Breast Cancer ICYMI

Key clinical point: Scalp cooling therapy for chemotherapy-induced alopecia in patients with breast cancer is associated with 61% effectiveness, according to a meta-analysis.

Major finding: Scalp cooling therapy showed an effectiveness of 61% against hair loss. The region-specific efficacy was 65% in Europe and 53% in Asia.

Study details: Meta-analysis of 27 studies (3 randomized controlled trials, 12 cross-sectional, and 12 cohort studies) with 2,202 participants.

Disclosures: The study funding source was not identified. The authors declared no conflict of interests.

Source: Wang S et al. Support Care Cancer. 2021 Apr 13. doi: 10.1007/s00520-021-06188-8.

Key clinical point: Scalp cooling therapy for chemotherapy-induced alopecia in patients with breast cancer is associated with 61% effectiveness, according to a meta-analysis.

Major finding: Scalp cooling therapy showed an effectiveness of 61% against hair loss. The region-specific efficacy was 65% in Europe and 53% in Asia.

Study details: Meta-analysis of 27 studies (3 randomized controlled trials, 12 cross-sectional, and 12 cohort studies) with 2,202 participants.

Disclosures: The study funding source was not identified. The authors declared no conflict of interests.

Source: Wang S et al. Support Care Cancer. 2021 Apr 13. doi: 10.1007/s00520-021-06188-8.

Key clinical point: Scalp cooling therapy for chemotherapy-induced alopecia in patients with breast cancer is associated with 61% effectiveness, according to a meta-analysis.

Major finding: Scalp cooling therapy showed an effectiveness of 61% against hair loss. The region-specific efficacy was 65% in Europe and 53% in Asia.

Study details: Meta-analysis of 27 studies (3 randomized controlled trials, 12 cross-sectional, and 12 cohort studies) with 2,202 participants.

Disclosures: The study funding source was not identified. The authors declared no conflict of interests.

Source: Wang S et al. Support Care Cancer. 2021 Apr 13. doi: 10.1007/s00520-021-06188-8.

Key clinical point: Increasing body mass index (BMI) among survivors of early breast cancer is associated with a higher risk of developing a second primary cancer.

Major finding: At a mean follow-up of 88.0 months, 12.7% of patients developed a second primary cancer. For every 5 kg/m² increase in the BMI, the risk for any second cancer diagnosis increased by 7% and for obesity-related cancers by 13%. The risk for a second breast cancer and second estrogen receptor-positive breast cancer increased by 11% and 15%, respectively, for every 5 kg/m² increase in the BMI.

Study details: A retrospective cohort study of 6,481 women with early-stage primary breast cancer, wherein 33.4% of patients were overweight, and 33.8% were obese.

Disclosures: This work was supported in part by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics of the US National Cancer Institute, and American Cancer Society. The authors disclosed no conflict of interests.

Source: Feigelson HS et al. J Natl Cancer Inst. 2021 Apr 5. doi: 10.1093/jnci/djab053.

Key clinical point: Increasing body mass index (BMI) among survivors of early breast cancer is associated with a higher risk of developing a second primary cancer.

Major finding: At a mean follow-up of 88.0 months, 12.7% of patients developed a second primary cancer. For every 5 kg/m² increase in the BMI, the risk for any second cancer diagnosis increased by 7% and for obesity-related cancers by 13%. The risk for a second breast cancer and second estrogen receptor-positive breast cancer increased by 11% and 15%, respectively, for every 5 kg/m² increase in the BMI.

Study details: A retrospective cohort study of 6,481 women with early-stage primary breast cancer, wherein 33.4% of patients were overweight, and 33.8% were obese.

Disclosures: This work was supported in part by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics of the US National Cancer Institute, and American Cancer Society. The authors disclosed no conflict of interests.

Source: Feigelson HS et al. J Natl Cancer Inst. 2021 Apr 5. doi: 10.1093/jnci/djab053.

Key clinical point: Increasing body mass index (BMI) among survivors of early breast cancer is associated with a higher risk of developing a second primary cancer.

Major finding: At a mean follow-up of 88.0 months, 12.7% of patients developed a second primary cancer. For every 5 kg/m² increase in the BMI, the risk for any second cancer diagnosis increased by 7% and for obesity-related cancers by 13%. The risk for a second breast cancer and second estrogen receptor-positive breast cancer increased by 11% and 15%, respectively, for every 5 kg/m² increase in the BMI.

Study details: A retrospective cohort study of 6,481 women with early-stage primary breast cancer, wherein 33.4% of patients were overweight, and 33.8% were obese.

Disclosures: This work was supported in part by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics of the US National Cancer Institute, and American Cancer Society. The authors disclosed no conflict of interests.

Source: Feigelson HS et al. J Natl Cancer Inst. 2021 Apr 5. doi: 10.1093/jnci/djab053.

Key clinical point: High rates of sentinel lymph node biopsy (SLNB) and radiotherapy (RT) do not show benefit in older women with early estrogen receptor-positive (ER+) breast cancer.

Major finding: Among all patients, 65.3% received SLNB and 54.4% received adjuvant RT. No association was found between SLNB and locoregional recurrence-free survival (LRFS; P = .71) or disease-free survival (DFS; P = .11). RT showed no association with LRFS (P = .10) or DFS (P = .97).

Study details: A retrospective cohort study of 3,361 consecutive patients aged 70 years or older with early ER+ breast cancer.

Disclosures: This study was funded by UPMC Health Services Division and Shear Family Foundation. The authors declared receiving consulting fees, personal fees and/or research funding outside this work.

Source: Carleton N et al. JAMA Netw Open. 2021 Apr 1. doi: 10.1001/jamanetworkopen.2021.6322.

Key clinical point: High rates of sentinel lymph node biopsy (SLNB) and radiotherapy (RT) do not show benefit in older women with early estrogen receptor-positive (ER+) breast cancer.

Major finding: Among all patients, 65.3% received SLNB and 54.4% received adjuvant RT. No association was found between SLNB and locoregional recurrence-free survival (LRFS; P = .71) or disease-free survival (DFS; P = .11). RT showed no association with LRFS (P = .10) or DFS (P = .97).

Study details: A retrospective cohort study of 3,361 consecutive patients aged 70 years or older with early ER+ breast cancer.

Disclosures: This study was funded by UPMC Health Services Division and Shear Family Foundation. The authors declared receiving consulting fees, personal fees and/or research funding outside this work.

Source: Carleton N et al. JAMA Netw Open. 2021 Apr 1. doi: 10.1001/jamanetworkopen.2021.6322.

Key clinical point: High rates of sentinel lymph node biopsy (SLNB) and radiotherapy (RT) do not show benefit in older women with early estrogen receptor-positive (ER+) breast cancer.

Major finding: Among all patients, 65.3% received SLNB and 54.4% received adjuvant RT. No association was found between SLNB and locoregional recurrence-free survival (LRFS; P = .71) or disease-free survival (DFS; P = .11). RT showed no association with LRFS (P = .10) or DFS (P = .97).

Study details: A retrospective cohort study of 3,361 consecutive patients aged 70 years or older with early ER+ breast cancer.

Disclosures: This study was funded by UPMC Health Services Division and Shear Family Foundation. The authors declared receiving consulting fees, personal fees and/or research funding outside this work.

Source: Carleton N et al. JAMA Netw Open. 2021 Apr 1. doi: 10.1001/jamanetworkopen.2021.6322.

Key clinical point: The addition of oral alisertib to a reduced dose of weekly paclitaxel improves progression-free survival (PFS) compared with paclitaxel alone in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

Major finding: At a median follow-up of 22 months, the median PFS was 10.2 months with paclitaxel plus alisertib vs. 7.1 months with paclitaxel alone (hazard ratio, 0.56; P = .005) in the patients with ER+, HER2-negative disease. Grade 3-4 adverse event rate was higher with paclitaxel plus alisertib vs. paclitaxel alone (84.8% vs. 48.6%).

Study details: A phase 2, open-label, randomized study of 139 patients with metastatic breast cancer who received either paclitaxel or paclitaxel plus alisertib.

Disclosures: The study was supported by a research grant from Takeda Pharmaceuticals. Dr. O’Shaughnessy and Dr. Andorsky declared receiving personal fees, consulting and/or serving on steering committee meetings for various sources.

Source: O'Shaughnessy J et al. JAMA Netw Open. 2021 Apr 20. doi: 10.1001/jamanetworkopen.2021.4103.

Key clinical point: The addition of oral alisertib to a reduced dose of weekly paclitaxel improves progression-free survival (PFS) compared with paclitaxel alone in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

Major finding: At a median follow-up of 22 months, the median PFS was 10.2 months with paclitaxel plus alisertib vs. 7.1 months with paclitaxel alone (hazard ratio, 0.56; P = .005) in the patients with ER+, HER2-negative disease. Grade 3-4 adverse event rate was higher with paclitaxel plus alisertib vs. paclitaxel alone (84.8% vs. 48.6%).

Study details: A phase 2, open-label, randomized study of 139 patients with metastatic breast cancer who received either paclitaxel or paclitaxel plus alisertib.

Disclosures: The study was supported by a research grant from Takeda Pharmaceuticals. Dr. O’Shaughnessy and Dr. Andorsky declared receiving personal fees, consulting and/or serving on steering committee meetings for various sources.

Source: O'Shaughnessy J et al. JAMA Netw Open. 2021 Apr 20. doi: 10.1001/jamanetworkopen.2021.4103.

Key clinical point: The addition of oral alisertib to a reduced dose of weekly paclitaxel improves progression-free survival (PFS) compared with paclitaxel alone in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

Major finding: At a median follow-up of 22 months, the median PFS was 10.2 months with paclitaxel plus alisertib vs. 7.1 months with paclitaxel alone (hazard ratio, 0.56; P = .005) in the patients with ER+, HER2-negative disease. Grade 3-4 adverse event rate was higher with paclitaxel plus alisertib vs. paclitaxel alone (84.8% vs. 48.6%).

Study details: A phase 2, open-label, randomized study of 139 patients with metastatic breast cancer who received either paclitaxel or paclitaxel plus alisertib.

Disclosures: The study was supported by a research grant from Takeda Pharmaceuticals. Dr. O’Shaughnessy and Dr. Andorsky declared receiving personal fees, consulting and/or serving on steering committee meetings for various sources.

Source: O'Shaughnessy J et al. JAMA Netw Open. 2021 Apr 20. doi: 10.1001/jamanetworkopen.2021.4103.

Key clinical point: The detrimental effects of chemotherapy on quality of life (QoL) are significant at 12 months in older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer treated with either chemotherapy plus trastuzumab vs. trastuzumab monotherapy. There was no difference in QoL after 36 months between treatments.

Major finding: At 12 months, the proportion of patients showing QoL deterioration was significantly lower in the trastuzumab monotherapy vs. trastuzumab plus chemotherapy group (19% vs. 38%; P = .009). A significantly higher number of patients showed improvement in QoL with trastuzumab monotherapy at 12 months (43% vs. 25%; P = .021). No difference was reported in any QoL items at 36 months between the 2 treatment groups.

Study details: The QoL analysis of phase 3, randomized RESPECT trial included 231 older patients with HER2-positive breast cancer who received either trastuzumab monotherapy (mean age, 73.9 years) or trastuzumab plus chemotherapy (mean age, 73.7 years).

Disclosures: The analysis was supported by the Comprehensive Support Project for Oncology Research of the Public Health Research Foundation, Japan. The authors received consulting fees, honoraria, and research funding outside this work.

Source: Taira N et al. J Clin Oncol. 2021 Apr 9. doi: 10.1200/JCO.20.02751.

Key clinical point: The detrimental effects of chemotherapy on quality of life (QoL) are significant at 12 months in older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer treated with either chemotherapy plus trastuzumab vs. trastuzumab monotherapy. There was no difference in QoL after 36 months between treatments.

Major finding: At 12 months, the proportion of patients showing QoL deterioration was significantly lower in the trastuzumab monotherapy vs. trastuzumab plus chemotherapy group (19% vs. 38%; P = .009). A significantly higher number of patients showed improvement in QoL with trastuzumab monotherapy at 12 months (43% vs. 25%; P = .021). No difference was reported in any QoL items at 36 months between the 2 treatment groups.

Study details: The QoL analysis of phase 3, randomized RESPECT trial included 231 older patients with HER2-positive breast cancer who received either trastuzumab monotherapy (mean age, 73.9 years) or trastuzumab plus chemotherapy (mean age, 73.7 years).

Disclosures: The analysis was supported by the Comprehensive Support Project for Oncology Research of the Public Health Research Foundation, Japan. The authors received consulting fees, honoraria, and research funding outside this work.

Source: Taira N et al. J Clin Oncol. 2021 Apr 9. doi: 10.1200/JCO.20.02751.

Key clinical point: The detrimental effects of chemotherapy on quality of life (QoL) are significant at 12 months in older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer treated with either chemotherapy plus trastuzumab vs. trastuzumab monotherapy. There was no difference in QoL after 36 months between treatments.

Major finding: At 12 months, the proportion of patients showing QoL deterioration was significantly lower in the trastuzumab monotherapy vs. trastuzumab plus chemotherapy group (19% vs. 38%; P = .009). A significantly higher number of patients showed improvement in QoL with trastuzumab monotherapy at 12 months (43% vs. 25%; P = .021). No difference was reported in any QoL items at 36 months between the 2 treatment groups.

Study details: The QoL analysis of phase 3, randomized RESPECT trial included 231 older patients with HER2-positive breast cancer who received either trastuzumab monotherapy (mean age, 73.9 years) or trastuzumab plus chemotherapy (mean age, 73.7 years).

Disclosures: The analysis was supported by the Comprehensive Support Project for Oncology Research of the Public Health Research Foundation, Japan. The authors received consulting fees, honoraria, and research funding outside this work.

Source: Taira N et al. J Clin Oncol. 2021 Apr 9. doi: 10.1200/JCO.20.02751.

Key clinical point: Pembrolizumab plus eribulin shows activity in patients with heavily pretreated, hormone-receptor–positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative, locally recurrent, or metastatic breast cancer.

Major finding: The clinical benefit rate was 56.8%, and the objective response rate was 40.9%. The median progression-free survival was 6.0 months. The serious adverse event rate was 31.8%, and 25.0% of patients experienced immune-related adverse events.

Study details: Phase 2 study of 44 previously treated patients with HR+, HER-negative, inoperable, locally recurrent breast cancer received pembrolizumab plus eribulin.

Disclosures: The study was supported by MSD Spain. Some of the authors declared receiving consulting fees, honoraria, travel expenses and/or research funding from various sources.

Source: Pérez-García JM et al. Eur J Cancer. 2021 Mar 29. doi: 10.1016/j.ejca.2021.02.028.

Key clinical point: Pembrolizumab plus eribulin shows activity in patients with heavily pretreated, hormone-receptor–positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative, locally recurrent, or metastatic breast cancer.

Major finding: The clinical benefit rate was 56.8%, and the objective response rate was 40.9%. The median progression-free survival was 6.0 months. The serious adverse event rate was 31.8%, and 25.0% of patients experienced immune-related adverse events.

Study details: Phase 2 study of 44 previously treated patients with HR+, HER-negative, inoperable, locally recurrent breast cancer received pembrolizumab plus eribulin.

Disclosures: The study was supported by MSD Spain. Some of the authors declared receiving consulting fees, honoraria, travel expenses and/or research funding from various sources.

Source: Pérez-García JM et al. Eur J Cancer. 2021 Mar 29. doi: 10.1016/j.ejca.2021.02.028.

Key clinical point: Pembrolizumab plus eribulin shows activity in patients with heavily pretreated, hormone-receptor–positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative, locally recurrent, or metastatic breast cancer.

Major finding: The clinical benefit rate was 56.8%, and the objective response rate was 40.9%. The median progression-free survival was 6.0 months. The serious adverse event rate was 31.8%, and 25.0% of patients experienced immune-related adverse events.

Study details: Phase 2 study of 44 previously treated patients with HR+, HER-negative, inoperable, locally recurrent breast cancer received pembrolizumab plus eribulin.

Disclosures: The study was supported by MSD Spain. Some of the authors declared receiving consulting fees, honoraria, travel expenses and/or research funding from various sources.

Source: Pérez-García JM et al. Eur J Cancer. 2021 Mar 29. doi: 10.1016/j.ejca.2021.02.028.

Key clinical point: Long-term data show similar local control rates with 10-Gy intraoperative electron radiotherapy (IOERT) vs. external beam radiotherapy (EBRT).

Major finding: The cumulative risk for in-breast true recurrences at 10 years was 4.3% after IOERT vs. 5.3% after EBRT boost (P = .493). The cumulative risk for out-field local recurrence at 10 years was 7.9% for IOERT vs. 10.3% for EBRT (P = .611).

Study details: Phase 3 randomized study of 245 patients with early-stage breast cancer who underwent breast-conserving surgery with either 10-Gy IOERT or EBRT boost.

Disclosures: An author received a study grant from IntraOp Medical. The authors declared no conflict of interests.

Source: Ciabattoni A et al. Breast Can Res. 2021 Apr 13. doi: 10.1186/s13058-021-01424-9.

Key clinical point: Long-term data show similar local control rates with 10-Gy intraoperative electron radiotherapy (IOERT) vs. external beam radiotherapy (EBRT).

Major finding: The cumulative risk for in-breast true recurrences at 10 years was 4.3% after IOERT vs. 5.3% after EBRT boost (P = .493). The cumulative risk for out-field local recurrence at 10 years was 7.9% for IOERT vs. 10.3% for EBRT (P = .611).

Study details: Phase 3 randomized study of 245 patients with early-stage breast cancer who underwent breast-conserving surgery with either 10-Gy IOERT or EBRT boost.

Disclosures: An author received a study grant from IntraOp Medical. The authors declared no conflict of interests.

Source: Ciabattoni A et al. Breast Can Res. 2021 Apr 13. doi: 10.1186/s13058-021-01424-9.

Key clinical point: Long-term data show similar local control rates with 10-Gy intraoperative electron radiotherapy (IOERT) vs. external beam radiotherapy (EBRT).

Major finding: The cumulative risk for in-breast true recurrences at 10 years was 4.3% after IOERT vs. 5.3% after EBRT boost (P = .493). The cumulative risk for out-field local recurrence at 10 years was 7.9% for IOERT vs. 10.3% for EBRT (P = .611).

Study details: Phase 3 randomized study of 245 patients with early-stage breast cancer who underwent breast-conserving surgery with either 10-Gy IOERT or EBRT boost.

Disclosures: An author received a study grant from IntraOp Medical. The authors declared no conflict of interests.

Source: Ciabattoni A et al. Breast Can Res. 2021 Apr 13. doi: 10.1186/s13058-021-01424-9.

Key clinical point: Sacituzumab govitecan improves survival vs. single-agent chemotherapy in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: Sacituzumab govitecan vs. chemotherapy showed 59% and 52% reduction in the risk for progression and mortality, respectively (P less than .001 for both). The objective response rate was 35% with sacituzumab govitecan and 5% with chemotherapy. Grade 3-4 adverse event rate was 64% and 47% in the sacituzumab govitecan and chemotherapy groups, respectively.

Study details: A phase 3 ASCENT study of patients with relapsed or refractory TNBC, randomly assigned to receive either sacituzumab govitecan or single-agent chemotherapy of physician’s choice.

Disclosures: The study was supported by Immunomedics, a subsidiary of Gilead Sciences. The authors received consulting fees outside this work.

Source: Bardia A et al. New Eng J Med. 2021 Apr 22. doi: 10.1056/NEJMoa2028485.

Key clinical point: Sacituzumab govitecan improves survival vs. single-agent chemotherapy in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: Sacituzumab govitecan vs. chemotherapy showed 59% and 52% reduction in the risk for progression and mortality, respectively (P less than .001 for both). The objective response rate was 35% with sacituzumab govitecan and 5% with chemotherapy. Grade 3-4 adverse event rate was 64% and 47% in the sacituzumab govitecan and chemotherapy groups, respectively.

Study details: A phase 3 ASCENT study of patients with relapsed or refractory TNBC, randomly assigned to receive either sacituzumab govitecan or single-agent chemotherapy of physician’s choice.

Disclosures: The study was supported by Immunomedics, a subsidiary of Gilead Sciences. The authors received consulting fees outside this work.

Source: Bardia A et al. New Eng J Med. 2021 Apr 22. doi: 10.1056/NEJMoa2028485.

Key clinical point: Sacituzumab govitecan improves survival vs. single-agent chemotherapy in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: Sacituzumab govitecan vs. chemotherapy showed 59% and 52% reduction in the risk for progression and mortality, respectively (P less than .001 for both). The objective response rate was 35% with sacituzumab govitecan and 5% with chemotherapy. Grade 3-4 adverse event rate was 64% and 47% in the sacituzumab govitecan and chemotherapy groups, respectively.

Study details: A phase 3 ASCENT study of patients with relapsed or refractory TNBC, randomly assigned to receive either sacituzumab govitecan or single-agent chemotherapy of physician’s choice.

Disclosures: The study was supported by Immunomedics, a subsidiary of Gilead Sciences. The authors received consulting fees outside this work.

Source: Bardia A et al. New Eng J Med. 2021 Apr 22. doi: 10.1056/NEJMoa2028485.

Hormonal therapies for the treatment of hormone-dependent breast and prostate cancer could raise the risk for myocardial infarction and stroke, and patients need to be closely monitored to allow early detection and treatment of cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.
 

“The statement provides data on the risks of each type of hormonal therapy so clinicians can use it as a guide to help manage cardiovascular risks during cancer treatment,” Tochi Okwuosa, DO, chair of the writing group, said in a news release.

“A team-based approach to patient care that includes the oncology team, cardiologist, primary care clinician, dietitian, endocrinologist, and other health care professionals as appropriate is needed to work with each patient to manage and reduce the increased risk of heart disease and strokes associated with hormonal therapy in breast and prostate cancer treatment,” said Dr. Okwuosa, director of cardio-oncology services, Rush University Medical Center, Chicago.

The scientific statement was published online April 26 in Circulation: Genomic and Precision Medicine.

Hormone-dependent cancers, such as prostate and breast cancer, are the most common noncutaneous cancers in the United States and around the world. As hormonal therapies have markedly improved survival in these patients, CVD has emerged as a leading cause illness and death.

The increased CVD burden might be explained by the increasing average age of cancer survivors, leading to higher rates of age-related CV risk factors and coronary artery disease.

The writing group reviewed existing evidence from observational studies and randomized controlled trials on the cardiovascular impact of anticancer hormonal therapies.



Among the key findings:

• In patients with breast cancer,  has been shown to increase the risk for venous thromboembolic events, but to have somewhat protective to neutral effects on CVD risk burden and CVD events. Conversely, aromatase inhibitors have been shown to increase the risk for CVD risk factors and events, including MI and stroke.
• Androgen-deprivation therapy for prostate cancer appears to increase the risk for CV events, although gonadotrophin-releasing hormone (GnRH) antagonists are associated with a lower risk for CV events than are GnRH agonists. The oral antiandrogens appear to be associated with increased CVD risk as well, particularly when used for complete androgen blockade as combination GnRH/anti-androgen therapy.
• The duration of hormonal therapies has a significant impact on CVD risk; the longer patients receive hormonal therapy, the greater the risk. More research is needed to better define the risks associated with duration of treatment.
• The data are mixed on the impact of preexisting CV risk factors and CVD on CV events associated with hormonal therapy. Although the presence of baseline CV risk factors and CVD can increase CV events associated with aromatase inhibitors, it is not clear that tamoxifen does.
• Studies suggest that patients with prostate cancer and baseline CVD and CV risk factors have increased rates of CV events when treated with androgen-deprivation therapy.
• Although the prolonged use of some hormonal therapies worsens CV risk factors and , the effects of the duration of therapy on CV events are less clear.

The writing group noted that there are no definitive guidelines for the monitoring and management of hormonal therapy-related CVD risks.

The authors encourage clinicians to be alert for worsening CV problems in those with preexisting heart disease or risk factors, and to recognize that even patients without preexisting CV problems are at higher risk because of their exposure to hormonal therapies.

“For patients who have two or more cardiovascular risk factors, it is likely that referral to a cardiologist would be appropriate prior to beginning hormone treatment. For patients already receiving hormonal therapies, a discussion with the oncology team can help to determine if a cardiology referral is recommended,” Dr. Okwuosa said in the news release.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Cardio-Oncology Subcommittee of the Council on Clinical Cardiology and the Council on Genomic and Precision Medicine; the Council on Arteriosclerosis, Thrombosis, and Vascular Biology; and the Council on Cardiovascular Radiology and Intervention.

The research had no commercial funding. Dr. Okwuosa has disclosed no relevant financial relationships.

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

Hormonal therapies for the treatment of hormone-dependent breast and prostate cancer could raise the risk for myocardial infarction and stroke, and patients need to be closely monitored to allow early detection and treatment of cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.
 

“The statement provides data on the risks of each type of hormonal therapy so clinicians can use it as a guide to help manage cardiovascular risks during cancer treatment,” Tochi Okwuosa, DO, chair of the writing group, said in a news release.

“A team-based approach to patient care that includes the oncology team, cardiologist, primary care clinician, dietitian, endocrinologist, and other health care professionals as appropriate is needed to work with each patient to manage and reduce the increased risk of heart disease and strokes associated with hormonal therapy in breast and prostate cancer treatment,” said Dr. Okwuosa, director of cardio-oncology services, Rush University Medical Center, Chicago.

The scientific statement was published online April 26 in Circulation: Genomic and Precision Medicine.

Hormone-dependent cancers, such as prostate and breast cancer, are the most common noncutaneous cancers in the United States and around the world. As hormonal therapies have markedly improved survival in these patients, CVD has emerged as a leading cause illness and death.

The increased CVD burden might be explained by the increasing average age of cancer survivors, leading to higher rates of age-related CV risk factors and coronary artery disease.

The writing group reviewed existing evidence from observational studies and randomized controlled trials on the cardiovascular impact of anticancer hormonal therapies.



Among the key findings:

• In patients with breast cancer,  has been shown to increase the risk for venous thromboembolic events, but to have somewhat protective to neutral effects on CVD risk burden and CVD events. Conversely, aromatase inhibitors have been shown to increase the risk for CVD risk factors and events, including MI and stroke.
• Androgen-deprivation therapy for prostate cancer appears to increase the risk for CV events, although gonadotrophin-releasing hormone (GnRH) antagonists are associated with a lower risk for CV events than are GnRH agonists. The oral antiandrogens appear to be associated with increased CVD risk as well, particularly when used for complete androgen blockade as combination GnRH/anti-androgen therapy.
• The duration of hormonal therapies has a significant impact on CVD risk; the longer patients receive hormonal therapy, the greater the risk. More research is needed to better define the risks associated with duration of treatment.
• The data are mixed on the impact of preexisting CV risk factors and CVD on CV events associated with hormonal therapy. Although the presence of baseline CV risk factors and CVD can increase CV events associated with aromatase inhibitors, it is not clear that tamoxifen does.
• Studies suggest that patients with prostate cancer and baseline CVD and CV risk factors have increased rates of CV events when treated with androgen-deprivation therapy.
• Although the prolonged use of some hormonal therapies worsens CV risk factors and , the effects of the duration of therapy on CV events are less clear.

The writing group noted that there are no definitive guidelines for the monitoring and management of hormonal therapy-related CVD risks.

The authors encourage clinicians to be alert for worsening CV problems in those with preexisting heart disease or risk factors, and to recognize that even patients without preexisting CV problems are at higher risk because of their exposure to hormonal therapies.

“For patients who have two or more cardiovascular risk factors, it is likely that referral to a cardiologist would be appropriate prior to beginning hormone treatment. For patients already receiving hormonal therapies, a discussion with the oncology team can help to determine if a cardiology referral is recommended,” Dr. Okwuosa said in the news release.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Cardio-Oncology Subcommittee of the Council on Clinical Cardiology and the Council on Genomic and Precision Medicine; the Council on Arteriosclerosis, Thrombosis, and Vascular Biology; and the Council on Cardiovascular Radiology and Intervention.

The research had no commercial funding. Dr. Okwuosa has disclosed no relevant financial relationships.

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

Hormonal therapies for the treatment of hormone-dependent breast and prostate cancer could raise the risk for myocardial infarction and stroke, and patients need to be closely monitored to allow early detection and treatment of cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.
 

“The statement provides data on the risks of each type of hormonal therapy so clinicians can use it as a guide to help manage cardiovascular risks during cancer treatment,” Tochi Okwuosa, DO, chair of the writing group, said in a news release.

“A team-based approach to patient care that includes the oncology team, cardiologist, primary care clinician, dietitian, endocrinologist, and other health care professionals as appropriate is needed to work with each patient to manage and reduce the increased risk of heart disease and strokes associated with hormonal therapy in breast and prostate cancer treatment,” said Dr. Okwuosa, director of cardio-oncology services, Rush University Medical Center, Chicago.

The scientific statement was published online April 26 in Circulation: Genomic and Precision Medicine.

Hormone-dependent cancers, such as prostate and breast cancer, are the most common noncutaneous cancers in the United States and around the world. As hormonal therapies have markedly improved survival in these patients, CVD has emerged as a leading cause illness and death.

The increased CVD burden might be explained by the increasing average age of cancer survivors, leading to higher rates of age-related CV risk factors and coronary artery disease.

The writing group reviewed existing evidence from observational studies and randomized controlled trials on the cardiovascular impact of anticancer hormonal therapies.



Among the key findings:

• In patients with breast cancer,  has been shown to increase the risk for venous thromboembolic events, but to have somewhat protective to neutral effects on CVD risk burden and CVD events. Conversely, aromatase inhibitors have been shown to increase the risk for CVD risk factors and events, including MI and stroke.
• Androgen-deprivation therapy for prostate cancer appears to increase the risk for CV events, although gonadotrophin-releasing hormone (GnRH) antagonists are associated with a lower risk for CV events than are GnRH agonists. The oral antiandrogens appear to be associated with increased CVD risk as well, particularly when used for complete androgen blockade as combination GnRH/anti-androgen therapy.
• The duration of hormonal therapies has a significant impact on CVD risk; the longer patients receive hormonal therapy, the greater the risk. More research is needed to better define the risks associated with duration of treatment.
• The data are mixed on the impact of preexisting CV risk factors and CVD on CV events associated with hormonal therapy. Although the presence of baseline CV risk factors and CVD can increase CV events associated with aromatase inhibitors, it is not clear that tamoxifen does.
• Studies suggest that patients with prostate cancer and baseline CVD and CV risk factors have increased rates of CV events when treated with androgen-deprivation therapy.
• Although the prolonged use of some hormonal therapies worsens CV risk factors and , the effects of the duration of therapy on CV events are less clear.

The writing group noted that there are no definitive guidelines for the monitoring and management of hormonal therapy-related CVD risks.

The authors encourage clinicians to be alert for worsening CV problems in those with preexisting heart disease or risk factors, and to recognize that even patients without preexisting CV problems are at higher risk because of their exposure to hormonal therapies.

“For patients who have two or more cardiovascular risk factors, it is likely that referral to a cardiologist would be appropriate prior to beginning hormone treatment. For patients already receiving hormonal therapies, a discussion with the oncology team can help to determine if a cardiology referral is recommended,” Dr. Okwuosa said in the news release.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Cardio-Oncology Subcommittee of the Council on Clinical Cardiology and the Council on Genomic and Precision Medicine; the Council on Arteriosclerosis, Thrombosis, and Vascular Biology; and the Council on Cardiovascular Radiology and Intervention.

The research had no commercial funding. Dr. Okwuosa has disclosed no relevant financial relationships.

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

On the first day of a historic 3-day meeting about drugs that were granted an accelerated approval by the Food and Drug Administration for cancer indications, the first approval to come under discussion is staying in place, at least for now.

Members of the FDA’s Oncologic Drugs Advisory Committee voted 7-2 in favor of keeping in place the indication for atezolizumab (Tecentriq) for use in a certain form of breast cancer. At the same time, the committee urged the manufacturer, Genentech, to do the research needed to prove the medicine works for these patients.

The specific indication is for atezolizumab as part of a combination with nab-paclitaxel for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors are PD-L1 positive.

The FDA granted accelerated approval in 2019 for this use of atezolizumab, expecting Genentech to produce more extensive evidence of this benefit. But so far, Genentech has not produced the data proving to the FDA that atezolizumab provides the expected benefit.

The drug was already available for use in bladder cancer, having been granted a full approval for this indication in 2016.
 

Other accelerated approvals withdrawn

This week’s 3-day ODAC meeting is part of the FDA’s broader reconsideration of what it has described as “dangling accelerated approvals.”

Earlier discussions between the FDA and drugmakers have already triggered four voluntary withdrawals of cancer indications with these accelerated approvals, noted Julia A. Beaver, MD, and Richard Pazdur, MD, two of the FDA’s top regulators of oncology medicine, in an April 21 perspective article in the New England Journal of Medicine.

“The small percentage of drugs whose clinical benefit is ultimately not confirmed should be viewed not as a failure of accelerated approval but rather as an expected trade-off in expediting drug development that benefits patients with severe or life-threatening diseases,” Dr. Beaver and Dr. Pazdur wrote.

But making these calls can be tough. On the first day of the meeting, even ODAC panelists who backed Genentech’s bid to maintain an mTNBC indication for atezolizumab expressed discomfort with this choice.

The FDA granted the accelerated approval for use of this drug in March 2019 based on improved progression-free survival from the IMpassion130 trial. But the drug fell short in subsequent efforts to confirm the results seen in that study. The confirmatory IMpassion131 trial failed to meet the primary endpoint, the FDA staff noted in briefing materials for the ODAC meeting.

ODAC panelist Stan Lipkowitz, MD, PhD, of the National Cancer Institute, said he expected this vote had been a tough one for all members serving on ODAC that day.

“In some ways, the purist in me said I should have voted no. But when I looked at the data, there are a couple of things that struck me,” said Dr. Lipkowitz, who is the chief of the Women’s Malignancies Branch at NCI’s Center for Cancer Research. “First of all, the landscape hasn’t changed. There’s really no therapy in the first line for triple-negative metastatic that is shown to improve survival.”

Dr. Lipkowitz emphasized that Genentech needs to continue to try to prove atezolizumab works in this setting.

“There needs to be confirmatory study,” Dr. Lipkowitz concluded.

ODAC panelist Matthew Ellis, MD, PhD, of Baylor College of Medicine, Houston, said he also understood the difficult outlook for women fighting this cancer, but he voted against maintaining the approval.

“It’s not that I don’t feel the tragedy of these women,” said Dr. Ellis, citing his own decades of clinical experience.

“I just think that the data are the data,” Dr. Ellis said, adding that, in his view, “the only correct interpretation” of the evidence supported a vote against allowing the indication to stay.

The FDA considers the recommendations of its advisory committees but is not bound by them.

In a statement issued after the vote, Genentech said it intends to work with the FDA to determine the next steps for this indication of atezolizumab because “the clinically meaningful benefit demonstrated in the IMpassion130 study remains.”

The ODAC meeting continues for 2 more days, and will consider five more cancer indications that have been granted an accelerated approval.

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

On the first day of a historic 3-day meeting about drugs that were granted an accelerated approval by the Food and Drug Administration for cancer indications, the first approval to come under discussion is staying in place, at least for now.

Members of the FDA’s Oncologic Drugs Advisory Committee voted 7-2 in favor of keeping in place the indication for atezolizumab (Tecentriq) for use in a certain form of breast cancer. At the same time, the committee urged the manufacturer, Genentech, to do the research needed to prove the medicine works for these patients.

The specific indication is for atezolizumab as part of a combination with nab-paclitaxel for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors are PD-L1 positive.

The FDA granted accelerated approval in 2019 for this use of atezolizumab, expecting Genentech to produce more extensive evidence of this benefit. But so far, Genentech has not produced the data proving to the FDA that atezolizumab provides the expected benefit.

The drug was already available for use in bladder cancer, having been granted a full approval for this indication in 2016.
 

Other accelerated approvals withdrawn

This week’s 3-day ODAC meeting is part of the FDA’s broader reconsideration of what it has described as “dangling accelerated approvals.”

Earlier discussions between the FDA and drugmakers have already triggered four voluntary withdrawals of cancer indications with these accelerated approvals, noted Julia A. Beaver, MD, and Richard Pazdur, MD, two of the FDA’s top regulators of oncology medicine, in an April 21 perspective article in the New England Journal of Medicine.

“The small percentage of drugs whose clinical benefit is ultimately not confirmed should be viewed not as a failure of accelerated approval but rather as an expected trade-off in expediting drug development that benefits patients with severe or life-threatening diseases,” Dr. Beaver and Dr. Pazdur wrote.

But making these calls can be tough. On the first day of the meeting, even ODAC panelists who backed Genentech’s bid to maintain an mTNBC indication for atezolizumab expressed discomfort with this choice.

The FDA granted the accelerated approval for use of this drug in March 2019 based on improved progression-free survival from the IMpassion130 trial. But the drug fell short in subsequent efforts to confirm the results seen in that study. The confirmatory IMpassion131 trial failed to meet the primary endpoint, the FDA staff noted in briefing materials for the ODAC meeting.

ODAC panelist Stan Lipkowitz, MD, PhD, of the National Cancer Institute, said he expected this vote had been a tough one for all members serving on ODAC that day.

“In some ways, the purist in me said I should have voted no. But when I looked at the data, there are a couple of things that struck me,” said Dr. Lipkowitz, who is the chief of the Women’s Malignancies Branch at NCI’s Center for Cancer Research. “First of all, the landscape hasn’t changed. There’s really no therapy in the first line for triple-negative metastatic that is shown to improve survival.”

Dr. Lipkowitz emphasized that Genentech needs to continue to try to prove atezolizumab works in this setting.

“There needs to be confirmatory study,” Dr. Lipkowitz concluded.

ODAC panelist Matthew Ellis, MD, PhD, of Baylor College of Medicine, Houston, said he also understood the difficult outlook for women fighting this cancer, but he voted against maintaining the approval.

“It’s not that I don’t feel the tragedy of these women,” said Dr. Ellis, citing his own decades of clinical experience.

“I just think that the data are the data,” Dr. Ellis said, adding that, in his view, “the only correct interpretation” of the evidence supported a vote against allowing the indication to stay.

The FDA considers the recommendations of its advisory committees but is not bound by them.

In a statement issued after the vote, Genentech said it intends to work with the FDA to determine the next steps for this indication of atezolizumab because “the clinically meaningful benefit demonstrated in the IMpassion130 study remains.”

The ODAC meeting continues for 2 more days, and will consider five more cancer indications that have been granted an accelerated approval.

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

On the first day of a historic 3-day meeting about drugs that were granted an accelerated approval by the Food and Drug Administration for cancer indications, the first approval to come under discussion is staying in place, at least for now.

Members of the FDA’s Oncologic Drugs Advisory Committee voted 7-2 in favor of keeping in place the indication for atezolizumab (Tecentriq) for use in a certain form of breast cancer. At the same time, the committee urged the manufacturer, Genentech, to do the research needed to prove the medicine works for these patients.

The specific indication is for atezolizumab as part of a combination with nab-paclitaxel for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors are PD-L1 positive.

The FDA granted accelerated approval in 2019 for this use of atezolizumab, expecting Genentech to produce more extensive evidence of this benefit. But so far, Genentech has not produced the data proving to the FDA that atezolizumab provides the expected benefit.

The drug was already available for use in bladder cancer, having been granted a full approval for this indication in 2016.
 

Other accelerated approvals withdrawn

This week’s 3-day ODAC meeting is part of the FDA’s broader reconsideration of what it has described as “dangling accelerated approvals.”

Earlier discussions between the FDA and drugmakers have already triggered four voluntary withdrawals of cancer indications with these accelerated approvals, noted Julia A. Beaver, MD, and Richard Pazdur, MD, two of the FDA’s top regulators of oncology medicine, in an April 21 perspective article in the New England Journal of Medicine.

“The small percentage of drugs whose clinical benefit is ultimately not confirmed should be viewed not as a failure of accelerated approval but rather as an expected trade-off in expediting drug development that benefits patients with severe or life-threatening diseases,” Dr. Beaver and Dr. Pazdur wrote.

But making these calls can be tough. On the first day of the meeting, even ODAC panelists who backed Genentech’s bid to maintain an mTNBC indication for atezolizumab expressed discomfort with this choice.

The FDA granted the accelerated approval for use of this drug in March 2019 based on improved progression-free survival from the IMpassion130 trial. But the drug fell short in subsequent efforts to confirm the results seen in that study. The confirmatory IMpassion131 trial failed to meet the primary endpoint, the FDA staff noted in briefing materials for the ODAC meeting.

ODAC panelist Stan Lipkowitz, MD, PhD, of the National Cancer Institute, said he expected this vote had been a tough one for all members serving on ODAC that day.

“In some ways, the purist in me said I should have voted no. But when I looked at the data, there are a couple of things that struck me,” said Dr. Lipkowitz, who is the chief of the Women’s Malignancies Branch at NCI’s Center for Cancer Research. “First of all, the landscape hasn’t changed. There’s really no therapy in the first line for triple-negative metastatic that is shown to improve survival.”

Dr. Lipkowitz emphasized that Genentech needs to continue to try to prove atezolizumab works in this setting.

“There needs to be confirmatory study,” Dr. Lipkowitz concluded.

ODAC panelist Matthew Ellis, MD, PhD, of Baylor College of Medicine, Houston, said he also understood the difficult outlook for women fighting this cancer, but he voted against maintaining the approval.

“It’s not that I don’t feel the tragedy of these women,” said Dr. Ellis, citing his own decades of clinical experience.

“I just think that the data are the data,” Dr. Ellis said, adding that, in his view, “the only correct interpretation” of the evidence supported a vote against allowing the indication to stay.

The FDA considers the recommendations of its advisory committees but is not bound by them.

In a statement issued after the vote, Genentech said it intends to work with the FDA to determine the next steps for this indication of atezolizumab because “the clinically meaningful benefit demonstrated in the IMpassion130 study remains.”

The ODAC meeting continues for 2 more days, and will consider five more cancer indications that have been granted an accelerated approval.

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