis was “higher than previous large-scale global estimates, with notable geographic and sociodemographic variability, highlighting the potential impact of environmental factors and cultural practices,” the authors wrote.

SOURCE:

The study was led by Meredith Tyree Polaskey, MS, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, and was published online on July 3, 2024, in the JAMA Dermatology.

LIMITATIONS:

Interpretation of the findings is limited by research gaps in Central Asia, much of Sub-Saharan Africa, Eastern Europe, Southeast Asia, Latin America (excluding Brazil), and the Caribbean, along with potential underreporting in regions with restricted healthcare access and significant heterogeneity across studies.

DISCLOSURES:

Funding information was not available. One author reported serving as an advisor, consultant, speaker, and/or investigator for multiple pharmaceutical companies, including AbbVie, Amgen, and Pfizer.

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.