Breast Cancer

The class of CDK 4/6 inhibitors represents a significant advance in the treatment of hormone receptor (HR)-positive breast cancer. All three CDK 4/6 inhibitors (palbociclib, abemaciclib, and ribociclib) are approved in combination with endocrine therapy in the metastatic setting. As drugs show promise in later-stage disease, they are then often studied in the curative space. Presently, abemaciclib is the only CDK 4/6 inhibitor that has been approved by the US Food and Drug Administration for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, high-risk early breast cancer, based on results from the monarchE trial, which demonstrated invasive disease-free survival benefit with the addition of 2 years of abemaciclib to endocrine therapy. At 4 years, the absolute difference in invasive disease-free survival (IDFS) between the groups was 6.4% (85.8% in the abemaciclib + endocrine therapy group vs 79.4% in the endocrine therapy–alone group).^[3] In contrast, the PENELOPE-B and PALLAS trials did not show benefit with the addition of palbociclib to endocrine therapy in the adjuvant setting.^[4,5] The phase 3 NATALEE trial randomly assigned patients with HR-positive, HER2-negative early breast cancer to ribociclib (400 mg daily for 3 weeks followed by 1 week off for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI) or an NSAI alone. At the time of prespecified interim analysis, among 5101 patients, ribociclib + NSAI led to a significant improvement in IDFS compared with endocrine therapy alone (3-year IDFS was 90.4% vs 87.1%; hazard ratio 0.75; 95% CI 0.62-0.91; P = .003). It is certainly noteworthy that the trial design, endocrine therapies, and patient populations differed between these adjuvant studies; for example, NATALEE included a lower-risk population, and all patients received an NSAI (in monarchE approximately 30% received tamoxifen). The current results of NATALEE are encouraging; an absolute benefit of 3.3% should be considered and weighed against toxicities and cost, and longer follow-up is needed to further elucidate the role of ribociclib in the adjuvant space.

The meaningful impact of achieving a pathologic complete response (pCR) has been demonstrated in various prior studies. Response to neoadjuvant chemotherapy informs prognosis and helps tailor adjuvant therapy, the latter of which is particularly relevant for the HER2-positive subtype. Strategies to identify patients who are more likely to achieve pCR and predictors of early responders may aid in improving efficacy outcomes and limiting toxicities. TRAIN-3 is a single-arm, phase 2 study that included 235 and 232 patients with stage II/III HR-/HER2+ and HR+/HER2+ breast cancer, respectively, undergoing neoadjuvant chemotherapy (weekly paclitaxel D1 and D8/carboplatin AUC 6 D1/trastuzumab D1/pertuzumab D1 every 3 weeks for up to nine cycles), and was designed to evaluate radiologic and pathologic response rates and event-free survival. Response was monitored by breast MRI every 3 cycles and lymph node biopsy. Among patients with HR-/HER2+ tumors, 84 (36%; 95% CI 30-43) achieved a radiologic complete response after one to three cycles, of whom the majority (88%; 95% CI 79-94) had pCR. Patients with HR+/HER2+ tumors did not show the same degree of benefit with an MRI-based monitoring strategy; among the 138 patients (59%; 95% CI 53-66) who had a complete radiologic response after one to nine cycles, 73 (53%; 95% CI 44-61) had pCR. Additional imaging-guided modalities being studied to tailor and optimize treatment include [¹⁸F]fluorodeoxyglucose-PET-CT and volumetric MRI, in the PHERGain and I-SPY trials, respectively.^[6,7]

Additional References:

1. Giuliano AE, Ballman KV, McCall L, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: The ACOSOG Z0011 (Alliance) randomized clinical trial. JAMA. 2017;318:918-926. doi: 10.1001/jama.2017.11470 Source
2. Bartels SAL, Donker M, Poncet C, et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981-22023 AMAROS trial. J Clin Oncol. 2023;41:2159-2165. doi: 10.1200/JCO.22.01565 Source
3. Johnston SRD, Toi M, O'Shaughnessy J, et al, on behalf of the monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): Results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023;24:77-90. doi: 10.1016/S1470-2045(22)00694-5 Source
4. Loibl S, Marmé F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer—The Penelope-B trial. J Clin Oncol. 2021;39:1518-1530. doi: 10.1200/JCO.20.03639 Source
5. Gnant M, Dueck AC, Frantal S, et al, on behalf of the PALLAS groups and investigators. Adjuvant palbociclib for early breast cancer: The PALLAS trial results (ABCSG-42/AFT-05/BIG-14-03). J Clin Oncol. 2022;40:282-293. doi: 10.1200/JCO.21.02554 Source
6. Pérez-García JM, Cortés J, Ruiz-Borrego M, et al, on behalf of the PHERGain trial investigators. 3-year invasive disease-free survival with chemotherapy de-escalation using an 18F-FDG-PET-based, pathological complete response-adapted strategy in HER2-positive early breast cancer (PHERGain): A randomised, open-label, phase 2 trial. Lancet. 2024;403:1649-1659. doi: 10.1016/S0140-6736(24)00054-0 Source
7. Hylton NM, Gatsonis CA, Rosen MA, et al, for the ACRIN 6657 trial team and I-SPY 1 trial investigators. Neoadjuvant chemotherapy for breast cancer: Functional tumor volume by MR imaging predicts recurrence-free survival-results from the ACRIN 6657/CALGB 150007 I-SPY 1 trial. Radiology. 2016;279:44-55. doi: 10.1148/radiol.2015150013 Source

The class of CDK 4/6 inhibitors represents a significant advance in the treatment of hormone receptor (HR)-positive breast cancer. All three CDK 4/6 inhibitors (palbociclib, abemaciclib, and ribociclib) are approved in combination with endocrine therapy in the metastatic setting. As drugs show promise in later-stage disease, they are then often studied in the curative space. Presently, abemaciclib is the only CDK 4/6 inhibitor that has been approved by the US Food and Drug Administration for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, high-risk early breast cancer, based on results from the monarchE trial, which demonstrated invasive disease-free survival benefit with the addition of 2 years of abemaciclib to endocrine therapy. At 4 years, the absolute difference in invasive disease-free survival (IDFS) between the groups was 6.4% (85.8% in the abemaciclib + endocrine therapy group vs 79.4% in the endocrine therapy–alone group).^[3] In contrast, the PENELOPE-B and PALLAS trials did not show benefit with the addition of palbociclib to endocrine therapy in the adjuvant setting.^[4,5] The phase 3 NATALEE trial randomly assigned patients with HR-positive, HER2-negative early breast cancer to ribociclib (400 mg daily for 3 weeks followed by 1 week off for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI) or an NSAI alone. At the time of prespecified interim analysis, among 5101 patients, ribociclib + NSAI led to a significant improvement in IDFS compared with endocrine therapy alone (3-year IDFS was 90.4% vs 87.1%; hazard ratio 0.75; 95% CI 0.62-0.91; P = .003). It is certainly noteworthy that the trial design, endocrine therapies, and patient populations differed between these adjuvant studies; for example, NATALEE included a lower-risk population, and all patients received an NSAI (in monarchE approximately 30% received tamoxifen). The current results of NATALEE are encouraging; an absolute benefit of 3.3% should be considered and weighed against toxicities and cost, and longer follow-up is needed to further elucidate the role of ribociclib in the adjuvant space.

The meaningful impact of achieving a pathologic complete response (pCR) has been demonstrated in various prior studies. Response to neoadjuvant chemotherapy informs prognosis and helps tailor adjuvant therapy, the latter of which is particularly relevant for the HER2-positive subtype. Strategies to identify patients who are more likely to achieve pCR and predictors of early responders may aid in improving efficacy outcomes and limiting toxicities. TRAIN-3 is a single-arm, phase 2 study that included 235 and 232 patients with stage II/III HR-/HER2+ and HR+/HER2+ breast cancer, respectively, undergoing neoadjuvant chemotherapy (weekly paclitaxel D1 and D8/carboplatin AUC 6 D1/trastuzumab D1/pertuzumab D1 every 3 weeks for up to nine cycles), and was designed to evaluate radiologic and pathologic response rates and event-free survival. Response was monitored by breast MRI every 3 cycles and lymph node biopsy. Among patients with HR-/HER2+ tumors, 84 (36%; 95% CI 30-43) achieved a radiologic complete response after one to three cycles, of whom the majority (88%; 95% CI 79-94) had pCR. Patients with HR+/HER2+ tumors did not show the same degree of benefit with an MRI-based monitoring strategy; among the 138 patients (59%; 95% CI 53-66) who had a complete radiologic response after one to nine cycles, 73 (53%; 95% CI 44-61) had pCR. Additional imaging-guided modalities being studied to tailor and optimize treatment include [¹⁸F]fluorodeoxyglucose-PET-CT and volumetric MRI, in the PHERGain and I-SPY trials, respectively.^[6,7]

Additional References:

1. Giuliano AE, Ballman KV, McCall L, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: The ACOSOG Z0011 (Alliance) randomized clinical trial. JAMA. 2017;318:918-926. doi: 10.1001/jama.2017.11470 Source
2. Bartels SAL, Donker M, Poncet C, et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981-22023 AMAROS trial. J Clin Oncol. 2023;41:2159-2165. doi: 10.1200/JCO.22.01565 Source
3. Johnston SRD, Toi M, O'Shaughnessy J, et al, on behalf of the monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): Results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023;24:77-90. doi: 10.1016/S1470-2045(22)00694-5 Source
4. Loibl S, Marmé F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer—The Penelope-B trial. J Clin Oncol. 2021;39:1518-1530. doi: 10.1200/JCO.20.03639 Source
5. Gnant M, Dueck AC, Frantal S, et al, on behalf of the PALLAS groups and investigators. Adjuvant palbociclib for early breast cancer: The PALLAS trial results (ABCSG-42/AFT-05/BIG-14-03). J Clin Oncol. 2022;40:282-293. doi: 10.1200/JCO.21.02554 Source
6. Pérez-García JM, Cortés J, Ruiz-Borrego M, et al, on behalf of the PHERGain trial investigators. 3-year invasive disease-free survival with chemotherapy de-escalation using an 18F-FDG-PET-based, pathological complete response-adapted strategy in HER2-positive early breast cancer (PHERGain): A randomised, open-label, phase 2 trial. Lancet. 2024;403:1649-1659. doi: 10.1016/S0140-6736(24)00054-0 Source
7. Hylton NM, Gatsonis CA, Rosen MA, et al, for the ACRIN 6657 trial team and I-SPY 1 trial investigators. Neoadjuvant chemotherapy for breast cancer: Functional tumor volume by MR imaging predicts recurrence-free survival-results from the ACRIN 6657/CALGB 150007 I-SPY 1 trial. Radiology. 2016;279:44-55. doi: 10.1148/radiol.2015150013 Source

The class of CDK 4/6 inhibitors represents a significant advance in the treatment of hormone receptor (HR)-positive breast cancer. All three CDK 4/6 inhibitors (palbociclib, abemaciclib, and ribociclib) are approved in combination with endocrine therapy in the metastatic setting. As drugs show promise in later-stage disease, they are then often studied in the curative space. Presently, abemaciclib is the only CDK 4/6 inhibitor that has been approved by the US Food and Drug Administration for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, high-risk early breast cancer, based on results from the monarchE trial, which demonstrated invasive disease-free survival benefit with the addition of 2 years of abemaciclib to endocrine therapy. At 4 years, the absolute difference in invasive disease-free survival (IDFS) between the groups was 6.4% (85.8% in the abemaciclib + endocrine therapy group vs 79.4% in the endocrine therapy–alone group).^[3] In contrast, the PENELOPE-B and PALLAS trials did not show benefit with the addition of palbociclib to endocrine therapy in the adjuvant setting.^[4,5] The phase 3 NATALEE trial randomly assigned patients with HR-positive, HER2-negative early breast cancer to ribociclib (400 mg daily for 3 weeks followed by 1 week off for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI) or an NSAI alone. At the time of prespecified interim analysis, among 5101 patients, ribociclib + NSAI led to a significant improvement in IDFS compared with endocrine therapy alone (3-year IDFS was 90.4% vs 87.1%; hazard ratio 0.75; 95% CI 0.62-0.91; P = .003). It is certainly noteworthy that the trial design, endocrine therapies, and patient populations differed between these adjuvant studies; for example, NATALEE included a lower-risk population, and all patients received an NSAI (in monarchE approximately 30% received tamoxifen). The current results of NATALEE are encouraging; an absolute benefit of 3.3% should be considered and weighed against toxicities and cost, and longer follow-up is needed to further elucidate the role of ribociclib in the adjuvant space.

The meaningful impact of achieving a pathologic complete response (pCR) has been demonstrated in various prior studies. Response to neoadjuvant chemotherapy informs prognosis and helps tailor adjuvant therapy, the latter of which is particularly relevant for the HER2-positive subtype. Strategies to identify patients who are more likely to achieve pCR and predictors of early responders may aid in improving efficacy outcomes and limiting toxicities. TRAIN-3 is a single-arm, phase 2 study that included 235 and 232 patients with stage II/III HR-/HER2+ and HR+/HER2+ breast cancer, respectively, undergoing neoadjuvant chemotherapy (weekly paclitaxel D1 and D8/carboplatin AUC 6 D1/trastuzumab D1/pertuzumab D1 every 3 weeks for up to nine cycles), and was designed to evaluate radiologic and pathologic response rates and event-free survival. Response was monitored by breast MRI every 3 cycles and lymph node biopsy. Among patients with HR-/HER2+ tumors, 84 (36%; 95% CI 30-43) achieved a radiologic complete response after one to three cycles, of whom the majority (88%; 95% CI 79-94) had pCR. Patients with HR+/HER2+ tumors did not show the same degree of benefit with an MRI-based monitoring strategy; among the 138 patients (59%; 95% CI 53-66) who had a complete radiologic response after one to nine cycles, 73 (53%; 95% CI 44-61) had pCR. Additional imaging-guided modalities being studied to tailor and optimize treatment include [¹⁸F]fluorodeoxyglucose-PET-CT and volumetric MRI, in the PHERGain and I-SPY trials, respectively.^[6,7]

Additional References:

1. Giuliano AE, Ballman KV, McCall L, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: The ACOSOG Z0011 (Alliance) randomized clinical trial. JAMA. 2017;318:918-926. doi: 10.1001/jama.2017.11470 Source
2. Bartels SAL, Donker M, Poncet C, et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer: 10-year results of the randomized controlled EORTC 10981-22023 AMAROS trial. J Clin Oncol. 2023;41:2159-2165. doi: 10.1200/JCO.22.01565 Source
3. Johnston SRD, Toi M, O'Shaughnessy J, et al, on behalf of the monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): Results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023;24:77-90. doi: 10.1016/S1470-2045(22)00694-5 Source
4. Loibl S, Marmé F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer—The Penelope-B trial. J Clin Oncol. 2021;39:1518-1530. doi: 10.1200/JCO.20.03639 Source
5. Gnant M, Dueck AC, Frantal S, et al, on behalf of the PALLAS groups and investigators. Adjuvant palbociclib for early breast cancer: The PALLAS trial results (ABCSG-42/AFT-05/BIG-14-03). J Clin Oncol. 2022;40:282-293. doi: 10.1200/JCO.21.02554 Source
6. Pérez-García JM, Cortés J, Ruiz-Borrego M, et al, on behalf of the PHERGain trial investigators. 3-year invasive disease-free survival with chemotherapy de-escalation using an 18F-FDG-PET-based, pathological complete response-adapted strategy in HER2-positive early breast cancer (PHERGain): A randomised, open-label, phase 2 trial. Lancet. 2024;403:1649-1659. doi: 10.1016/S0140-6736(24)00054-0 Source
7. Hylton NM, Gatsonis CA, Rosen MA, et al, for the ACRIN 6657 trial team and I-SPY 1 trial investigators. Neoadjuvant chemotherapy for breast cancer: Functional tumor volume by MR imaging predicts recurrence-free survival-results from the ACRIN 6657/CALGB 150007 I-SPY 1 trial. Radiology. 2016;279:44-55. doi: 10.1148/radiol.2015150013 Source

Adjuvant therapy with aspirin offers no protection against recurrence or survival benefit in patients with high-risk nonmetastatic breast cancer, the results of a new phase 3 randomized controlled trial suggest.

These data are more robust than the efficacy signals from previous studies, meaning healthcare providers should not recommend aspirin as adjuvant therapy for breast cancer, reported lead author Wendy Y. Chen, MD, of Dana Farber Cancer Institute, Boston, and colleagues.

What Data Support Aspirin for Treating Breast Cancer?

“Multiple observational studies have reported a decreased risk of death among survivors of breast cancer who were regular aspirin users,” the investigators wrote in JAMA. “Even more compelling were data from randomized trials of aspirin for cardiovascular disease.”

This possible benefit was reported with mechanistic support, as aspirin’s anti-inflammatory and anti-platelet properties could theoretically control tumor growth, they added. Furthermore, aspirin impacts several cancer pathways currently targeted by agents approved by the US Food and Drug Administration (FDA).

Brigham & Women's Hospital

What Were The Key Findings From The A011502 Trial?

The A011502 trial enrolled 3,020 patients aged 18-70 years with ERBB2-negative breast cancer who had received standard therapy via routine clinical care. Eligibility required that chemotherapy and local therapy were complete, but ongoing endocrine therapy was allowed.

Participants were randomized in a 1:1 ratio to receive aspirin 300 mg per day or matching placebo for 5 years. The primary outcome was invasive disease-free survival, and the key secondary outcome was overall survival.

After a median follow-up of almost 3 years, at the first interim analysis, the study was suspended early due to statistical futility. By that timepoint, 253 invasive disease-free survival events occurred, of which 141 occurred in the aspirin group, compared with 112 in the placebo group, providing a hazard ratio of 1.27 (95% CI, 0.99-1.63) that was not statistically significant  (P = .06). No statistically significant difference in overall survival was observed (hazard ratio, 1.19; 95% CI, 0.82-1.72). Safety profiles were similar across groups.

How Will This Study Change Practice?

In an accompanying editorial, Jeanne S. Mandelblatt, MD, of Georgetown Lombardi Institute for Cancer and Aging Research, Washington, and colleagues, praised the trial for its comprehensive approach, but they predicted that the negative result could spell friction for health care providers.

“[C]linicians may find it challenging to communicate with their patients about the negative result in the Alliance trial, because prior lay press articles, observational studies, and meta-analyses of cardiovascular trials suggested that aspirin may decrease breast cancer recurrence,” they wrote.

Georgetown University

How Might the Findings From the A011502 Trial Impact Future Research?

Finally, and “most critically,” the editorialists raised concerns about health equity, noting the limited diversity in trial participants and the potential exclusion of subgroups that might benefit from aspirin use, particularly those more likely to experience accelerated biological aging and disparities in cancer risk and outcomes due to systemic racism or adverse social determinants of health.

They concluded by emphasizing the need to consider the intersectionality of aging, cancer, and disparities in designing future trials to advance health equity.

This study was funded by the Department of Defense Breast Cancer Research Program and the National Cancer Institute of the National Institutes of Health. The research was also supported in part by Bayer, which provided the study drug. The investigators disclosed relationships with Novartis, Seagen, Orum Clinical, and others. The editorialists disclosed relationships with Cantex Pharmaceuticals, and Pfizer.

Adjuvant therapy with aspirin offers no protection against recurrence or survival benefit in patients with high-risk nonmetastatic breast cancer, the results of a new phase 3 randomized controlled trial suggest.

These data are more robust than the efficacy signals from previous studies, meaning healthcare providers should not recommend aspirin as adjuvant therapy for breast cancer, reported lead author Wendy Y. Chen, MD, of Dana Farber Cancer Institute, Boston, and colleagues.

What Data Support Aspirin for Treating Breast Cancer?

“Multiple observational studies have reported a decreased risk of death among survivors of breast cancer who were regular aspirin users,” the investigators wrote in JAMA. “Even more compelling were data from randomized trials of aspirin for cardiovascular disease.”

This possible benefit was reported with mechanistic support, as aspirin’s anti-inflammatory and anti-platelet properties could theoretically control tumor growth, they added. Furthermore, aspirin impacts several cancer pathways currently targeted by agents approved by the US Food and Drug Administration (FDA).

Brigham & Women's Hospital

What Were The Key Findings From The A011502 Trial?

The A011502 trial enrolled 3,020 patients aged 18-70 years with ERBB2-negative breast cancer who had received standard therapy via routine clinical care. Eligibility required that chemotherapy and local therapy were complete, but ongoing endocrine therapy was allowed.

Participants were randomized in a 1:1 ratio to receive aspirin 300 mg per day or matching placebo for 5 years. The primary outcome was invasive disease-free survival, and the key secondary outcome was overall survival.

After a median follow-up of almost 3 years, at the first interim analysis, the study was suspended early due to statistical futility. By that timepoint, 253 invasive disease-free survival events occurred, of which 141 occurred in the aspirin group, compared with 112 in the placebo group, providing a hazard ratio of 1.27 (95% CI, 0.99-1.63) that was not statistically significant  (P = .06). No statistically significant difference in overall survival was observed (hazard ratio, 1.19; 95% CI, 0.82-1.72). Safety profiles were similar across groups.

How Will This Study Change Practice?

In an accompanying editorial, Jeanne S. Mandelblatt, MD, of Georgetown Lombardi Institute for Cancer and Aging Research, Washington, and colleagues, praised the trial for its comprehensive approach, but they predicted that the negative result could spell friction for health care providers.

“[C]linicians may find it challenging to communicate with their patients about the negative result in the Alliance trial, because prior lay press articles, observational studies, and meta-analyses of cardiovascular trials suggested that aspirin may decrease breast cancer recurrence,” they wrote.

Georgetown University

How Might the Findings From the A011502 Trial Impact Future Research?

Finally, and “most critically,” the editorialists raised concerns about health equity, noting the limited diversity in trial participants and the potential exclusion of subgroups that might benefit from aspirin use, particularly those more likely to experience accelerated biological aging and disparities in cancer risk and outcomes due to systemic racism or adverse social determinants of health.

They concluded by emphasizing the need to consider the intersectionality of aging, cancer, and disparities in designing future trials to advance health equity.

This study was funded by the Department of Defense Breast Cancer Research Program and the National Cancer Institute of the National Institutes of Health. The research was also supported in part by Bayer, which provided the study drug. The investigators disclosed relationships with Novartis, Seagen, Orum Clinical, and others. The editorialists disclosed relationships with Cantex Pharmaceuticals, and Pfizer.

Adjuvant therapy with aspirin offers no protection against recurrence or survival benefit in patients with high-risk nonmetastatic breast cancer, the results of a new phase 3 randomized controlled trial suggest.

These data are more robust than the efficacy signals from previous studies, meaning healthcare providers should not recommend aspirin as adjuvant therapy for breast cancer, reported lead author Wendy Y. Chen, MD, of Dana Farber Cancer Institute, Boston, and colleagues.

What Data Support Aspirin for Treating Breast Cancer?

“Multiple observational studies have reported a decreased risk of death among survivors of breast cancer who were regular aspirin users,” the investigators wrote in JAMA. “Even more compelling were data from randomized trials of aspirin for cardiovascular disease.”

This possible benefit was reported with mechanistic support, as aspirin’s anti-inflammatory and anti-platelet properties could theoretically control tumor growth, they added. Furthermore, aspirin impacts several cancer pathways currently targeted by agents approved by the US Food and Drug Administration (FDA).

Brigham & Women's Hospital

What Were The Key Findings From The A011502 Trial?

The A011502 trial enrolled 3,020 patients aged 18-70 years with ERBB2-negative breast cancer who had received standard therapy via routine clinical care. Eligibility required that chemotherapy and local therapy were complete, but ongoing endocrine therapy was allowed.

Participants were randomized in a 1:1 ratio to receive aspirin 300 mg per day or matching placebo for 5 years. The primary outcome was invasive disease-free survival, and the key secondary outcome was overall survival.

After a median follow-up of almost 3 years, at the first interim analysis, the study was suspended early due to statistical futility. By that timepoint, 253 invasive disease-free survival events occurred, of which 141 occurred in the aspirin group, compared with 112 in the placebo group, providing a hazard ratio of 1.27 (95% CI, 0.99-1.63) that was not statistically significant  (P = .06). No statistically significant difference in overall survival was observed (hazard ratio, 1.19; 95% CI, 0.82-1.72). Safety profiles were similar across groups.

How Will This Study Change Practice?

In an accompanying editorial, Jeanne S. Mandelblatt, MD, of Georgetown Lombardi Institute for Cancer and Aging Research, Washington, and colleagues, praised the trial for its comprehensive approach, but they predicted that the negative result could spell friction for health care providers.

“[C]linicians may find it challenging to communicate with their patients about the negative result in the Alliance trial, because prior lay press articles, observational studies, and meta-analyses of cardiovascular trials suggested that aspirin may decrease breast cancer recurrence,” they wrote.

Georgetown University

How Might the Findings From the A011502 Trial Impact Future Research?

Finally, and “most critically,” the editorialists raised concerns about health equity, noting the limited diversity in trial participants and the potential exclusion of subgroups that might benefit from aspirin use, particularly those more likely to experience accelerated biological aging and disparities in cancer risk and outcomes due to systemic racism or adverse social determinants of health.

They concluded by emphasizing the need to consider the intersectionality of aging, cancer, and disparities in designing future trials to advance health equity.

This study was funded by the Department of Defense Breast Cancer Research Program and the National Cancer Institute of the National Institutes of Health. The research was also supported in part by Bayer, which provided the study drug. The investigators disclosed relationships with Novartis, Seagen, Orum Clinical, and others. The editorialists disclosed relationships with Cantex Pharmaceuticals, and Pfizer.

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

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

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

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

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

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

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

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

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

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

The addition of an angiotensin-converting enzyme (ACE) inhibitor did not decrease risk for chemotherapy-related cardiac damage in patients being treated for breast cancer and non-Hodgkin lymphoma (NHL), a new randomized trial showed.

The results suggested adding an ACE inhibitor doesn’t affect cardiac injury or cardiac function outcomes “and should not be used as a preventative strategy” in these patients, David Austin, MD, consultant cardiologist, Academic Cardiovascular Unit, The James Cook University Hospital, Middlesbrough, England, and chief investigator for the PROACT study, told this news organization.

But while these negative results are disappointing, he said, “we now have a definitive result in a robustly conducted trial that will take the field forward.”

The findings were presented on April 8, 2024, at the American College of Cardiology (ACC) Scientific Session 2024.

Anthracyclines, which are extracted from Streptomyces bacterium, are chemotherapy drugs widely used to treat several types of cancer. Doxorubicin is among the most clinically important anthracyclines.

While extremely effective, anthracyclines can cause irreversible damage to cardiac cells and ultimately impair cardiac function and even cause heart failure, which may only be evident years after exposure. “Cardiac injury is very common in patients treated with high dose anthracyclines,” noted Dr. Austin.

The open-label PROACT study included 111 adult patients, mean age 58 years and predominantly White and women, being treated for breast cancer (62%) or NHL (38%) at National Health Service hospitals in England with high-dose anthracycline-based chemotherapy.

Patients were randomized to standard care (six cycles of high-dose doxorubicin-equivalent anthracycline-based chemotherapy) plus the ACE inhibitor enalapril maleate or standard care alone. The mean chemotherapy dose was 328 mg/m2; any dose greater than 300 is considered high.

The starting dose of enalapril was 2.5 mg twice a day, which was titrated up to a maximum of 10 mg twice a day. The ACE inhibitor was started at least 2 days before chemotherapy began and finished 3 weeks after the last anthracycline dose.

During the study, enalapril was titrated to 20 mg in more than 75% of patients, with the mean dose being 17.7 mg.
 

Myocardial Injury Outcome

The primary outcome was myocardial injury measured by the presence (≥ 14 ng/L) of high sensitivity cardiac troponin T (cTnT) during anthracycline treatment and 1 month after the last dose of anthracycline.

cTnT is highly expressed in cardiomyocytes and has become a preferred biomarker for detecting acute myocardial infarction and other causes of myocardial injury.

Blood sampling for cTnT and cardiac troponin I (cTnI) was performed at baseline, within 72 hours prior to chemotherapy and at trial completion. All patients had negative troponin results at baseline, indicating no heart damage.

A majority of patients experienced elevations in troponin (78% in the enalapril group and 83% in the standard of care group), but there was no statistically significant difference between groups (adjusted odds ratio [OR], 0.65; 95% CI, 0.23-1.78; P = .405).

There was also no significant difference between groups in terms of cTnI, a secondary endpoint. However, the proportion of patients testing positive for cTnI (47% in the enalapril group and 45% in controls) was substantially lower than that for cTnT.
 

Large Discrepancy

The “large discrepancy in the rate of injury” with cTnT “has implications for the clinical interpretation of cardiac biomarkers in routine practice, and we should proceed with caution,” Dr. Austin told this news organization.

The finding has implications because guidelines don’t currently differentiate based on the type of troponin, Dr. Austin said in a press release. “I was surprised by the difference, and I think this raises the question of what troponin we should be using.”

Secondary outcomes focused on cardiac function, measured using echocardiography and included left ventricular global longitudinal strain (LVGLS) and left ventricular ejection fraction (LVEF). These were measured at baseline, 4 weeks after the last anthracycline dose and 1 year after the final chemotherapy.

There was no between-group difference in LVGLS cardiac function (21% for enalapril vs 22% for standard of care; adjusted OR, 0.95; 95% CI, 0.33-2.74; P = .921). This was also true for LVEF (4% for enalapril vs 0% for standard of care group; adjusted OR, 4.89; 95% CI, 0.40-674.62; P = .236).

Asked what the research team plans to do next, Dr. Austin said “the immediate first step” is to continue following PROACT patients. “We know heart failure events and cardiac dysfunction can occur later down the line.”

Due to the challenge of enrolling patients into trials like PROACT, “we should come together as a sort of a broader cardiovascular/oncology academic community to try to understand how we can better recruit patients into these studies,” said Dr. Austin.

“We need to solve that problem before we then go on to maybe examine other potential preventative therapies.”

He doesn’t think an alternative ACE inhibitor would prove beneficial. “We need to look elsewhere for effective therapies in this area.”

He noted these new findings are “broadly consistent” with other trials that investigated angiotensin receptor blockers.
 

Tough Population

Commenting on the study during a media briefing, Anita Deswal, chair, medicine, Department of Cardiology, Division of Internal Medicine, The University of Texas, commended the researchers for managing to enroll patients with cancer as this is “a tough” population to get to agree to being in a clinical trial.

“These patients are often overwhelmed financially, physically, and emotionally with the cancer diagnosis, as well as the cancer therapy and, therefore, to enroll them in something to prevent, maybe, some potential cardiac toxicity down the line, is really hard.”

Past trials investigating neuro-hormonal blockers to prevent cardiotoxicity have been criticized for enrolling patients at “too low risk,” said Dr. Deswal. “But investigators here went that step beyond and enrolled patients who were going to receive higher doses of anthracyclines, so kudos to that.”

And she noted investigators managed to get patients on almost the maximum dose of enalapril. “So, the drug was poised to have an effect — if it was there.”

The negative results may have something to do with endpoints. “Maybe we haven’t quite figured out what are the cutoffs for high sensitivity troponin I that identify patients truly at risk” of developing heart failure in the future.

Commenting on the study for this news organization, Anu Lala, MD, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, said the results may come as a surprise to some.

“ACE inhibitors are considered cardioprotective and for this reason are often used prophylactically in patients receiving chemotherapy.”

Dr. Lala agrees troponin may not be the right endpoint. “Another question is whether clinical outcomes should be followed in addition to symptoms or onset of any heart failure symptoms, which may hold greater prognostic significance.”

The study was funded by the National Institute for Health and Care Research.

A version of this article appeared on Medscape.com.

The addition of an angiotensin-converting enzyme (ACE) inhibitor did not decrease risk for chemotherapy-related cardiac damage in patients being treated for breast cancer and non-Hodgkin lymphoma (NHL), a new randomized trial showed.

The results suggested adding an ACE inhibitor doesn’t affect cardiac injury or cardiac function outcomes “and should not be used as a preventative strategy” in these patients, David Austin, MD, consultant cardiologist, Academic Cardiovascular Unit, The James Cook University Hospital, Middlesbrough, England, and chief investigator for the PROACT study, told this news organization.

But while these negative results are disappointing, he said, “we now have a definitive result in a robustly conducted trial that will take the field forward.”

The findings were presented on April 8, 2024, at the American College of Cardiology (ACC) Scientific Session 2024.

Anthracyclines, which are extracted from Streptomyces bacterium, are chemotherapy drugs widely used to treat several types of cancer. Doxorubicin is among the most clinically important anthracyclines.

While extremely effective, anthracyclines can cause irreversible damage to cardiac cells and ultimately impair cardiac function and even cause heart failure, which may only be evident years after exposure. “Cardiac injury is very common in patients treated with high dose anthracyclines,” noted Dr. Austin.

The open-label PROACT study included 111 adult patients, mean age 58 years and predominantly White and women, being treated for breast cancer (62%) or NHL (38%) at National Health Service hospitals in England with high-dose anthracycline-based chemotherapy.

Patients were randomized to standard care (six cycles of high-dose doxorubicin-equivalent anthracycline-based chemotherapy) plus the ACE inhibitor enalapril maleate or standard care alone. The mean chemotherapy dose was 328 mg/m2; any dose greater than 300 is considered high.

The starting dose of enalapril was 2.5 mg twice a day, which was titrated up to a maximum of 10 mg twice a day. The ACE inhibitor was started at least 2 days before chemotherapy began and finished 3 weeks after the last anthracycline dose.

During the study, enalapril was titrated to 20 mg in more than 75% of patients, with the mean dose being 17.7 mg.
 

Myocardial Injury Outcome

The primary outcome was myocardial injury measured by the presence (≥ 14 ng/L) of high sensitivity cardiac troponin T (cTnT) during anthracycline treatment and 1 month after the last dose of anthracycline.

cTnT is highly expressed in cardiomyocytes and has become a preferred biomarker for detecting acute myocardial infarction and other causes of myocardial injury.

Blood sampling for cTnT and cardiac troponin I (cTnI) was performed at baseline, within 72 hours prior to chemotherapy and at trial completion. All patients had negative troponin results at baseline, indicating no heart damage.

A majority of patients experienced elevations in troponin (78% in the enalapril group and 83% in the standard of care group), but there was no statistically significant difference between groups (adjusted odds ratio [OR], 0.65; 95% CI, 0.23-1.78; P = .405).

There was also no significant difference between groups in terms of cTnI, a secondary endpoint. However, the proportion of patients testing positive for cTnI (47% in the enalapril group and 45% in controls) was substantially lower than that for cTnT.
 

Large Discrepancy

The “large discrepancy in the rate of injury” with cTnT “has implications for the clinical interpretation of cardiac biomarkers in routine practice, and we should proceed with caution,” Dr. Austin told this news organization.

The finding has implications because guidelines don’t currently differentiate based on the type of troponin, Dr. Austin said in a press release. “I was surprised by the difference, and I think this raises the question of what troponin we should be using.”

Secondary outcomes focused on cardiac function, measured using echocardiography and included left ventricular global longitudinal strain (LVGLS) and left ventricular ejection fraction (LVEF). These were measured at baseline, 4 weeks after the last anthracycline dose and 1 year after the final chemotherapy.

There was no between-group difference in LVGLS cardiac function (21% for enalapril vs 22% for standard of care; adjusted OR, 0.95; 95% CI, 0.33-2.74; P = .921). This was also true for LVEF (4% for enalapril vs 0% for standard of care group; adjusted OR, 4.89; 95% CI, 0.40-674.62; P = .236).

Asked what the research team plans to do next, Dr. Austin said “the immediate first step” is to continue following PROACT patients. “We know heart failure events and cardiac dysfunction can occur later down the line.”

Due to the challenge of enrolling patients into trials like PROACT, “we should come together as a sort of a broader cardiovascular/oncology academic community to try to understand how we can better recruit patients into these studies,” said Dr. Austin.

“We need to solve that problem before we then go on to maybe examine other potential preventative therapies.”

He doesn’t think an alternative ACE inhibitor would prove beneficial. “We need to look elsewhere for effective therapies in this area.”

He noted these new findings are “broadly consistent” with other trials that investigated angiotensin receptor blockers.
 

Tough Population

Commenting on the study during a media briefing, Anita Deswal, chair, medicine, Department of Cardiology, Division of Internal Medicine, The University of Texas, commended the researchers for managing to enroll patients with cancer as this is “a tough” population to get to agree to being in a clinical trial.

“These patients are often overwhelmed financially, physically, and emotionally with the cancer diagnosis, as well as the cancer therapy and, therefore, to enroll them in something to prevent, maybe, some potential cardiac toxicity down the line, is really hard.”

Past trials investigating neuro-hormonal blockers to prevent cardiotoxicity have been criticized for enrolling patients at “too low risk,” said Dr. Deswal. “But investigators here went that step beyond and enrolled patients who were going to receive higher doses of anthracyclines, so kudos to that.”

And she noted investigators managed to get patients on almost the maximum dose of enalapril. “So, the drug was poised to have an effect — if it was there.”

The negative results may have something to do with endpoints. “Maybe we haven’t quite figured out what are the cutoffs for high sensitivity troponin I that identify patients truly at risk” of developing heart failure in the future.

Commenting on the study for this news organization, Anu Lala, MD, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, said the results may come as a surprise to some.

“ACE inhibitors are considered cardioprotective and for this reason are often used prophylactically in patients receiving chemotherapy.”

Dr. Lala agrees troponin may not be the right endpoint. “Another question is whether clinical outcomes should be followed in addition to symptoms or onset of any heart failure symptoms, which may hold greater prognostic significance.”

The study was funded by the National Institute for Health and Care Research.

A version of this article appeared on Medscape.com.

The addition of an angiotensin-converting enzyme (ACE) inhibitor did not decrease risk for chemotherapy-related cardiac damage in patients being treated for breast cancer and non-Hodgkin lymphoma (NHL), a new randomized trial showed.

The results suggested adding an ACE inhibitor doesn’t affect cardiac injury or cardiac function outcomes “and should not be used as a preventative strategy” in these patients, David Austin, MD, consultant cardiologist, Academic Cardiovascular Unit, The James Cook University Hospital, Middlesbrough, England, and chief investigator for the PROACT study, told this news organization.

But while these negative results are disappointing, he said, “we now have a definitive result in a robustly conducted trial that will take the field forward.”

The findings were presented on April 8, 2024, at the American College of Cardiology (ACC) Scientific Session 2024.

Anthracyclines, which are extracted from Streptomyces bacterium, are chemotherapy drugs widely used to treat several types of cancer. Doxorubicin is among the most clinically important anthracyclines.

While extremely effective, anthracyclines can cause irreversible damage to cardiac cells and ultimately impair cardiac function and even cause heart failure, which may only be evident years after exposure. “Cardiac injury is very common in patients treated with high dose anthracyclines,” noted Dr. Austin.

The open-label PROACT study included 111 adult patients, mean age 58 years and predominantly White and women, being treated for breast cancer (62%) or NHL (38%) at National Health Service hospitals in England with high-dose anthracycline-based chemotherapy.

Patients were randomized to standard care (six cycles of high-dose doxorubicin-equivalent anthracycline-based chemotherapy) plus the ACE inhibitor enalapril maleate or standard care alone. The mean chemotherapy dose was 328 mg/m2; any dose greater than 300 is considered high.

The starting dose of enalapril was 2.5 mg twice a day, which was titrated up to a maximum of 10 mg twice a day. The ACE inhibitor was started at least 2 days before chemotherapy began and finished 3 weeks after the last anthracycline dose.

During the study, enalapril was titrated to 20 mg in more than 75% of patients, with the mean dose being 17.7 mg.
 

Myocardial Injury Outcome

The primary outcome was myocardial injury measured by the presence (≥ 14 ng/L) of high sensitivity cardiac troponin T (cTnT) during anthracycline treatment and 1 month after the last dose of anthracycline.

cTnT is highly expressed in cardiomyocytes and has become a preferred biomarker for detecting acute myocardial infarction and other causes of myocardial injury.

Blood sampling for cTnT and cardiac troponin I (cTnI) was performed at baseline, within 72 hours prior to chemotherapy and at trial completion. All patients had negative troponin results at baseline, indicating no heart damage.

A majority of patients experienced elevations in troponin (78% in the enalapril group and 83% in the standard of care group), but there was no statistically significant difference between groups (adjusted odds ratio [OR], 0.65; 95% CI, 0.23-1.78; P = .405).

There was also no significant difference between groups in terms of cTnI, a secondary endpoint. However, the proportion of patients testing positive for cTnI (47% in the enalapril group and 45% in controls) was substantially lower than that for cTnT.
 

Large Discrepancy

The “large discrepancy in the rate of injury” with cTnT “has implications for the clinical interpretation of cardiac biomarkers in routine practice, and we should proceed with caution,” Dr. Austin told this news organization.

The finding has implications because guidelines don’t currently differentiate based on the type of troponin, Dr. Austin said in a press release. “I was surprised by the difference, and I think this raises the question of what troponin we should be using.”

Secondary outcomes focused on cardiac function, measured using echocardiography and included left ventricular global longitudinal strain (LVGLS) and left ventricular ejection fraction (LVEF). These were measured at baseline, 4 weeks after the last anthracycline dose and 1 year after the final chemotherapy.

There was no between-group difference in LVGLS cardiac function (21% for enalapril vs 22% for standard of care; adjusted OR, 0.95; 95% CI, 0.33-2.74; P = .921). This was also true for LVEF (4% for enalapril vs 0% for standard of care group; adjusted OR, 4.89; 95% CI, 0.40-674.62; P = .236).

Asked what the research team plans to do next, Dr. Austin said “the immediate first step” is to continue following PROACT patients. “We know heart failure events and cardiac dysfunction can occur later down the line.”

Due to the challenge of enrolling patients into trials like PROACT, “we should come together as a sort of a broader cardiovascular/oncology academic community to try to understand how we can better recruit patients into these studies,” said Dr. Austin.

“We need to solve that problem before we then go on to maybe examine other potential preventative therapies.”

He doesn’t think an alternative ACE inhibitor would prove beneficial. “We need to look elsewhere for effective therapies in this area.”

He noted these new findings are “broadly consistent” with other trials that investigated angiotensin receptor blockers.
 

Tough Population

Commenting on the study during a media briefing, Anita Deswal, chair, medicine, Department of Cardiology, Division of Internal Medicine, The University of Texas, commended the researchers for managing to enroll patients with cancer as this is “a tough” population to get to agree to being in a clinical trial.

“These patients are often overwhelmed financially, physically, and emotionally with the cancer diagnosis, as well as the cancer therapy and, therefore, to enroll them in something to prevent, maybe, some potential cardiac toxicity down the line, is really hard.”

Past trials investigating neuro-hormonal blockers to prevent cardiotoxicity have been criticized for enrolling patients at “too low risk,” said Dr. Deswal. “But investigators here went that step beyond and enrolled patients who were going to receive higher doses of anthracyclines, so kudos to that.”

And she noted investigators managed to get patients on almost the maximum dose of enalapril. “So, the drug was poised to have an effect — if it was there.”

The negative results may have something to do with endpoints. “Maybe we haven’t quite figured out what are the cutoffs for high sensitivity troponin I that identify patients truly at risk” of developing heart failure in the future.

Commenting on the study for this news organization, Anu Lala, MD, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, said the results may come as a surprise to some.

“ACE inhibitors are considered cardioprotective and for this reason are often used prophylactically in patients receiving chemotherapy.”

Dr. Lala agrees troponin may not be the right endpoint. “Another question is whether clinical outcomes should be followed in addition to symptoms or onset of any heart failure symptoms, which may hold greater prognostic significance.”

The study was funded by the National Institute for Health and Care Research.

A version of this article appeared on Medscape.com.

More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.

However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.

Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.

In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.

American Cancer Society

“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.

The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.

While social determinants of health (SDH) seem to be drivers of higher breast cancer mortality in Black women, biological differences between Black and White women are also linked to poorer outcomes in Black women with breast cancer, new studies suggest. Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
 

SDH and Screening Rates Differences By Race

A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.

Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.

Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.

Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.

University of Illinois Cancer Center

Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes

Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.

Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.

Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.

DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.

“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”

Sanford Burnham Prebys

University of Illinois Cancer Center

How Neighborhood Impacts Breast Cancer, Death Rates

Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.

Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)

Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).

Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.

Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).

Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.

“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.

Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.

Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.

University of Mississippi Medical Center

Hope for Improved Outcomes, Higher Survival Rates

Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.

Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.

There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.

“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.

The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.

Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”

More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.

However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.

Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.

In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.

American Cancer Society

“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.

The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.

While social determinants of health (SDH) seem to be drivers of higher breast cancer mortality in Black women, biological differences between Black and White women are also linked to poorer outcomes in Black women with breast cancer, new studies suggest. Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
 

SDH and Screening Rates Differences By Race

A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.

Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.

Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.

Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.

University of Illinois Cancer Center

Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes

Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.

Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.

Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.

DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.

“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”

Sanford Burnham Prebys

University of Illinois Cancer Center

How Neighborhood Impacts Breast Cancer, Death Rates

Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.

Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)

Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).

Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.

Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).

Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.

“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.

Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.

Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.

University of Mississippi Medical Center

Hope for Improved Outcomes, Higher Survival Rates

Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.

Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.

There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.

“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.

The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.

Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”

More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.

However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.

Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.

In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.

American Cancer Society

“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.

The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.

While social determinants of health (SDH) seem to be drivers of higher breast cancer mortality in Black women, biological differences between Black and White women are also linked to poorer outcomes in Black women with breast cancer, new studies suggest. Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
 

SDH and Screening Rates Differences By Race

A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.

Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.

Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.

Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.

University of Illinois Cancer Center

Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes

Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.

Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.

Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.

DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.

“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”

Sanford Burnham Prebys

University of Illinois Cancer Center

How Neighborhood Impacts Breast Cancer, Death Rates

Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.

Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)

Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).

Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.

Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).

Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.

“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.

Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.

Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.

University of Mississippi Medical Center

Hope for Improved Outcomes, Higher Survival Rates

Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.

Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.

There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.

“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.

The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.

Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

A version of this article appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.

Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.

Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.

Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.

Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source

Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.

Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio  0.76; 95% CI 0.38-1.33) or tamoxifen  + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).

Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).

Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.

Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source

Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.

Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).

Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.

Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.

Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source

Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.

Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).

Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.

Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.

Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source

Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.

Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).

Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.

Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.

Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source