Breast Cancer

Wildfire smoke exposure may be associated with increased risks for multiple types of cancer, suggests an analysis of prospective cohort data from over 90,000 individuals.

To determine how this widespread pollution might be affecting cancer risk, senior author Shuguang Leng, MBBS, PhD, and colleagues analyzed data from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. That prospective national study enrolled approximately 154,000 participants between 1993 and 2001 and tracked cancer incidence through 2018. Of these, 91,460 participants had wildfire smoke exposure data and were included in the analysis.

During the 2006-2018 exposure period, the investigators identified incident cases of 242 ovarian, 800 colorectal, 896 bladder, 1696 hematopoietic, 1739 breast, and 1758 lung cancers, as well as 1127 melanoma cases. The median 36-month moving average for wildfire smoke PM_2.5 (fine particulate matter) across the cohort was 0.37 µg/m³.

Wildfire smoke exposure was significantly associated with increased risks for lung, colorectal, breast, bladder, and hematopoietic cancer, according to the results of the study presented by Leng at American Association for Cancer Research (AACR) Annual Meeting 2026.

Each 1 µg/m³ increase in the 36-month moving average of wildfire smoke PM_2.5 was associated with a 63% higher risk for hematopoietic cancer (HR, 1.63; 95% CI, 1.02-2.60), a nearly twofold higher risk for lung cancer (hazard ratio [HR], 1.92; 95% CI, 1.18-3.15), more than twofold higher risks for breast cancer (HR, 2.09; 95% CI, 1.34-3.26) and colorectal cancer (HR, 2.31; 95% CI, 1.11-4.81), and a more than threefold higher risk for bladder cancer (HR, 3.49; 95% CI, 1.66-7.34). No significant associations were observed for ovarian cancer or melanoma.

The investigators quantified wildfire smoke exposure at each participant’s residence on a monthly basis using three measures: near-ground wildfire smoke PM_2.5, wildfire smoke black carbon, and satellite-derived wildfire smoke plume-day counts, with measurements available from 2006 until first cancer diagnosis or last contact.

Given evidence that 3 years of air pollution exposure can influence the development of epidermal growth factor receptor-positive lung adenocarcinoma, the team modeled exposure as a time-varying variable using 36-month moving averages preceding each month. HRs were estimated using Cox proportional hazards models stratified by study center, with restricted cubic splines applied to evaluate dose-response relationships. Models were adjusted for age, sex, race and ethnicity, education, smoking history, BMI, and trial arm.

All five cancer types linked with wildfire smoke exposure showed linear dose-response relationships, Leng noted, “which means the higher the exposure, the higher the cancer risk.”

Results based on wildfire smoke plume-day counts were generally consistent with those for PM_2.5, while associations for black carbon exposure were observed only for breast and bladder cancers.

With wildfires on the rise, these findings suggest that the resulting smoke may become a “major driver for cancer burden in the US in the coming decades,” said Leng, of the University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico.

“Wildfire smoke has become a major source of air pollution in the United States,” he continued. Large fires in the US are three times more common than they were 50 years ago, and the “tons of toxicants and particles” released by these fires “can travel hundreds of miles to affect communities far away.”

The investigators also conducted histology-specific analyses, finding that adenocarcinoma showed the strongest association with wildfire smoke among lung cancer subtypes. Among colorectal cancers, proximal tumors appeared more sensitive to wildfire smoke exposure, while among bladder cancers, the association was strongest for muscle-invasive disease.

Wildfire Smoke Exposure Expected to Rise

Under even the most conservative climate projections, wildfire smoke exposure in the US is expected to rise over the next 20-30 years, Leng said.

Annual average wildfire smoke PM_2.5 levels, currently estimated at around 0.5 µg/m³, could rise to 1 µg/m³. Based on the study’s dose-response data, this would correspond to substantially greater cancer risk.

There will be “a much larger area” of the US exposed “at a much higher dose,” Leng predicted.

Mitigating the Risks of Wildfire Smoke

This is a “strong hypothesis-generating study,” Jun Wu, PhD, professor of environmental and occupational health at the UC Irvine Program in Public Health, Irvine, California, told Medscape Medical News.

“This is one of the first large, prospective US cohort studies to examine wildfire smoke specifically in relation to cancer risk, especially cancer sites beyond the lung,” Wu said. “A major strength is that the PLCO platform has around 91,000 participants with longitudinal follow-up and detailed covariate data, including smoking history, which is often a weak point in previous air pollution-cancer studies.”

According to Wu, who was not involved in the analysis but recently published data linking wildfire smoke exposure to preterm birth, the reported risks for colorectal, breast, bladder, and hematopoietic cancers represent novel contributions to the literature. However, she cautioned against viewing the specific HRs as a precise estimates of risk due to wide confidence intervals.

The findings should encourage individuals, public health officials, and clinicians to mitigate the risks of wildfire smoke, Wu said.

Specifically, she suggested that public health assessments expand beyond acute outcomes like emergency department visits to include long-term endpoints such as cancer, while community clean-air shelters need to be made more widely available.

She advised clinicians to incorporate wildfire exposure into routine patient histories and to provide vulnerable patients — such as those with asthma, chronic obstructive pulmonary disease, heart failure, or pregnancy — with smoke-season action plans.

Risk mitigation begins with awareness, according to Wu, who advised individuals check their local air quality index on AirNow.gov or PurpleAir.

On smoky days, she suggested prioritizing indoor air quality by keeping windows closed and running air purifiers. If going outside on such days is necessary, she suggested an N95 or KN95 mask, as these offer “meaningful protection,” while cloth and surgical masks do not.

These preventive steps may have once been out of the ordinary, Wu said, but the risk for wildfire smoke exposure is becoming a part of everyday life.

“The common thread is a shift in framing,” Wu said. “Wildfire smoke has traditionally been treated as an acute event, but the emerging evidence points to a chronic environmental exposure. Both our clinical and public health systems have room to grow into that reality.”

The analysis was funded by the National Institutes of Health. The investigators and Wu reported having no conflicts of interest.

This article was previously published on Medscape.

Wildfire smoke exposure may be associated with increased risks for multiple types of cancer, suggests an analysis of prospective cohort data from over 90,000 individuals.

To determine how this widespread pollution might be affecting cancer risk, senior author Shuguang Leng, MBBS, PhD, and colleagues analyzed data from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. That prospective national study enrolled approximately 154,000 participants between 1993 and 2001 and tracked cancer incidence through 2018. Of these, 91,460 participants had wildfire smoke exposure data and were included in the analysis.

During the 2006-2018 exposure period, the investigators identified incident cases of 242 ovarian, 800 colorectal, 896 bladder, 1696 hematopoietic, 1739 breast, and 1758 lung cancers, as well as 1127 melanoma cases. The median 36-month moving average for wildfire smoke PM_2.5 (fine particulate matter) across the cohort was 0.37 µg/m³.

Wildfire smoke exposure was significantly associated with increased risks for lung, colorectal, breast, bladder, and hematopoietic cancer, according to the results of the study presented by Leng at American Association for Cancer Research (AACR) Annual Meeting 2026.

Each 1 µg/m³ increase in the 36-month moving average of wildfire smoke PM_2.5 was associated with a 63% higher risk for hematopoietic cancer (HR, 1.63; 95% CI, 1.02-2.60), a nearly twofold higher risk for lung cancer (hazard ratio [HR], 1.92; 95% CI, 1.18-3.15), more than twofold higher risks for breast cancer (HR, 2.09; 95% CI, 1.34-3.26) and colorectal cancer (HR, 2.31; 95% CI, 1.11-4.81), and a more than threefold higher risk for bladder cancer (HR, 3.49; 95% CI, 1.66-7.34). No significant associations were observed for ovarian cancer or melanoma.

The investigators quantified wildfire smoke exposure at each participant’s residence on a monthly basis using three measures: near-ground wildfire smoke PM_2.5, wildfire smoke black carbon, and satellite-derived wildfire smoke plume-day counts, with measurements available from 2006 until first cancer diagnosis or last contact.

Given evidence that 3 years of air pollution exposure can influence the development of epidermal growth factor receptor-positive lung adenocarcinoma, the team modeled exposure as a time-varying variable using 36-month moving averages preceding each month. HRs were estimated using Cox proportional hazards models stratified by study center, with restricted cubic splines applied to evaluate dose-response relationships. Models were adjusted for age, sex, race and ethnicity, education, smoking history, BMI, and trial arm.

All five cancer types linked with wildfire smoke exposure showed linear dose-response relationships, Leng noted, “which means the higher the exposure, the higher the cancer risk.”

Results based on wildfire smoke plume-day counts were generally consistent with those for PM_2.5, while associations for black carbon exposure were observed only for breast and bladder cancers.

With wildfires on the rise, these findings suggest that the resulting smoke may become a “major driver for cancer burden in the US in the coming decades,” said Leng, of the University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico.

“Wildfire smoke has become a major source of air pollution in the United States,” he continued. Large fires in the US are three times more common than they were 50 years ago, and the “tons of toxicants and particles” released by these fires “can travel hundreds of miles to affect communities far away.”

The investigators also conducted histology-specific analyses, finding that adenocarcinoma showed the strongest association with wildfire smoke among lung cancer subtypes. Among colorectal cancers, proximal tumors appeared more sensitive to wildfire smoke exposure, while among bladder cancers, the association was strongest for muscle-invasive disease.

Wildfire Smoke Exposure Expected to Rise

Under even the most conservative climate projections, wildfire smoke exposure in the US is expected to rise over the next 20-30 years, Leng said.

Annual average wildfire smoke PM_2.5 levels, currently estimated at around 0.5 µg/m³, could rise to 1 µg/m³. Based on the study’s dose-response data, this would correspond to substantially greater cancer risk.

There will be “a much larger area” of the US exposed “at a much higher dose,” Leng predicted.

Mitigating the Risks of Wildfire Smoke

This is a “strong hypothesis-generating study,” Jun Wu, PhD, professor of environmental and occupational health at the UC Irvine Program in Public Health, Irvine, California, told Medscape Medical News.

“This is one of the first large, prospective US cohort studies to examine wildfire smoke specifically in relation to cancer risk, especially cancer sites beyond the lung,” Wu said. “A major strength is that the PLCO platform has around 91,000 participants with longitudinal follow-up and detailed covariate data, including smoking history, which is often a weak point in previous air pollution-cancer studies.”

According to Wu, who was not involved in the analysis but recently published data linking wildfire smoke exposure to preterm birth, the reported risks for colorectal, breast, bladder, and hematopoietic cancers represent novel contributions to the literature. However, she cautioned against viewing the specific HRs as a precise estimates of risk due to wide confidence intervals.

The findings should encourage individuals, public health officials, and clinicians to mitigate the risks of wildfire smoke, Wu said.

Specifically, she suggested that public health assessments expand beyond acute outcomes like emergency department visits to include long-term endpoints such as cancer, while community clean-air shelters need to be made more widely available.

She advised clinicians to incorporate wildfire exposure into routine patient histories and to provide vulnerable patients — such as those with asthma, chronic obstructive pulmonary disease, heart failure, or pregnancy — with smoke-season action plans.

Risk mitigation begins with awareness, according to Wu, who advised individuals check their local air quality index on AirNow.gov or PurpleAir.

On smoky days, she suggested prioritizing indoor air quality by keeping windows closed and running air purifiers. If going outside on such days is necessary, she suggested an N95 or KN95 mask, as these offer “meaningful protection,” while cloth and surgical masks do not.

These preventive steps may have once been out of the ordinary, Wu said, but the risk for wildfire smoke exposure is becoming a part of everyday life.

“The common thread is a shift in framing,” Wu said. “Wildfire smoke has traditionally been treated as an acute event, but the emerging evidence points to a chronic environmental exposure. Both our clinical and public health systems have room to grow into that reality.”

The analysis was funded by the National Institutes of Health. The investigators and Wu reported having no conflicts of interest.

This article was previously published on Medscape.

Wildfire smoke exposure may be associated with increased risks for multiple types of cancer, suggests an analysis of prospective cohort data from over 90,000 individuals.

To determine how this widespread pollution might be affecting cancer risk, senior author Shuguang Leng, MBBS, PhD, and colleagues analyzed data from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. That prospective national study enrolled approximately 154,000 participants between 1993 and 2001 and tracked cancer incidence through 2018. Of these, 91,460 participants had wildfire smoke exposure data and were included in the analysis.

During the 2006-2018 exposure period, the investigators identified incident cases of 242 ovarian, 800 colorectal, 896 bladder, 1696 hematopoietic, 1739 breast, and 1758 lung cancers, as well as 1127 melanoma cases. The median 36-month moving average for wildfire smoke PM_2.5 (fine particulate matter) across the cohort was 0.37 µg/m³.

Wildfire smoke exposure was significantly associated with increased risks for lung, colorectal, breast, bladder, and hematopoietic cancer, according to the results of the study presented by Leng at American Association for Cancer Research (AACR) Annual Meeting 2026.

Each 1 µg/m³ increase in the 36-month moving average of wildfire smoke PM_2.5 was associated with a 63% higher risk for hematopoietic cancer (HR, 1.63; 95% CI, 1.02-2.60), a nearly twofold higher risk for lung cancer (hazard ratio [HR], 1.92; 95% CI, 1.18-3.15), more than twofold higher risks for breast cancer (HR, 2.09; 95% CI, 1.34-3.26) and colorectal cancer (HR, 2.31; 95% CI, 1.11-4.81), and a more than threefold higher risk for bladder cancer (HR, 3.49; 95% CI, 1.66-7.34). No significant associations were observed for ovarian cancer or melanoma.

The investigators quantified wildfire smoke exposure at each participant’s residence on a monthly basis using three measures: near-ground wildfire smoke PM_2.5, wildfire smoke black carbon, and satellite-derived wildfire smoke plume-day counts, with measurements available from 2006 until first cancer diagnosis or last contact.

Given evidence that 3 years of air pollution exposure can influence the development of epidermal growth factor receptor-positive lung adenocarcinoma, the team modeled exposure as a time-varying variable using 36-month moving averages preceding each month. HRs were estimated using Cox proportional hazards models stratified by study center, with restricted cubic splines applied to evaluate dose-response relationships. Models were adjusted for age, sex, race and ethnicity, education, smoking history, BMI, and trial arm.

All five cancer types linked with wildfire smoke exposure showed linear dose-response relationships, Leng noted, “which means the higher the exposure, the higher the cancer risk.”

Results based on wildfire smoke plume-day counts were generally consistent with those for PM_2.5, while associations for black carbon exposure were observed only for breast and bladder cancers.

With wildfires on the rise, these findings suggest that the resulting smoke may become a “major driver for cancer burden in the US in the coming decades,” said Leng, of the University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico.

“Wildfire smoke has become a major source of air pollution in the United States,” he continued. Large fires in the US are three times more common than they were 50 years ago, and the “tons of toxicants and particles” released by these fires “can travel hundreds of miles to affect communities far away.”

The investigators also conducted histology-specific analyses, finding that adenocarcinoma showed the strongest association with wildfire smoke among lung cancer subtypes. Among colorectal cancers, proximal tumors appeared more sensitive to wildfire smoke exposure, while among bladder cancers, the association was strongest for muscle-invasive disease.

Wildfire Smoke Exposure Expected to Rise

Under even the most conservative climate projections, wildfire smoke exposure in the US is expected to rise over the next 20-30 years, Leng said.

Annual average wildfire smoke PM_2.5 levels, currently estimated at around 0.5 µg/m³, could rise to 1 µg/m³. Based on the study’s dose-response data, this would correspond to substantially greater cancer risk.

There will be “a much larger area” of the US exposed “at a much higher dose,” Leng predicted.

Mitigating the Risks of Wildfire Smoke

This is a “strong hypothesis-generating study,” Jun Wu, PhD, professor of environmental and occupational health at the UC Irvine Program in Public Health, Irvine, California, told Medscape Medical News.

“This is one of the first large, prospective US cohort studies to examine wildfire smoke specifically in relation to cancer risk, especially cancer sites beyond the lung,” Wu said. “A major strength is that the PLCO platform has around 91,000 participants with longitudinal follow-up and detailed covariate data, including smoking history, which is often a weak point in previous air pollution-cancer studies.”

According to Wu, who was not involved in the analysis but recently published data linking wildfire smoke exposure to preterm birth, the reported risks for colorectal, breast, bladder, and hematopoietic cancers represent novel contributions to the literature. However, she cautioned against viewing the specific HRs as a precise estimates of risk due to wide confidence intervals.

The findings should encourage individuals, public health officials, and clinicians to mitigate the risks of wildfire smoke, Wu said.

Specifically, she suggested that public health assessments expand beyond acute outcomes like emergency department visits to include long-term endpoints such as cancer, while community clean-air shelters need to be made more widely available.

She advised clinicians to incorporate wildfire exposure into routine patient histories and to provide vulnerable patients — such as those with asthma, chronic obstructive pulmonary disease, heart failure, or pregnancy — with smoke-season action plans.

Risk mitigation begins with awareness, according to Wu, who advised individuals check their local air quality index on AirNow.gov or PurpleAir.

On smoky days, she suggested prioritizing indoor air quality by keeping windows closed and running air purifiers. If going outside on such days is necessary, she suggested an N95 or KN95 mask, as these offer “meaningful protection,” while cloth and surgical masks do not.

These preventive steps may have once been out of the ordinary, Wu said, but the risk for wildfire smoke exposure is becoming a part of everyday life.

“The common thread is a shift in framing,” Wu said. “Wildfire smoke has traditionally been treated as an acute event, but the emerging evidence points to a chronic environmental exposure. Both our clinical and public health systems have room to grow into that reality.”

The analysis was funded by the National Institutes of Health. The investigators and Wu reported having no conflicts of interest.

This article was previously published on Medscape.

TOPLINE:

Among 1.3 million male veterans treated for prostate cancer, 11,327 (0.86%) developed breast cancer an average of 5.4 years after initial diagnosis. Younger age at prostate cancer diagnosis, metastatic disease, androgen deprivation therapy (ADT), radiation treatment, and prolonged use of certain cardiovascular disease (CVD) medications were associated with increased risk for breast cancer.

METHODOLOGY:

• Researchers used a retrospective cohort design in Veterans Health Administration (VHA) care, pulling data from the Veterans Affairs (VA) Prostate Cancer Data Core at the VA Corporate Data Warehouse.
• Participants included 1,314,492 male veterans with prostate cancer treated at VHA facilities from January 1, 2000, to March 12, 2024.
• Exposure definitions included prostate cancer treatments (ADT, anti-androgen treatment, radiation-brachytherapy, and platinum chemotherapy) and CVD medications (furosemide, spironolactone, digoxin) captured via inpatient/outpatient/fee-based pharmacy and Current Procedural Terminology codes.
• Analysis measured time from prostate cancer diagnosis to breast cancer diagnosis, death, or March 12, 2024, applying Cox proportional hazards and Fine-Gray competing risk methods, with a sensitivity analysis adding body mass index (BMI) after excluding 71,718 missing values.

TAKEAWAY:

• Metastatic prostate cancer at diagnosis more than doubled the risk for breast cancer compared to nonmetastatic disease (hazard ratio [HR], 2.03; 95% CI, 1.90-2.17; P < .0001; subdistribution hazard ratio [SHR], 1.68; 95% CI, 1.57-1.81; P < .0001).
• Younger age at prostate cancer diagnosis was associated with increased risk for breast cancer (HR, 0.97; 95% CI, 0.97-0.98; P < .0001; SHR, 0.957; 95% CI, 0.955-0.959; P < .0001), indicating that for each additional year of age at diagnosis, the risk decreased.
• Continuation of CVD medications after prostate cancer diagnosis was associated with increased risk for breast cancer: furosemide (HR, 1.51; 95% CI, 1.39-1.63; P < .0001; SHR, 1.21; 95% CI, 1.12-1.31; P < .0001), spironolactone (HR, 1.36; 95% CI, 1.15-1.61; P = .0004; SHR, 1.23; 95% CI, 1.04-1.47; P = .0174), and digoxin (HR, 1.49; 95% CI, 1.29-1.72; P < .0001; SHR, 1.26; 95% CI, 1.10-1.46; P = .0015).
• Radiation therapy and ADT were associated with increased risk for breast cancer (radiation: HR, 1.06; 95% CI, 1.02-1.11; P = .0088; SHR, 1.10; 95% CI, 1.05-1.15; P < .0001; ADT: HR, 1.24; 95% CI, 1.17-1.32; P < .0001; SHR, 1.28; 95% CI, 1.20-1.37; P < .0001), while abiraterone was associated with decreased risk (HR, 0.36; 95% CI, 0.31-0.42; P < .0001; SHR, 0.39; 95% CI, 0.34-0.45; P < .0001).

IN PRACTICE:

"While there is a lack of data, male veterans with previous prostate cancer are at an elevated risk of breast cancer (0.87%), than their civilian counterparts (0.14%),” the authors wrote. “To address the current gap in knowledge and data, this study leveraged an existing large cohort of male veterans with prostate cancer and examined factors associated with increased risk of male breast cancer."

SOURCE:

The study was led by Erum Z. Whyne, VA North Texas Health Care System in Dallas, and Haekyung Jeon-Slaughter, University of Texas Southwestern Medical Center in Dallas. It was published online in The Prostate.

LIMITATIONS:

Though the study findings are based on large, representative data from male veterans with previously diagnosed prostate cancer, the results might not be generalizable to the overall male breast cancer population. As a retrospective cohort study, results may be biased and causality is difficult to establish. The study did not examine other known risk factors for male breast cancer incidence, such as family history, BRCA2 mutations, and military environmental exposure due to lack of data. BMI had missingness of 5.46% (n = 71,718) and was not included as a covariate in the final model, though sensitivity analysis showed it was not significantly associated with increased risk for male breast cancer.

DISCLOSURES:

The research was supported using resources and facilities of the VA Informatics and Computing Infrastructure (VINCI), VA HSR RES 13-457. The VA North Texas Health Care System Institutional Review Board approved the study and waived informed consent. No 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.

TOPLINE:

Among 1.3 million male veterans treated for prostate cancer, 11,327 (0.86%) developed breast cancer an average of 5.4 years after initial diagnosis. Younger age at prostate cancer diagnosis, metastatic disease, androgen deprivation therapy (ADT), radiation treatment, and prolonged use of certain cardiovascular disease (CVD) medications were associated with increased risk for breast cancer.

METHODOLOGY:

• Researchers used a retrospective cohort design in Veterans Health Administration (VHA) care, pulling data from the Veterans Affairs (VA) Prostate Cancer Data Core at the VA Corporate Data Warehouse.
• Participants included 1,314,492 male veterans with prostate cancer treated at VHA facilities from January 1, 2000, to March 12, 2024.
• Exposure definitions included prostate cancer treatments (ADT, anti-androgen treatment, radiation-brachytherapy, and platinum chemotherapy) and CVD medications (furosemide, spironolactone, digoxin) captured via inpatient/outpatient/fee-based pharmacy and Current Procedural Terminology codes.
• Analysis measured time from prostate cancer diagnosis to breast cancer diagnosis, death, or March 12, 2024, applying Cox proportional hazards and Fine-Gray competing risk methods, with a sensitivity analysis adding body mass index (BMI) after excluding 71,718 missing values.

TAKEAWAY:

• Metastatic prostate cancer at diagnosis more than doubled the risk for breast cancer compared to nonmetastatic disease (hazard ratio [HR], 2.03; 95% CI, 1.90-2.17; P < .0001; subdistribution hazard ratio [SHR], 1.68; 95% CI, 1.57-1.81; P < .0001).
• Younger age at prostate cancer diagnosis was associated with increased risk for breast cancer (HR, 0.97; 95% CI, 0.97-0.98; P < .0001; SHR, 0.957; 95% CI, 0.955-0.959; P < .0001), indicating that for each additional year of age at diagnosis, the risk decreased.
• Continuation of CVD medications after prostate cancer diagnosis was associated with increased risk for breast cancer: furosemide (HR, 1.51; 95% CI, 1.39-1.63; P < .0001; SHR, 1.21; 95% CI, 1.12-1.31; P < .0001), spironolactone (HR, 1.36; 95% CI, 1.15-1.61; P = .0004; SHR, 1.23; 95% CI, 1.04-1.47; P = .0174), and digoxin (HR, 1.49; 95% CI, 1.29-1.72; P < .0001; SHR, 1.26; 95% CI, 1.10-1.46; P = .0015).
• Radiation therapy and ADT were associated with increased risk for breast cancer (radiation: HR, 1.06; 95% CI, 1.02-1.11; P = .0088; SHR, 1.10; 95% CI, 1.05-1.15; P < .0001; ADT: HR, 1.24; 95% CI, 1.17-1.32; P < .0001; SHR, 1.28; 95% CI, 1.20-1.37; P < .0001), while abiraterone was associated with decreased risk (HR, 0.36; 95% CI, 0.31-0.42; P < .0001; SHR, 0.39; 95% CI, 0.34-0.45; P < .0001).

IN PRACTICE:

"While there is a lack of data, male veterans with previous prostate cancer are at an elevated risk of breast cancer (0.87%), than their civilian counterparts (0.14%),” the authors wrote. “To address the current gap in knowledge and data, this study leveraged an existing large cohort of male veterans with prostate cancer and examined factors associated with increased risk of male breast cancer."

SOURCE:

The study was led by Erum Z. Whyne, VA North Texas Health Care System in Dallas, and Haekyung Jeon-Slaughter, University of Texas Southwestern Medical Center in Dallas. It was published online in The Prostate.

LIMITATIONS:

Though the study findings are based on large, representative data from male veterans with previously diagnosed prostate cancer, the results might not be generalizable to the overall male breast cancer population. As a retrospective cohort study, results may be biased and causality is difficult to establish. The study did not examine other known risk factors for male breast cancer incidence, such as family history, BRCA2 mutations, and military environmental exposure due to lack of data. BMI had missingness of 5.46% (n = 71,718) and was not included as a covariate in the final model, though sensitivity analysis showed it was not significantly associated with increased risk for male breast cancer.

DISCLOSURES:

The research was supported using resources and facilities of the VA Informatics and Computing Infrastructure (VINCI), VA HSR RES 13-457. The VA North Texas Health Care System Institutional Review Board approved the study and waived informed consent. No 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.

TOPLINE:

Among 1.3 million male veterans treated for prostate cancer, 11,327 (0.86%) developed breast cancer an average of 5.4 years after initial diagnosis. Younger age at prostate cancer diagnosis, metastatic disease, androgen deprivation therapy (ADT), radiation treatment, and prolonged use of certain cardiovascular disease (CVD) medications were associated with increased risk for breast cancer.

METHODOLOGY:

• Researchers used a retrospective cohort design in Veterans Health Administration (VHA) care, pulling data from the Veterans Affairs (VA) Prostate Cancer Data Core at the VA Corporate Data Warehouse.
• Participants included 1,314,492 male veterans with prostate cancer treated at VHA facilities from January 1, 2000, to March 12, 2024.
• Exposure definitions included prostate cancer treatments (ADT, anti-androgen treatment, radiation-brachytherapy, and platinum chemotherapy) and CVD medications (furosemide, spironolactone, digoxin) captured via inpatient/outpatient/fee-based pharmacy and Current Procedural Terminology codes.
• Analysis measured time from prostate cancer diagnosis to breast cancer diagnosis, death, or March 12, 2024, applying Cox proportional hazards and Fine-Gray competing risk methods, with a sensitivity analysis adding body mass index (BMI) after excluding 71,718 missing values.

TAKEAWAY:

• Metastatic prostate cancer at diagnosis more than doubled the risk for breast cancer compared to nonmetastatic disease (hazard ratio [HR], 2.03; 95% CI, 1.90-2.17; P < .0001; subdistribution hazard ratio [SHR], 1.68; 95% CI, 1.57-1.81; P < .0001).
• Younger age at prostate cancer diagnosis was associated with increased risk for breast cancer (HR, 0.97; 95% CI, 0.97-0.98; P < .0001; SHR, 0.957; 95% CI, 0.955-0.959; P < .0001), indicating that for each additional year of age at diagnosis, the risk decreased.
• Continuation of CVD medications after prostate cancer diagnosis was associated with increased risk for breast cancer: furosemide (HR, 1.51; 95% CI, 1.39-1.63; P < .0001; SHR, 1.21; 95% CI, 1.12-1.31; P < .0001), spironolactone (HR, 1.36; 95% CI, 1.15-1.61; P = .0004; SHR, 1.23; 95% CI, 1.04-1.47; P = .0174), and digoxin (HR, 1.49; 95% CI, 1.29-1.72; P < .0001; SHR, 1.26; 95% CI, 1.10-1.46; P = .0015).
• Radiation therapy and ADT were associated with increased risk for breast cancer (radiation: HR, 1.06; 95% CI, 1.02-1.11; P = .0088; SHR, 1.10; 95% CI, 1.05-1.15; P < .0001; ADT: HR, 1.24; 95% CI, 1.17-1.32; P < .0001; SHR, 1.28; 95% CI, 1.20-1.37; P < .0001), while abiraterone was associated with decreased risk (HR, 0.36; 95% CI, 0.31-0.42; P < .0001; SHR, 0.39; 95% CI, 0.34-0.45; P < .0001).

IN PRACTICE:

"While there is a lack of data, male veterans with previous prostate cancer are at an elevated risk of breast cancer (0.87%), than their civilian counterparts (0.14%),” the authors wrote. “To address the current gap in knowledge and data, this study leveraged an existing large cohort of male veterans with prostate cancer and examined factors associated with increased risk of male breast cancer."

SOURCE:

The study was led by Erum Z. Whyne, VA North Texas Health Care System in Dallas, and Haekyung Jeon-Slaughter, University of Texas Southwestern Medical Center in Dallas. It was published online in The Prostate.

LIMITATIONS:

Though the study findings are based on large, representative data from male veterans with previously diagnosed prostate cancer, the results might not be generalizable to the overall male breast cancer population. As a retrospective cohort study, results may be biased and causality is difficult to establish. The study did not examine other known risk factors for male breast cancer incidence, such as family history, BRCA2 mutations, and military environmental exposure due to lack of data. BMI had missingness of 5.46% (n = 71,718) and was not included as a covariate in the final model, though sensitivity analysis showed it was not significantly associated with increased risk for male breast cancer.

DISCLOSURES:

The research was supported using resources and facilities of the VA Informatics and Computing Infrastructure (VINCI), VA HSR RES 13-457. The VA North Texas Health Care System Institutional Review Board approved the study and waived informed consent. No 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.

TOPLINE: Among Veterans Health Administration (VHA) patients experiencing homelessness, gaining housing is linked to higher 24-month colorectal (CRC) and breast cancer screening completion. In cohorts of 117,619 veterans eligible for colorectal screening and 6517 veterans eligible for breast cancer screening veterans, screening occurs in 36.1% and 47.9% after housing gain vs 18.8% and 23.7% if homelessness persists.

METHODOLOGY

• A retrospective cohort study examined all veterans experiencing homelessness who received care at the VHA from 2011 to 2021 and were eligible for but not up to date on CRC and breast cancer screening.

• 117,619 veterans experiencing homelessness were eligible for but not up to date on CRC screening (aged 50-75 years without prior cancer diagnosis, inflammatory bowel disease, or colectomy) and 6517 veterans experiencing homelessness were eligible for but not up to date on breast cancer screening (women aged 50-75 years without prior cancer diagnosis, lumpectomy, or mastectomy) were included at their index clinic visit.

• Exposure was defined as gaining housing within 24 months following index clinic visit, identified through the Homeless Screening Clinical Reminder, US Department of Veterans Affairs (VA) Homeless Operations, Management, and Evaluation System assessments, or US Department of Housing and Urban Development—VA Supportive Housing program move-in dates.

• Primary outcome were undergoing screening for CRC (colonoscopy, flexible sigmoidoscopy, computed tomography colonography, barium enema, or stool-based study) or breast cancer (mammogram) that was at a VHA facility or paid by VA within 24 months following index clinic visit.

TAKEAWAY

• Among veterans who gained housing, 36.1% underwent CRC screening and 47.9% underwent breast cancer screening during the 24-month observation period, compared with 18.8% and 23.7% of veterans, respectively, among those who remained homeless.

• Veterans who gained housing had 2.3 times the adjusted hazard ratio (aHR) of undergoing CRC screening compared with those who remained homeless (AHR, 2.3; 95% CI, 2.2-2.3; P < .001).

• Veterans who gained housing had 2.4 times the adjusted hazard of undergoing breast cancer screening compared with those who remained homeless (AHR, 2.4; 95% CI, 2.2-2.7; P < .001).

• Median (interquartile range [IQR]) time from index visit to cancer screening was 8 months (4-15) for CRC screening and 8 months (3-14) for breast cancer screening; median (IQR) time from gaining housing to screening was 4 months (1-9) and 3 months (1-8), respectively.

IN PRACTICE: Veterans experiencing homelessness who gain housing have higher rates of cancer screening. “This finding supports promotion of housing to improve health outcomes for homeless individuals," wrote the authors of the study.

SOURCE: The study was led by researchers at the University of California, San Francisco. It was published online in Annals of Family Medicine.

LIMITATIONS: Residual unmeasured confounding was likely due to the observational design of this study, because veterans able to navigate services to obtain housing may also be more likely to complete preventive care. Housing transitions may be misclassified because the Homeless Screening Clinical Reminder was not designed to track changes and may not be administered to veterans already identified as experiencing homelessness. The study did not capture data for screening completed outside VHA or that was not paid for by it. The study cohort only includes veterans with VHA contact, which may limit generalizability.

DISCLOSURES: Benioff Homelessness and Housing Initiative provided grant support for the work; Project Grant K24AG046372 was also awarded to Kushel for the study. Decker is a National Clinician Scholar with salary support from the US Department of Veterans Affairs and reported receiving personal fees from Moon Surgical. Kanzaria and Kushel are faculty members of the Benioff Homelessness and Housing Initiative; Kanzaria also reported advisory work for Amae Health. Kushel is listed as serving on boards including Housing California, National Homelessness Law Center, and Steinberg Institute; other authors reported no conflicts.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

TOPLINE: Among Veterans Health Administration (VHA) patients experiencing homelessness, gaining housing is linked to higher 24-month colorectal (CRC) and breast cancer screening completion. In cohorts of 117,619 veterans eligible for colorectal screening and 6517 veterans eligible for breast cancer screening veterans, screening occurs in 36.1% and 47.9% after housing gain vs 18.8% and 23.7% if homelessness persists.

METHODOLOGY

• A retrospective cohort study examined all veterans experiencing homelessness who received care at the VHA from 2011 to 2021 and were eligible for but not up to date on CRC and breast cancer screening.

• 117,619 veterans experiencing homelessness were eligible for but not up to date on CRC screening (aged 50-75 years without prior cancer diagnosis, inflammatory bowel disease, or colectomy) and 6517 veterans experiencing homelessness were eligible for but not up to date on breast cancer screening (women aged 50-75 years without prior cancer diagnosis, lumpectomy, or mastectomy) were included at their index clinic visit.

• Exposure was defined as gaining housing within 24 months following index clinic visit, identified through the Homeless Screening Clinical Reminder, US Department of Veterans Affairs (VA) Homeless Operations, Management, and Evaluation System assessments, or US Department of Housing and Urban Development—VA Supportive Housing program move-in dates.

• Primary outcome were undergoing screening for CRC (colonoscopy, flexible sigmoidoscopy, computed tomography colonography, barium enema, or stool-based study) or breast cancer (mammogram) that was at a VHA facility or paid by VA within 24 months following index clinic visit.

TAKEAWAY

• Among veterans who gained housing, 36.1% underwent CRC screening and 47.9% underwent breast cancer screening during the 24-month observation period, compared with 18.8% and 23.7% of veterans, respectively, among those who remained homeless.

• Veterans who gained housing had 2.3 times the adjusted hazard ratio (aHR) of undergoing CRC screening compared with those who remained homeless (AHR, 2.3; 95% CI, 2.2-2.3; P < .001).

• Veterans who gained housing had 2.4 times the adjusted hazard of undergoing breast cancer screening compared with those who remained homeless (AHR, 2.4; 95% CI, 2.2-2.7; P < .001).

• Median (interquartile range [IQR]) time from index visit to cancer screening was 8 months (4-15) for CRC screening and 8 months (3-14) for breast cancer screening; median (IQR) time from gaining housing to screening was 4 months (1-9) and 3 months (1-8), respectively.

IN PRACTICE: Veterans experiencing homelessness who gain housing have higher rates of cancer screening. “This finding supports promotion of housing to improve health outcomes for homeless individuals," wrote the authors of the study.

SOURCE: The study was led by researchers at the University of California, San Francisco. It was published online in Annals of Family Medicine.

LIMITATIONS: Residual unmeasured confounding was likely due to the observational design of this study, because veterans able to navigate services to obtain housing may also be more likely to complete preventive care. Housing transitions may be misclassified because the Homeless Screening Clinical Reminder was not designed to track changes and may not be administered to veterans already identified as experiencing homelessness. The study did not capture data for screening completed outside VHA or that was not paid for by it. The study cohort only includes veterans with VHA contact, which may limit generalizability.

DISCLOSURES: Benioff Homelessness and Housing Initiative provided grant support for the work; Project Grant K24AG046372 was also awarded to Kushel for the study. Decker is a National Clinician Scholar with salary support from the US Department of Veterans Affairs and reported receiving personal fees from Moon Surgical. Kanzaria and Kushel are faculty members of the Benioff Homelessness and Housing Initiative; Kanzaria also reported advisory work for Amae Health. Kushel is listed as serving on boards including Housing California, National Homelessness Law Center, and Steinberg Institute; other authors reported no conflicts.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

TOPLINE: Among Veterans Health Administration (VHA) patients experiencing homelessness, gaining housing is linked to higher 24-month colorectal (CRC) and breast cancer screening completion. In cohorts of 117,619 veterans eligible for colorectal screening and 6517 veterans eligible for breast cancer screening veterans, screening occurs in 36.1% and 47.9% after housing gain vs 18.8% and 23.7% if homelessness persists.

METHODOLOGY

• A retrospective cohort study examined all veterans experiencing homelessness who received care at the VHA from 2011 to 2021 and were eligible for but not up to date on CRC and breast cancer screening.

• 117,619 veterans experiencing homelessness were eligible for but not up to date on CRC screening (aged 50-75 years without prior cancer diagnosis, inflammatory bowel disease, or colectomy) and 6517 veterans experiencing homelessness were eligible for but not up to date on breast cancer screening (women aged 50-75 years without prior cancer diagnosis, lumpectomy, or mastectomy) were included at their index clinic visit.

• Exposure was defined as gaining housing within 24 months following index clinic visit, identified through the Homeless Screening Clinical Reminder, US Department of Veterans Affairs (VA) Homeless Operations, Management, and Evaluation System assessments, or US Department of Housing and Urban Development—VA Supportive Housing program move-in dates.

• Primary outcome were undergoing screening for CRC (colonoscopy, flexible sigmoidoscopy, computed tomography colonography, barium enema, or stool-based study) or breast cancer (mammogram) that was at a VHA facility or paid by VA within 24 months following index clinic visit.

TAKEAWAY

• Among veterans who gained housing, 36.1% underwent CRC screening and 47.9% underwent breast cancer screening during the 24-month observation period, compared with 18.8% and 23.7% of veterans, respectively, among those who remained homeless.

• Veterans who gained housing had 2.3 times the adjusted hazard ratio (aHR) of undergoing CRC screening compared with those who remained homeless (AHR, 2.3; 95% CI, 2.2-2.3; P < .001).

• Veterans who gained housing had 2.4 times the adjusted hazard of undergoing breast cancer screening compared with those who remained homeless (AHR, 2.4; 95% CI, 2.2-2.7; P < .001).

• Median (interquartile range [IQR]) time from index visit to cancer screening was 8 months (4-15) for CRC screening and 8 months (3-14) for breast cancer screening; median (IQR) time from gaining housing to screening was 4 months (1-9) and 3 months (1-8), respectively.

IN PRACTICE: Veterans experiencing homelessness who gain housing have higher rates of cancer screening. “This finding supports promotion of housing to improve health outcomes for homeless individuals," wrote the authors of the study.

SOURCE: The study was led by researchers at the University of California, San Francisco. It was published online in Annals of Family Medicine.

LIMITATIONS: Residual unmeasured confounding was likely due to the observational design of this study, because veterans able to navigate services to obtain housing may also be more likely to complete preventive care. Housing transitions may be misclassified because the Homeless Screening Clinical Reminder was not designed to track changes and may not be administered to veterans already identified as experiencing homelessness. The study did not capture data for screening completed outside VHA or that was not paid for by it. The study cohort only includes veterans with VHA contact, which may limit generalizability.

DISCLOSURES: Benioff Homelessness and Housing Initiative provided grant support for the work; Project Grant K24AG046372 was also awarded to Kushel for the study. Decker is a National Clinician Scholar with salary support from the US Department of Veterans Affairs and reported receiving personal fees from Moon Surgical. Kanzaria and Kushel are faculty members of the Benioff Homelessness and Housing Initiative; Kanzaria also reported advisory work for Amae Health. Kushel is listed as serving on boards including Housing California, National Homelessness Law Center, and Steinberg Institute; other authors reported no conflicts.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

Transcript generated from video captions.

Hello. I'm Dr Maurie Markman, from City of Hope. I'd like to discuss over the next few minutes an absolutely provocative — and I don't use that term loosely — report that I would humbly suggest may, or perhaps even should, change standard of practice in the care of patients with breast cancer. The paper was published in the Journal of the National Cancer Institute, entitled, “Aprepitant Use During Chemotherapy and Association With Survival in Women With Early Breast Cancer.”

This is a very complex, important, and provocative topic, and I'm only going to have a short time to summarize these results, but again, I would suggest this is a topic worthy of very serious consideration in terms of the implications.

Aprepitant, as many of you know, is a standard antiemetic that has been used for many years. It’s very effective and very well tolerated. There’s not any question about that. It’s a supportive-care medication that may be used or not used; a variety of drugs might be used in its place.

However, there are preclinical data —I cannot go into any kind of detail here—that have revealed that aprepitant in these preclinical settings will slow breast cancer growth and progression.

What we're looking at in this report is retrospective data linking a nationwide registry of 13,811 women diagnosed with early breast cancer between 2008 and 2020 in Norway. These are population-based data that were very well documented because that's how things work in Scandinavian countries in general, but in Norway in particular. They know what patients receive nationally, over time, and there's follow-up.

The point is that they had knowledge of the diagnoses and the therapy. These women that I'm referring to had received chemotherapy and antiemetics, which, of course, is standard of care and has been for decades. These women were followed for the development of metastatic disease and death from 1 year after diagnosis to the end of 2021, which was the duration of this particular report.

During this period of time, of these 13,811 women, 7047 were given aprepitant, which is, interestingly, 51% or about half of the population. Here's the bottom line: Aprepitant use resulted in superior distant disease-free survival, with a hazard ratio of 0.89, and breast cancer-specific survival, with a hazard ratio of 0.83.

Increasingly interesting, only nonluminal breast cancer had this demonstrated benefit, with a hazard ratio of 0.69. Again, that's a hazard ratio for metastatic disease or death of 0.69 if aprepitant was used. It was strongest in triple-negative breast cancer, with a hazard ratio of 0.66. Let me repeat that: a hazard ratio of 0.66 for the reduction in the risk of distant disease or death. This was a difference that was able to be documented with the use of aprepitant or not.

Finally, in this analysis, survival outcomes were not observed with any other class of antiemetics, only aprepitant. In the nonluminal breast cancer population, the longer duration of aprepitant use — presumably multiple cycles over time — was associated with increasingly favorable survival outcomes. This was a trend analysis, so the longer it was used, the more superior the outcomes.

I’m not surprised. To get this paper published in a high-impact journal, the authors had to conclude that clinical trials are required to confirm these findings. Really?

If you're a patient, a family member, or an oncologist caring for a woman with triple-negative breast cancer, you are going to wait for a phase 3, randomized trial to be conducted and reported maybe in 5 or 10 years? When you're talking about a drug that is widely used and is safe, you're going to make a decision to wait for the clinical trial before you conclude that aprepitant should be used in this setting, based upon these excellent data?

I would challenge that and ask, on average today, certainly in patients that I'm seeing or counseling, aprepitant should become a component of the standard of care unless there's a contraindication to the use of the drug, based upon these excellent registry and population-based data.

We don't have to wait for randomized phase 3 trials to answer every question if what we see here makes sense, based on a plausible biological explanation and well-analyzed data. Obviously, other databases can look at this and see if they come up with different answers, but we do not need to wait for a phase 3, randomized trial before we incorporate something that we believe the data support as having a favorable impact on the outcome of patients we are seeing today.

I thank you for your attention.

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

Transcript generated from video captions.

Hello. I'm Dr Maurie Markman, from City of Hope. I'd like to discuss over the next few minutes an absolutely provocative — and I don't use that term loosely — report that I would humbly suggest may, or perhaps even should, change standard of practice in the care of patients with breast cancer. The paper was published in the Journal of the National Cancer Institute, entitled, “Aprepitant Use During Chemotherapy and Association With Survival in Women With Early Breast Cancer.”

This is a very complex, important, and provocative topic, and I'm only going to have a short time to summarize these results, but again, I would suggest this is a topic worthy of very serious consideration in terms of the implications.

Aprepitant, as many of you know, is a standard antiemetic that has been used for many years. It’s very effective and very well tolerated. There’s not any question about that. It’s a supportive-care medication that may be used or not used; a variety of drugs might be used in its place.

However, there are preclinical data —I cannot go into any kind of detail here—that have revealed that aprepitant in these preclinical settings will slow breast cancer growth and progression.

What we're looking at in this report is retrospective data linking a nationwide registry of 13,811 women diagnosed with early breast cancer between 2008 and 2020 in Norway. These are population-based data that were very well documented because that's how things work in Scandinavian countries in general, but in Norway in particular. They know what patients receive nationally, over time, and there's follow-up.

The point is that they had knowledge of the diagnoses and the therapy. These women that I'm referring to had received chemotherapy and antiemetics, which, of course, is standard of care and has been for decades. These women were followed for the development of metastatic disease and death from 1 year after diagnosis to the end of 2021, which was the duration of this particular report.

During this period of time, of these 13,811 women, 7047 were given aprepitant, which is, interestingly, 51% or about half of the population. Here's the bottom line: Aprepitant use resulted in superior distant disease-free survival, with a hazard ratio of 0.89, and breast cancer-specific survival, with a hazard ratio of 0.83.

Increasingly interesting, only nonluminal breast cancer had this demonstrated benefit, with a hazard ratio of 0.69. Again, that's a hazard ratio for metastatic disease or death of 0.69 if aprepitant was used. It was strongest in triple-negative breast cancer, with a hazard ratio of 0.66. Let me repeat that: a hazard ratio of 0.66 for the reduction in the risk of distant disease or death. This was a difference that was able to be documented with the use of aprepitant or not.

Finally, in this analysis, survival outcomes were not observed with any other class of antiemetics, only aprepitant. In the nonluminal breast cancer population, the longer duration of aprepitant use — presumably multiple cycles over time — was associated with increasingly favorable survival outcomes. This was a trend analysis, so the longer it was used, the more superior the outcomes.

I’m not surprised. To get this paper published in a high-impact journal, the authors had to conclude that clinical trials are required to confirm these findings. Really?

If you're a patient, a family member, or an oncologist caring for a woman with triple-negative breast cancer, you are going to wait for a phase 3, randomized trial to be conducted and reported maybe in 5 or 10 years? When you're talking about a drug that is widely used and is safe, you're going to make a decision to wait for the clinical trial before you conclude that aprepitant should be used in this setting, based upon these excellent data?

I would challenge that and ask, on average today, certainly in patients that I'm seeing or counseling, aprepitant should become a component of the standard of care unless there's a contraindication to the use of the drug, based upon these excellent registry and population-based data.

We don't have to wait for randomized phase 3 trials to answer every question if what we see here makes sense, based on a plausible biological explanation and well-analyzed data. Obviously, other databases can look at this and see if they come up with different answers, but we do not need to wait for a phase 3, randomized trial before we incorporate something that we believe the data support as having a favorable impact on the outcome of patients we are seeing today.

I thank you for your attention.

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

Transcript generated from video captions.

Hello. I'm Dr Maurie Markman, from City of Hope. I'd like to discuss over the next few minutes an absolutely provocative — and I don't use that term loosely — report that I would humbly suggest may, or perhaps even should, change standard of practice in the care of patients with breast cancer. The paper was published in the Journal of the National Cancer Institute, entitled, “Aprepitant Use During Chemotherapy and Association With Survival in Women With Early Breast Cancer.”

This is a very complex, important, and provocative topic, and I'm only going to have a short time to summarize these results, but again, I would suggest this is a topic worthy of very serious consideration in terms of the implications.

Aprepitant, as many of you know, is a standard antiemetic that has been used for many years. It’s very effective and very well tolerated. There’s not any question about that. It’s a supportive-care medication that may be used or not used; a variety of drugs might be used in its place.

However, there are preclinical data —I cannot go into any kind of detail here—that have revealed that aprepitant in these preclinical settings will slow breast cancer growth and progression.

What we're looking at in this report is retrospective data linking a nationwide registry of 13,811 women diagnosed with early breast cancer between 2008 and 2020 in Norway. These are population-based data that were very well documented because that's how things work in Scandinavian countries in general, but in Norway in particular. They know what patients receive nationally, over time, and there's follow-up.

The point is that they had knowledge of the diagnoses and the therapy. These women that I'm referring to had received chemotherapy and antiemetics, which, of course, is standard of care and has been for decades. These women were followed for the development of metastatic disease and death from 1 year after diagnosis to the end of 2021, which was the duration of this particular report.

During this period of time, of these 13,811 women, 7047 were given aprepitant, which is, interestingly, 51% or about half of the population. Here's the bottom line: Aprepitant use resulted in superior distant disease-free survival, with a hazard ratio of 0.89, and breast cancer-specific survival, with a hazard ratio of 0.83.

Increasingly interesting, only nonluminal breast cancer had this demonstrated benefit, with a hazard ratio of 0.69. Again, that's a hazard ratio for metastatic disease or death of 0.69 if aprepitant was used. It was strongest in triple-negative breast cancer, with a hazard ratio of 0.66. Let me repeat that: a hazard ratio of 0.66 for the reduction in the risk of distant disease or death. This was a difference that was able to be documented with the use of aprepitant or not.

Finally, in this analysis, survival outcomes were not observed with any other class of antiemetics, only aprepitant. In the nonluminal breast cancer population, the longer duration of aprepitant use — presumably multiple cycles over time — was associated with increasingly favorable survival outcomes. This was a trend analysis, so the longer it was used, the more superior the outcomes.

I’m not surprised. To get this paper published in a high-impact journal, the authors had to conclude that clinical trials are required to confirm these findings. Really?

If you're a patient, a family member, or an oncologist caring for a woman with triple-negative breast cancer, you are going to wait for a phase 3, randomized trial to be conducted and reported maybe in 5 or 10 years? When you're talking about a drug that is widely used and is safe, you're going to make a decision to wait for the clinical trial before you conclude that aprepitant should be used in this setting, based upon these excellent data?

I would challenge that and ask, on average today, certainly in patients that I'm seeing or counseling, aprepitant should become a component of the standard of care unless there's a contraindication to the use of the drug, based upon these excellent registry and population-based data.

We don't have to wait for randomized phase 3 trials to answer every question if what we see here makes sense, based on a plausible biological explanation and well-analyzed data. Obviously, other databases can look at this and see if they come up with different answers, but we do not need to wait for a phase 3, randomized trial before we incorporate something that we believe the data support as having a favorable impact on the outcome of patients we are seeing today.

I thank you for your attention.

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

TOPLINE:

New research examining recreational physical activity’s relationship with breast tissue composition, oxidative stress, and inflammation in adolescent girls revealed potential pathways for cancer risk reduction.

METHODOLOGY:

• Recent research shows 12-22% lower risk for breast cancer among highly active women, but the biological mechanisms explaining this remain unclear. Breast tissue composition, particularly mammographic density, is one of the strongest predictors of breast cancer risk, and breast tissue composition tracks across the life course.
• Researchers analyzed data from a population-based urban cohort of 191 Black/African American and Hispanic (Dominican) adolescent girls aged 11-20 years.
• Participants reported organized and unorganized recreational physical activity in the past week, categorized as none, < 2 hours, or ≥ 2 hours.
• Optical spectroscopy measured breast tissue composition through chromophores that are positively (percent water content and percent collagen content) or negatively (percent lipid content) correlated with mammographic breast density.
• Analysis included urinary concentrations of 15-F2-isoprostane for oxidative stress and blood biomarkers of inflammation including TNF-alpha, interleukin-6, and high-sensitivity C-reactive protein.

TAKEAWAY:

• Fifty-one percent of adolescent girls reported no past-week engagement in any type of recreational physical activity, with 73% reporting no participation in organized activities and 66% reporting no participation in unorganized activities.
• Girls engaging in at least 2 hours of organized recreational physical activity vs none showed lower percent water content in breast tissue (beta coefficient, -0.41; 95% CI, -0.77 to -0.05) and lower urinary concentrations of 15-F2-isoprostane (beta coefficient, -0.50; 95% CI, -0.95 to -0.05).
• Higher urinary concentrations of 15-F2-isoprostane were associated with higher percent collagen content in breast tissue (beta coefficient, 0.15; 95% CI, 0.00-0.31).
• No associations were found between recreational physical activity and inflammatory biomarkers, and these biomarkers showed no association with breast tissue composition after adjusting for percent body fat.

IN PRACTICE:

“These findings support that recreational physical activity is associated with breast tissue composition and oxidative stress in adolescent girls, independent of body fat. Additional longitudinal research is needed to understand the implications of these findings regarding subsequent breast cancer risk,” the authors of the study wrote.

SOURCE:

The study was led by Rebecca D. Kehm, PhD, Department of Epidemiology, Mailman School of Public Health, Columbia University, New York City. It was published online in Breast Cancer Research.

LIMITATIONS:

Recreational physical activity was assessed using self-reported data capturing only a 1-week timeframe, which may not fully reflect habitual patterns and is susceptible to measurement error. The cross-sectional nature of the analysis prevented establishing temporal relationships or causal inferences. The relatively small sample size limited statistical power, though researchers were able to detect modest associations. The findings may not be generalizable to populations with different demographics or higher levels of physical activity because recreational physical activity was notably low in this cohort. Additionally, while several validated biomarkers were examined, other mechanisms such as hormonal regulation and insulin sensitivity may also be important for understanding the relationship between adolescent physical activity and breast cancer risk.

DISCLOSURES:

The study received support from the National Institute of Environmental Health Sciences through grants U01ES026122 and P30ES009089, as well as grant ROICA263024 from the National Cancer Institute.

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:

New research examining recreational physical activity’s relationship with breast tissue composition, oxidative stress, and inflammation in adolescent girls revealed potential pathways for cancer risk reduction.

METHODOLOGY:

• Recent research shows 12-22% lower risk for breast cancer among highly active women, but the biological mechanisms explaining this remain unclear. Breast tissue composition, particularly mammographic density, is one of the strongest predictors of breast cancer risk, and breast tissue composition tracks across the life course.
• Researchers analyzed data from a population-based urban cohort of 191 Black/African American and Hispanic (Dominican) adolescent girls aged 11-20 years.
• Participants reported organized and unorganized recreational physical activity in the past week, categorized as none, < 2 hours, or ≥ 2 hours.
• Optical spectroscopy measured breast tissue composition through chromophores that are positively (percent water content and percent collagen content) or negatively (percent lipid content) correlated with mammographic breast density.
• Analysis included urinary concentrations of 15-F2-isoprostane for oxidative stress and blood biomarkers of inflammation including TNF-alpha, interleukin-6, and high-sensitivity C-reactive protein.

TAKEAWAY:

• Fifty-one percent of adolescent girls reported no past-week engagement in any type of recreational physical activity, with 73% reporting no participation in organized activities and 66% reporting no participation in unorganized activities.
• Girls engaging in at least 2 hours of organized recreational physical activity vs none showed lower percent water content in breast tissue (beta coefficient, -0.41; 95% CI, -0.77 to -0.05) and lower urinary concentrations of 15-F2-isoprostane (beta coefficient, -0.50; 95% CI, -0.95 to -0.05).
• Higher urinary concentrations of 15-F2-isoprostane were associated with higher percent collagen content in breast tissue (beta coefficient, 0.15; 95% CI, 0.00-0.31).
• No associations were found between recreational physical activity and inflammatory biomarkers, and these biomarkers showed no association with breast tissue composition after adjusting for percent body fat.

IN PRACTICE:

“These findings support that recreational physical activity is associated with breast tissue composition and oxidative stress in adolescent girls, independent of body fat. Additional longitudinal research is needed to understand the implications of these findings regarding subsequent breast cancer risk,” the authors of the study wrote.

SOURCE:

The study was led by Rebecca D. Kehm, PhD, Department of Epidemiology, Mailman School of Public Health, Columbia University, New York City. It was published online in Breast Cancer Research.

LIMITATIONS:

Recreational physical activity was assessed using self-reported data capturing only a 1-week timeframe, which may not fully reflect habitual patterns and is susceptible to measurement error. The cross-sectional nature of the analysis prevented establishing temporal relationships or causal inferences. The relatively small sample size limited statistical power, though researchers were able to detect modest associations. The findings may not be generalizable to populations with different demographics or higher levels of physical activity because recreational physical activity was notably low in this cohort. Additionally, while several validated biomarkers were examined, other mechanisms such as hormonal regulation and insulin sensitivity may also be important for understanding the relationship between adolescent physical activity and breast cancer risk.

DISCLOSURES:

The study received support from the National Institute of Environmental Health Sciences through grants U01ES026122 and P30ES009089, as well as grant ROICA263024 from the National Cancer Institute.

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:

New research examining recreational physical activity’s relationship with breast tissue composition, oxidative stress, and inflammation in adolescent girls revealed potential pathways for cancer risk reduction.

METHODOLOGY:

• Recent research shows 12-22% lower risk for breast cancer among highly active women, but the biological mechanisms explaining this remain unclear. Breast tissue composition, particularly mammographic density, is one of the strongest predictors of breast cancer risk, and breast tissue composition tracks across the life course.
• Researchers analyzed data from a population-based urban cohort of 191 Black/African American and Hispanic (Dominican) adolescent girls aged 11-20 years.
• Participants reported organized and unorganized recreational physical activity in the past week, categorized as none, < 2 hours, or ≥ 2 hours.
• Optical spectroscopy measured breast tissue composition through chromophores that are positively (percent water content and percent collagen content) or negatively (percent lipid content) correlated with mammographic breast density.
• Analysis included urinary concentrations of 15-F2-isoprostane for oxidative stress and blood biomarkers of inflammation including TNF-alpha, interleukin-6, and high-sensitivity C-reactive protein.

TAKEAWAY:

• Fifty-one percent of adolescent girls reported no past-week engagement in any type of recreational physical activity, with 73% reporting no participation in organized activities and 66% reporting no participation in unorganized activities.
• Girls engaging in at least 2 hours of organized recreational physical activity vs none showed lower percent water content in breast tissue (beta coefficient, -0.41; 95% CI, -0.77 to -0.05) and lower urinary concentrations of 15-F2-isoprostane (beta coefficient, -0.50; 95% CI, -0.95 to -0.05).
• Higher urinary concentrations of 15-F2-isoprostane were associated with higher percent collagen content in breast tissue (beta coefficient, 0.15; 95% CI, 0.00-0.31).
• No associations were found between recreational physical activity and inflammatory biomarkers, and these biomarkers showed no association with breast tissue composition after adjusting for percent body fat.

IN PRACTICE:

“These findings support that recreational physical activity is associated with breast tissue composition and oxidative stress in adolescent girls, independent of body fat. Additional longitudinal research is needed to understand the implications of these findings regarding subsequent breast cancer risk,” the authors of the study wrote.

SOURCE:

The study was led by Rebecca D. Kehm, PhD, Department of Epidemiology, Mailman School of Public Health, Columbia University, New York City. It was published online in Breast Cancer Research.

LIMITATIONS:

Recreational physical activity was assessed using self-reported data capturing only a 1-week timeframe, which may not fully reflect habitual patterns and is susceptible to measurement error. The cross-sectional nature of the analysis prevented establishing temporal relationships or causal inferences. The relatively small sample size limited statistical power, though researchers were able to detect modest associations. The findings may not be generalizable to populations with different demographics or higher levels of physical activity because recreational physical activity was notably low in this cohort. Additionally, while several validated biomarkers were examined, other mechanisms such as hormonal regulation and insulin sensitivity may also be important for understanding the relationship between adolescent physical activity and breast cancer risk.

DISCLOSURES:

The study received support from the National Institute of Environmental Health Sciences through grants U01ES026122 and P30ES009089, as well as grant ROICA263024 from the National Cancer Institute.

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.

Male veterans with breast cancer may have a more difficult time receiving appropriate health care due to a recently revised US Department of Veterans Affairs (VA) policy that requires each individual to prove the disease’s connection to their service to qualify for coverage. 

According to a VA memo obtained by ProPublica, the change is based on a Jan. 1 presidential order titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” VA Press Secretary Pete Kasperowicz told ProPublica that the policy was changed because the previous policy “falsely classified male breasts as reproductive organs.” 

In 2024, the VA added male breast cancer (along with urethral cancer and cancer of the paraurethral glands) to its list of presumed service-connected disabilities due to military environmental exposure, such as toxic burn pits. Male breast cancer was added to the category of “reproductive cancer of any type” after experts pointed to the similarity of male and female breast cancers.

Establishing a connection between a variety of cancers and military service has been a years-long fight only resolved recently in the form of the 2022 PACT Act. The VA lists > 20 medical conditions as “presumptive” for service connection, with some caveats, such as area of service. The act reduced the burden of proof needed: The terms “presumptive conditions” and “presumptive-exposure locations” mean veterans only have to provide their military records to show they were in an exposure location to have their care for certain conditions covered. 

Supporters of the PACT Act say the policy change could make it harder for veterans to receive timely care, a serious issue for men with breast cancer who have been “severely underrepresented” in clinical studies and many studies specifically exclude males. The American Cancer Society estimates about 2800 men have been or will be diagnosed with invasive breast cancer in 2025. Less than 1% of breast cancers in the US occur in men, but breast cancer is notably higher among veterans: 11% of 3304 veterans, according to a 2023 study. 

Breast cancer is more aggressive in men—they’re more often diagnosed at Stage IV and tend to be older—and survival rates have been lower than in women. In a 2019 study of 16,025 male and 1,800,708 female patients with breast cancer, men had 19% higher overall mortality.

Treatment for male breast cancer has lagged. A 2021 study found men were less likely than women to receive radiation therapy. However, that’s changing. Since that study, however, the American Cancer Society claims treatments and survival rates have improved. According to the Surveillance, Epidemiology, and End Results database, 5-year survival rates are 97% for localized, 86% for regional, and 31% for distant; 84% for all stages combined.

Screening and treatment have focused on women. But the VA Breast and Gynecologic Oncology System of Excellence (BGSoE) provides cancer care for all veterans diagnosed with breast malignancies. Male veterans with breast cancer do face additional challenges in addressing a cancer that is most often associated with females. “I must admit, it was awkward every time I went [to the Women’s Health Center for postmastectomy follow-ups]” William K. Lewis, described in his patient perspective on male breast cancer treatment in the VA.

Though the policy has changed, Kasperowicz told ProPublica that veterans who previously qualified for coverage can keep it: “The department grants disability benefits compensation claims for male Veterans with breast cancer on an individual basis and will continue to do so. VA encourages any male Veterans with breast cancer who feel their health may have been impacted by their military service to submit a disability compensation claim.”

Male veterans with breast cancer may have a more difficult time receiving appropriate health care due to a recently revised US Department of Veterans Affairs (VA) policy that requires each individual to prove the disease’s connection to their service to qualify for coverage. 

According to a VA memo obtained by ProPublica, the change is based on a Jan. 1 presidential order titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” VA Press Secretary Pete Kasperowicz told ProPublica that the policy was changed because the previous policy “falsely classified male breasts as reproductive organs.” 

In 2024, the VA added male breast cancer (along with urethral cancer and cancer of the paraurethral glands) to its list of presumed service-connected disabilities due to military environmental exposure, such as toxic burn pits. Male breast cancer was added to the category of “reproductive cancer of any type” after experts pointed to the similarity of male and female breast cancers.

Establishing a connection between a variety of cancers and military service has been a years-long fight only resolved recently in the form of the 2022 PACT Act. The VA lists > 20 medical conditions as “presumptive” for service connection, with some caveats, such as area of service. The act reduced the burden of proof needed: The terms “presumptive conditions” and “presumptive-exposure locations” mean veterans only have to provide their military records to show they were in an exposure location to have their care for certain conditions covered. 

Supporters of the PACT Act say the policy change could make it harder for veterans to receive timely care, a serious issue for men with breast cancer who have been “severely underrepresented” in clinical studies and many studies specifically exclude males. The American Cancer Society estimates about 2800 men have been or will be diagnosed with invasive breast cancer in 2025. Less than 1% of breast cancers in the US occur in men, but breast cancer is notably higher among veterans: 11% of 3304 veterans, according to a 2023 study. 

Breast cancer is more aggressive in men—they’re more often diagnosed at Stage IV and tend to be older—and survival rates have been lower than in women. In a 2019 study of 16,025 male and 1,800,708 female patients with breast cancer, men had 19% higher overall mortality.

Treatment for male breast cancer has lagged. A 2021 study found men were less likely than women to receive radiation therapy. However, that’s changing. Since that study, however, the American Cancer Society claims treatments and survival rates have improved. According to the Surveillance, Epidemiology, and End Results database, 5-year survival rates are 97% for localized, 86% for regional, and 31% for distant; 84% for all stages combined.

Screening and treatment have focused on women. But the VA Breast and Gynecologic Oncology System of Excellence (BGSoE) provides cancer care for all veterans diagnosed with breast malignancies. Male veterans with breast cancer do face additional challenges in addressing a cancer that is most often associated with females. “I must admit, it was awkward every time I went [to the Women’s Health Center for postmastectomy follow-ups]” William K. Lewis, described in his patient perspective on male breast cancer treatment in the VA.

Though the policy has changed, Kasperowicz told ProPublica that veterans who previously qualified for coverage can keep it: “The department grants disability benefits compensation claims for male Veterans with breast cancer on an individual basis and will continue to do so. VA encourages any male Veterans with breast cancer who feel their health may have been impacted by their military service to submit a disability compensation claim.”

Male veterans with breast cancer may have a more difficult time receiving appropriate health care due to a recently revised US Department of Veterans Affairs (VA) policy that requires each individual to prove the disease’s connection to their service to qualify for coverage. 

According to a VA memo obtained by ProPublica, the change is based on a Jan. 1 presidential order titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” VA Press Secretary Pete Kasperowicz told ProPublica that the policy was changed because the previous policy “falsely classified male breasts as reproductive organs.” 

In 2024, the VA added male breast cancer (along with urethral cancer and cancer of the paraurethral glands) to its list of presumed service-connected disabilities due to military environmental exposure, such as toxic burn pits. Male breast cancer was added to the category of “reproductive cancer of any type” after experts pointed to the similarity of male and female breast cancers.

Establishing a connection between a variety of cancers and military service has been a years-long fight only resolved recently in the form of the 2022 PACT Act. The VA lists > 20 medical conditions as “presumptive” for service connection, with some caveats, such as area of service. The act reduced the burden of proof needed: The terms “presumptive conditions” and “presumptive-exposure locations” mean veterans only have to provide their military records to show they were in an exposure location to have their care for certain conditions covered. 

Supporters of the PACT Act say the policy change could make it harder for veterans to receive timely care, a serious issue for men with breast cancer who have been “severely underrepresented” in clinical studies and many studies specifically exclude males. The American Cancer Society estimates about 2800 men have been or will be diagnosed with invasive breast cancer in 2025. Less than 1% of breast cancers in the US occur in men, but breast cancer is notably higher among veterans: 11% of 3304 veterans, according to a 2023 study. 

Breast cancer is more aggressive in men—they’re more often diagnosed at Stage IV and tend to be older—and survival rates have been lower than in women. In a 2019 study of 16,025 male and 1,800,708 female patients with breast cancer, men had 19% higher overall mortality.

Treatment for male breast cancer has lagged. A 2021 study found men were less likely than women to receive radiation therapy. However, that’s changing. Since that study, however, the American Cancer Society claims treatments and survival rates have improved. According to the Surveillance, Epidemiology, and End Results database, 5-year survival rates are 97% for localized, 86% for regional, and 31% for distant; 84% for all stages combined.

Screening and treatment have focused on women. But the VA Breast and Gynecologic Oncology System of Excellence (BGSoE) provides cancer care for all veterans diagnosed with breast malignancies. Male veterans with breast cancer do face additional challenges in addressing a cancer that is most often associated with females. “I must admit, it was awkward every time I went [to the Women’s Health Center for postmastectomy follow-ups]” William K. Lewis, described in his patient perspective on male breast cancer treatment in the VA.

Though the policy has changed, Kasperowicz told ProPublica that veterans who previously qualified for coverage can keep it: “The department grants disability benefits compensation claims for male Veterans with breast cancer on an individual basis and will continue to do so. VA encourages any male Veterans with breast cancer who feel their health may have been impacted by their military service to submit a disability compensation claim.”

BERLIN — Patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) who are not candidates for immunotherapy may experience improved survival outcomes with TROP2-directed antibody-drug conjugates (ADCs), suggested two trials presented at European Society for Medical Oncology (ESMO) Annual Meeting 2025 on October 19.

ASCENT-03 compared sacituzumab govitecan with standard of care chemotherapy, finding that the drug was associated with a 38% improvement in progression-free survival (PFS) in this patient population that has, traditionally, a poor prognosis. Overall survival data remain immature.

TROPION-Breast02 studied datopotamab deruxtecan (Dato-DXd) against investigator’s choice of chemotherapy. The PFS improvement with the ADC was 43%, while patients also experienced a 21% improvement in overall survival. In both cases, the safety profile of the experimental drugs was deemed to be manageable.

Discussant Ana C. Garrido-Castro, MD, director, Triple-Negative Breast Cancer Research, Dana-Farber Cancer Institute, Boston, who was not involved in either study, said that both sacituzumab govitecan and Dato-DXd showed a PFS benefit. The choice between them, leaving aside overall survival until the data are mature, will be largely based on factors such as the safety profile and the patient preference, she continued.

Sacituzumab govitecan is associated with an increase in neutropenia, nausea, and diarrhea, she pointed out, while Dato-DXd has increased rates of ocular surface toxicity, oral mucositis/stomatitis, and requires monitoring for interstitial lung disease.

Dato-DXd has a higher objective response rate than chemotherapy, unlike sacituzumab govitecan, but, crucially, requires one infusion vs 2 for sacituzumab govitecan per 21-day cycle, and has a shorter total infusion time.

There are nevertheless a number of unanswered questions about the drugs, including how the ADCs affect quality of life, and how common patient adherence to the recommended prophylaxis is. Patients with early relapse of < 12 months remain an “urgent unmet need,” Garrido-Castro said, and the role of immunotherapy rechallenge remains to be explored.

ADCs are also being tested in the neo-adjuvant TNBC setting, and the potential impact of that on the use of the drugs in the metastatic setting is currently unclear. In addition, there are questions around access to therapy.

“Ultimately, it will be very important to have a better understanding of the biomarkers of response and resistance and toxicity to these agents, and whether we should be sequencing antibody drug conjugates,” Garrido-Castro said. “All of this will help shape the next wave of treatment strategies for this patient population.”

She concluded: “Today, marks a paradigm shift of metastatic TNBC, in my opinion. ASCENT-03 and TROPION-Breast02 support TROP2 ADC therapy as the new preferred first-line regimen for this patient population.”

 

Method and Results of ASCENT-03

ASCENT-03 study presenter Javier C. Cortés, MD, PhD, International Breast Cancer Center, Pangaea Oncology, Quiron Group, Barcelona, Spain, said there is currently an unmet clinical need in the approximately 60% of patients with previously untreated metastatic TNBC who are not candidates for immune checkpoint inhibitors.

Median PFS in previous first-line studies was < 6 months with chemotherapy — the current standard of care — and Cortés said that around half of the patients who receive that in the first-line do not receive second-line therapy because of clinical deterioration or death.

“The sobering truth is that across studies in the US and Europe, approximately 25% to 30% of patients diagnosed with metastatic TNBC are no longer alive at 6 months from their metastatic diagnosis,” said Garrido-Castro. “So if there is a new drug that is able to significantly improve PFS with an acceptable toxicity profile, this should be sufficient to change the current standard of care in the first-line setting.”

As sacituzumab govitecan is already approved for second-line metastatic TNBC and for pretreated hormone receptor positive/HER2- metastatic breast cancer, the ASCENT-03 researchers studied the drug in patients with previously untreated locally advanced inoperable, or metastatic TNBC.

The patients were deemed not to be candidates for PD-L1 inhibitors through having PD-L1-negative tumors, by having PD-L1-positive tumors that had previously been treated with PD-L1 inhibitors in the curative setting, or by having a comorbidity that precluded PD-L1 inhibitor use.

The patients were required to have finished any prior treatment in the curative setting at least 6 months previously. Previously treated, stable central nervous system metastases were allowed.

They were randomized to sacituzumab govitecan or chemotherapy, comprising paclitaxel or nab-paclitaxel, or gemcitabine plus carboplatin, until progression, as verified by blinded independent central review (BICR), or unacceptable toxicity. Patients who progressed on chemotherapy were offered crossover to second-line sacituzumab govitecan.

In all, 558 patients were randomized. The median age was 56 years in the sacituzumab govitecan group vs 54 years in the chemotherapy group. The majority (64% in both groups) of patients were White individuals. The most common metastatic site was the lung (59% vs 61%), and 58% of patients in both groups had previously received a taxane.

Cortés reported that sacituzumab govitecan was associated with a “statistically significant and clinically meaningful” improvement in PFS by BICR, at a median of 9.7 months vs 6.9 months, or a hazard ratio (HR) of 0.62 (P < .0001). This benefit was seen across prespecified subgroups.

The objective response rate was almost identical between the two treatment groups, at 48% with sacituzumab govitecan vs 46% with chemotherapy, although the median duration of response was longer with the ADC, at 12.2 months vs 7.2 months.

Cortés showed the latest results on overall survival. This showed no significant difference between the two treatments, although he underlined that the data are not yet mature.

He also reported that the rates of grade ≥ 3 treatment-emergent adverse events (TEAEs) were similar in the two groups, at 66% with sacituzumab govitecan vs 62% with chemotherapy. However, the rates of TEAEs leading to treatment discontinuation (4% vs 12%) or dose reduction (37% vs 45%) were lower with the ADC.

Cortés concluded that the results suggest that sacituzumab govitecan “is a good option for patients with triple negative breast cancer when they develop metastasis and are unable to receive immune checkpoint inhibitors.”

 

TROPION-Breast02 Methods and Results

Presenting TROPION-Breast02, Rebecca A. Dent, MD, MSc, National Cancer Center Singapore and Duke-NUS Medical School, Singapore, explained that the trial looked at a patient population similar to that of ASCENT-03, here focusing instead on Dato-DXd.

Patients were included if they had histologically or cytologically documented locally recurrent inoperable or metastatic TNBC, no prior chemotherapy or targeted systemic therapy in this setting, and in whom immunotherapy was not an option.

They were randomized to Dato-DXd or the investigator’s choice of chemotherapy, with treatment continued until investigator-assessed progressive disease on RECIST v1.1, unacceptable toxicity, or another criterion for discontinuation was met.

In total, 642 patients were enrolled. The median age was 56 years for those in the Dato-DXd group and 57 years for those in chemotherapy group, and less than half (41% in the Dato-DXd group and 48% in the chemotherapy group) were White individuals. The number of metastatic sites was less than three in 64% and 67% of patients, respectively.

Dent showed that Dato-DXd was associated with a statistically significant and clinically meaningful improvement in BICR-assessed PFS, at a median of 10.8 months vs 5.6 months with chemotherapy, at a HR of 0.57 (P < .0001). The findings were replicated across the prespecified subgroups.

There was a marked overall survival benefit with Dato-DXd, at a median of 23.7 months vs 18.7 months, at a HR of 0.79 (P = .0291). Dent reported that, at 18 months, 61.2% of patients in the Dato-DXd group were still alive vs 51.3% in the chemotherapy group. Again, the benefit was seen across subgroups.

The confirmed objective response rate with Dato-DXd was far higher than that with chemotherapy, at 62.5% vs 29.3%, or an odds ratio of 4.24. The duration of response was also longer, at 12.3 months vs 7.1 months.

Rates of grade ≥ 3 adverse events were comparable, at 33% with Dato-DXd vs 29% with chemotherapy, although there were more events associated with dose reduction (27% vs 18%) and dose interruption (24% vs 19%) with the ADC.

“These results support Dato-DXd as the first new first-line standard of care for patients with locally recurrent inoperable or metastatic TNBC for whom immunotherapy is not an option,” Dent said.

“What’s important is the patients enrolled into this trial are clearly representative of real world patients that we are treating in our clinics every day. These patients are often excluded from our current clinical trials,” she said.

ASCENT-03 was funded by Gilead Sciences.

TROPION-Breast02 was funded by AstraZeneca.Cortés declared relationships with Roche, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Lilly, Merck Sharpe & Dohme, Leuko, Bioasis, Clovis oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies, Jazz Pharmaceuticals, AbbVie, Scorpion Therapeutics, Bridgebio, Biocon, Biontech, Circle Pharma, Delcath Systems, Hexagon Bio, Novartis, Eisai, Pfizer, Stemline Therapeutics, MAJ3 Capital, Leuko, Ariad Pharmaceuticals, Baxalta GmbH/Servier Affaires, Bayer healthcare, Guardant Health, and PIQUR Therapeutics.

Dent declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, and Gilead Sciences.

Garrido-Castro declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, Gilead Sciences, Pfizer, TD Cowen, and Roche/Genentech.

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

BERLIN — Patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) who are not candidates for immunotherapy may experience improved survival outcomes with TROP2-directed antibody-drug conjugates (ADCs), suggested two trials presented at European Society for Medical Oncology (ESMO) Annual Meeting 2025 on October 19.

ASCENT-03 compared sacituzumab govitecan with standard of care chemotherapy, finding that the drug was associated with a 38% improvement in progression-free survival (PFS) in this patient population that has, traditionally, a poor prognosis. Overall survival data remain immature.

TROPION-Breast02 studied datopotamab deruxtecan (Dato-DXd) against investigator’s choice of chemotherapy. The PFS improvement with the ADC was 43%, while patients also experienced a 21% improvement in overall survival. In both cases, the safety profile of the experimental drugs was deemed to be manageable.

Discussant Ana C. Garrido-Castro, MD, director, Triple-Negative Breast Cancer Research, Dana-Farber Cancer Institute, Boston, who was not involved in either study, said that both sacituzumab govitecan and Dato-DXd showed a PFS benefit. The choice between them, leaving aside overall survival until the data are mature, will be largely based on factors such as the safety profile and the patient preference, she continued.

Sacituzumab govitecan is associated with an increase in neutropenia, nausea, and diarrhea, she pointed out, while Dato-DXd has increased rates of ocular surface toxicity, oral mucositis/stomatitis, and requires monitoring for interstitial lung disease.

Dato-DXd has a higher objective response rate than chemotherapy, unlike sacituzumab govitecan, but, crucially, requires one infusion vs 2 for sacituzumab govitecan per 21-day cycle, and has a shorter total infusion time.

There are nevertheless a number of unanswered questions about the drugs, including how the ADCs affect quality of life, and how common patient adherence to the recommended prophylaxis is. Patients with early relapse of < 12 months remain an “urgent unmet need,” Garrido-Castro said, and the role of immunotherapy rechallenge remains to be explored.

ADCs are also being tested in the neo-adjuvant TNBC setting, and the potential impact of that on the use of the drugs in the metastatic setting is currently unclear. In addition, there are questions around access to therapy.

“Ultimately, it will be very important to have a better understanding of the biomarkers of response and resistance and toxicity to these agents, and whether we should be sequencing antibody drug conjugates,” Garrido-Castro said. “All of this will help shape the next wave of treatment strategies for this patient population.”

She concluded: “Today, marks a paradigm shift of metastatic TNBC, in my opinion. ASCENT-03 and TROPION-Breast02 support TROP2 ADC therapy as the new preferred first-line regimen for this patient population.”

 

Method and Results of ASCENT-03

ASCENT-03 study presenter Javier C. Cortés, MD, PhD, International Breast Cancer Center, Pangaea Oncology, Quiron Group, Barcelona, Spain, said there is currently an unmet clinical need in the approximately 60% of patients with previously untreated metastatic TNBC who are not candidates for immune checkpoint inhibitors.

Median PFS in previous first-line studies was < 6 months with chemotherapy — the current standard of care — and Cortés said that around half of the patients who receive that in the first-line do not receive second-line therapy because of clinical deterioration or death.

“The sobering truth is that across studies in the US and Europe, approximately 25% to 30% of patients diagnosed with metastatic TNBC are no longer alive at 6 months from their metastatic diagnosis,” said Garrido-Castro. “So if there is a new drug that is able to significantly improve PFS with an acceptable toxicity profile, this should be sufficient to change the current standard of care in the first-line setting.”

As sacituzumab govitecan is already approved for second-line metastatic TNBC and for pretreated hormone receptor positive/HER2- metastatic breast cancer, the ASCENT-03 researchers studied the drug in patients with previously untreated locally advanced inoperable, or metastatic TNBC.

The patients were deemed not to be candidates for PD-L1 inhibitors through having PD-L1-negative tumors, by having PD-L1-positive tumors that had previously been treated with PD-L1 inhibitors in the curative setting, or by having a comorbidity that precluded PD-L1 inhibitor use.

The patients were required to have finished any prior treatment in the curative setting at least 6 months previously. Previously treated, stable central nervous system metastases were allowed.

They were randomized to sacituzumab govitecan or chemotherapy, comprising paclitaxel or nab-paclitaxel, or gemcitabine plus carboplatin, until progression, as verified by blinded independent central review (BICR), or unacceptable toxicity. Patients who progressed on chemotherapy were offered crossover to second-line sacituzumab govitecan.

In all, 558 patients were randomized. The median age was 56 years in the sacituzumab govitecan group vs 54 years in the chemotherapy group. The majority (64% in both groups) of patients were White individuals. The most common metastatic site was the lung (59% vs 61%), and 58% of patients in both groups had previously received a taxane.

Cortés reported that sacituzumab govitecan was associated with a “statistically significant and clinically meaningful” improvement in PFS by BICR, at a median of 9.7 months vs 6.9 months, or a hazard ratio (HR) of 0.62 (P < .0001). This benefit was seen across prespecified subgroups.

The objective response rate was almost identical between the two treatment groups, at 48% with sacituzumab govitecan vs 46% with chemotherapy, although the median duration of response was longer with the ADC, at 12.2 months vs 7.2 months.

Cortés showed the latest results on overall survival. This showed no significant difference between the two treatments, although he underlined that the data are not yet mature.

He also reported that the rates of grade ≥ 3 treatment-emergent adverse events (TEAEs) were similar in the two groups, at 66% with sacituzumab govitecan vs 62% with chemotherapy. However, the rates of TEAEs leading to treatment discontinuation (4% vs 12%) or dose reduction (37% vs 45%) were lower with the ADC.

Cortés concluded that the results suggest that sacituzumab govitecan “is a good option for patients with triple negative breast cancer when they develop metastasis and are unable to receive immune checkpoint inhibitors.”

 

TROPION-Breast02 Methods and Results

Presenting TROPION-Breast02, Rebecca A. Dent, MD, MSc, National Cancer Center Singapore and Duke-NUS Medical School, Singapore, explained that the trial looked at a patient population similar to that of ASCENT-03, here focusing instead on Dato-DXd.

Patients were included if they had histologically or cytologically documented locally recurrent inoperable or metastatic TNBC, no prior chemotherapy or targeted systemic therapy in this setting, and in whom immunotherapy was not an option.

They were randomized to Dato-DXd or the investigator’s choice of chemotherapy, with treatment continued until investigator-assessed progressive disease on RECIST v1.1, unacceptable toxicity, or another criterion for discontinuation was met.

In total, 642 patients were enrolled. The median age was 56 years for those in the Dato-DXd group and 57 years for those in chemotherapy group, and less than half (41% in the Dato-DXd group and 48% in the chemotherapy group) were White individuals. The number of metastatic sites was less than three in 64% and 67% of patients, respectively.

Dent showed that Dato-DXd was associated with a statistically significant and clinically meaningful improvement in BICR-assessed PFS, at a median of 10.8 months vs 5.6 months with chemotherapy, at a HR of 0.57 (P < .0001). The findings were replicated across the prespecified subgroups.

There was a marked overall survival benefit with Dato-DXd, at a median of 23.7 months vs 18.7 months, at a HR of 0.79 (P = .0291). Dent reported that, at 18 months, 61.2% of patients in the Dato-DXd group were still alive vs 51.3% in the chemotherapy group. Again, the benefit was seen across subgroups.

The confirmed objective response rate with Dato-DXd was far higher than that with chemotherapy, at 62.5% vs 29.3%, or an odds ratio of 4.24. The duration of response was also longer, at 12.3 months vs 7.1 months.

Rates of grade ≥ 3 adverse events were comparable, at 33% with Dato-DXd vs 29% with chemotherapy, although there were more events associated with dose reduction (27% vs 18%) and dose interruption (24% vs 19%) with the ADC.

“These results support Dato-DXd as the first new first-line standard of care for patients with locally recurrent inoperable or metastatic TNBC for whom immunotherapy is not an option,” Dent said.

“What’s important is the patients enrolled into this trial are clearly representative of real world patients that we are treating in our clinics every day. These patients are often excluded from our current clinical trials,” she said.

ASCENT-03 was funded by Gilead Sciences.

TROPION-Breast02 was funded by AstraZeneca.Cortés declared relationships with Roche, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Lilly, Merck Sharpe & Dohme, Leuko, Bioasis, Clovis oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies, Jazz Pharmaceuticals, AbbVie, Scorpion Therapeutics, Bridgebio, Biocon, Biontech, Circle Pharma, Delcath Systems, Hexagon Bio, Novartis, Eisai, Pfizer, Stemline Therapeutics, MAJ3 Capital, Leuko, Ariad Pharmaceuticals, Baxalta GmbH/Servier Affaires, Bayer healthcare, Guardant Health, and PIQUR Therapeutics.

Dent declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, and Gilead Sciences.

Garrido-Castro declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, Gilead Sciences, Pfizer, TD Cowen, and Roche/Genentech.

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

BERLIN — Patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) who are not candidates for immunotherapy may experience improved survival outcomes with TROP2-directed antibody-drug conjugates (ADCs), suggested two trials presented at European Society for Medical Oncology (ESMO) Annual Meeting 2025 on October 19.

ASCENT-03 compared sacituzumab govitecan with standard of care chemotherapy, finding that the drug was associated with a 38% improvement in progression-free survival (PFS) in this patient population that has, traditionally, a poor prognosis. Overall survival data remain immature.

TROPION-Breast02 studied datopotamab deruxtecan (Dato-DXd) against investigator’s choice of chemotherapy. The PFS improvement with the ADC was 43%, while patients also experienced a 21% improvement in overall survival. In both cases, the safety profile of the experimental drugs was deemed to be manageable.

Discussant Ana C. Garrido-Castro, MD, director, Triple-Negative Breast Cancer Research, Dana-Farber Cancer Institute, Boston, who was not involved in either study, said that both sacituzumab govitecan and Dato-DXd showed a PFS benefit. The choice between them, leaving aside overall survival until the data are mature, will be largely based on factors such as the safety profile and the patient preference, she continued.

Sacituzumab govitecan is associated with an increase in neutropenia, nausea, and diarrhea, she pointed out, while Dato-DXd has increased rates of ocular surface toxicity, oral mucositis/stomatitis, and requires monitoring for interstitial lung disease.

Dato-DXd has a higher objective response rate than chemotherapy, unlike sacituzumab govitecan, but, crucially, requires one infusion vs 2 for sacituzumab govitecan per 21-day cycle, and has a shorter total infusion time.

There are nevertheless a number of unanswered questions about the drugs, including how the ADCs affect quality of life, and how common patient adherence to the recommended prophylaxis is. Patients with early relapse of < 12 months remain an “urgent unmet need,” Garrido-Castro said, and the role of immunotherapy rechallenge remains to be explored.

ADCs are also being tested in the neo-adjuvant TNBC setting, and the potential impact of that on the use of the drugs in the metastatic setting is currently unclear. In addition, there are questions around access to therapy.

“Ultimately, it will be very important to have a better understanding of the biomarkers of response and resistance and toxicity to these agents, and whether we should be sequencing antibody drug conjugates,” Garrido-Castro said. “All of this will help shape the next wave of treatment strategies for this patient population.”

She concluded: “Today, marks a paradigm shift of metastatic TNBC, in my opinion. ASCENT-03 and TROPION-Breast02 support TROP2 ADC therapy as the new preferred first-line regimen for this patient population.”

 

Method and Results of ASCENT-03

ASCENT-03 study presenter Javier C. Cortés, MD, PhD, International Breast Cancer Center, Pangaea Oncology, Quiron Group, Barcelona, Spain, said there is currently an unmet clinical need in the approximately 60% of patients with previously untreated metastatic TNBC who are not candidates for immune checkpoint inhibitors.

Median PFS in previous first-line studies was < 6 months with chemotherapy — the current standard of care — and Cortés said that around half of the patients who receive that in the first-line do not receive second-line therapy because of clinical deterioration or death.

“The sobering truth is that across studies in the US and Europe, approximately 25% to 30% of patients diagnosed with metastatic TNBC are no longer alive at 6 months from their metastatic diagnosis,” said Garrido-Castro. “So if there is a new drug that is able to significantly improve PFS with an acceptable toxicity profile, this should be sufficient to change the current standard of care in the first-line setting.”

As sacituzumab govitecan is already approved for second-line metastatic TNBC and for pretreated hormone receptor positive/HER2- metastatic breast cancer, the ASCENT-03 researchers studied the drug in patients with previously untreated locally advanced inoperable, or metastatic TNBC.

The patients were deemed not to be candidates for PD-L1 inhibitors through having PD-L1-negative tumors, by having PD-L1-positive tumors that had previously been treated with PD-L1 inhibitors in the curative setting, or by having a comorbidity that precluded PD-L1 inhibitor use.

The patients were required to have finished any prior treatment in the curative setting at least 6 months previously. Previously treated, stable central nervous system metastases were allowed.

They were randomized to sacituzumab govitecan or chemotherapy, comprising paclitaxel or nab-paclitaxel, or gemcitabine plus carboplatin, until progression, as verified by blinded independent central review (BICR), or unacceptable toxicity. Patients who progressed on chemotherapy were offered crossover to second-line sacituzumab govitecan.

In all, 558 patients were randomized. The median age was 56 years in the sacituzumab govitecan group vs 54 years in the chemotherapy group. The majority (64% in both groups) of patients were White individuals. The most common metastatic site was the lung (59% vs 61%), and 58% of patients in both groups had previously received a taxane.

Cortés reported that sacituzumab govitecan was associated with a “statistically significant and clinically meaningful” improvement in PFS by BICR, at a median of 9.7 months vs 6.9 months, or a hazard ratio (HR) of 0.62 (P < .0001). This benefit was seen across prespecified subgroups.

The objective response rate was almost identical between the two treatment groups, at 48% with sacituzumab govitecan vs 46% with chemotherapy, although the median duration of response was longer with the ADC, at 12.2 months vs 7.2 months.

Cortés showed the latest results on overall survival. This showed no significant difference between the two treatments, although he underlined that the data are not yet mature.

He also reported that the rates of grade ≥ 3 treatment-emergent adverse events (TEAEs) were similar in the two groups, at 66% with sacituzumab govitecan vs 62% with chemotherapy. However, the rates of TEAEs leading to treatment discontinuation (4% vs 12%) or dose reduction (37% vs 45%) were lower with the ADC.

Cortés concluded that the results suggest that sacituzumab govitecan “is a good option for patients with triple negative breast cancer when they develop metastasis and are unable to receive immune checkpoint inhibitors.”

 

TROPION-Breast02 Methods and Results

Presenting TROPION-Breast02, Rebecca A. Dent, MD, MSc, National Cancer Center Singapore and Duke-NUS Medical School, Singapore, explained that the trial looked at a patient population similar to that of ASCENT-03, here focusing instead on Dato-DXd.

Patients were included if they had histologically or cytologically documented locally recurrent inoperable or metastatic TNBC, no prior chemotherapy or targeted systemic therapy in this setting, and in whom immunotherapy was not an option.

They were randomized to Dato-DXd or the investigator’s choice of chemotherapy, with treatment continued until investigator-assessed progressive disease on RECIST v1.1, unacceptable toxicity, or another criterion for discontinuation was met.

In total, 642 patients were enrolled. The median age was 56 years for those in the Dato-DXd group and 57 years for those in chemotherapy group, and less than half (41% in the Dato-DXd group and 48% in the chemotherapy group) were White individuals. The number of metastatic sites was less than three in 64% and 67% of patients, respectively.

Dent showed that Dato-DXd was associated with a statistically significant and clinically meaningful improvement in BICR-assessed PFS, at a median of 10.8 months vs 5.6 months with chemotherapy, at a HR of 0.57 (P < .0001). The findings were replicated across the prespecified subgroups.

There was a marked overall survival benefit with Dato-DXd, at a median of 23.7 months vs 18.7 months, at a HR of 0.79 (P = .0291). Dent reported that, at 18 months, 61.2% of patients in the Dato-DXd group were still alive vs 51.3% in the chemotherapy group. Again, the benefit was seen across subgroups.

The confirmed objective response rate with Dato-DXd was far higher than that with chemotherapy, at 62.5% vs 29.3%, or an odds ratio of 4.24. The duration of response was also longer, at 12.3 months vs 7.1 months.

Rates of grade ≥ 3 adverse events were comparable, at 33% with Dato-DXd vs 29% with chemotherapy, although there were more events associated with dose reduction (27% vs 18%) and dose interruption (24% vs 19%) with the ADC.

“These results support Dato-DXd as the first new first-line standard of care for patients with locally recurrent inoperable or metastatic TNBC for whom immunotherapy is not an option,” Dent said.

“What’s important is the patients enrolled into this trial are clearly representative of real world patients that we are treating in our clinics every day. These patients are often excluded from our current clinical trials,” she said.

ASCENT-03 was funded by Gilead Sciences.

TROPION-Breast02 was funded by AstraZeneca.Cortés declared relationships with Roche, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Lilly, Merck Sharpe & Dohme, Leuko, Bioasis, Clovis oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies, Jazz Pharmaceuticals, AbbVie, Scorpion Therapeutics, Bridgebio, Biocon, Biontech, Circle Pharma, Delcath Systems, Hexagon Bio, Novartis, Eisai, Pfizer, Stemline Therapeutics, MAJ3 Capital, Leuko, Ariad Pharmaceuticals, Baxalta GmbH/Servier Affaires, Bayer healthcare, Guardant Health, and PIQUR Therapeutics.

Dent declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, and Gilead Sciences.

Garrido-Castro declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, Gilead Sciences, Pfizer, TD Cowen, and Roche/Genentech.

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