Breast Cancer

Key clinical point: A survey-based study shows higher chemotherapy use in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer with poor prognostic factors.

Major finding: At least 1 poor prognostic factor was reported in 63% of patients, with varying degrees of overlap between factors. The ability of patients to maintain usual activities was more common in patients without poor prognostic factors. Chemotherapy was prescribed more frequently in patients with poor prognostic factors, whereas endocrine therapy and nonopioid analgesic were more common in patients without poor prognostic factors.

Study details: Real-world data were derived from a large multinational Adelphi Real World Disease Specific Programme survey of 410 oncologists and 2,259 patients with HR-positive, HER-negative advanced breast cancer.

Disclosures: This study was supported by Eli Lilly and Company Ltd, Windlesham, UK. The authors were employees of or received consulting/advisory fees and/or honoraria from Eli Lilly and Company.

Source: Davie A et al. ESMO Open. 2021;6(4):10226 doi: 10.1016/j.esmoop.2021.100226.

Key clinical point: A survey-based study shows higher chemotherapy use in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer with poor prognostic factors.

Major finding: At least 1 poor prognostic factor was reported in 63% of patients, with varying degrees of overlap between factors. The ability of patients to maintain usual activities was more common in patients without poor prognostic factors. Chemotherapy was prescribed more frequently in patients with poor prognostic factors, whereas endocrine therapy and nonopioid analgesic were more common in patients without poor prognostic factors.

Study details: Real-world data were derived from a large multinational Adelphi Real World Disease Specific Programme survey of 410 oncologists and 2,259 patients with HR-positive, HER-negative advanced breast cancer.

Disclosures: This study was supported by Eli Lilly and Company Ltd, Windlesham, UK. The authors were employees of or received consulting/advisory fees and/or honoraria from Eli Lilly and Company.

Source: Davie A et al. ESMO Open. 2021;6(4):10226 doi: 10.1016/j.esmoop.2021.100226.

Key clinical point: A survey-based study shows higher chemotherapy use in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer with poor prognostic factors.

Major finding: At least 1 poor prognostic factor was reported in 63% of patients, with varying degrees of overlap between factors. The ability of patients to maintain usual activities was more common in patients without poor prognostic factors. Chemotherapy was prescribed more frequently in patients with poor prognostic factors, whereas endocrine therapy and nonopioid analgesic were more common in patients without poor prognostic factors.

Study details: Real-world data were derived from a large multinational Adelphi Real World Disease Specific Programme survey of 410 oncologists and 2,259 patients with HR-positive, HER-negative advanced breast cancer.

Disclosures: This study was supported by Eli Lilly and Company Ltd, Windlesham, UK. The authors were employees of or received consulting/advisory fees and/or honoraria from Eli Lilly and Company.

Source: Davie A et al. ESMO Open. 2021;6(4):10226 doi: 10.1016/j.esmoop.2021.100226.

Key clinical point: Women aged 65 years and above with pathogenic variants (PVs) in BRCA1/2, checkpoint kinase 2 (CHEK2), and partner and localizer of the BRCA2 (PALB2) genes are at an increased risk for breast cancer.

Major finding: The rate of PVs was 3.18% in women with breast cancer and 1.48% in those without. PVs in BRCA1 (odds ratio [OR], 3.37), BRCA2 (OR, 2.64), PALB2 (OR, 3.09), and CHEK2 (OR, 2.13) and were associated with moderate risk for breast cancer. The remaining lifetime risk was 18.4%, 18.7%, 15.9%, and 14.9% for BRCA1, BRCA2, PALB2, and CHEK2 PVs

Study details: This was a population-based study of 13,762 women with breast cancer (age, 65 years and above) and matched 12,945 women without cancer who were tested for PVs in germline predisposition genes.

Disclosures: The study was supported by the National Institutes of Health and Breast Cancer Research Foundation. The authors declared receiving grants, research funding, speaker/personal fees, and/or travel/accommodation/expenses and/or employment and stock ownership.

Source: Boddicker NJ et al. J Clin Oncol. 2021 Jul 22 (in press). doi: 10.1200/JCO.21.00531.

Key clinical point: Women aged 65 years and above with pathogenic variants (PVs) in BRCA1/2, checkpoint kinase 2 (CHEK2), and partner and localizer of the BRCA2 (PALB2) genes are at an increased risk for breast cancer.

Major finding: The rate of PVs was 3.18% in women with breast cancer and 1.48% in those without. PVs in BRCA1 (odds ratio [OR], 3.37), BRCA2 (OR, 2.64), PALB2 (OR, 3.09), and CHEK2 (OR, 2.13) and were associated with moderate risk for breast cancer. The remaining lifetime risk was 18.4%, 18.7%, 15.9%, and 14.9% for BRCA1, BRCA2, PALB2, and CHEK2 PVs

Study details: This was a population-based study of 13,762 women with breast cancer (age, 65 years and above) and matched 12,945 women without cancer who were tested for PVs in germline predisposition genes.

Disclosures: The study was supported by the National Institutes of Health and Breast Cancer Research Foundation. The authors declared receiving grants, research funding, speaker/personal fees, and/or travel/accommodation/expenses and/or employment and stock ownership.

Source: Boddicker NJ et al. J Clin Oncol. 2021 Jul 22 (in press). doi: 10.1200/JCO.21.00531.

Key clinical point: Women aged 65 years and above with pathogenic variants (PVs) in BRCA1/2, checkpoint kinase 2 (CHEK2), and partner and localizer of the BRCA2 (PALB2) genes are at an increased risk for breast cancer.

Major finding: The rate of PVs was 3.18% in women with breast cancer and 1.48% in those without. PVs in BRCA1 (odds ratio [OR], 3.37), BRCA2 (OR, 2.64), PALB2 (OR, 3.09), and CHEK2 (OR, 2.13) and were associated with moderate risk for breast cancer. The remaining lifetime risk was 18.4%, 18.7%, 15.9%, and 14.9% for BRCA1, BRCA2, PALB2, and CHEK2 PVs

Study details: This was a population-based study of 13,762 women with breast cancer (age, 65 years and above) and matched 12,945 women without cancer who were tested for PVs in germline predisposition genes.

Disclosures: The study was supported by the National Institutes of Health and Breast Cancer Research Foundation. The authors declared receiving grants, research funding, speaker/personal fees, and/or travel/accommodation/expenses and/or employment and stock ownership.

Source: Boddicker NJ et al. J Clin Oncol. 2021 Jul 22 (in press). doi: 10.1200/JCO.21.00531.

Key clinical point: Targeted breast screening in women aged 30-60 years at an increased familial risk is associated with good long-term survival.

Major finding: A total of 649 breast cancers were detected during the follow-up of 129,119 person-years. Breast cancer-specific survival at 10 years was 91.3%, which was higher than the previously reported survival in women presenting with primary breast cancer. Moreover, 10-year survival for women diagnosed at age 40 years and below was 93.8%.

Study details: This was a retrospective study of women who were offered enhanced screening with annual mammography starting at age 35 years or 5 years younger than the youngest affected relative, with the upper age limit of 50 years for women at moderate risk and 60 years for those at high risk.

Disclosures: This work was supported by the National Institute for Health Research and Prevent Breast Cancer. Dr. DG Evans received consulting fees from companies. The other authors declared no conflict of interests.

Source: Evans DG et al. Breast Cancer Res Treat. 2021 Jul 26 (in press). doi: 10.1007/s10549-021-06333-1.

Key clinical point: Targeted breast screening in women aged 30-60 years at an increased familial risk is associated with good long-term survival.

Major finding: A total of 649 breast cancers were detected during the follow-up of 129,119 person-years. Breast cancer-specific survival at 10 years was 91.3%, which was higher than the previously reported survival in women presenting with primary breast cancer. Moreover, 10-year survival for women diagnosed at age 40 years and below was 93.8%.

Study details: This was a retrospective study of women who were offered enhanced screening with annual mammography starting at age 35 years or 5 years younger than the youngest affected relative, with the upper age limit of 50 years for women at moderate risk and 60 years for those at high risk.

Disclosures: This work was supported by the National Institute for Health Research and Prevent Breast Cancer. Dr. DG Evans received consulting fees from companies. The other authors declared no conflict of interests.

Source: Evans DG et al. Breast Cancer Res Treat. 2021 Jul 26 (in press). doi: 10.1007/s10549-021-06333-1.

Key clinical point: Targeted breast screening in women aged 30-60 years at an increased familial risk is associated with good long-term survival.

Major finding: A total of 649 breast cancers were detected during the follow-up of 129,119 person-years. Breast cancer-specific survival at 10 years was 91.3%, which was higher than the previously reported survival in women presenting with primary breast cancer. Moreover, 10-year survival for women diagnosed at age 40 years and below was 93.8%.

Study details: This was a retrospective study of women who were offered enhanced screening with annual mammography starting at age 35 years or 5 years younger than the youngest affected relative, with the upper age limit of 50 years for women at moderate risk and 60 years for those at high risk.

Disclosures: This work was supported by the National Institute for Health Research and Prevent Breast Cancer. Dr. DG Evans received consulting fees from companies. The other authors declared no conflict of interests.

Source: Evans DG et al. Breast Cancer Res Treat. 2021 Jul 26 (in press). doi: 10.1007/s10549-021-06333-1.

Key clinical point: Extended intermittent and continuous letrozole yield similar disease-free survival in postmenopausal women with hormone receptor (HR)-positive breast cancer. Circulating estrogen levels were restored after letrozole interruption.

Major finding: There was no difference in 7-year disease-free survival between intermittent and continuous letrozole groups (P = 0.64). The median change in estradiol levels after letrozole interruption was 141% vs. 2.2% with continuous letrozole during the same duration.

Study details: The Study of Letrozole Extension (SOLE) trial was an open-label, phase 3 study of 4,884 postmenopausal women with HR-positive, lymph node-positive, operable breast cancer, randomly assigned to extended intermittent or continuous letrozole. The SOLE-EST sub study (n=104) evaluated changes in circulating estrogen levels.

Disclosures: SOLE study was supported by Novartis and the International Breast Cancer Study Group. SOLE-EST was partially funded by the Belgian Foundation Against Cancer, Breast Cancer Trials Australia and New Zealand, and Susan G. Komen for the Cure. The authors received research support, honoraria, nonfinancial support, advisory/consulting/travel fees, and/or salary from various sources.

Source: Jerusalem G et al. Ann Oncol. 2021 Aug 9 (in press). doi: 10.1016/j.annonc.2021.07.017.

Key clinical point: Extended intermittent and continuous letrozole yield similar disease-free survival in postmenopausal women with hormone receptor (HR)-positive breast cancer. Circulating estrogen levels were restored after letrozole interruption.

Major finding: There was no difference in 7-year disease-free survival between intermittent and continuous letrozole groups (P = 0.64). The median change in estradiol levels after letrozole interruption was 141% vs. 2.2% with continuous letrozole during the same duration.

Study details: The Study of Letrozole Extension (SOLE) trial was an open-label, phase 3 study of 4,884 postmenopausal women with HR-positive, lymph node-positive, operable breast cancer, randomly assigned to extended intermittent or continuous letrozole. The SOLE-EST sub study (n=104) evaluated changes in circulating estrogen levels.

Disclosures: SOLE study was supported by Novartis and the International Breast Cancer Study Group. SOLE-EST was partially funded by the Belgian Foundation Against Cancer, Breast Cancer Trials Australia and New Zealand, and Susan G. Komen for the Cure. The authors received research support, honoraria, nonfinancial support, advisory/consulting/travel fees, and/or salary from various sources.

Source: Jerusalem G et al. Ann Oncol. 2021 Aug 9 (in press). doi: 10.1016/j.annonc.2021.07.017.

Key clinical point: Extended intermittent and continuous letrozole yield similar disease-free survival in postmenopausal women with hormone receptor (HR)-positive breast cancer. Circulating estrogen levels were restored after letrozole interruption.

Major finding: There was no difference in 7-year disease-free survival between intermittent and continuous letrozole groups (P = 0.64). The median change in estradiol levels after letrozole interruption was 141% vs. 2.2% with continuous letrozole during the same duration.

Study details: The Study of Letrozole Extension (SOLE) trial was an open-label, phase 3 study of 4,884 postmenopausal women with HR-positive, lymph node-positive, operable breast cancer, randomly assigned to extended intermittent or continuous letrozole. The SOLE-EST sub study (n=104) evaluated changes in circulating estrogen levels.

Disclosures: SOLE study was supported by Novartis and the International Breast Cancer Study Group. SOLE-EST was partially funded by the Belgian Foundation Against Cancer, Breast Cancer Trials Australia and New Zealand, and Susan G. Komen for the Cure. The authors received research support, honoraria, nonfinancial support, advisory/consulting/travel fees, and/or salary from various sources.

Source: Jerusalem G et al. Ann Oncol. 2021 Aug 9 (in press). doi: 10.1016/j.annonc.2021.07.017.

Key clinical point: In patients with inoperable locally advanced/metastatic triple-negative breast cancer (TNBC), the overall survival benefit with add-on ipatasertib was not statistically significant but numerically longer.

Major finding: The median overall survival with ipatasertib plus paclitaxel vs placebo plus paclitaxel was 25.8 months vs. 16.9 months (hazard ratio, 0.80; 95% confidence interval, 0.50-1.28). The most common grade ≥3 adverse events in the ipatasertib vs placebo groups were diarrhea (23% vs. 0%) and neutropenia (10% vs. 2%).

Study details: A multicenter, randomized, double-blind phase 2 study of 124 patients with inoperable locally advanced/metastatic TNBC who were randomly assigned to receive first-line paclitaxel with either ipatasertib or placebo.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors received honoraria, research funding, consultancy/advisory fees, travel/accommodation/expenses, and research funding. Some authors or their spouses were employed and/or held stocks and/or had ownership in companies.

Source: Dent R et al. Breast Cancer Res Treat. 2021;189:377-386.  doi: 10.1007/s10549-021-06143-5.

Key clinical point: In patients with inoperable locally advanced/metastatic triple-negative breast cancer (TNBC), the overall survival benefit with add-on ipatasertib was not statistically significant but numerically longer.

Major finding: The median overall survival with ipatasertib plus paclitaxel vs placebo plus paclitaxel was 25.8 months vs. 16.9 months (hazard ratio, 0.80; 95% confidence interval, 0.50-1.28). The most common grade ≥3 adverse events in the ipatasertib vs placebo groups were diarrhea (23% vs. 0%) and neutropenia (10% vs. 2%).

Study details: A multicenter, randomized, double-blind phase 2 study of 124 patients with inoperable locally advanced/metastatic TNBC who were randomly assigned to receive first-line paclitaxel with either ipatasertib or placebo.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors received honoraria, research funding, consultancy/advisory fees, travel/accommodation/expenses, and research funding. Some authors or their spouses were employed and/or held stocks and/or had ownership in companies.

Source: Dent R et al. Breast Cancer Res Treat. 2021;189:377-386.  doi: 10.1007/s10549-021-06143-5.

Key clinical point: In patients with inoperable locally advanced/metastatic triple-negative breast cancer (TNBC), the overall survival benefit with add-on ipatasertib was not statistically significant but numerically longer.

Major finding: The median overall survival with ipatasertib plus paclitaxel vs placebo plus paclitaxel was 25.8 months vs. 16.9 months (hazard ratio, 0.80; 95% confidence interval, 0.50-1.28). The most common grade ≥3 adverse events in the ipatasertib vs placebo groups were diarrhea (23% vs. 0%) and neutropenia (10% vs. 2%).

Study details: A multicenter, randomized, double-blind phase 2 study of 124 patients with inoperable locally advanced/metastatic TNBC who were randomly assigned to receive first-line paclitaxel with either ipatasertib or placebo.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors received honoraria, research funding, consultancy/advisory fees, travel/accommodation/expenses, and research funding. Some authors or their spouses were employed and/or held stocks and/or had ownership in companies.

Source: Dent R et al. Breast Cancer Res Treat. 2021;189:377-386.  doi: 10.1007/s10549-021-06143-5.

Key clinical point: Adjuvant celecoxib for 2 years vs placebo fails to extend survival in patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Major finding: In patients who received celecoxib vs placebo, no significant difference was observed in the disease-free survival (P = 0.75) and the overall survival (P = 0.78). In the celecoxib vs. placebo group, similar rates of cardiac events (15% vs. 13%) and new primary non-breast cancers (4% vs 4%) were reported.

Study details: A phase 3, randomized, double-blind study of patients with HER2-negative breast cancer who were randomly assigned to adjuvant celecoxib for 2 years or placebo following complete resection.

Disclosures: The study was supported by Pfizer, Cancer Research UK, The Royal Marsden NHS Foundation Trust, and the Institute of Cancer Research, London. The authors reported receiving grants, research funding, personal fees, advisory fees, nonfinancial support, and/or honoraria and/or having patents outside this work.

Source: Coombes RC et al. JAMA Oncol. 2021 Jul 15 (in press). doi: 10.1001/jamaoncol.2021.2193.

Key clinical point: Adjuvant celecoxib for 2 years vs placebo fails to extend survival in patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Major finding: In patients who received celecoxib vs placebo, no significant difference was observed in the disease-free survival (P = 0.75) and the overall survival (P = 0.78). In the celecoxib vs. placebo group, similar rates of cardiac events (15% vs. 13%) and new primary non-breast cancers (4% vs 4%) were reported.

Study details: A phase 3, randomized, double-blind study of patients with HER2-negative breast cancer who were randomly assigned to adjuvant celecoxib for 2 years or placebo following complete resection.

Disclosures: The study was supported by Pfizer, Cancer Research UK, The Royal Marsden NHS Foundation Trust, and the Institute of Cancer Research, London. The authors reported receiving grants, research funding, personal fees, advisory fees, nonfinancial support, and/or honoraria and/or having patents outside this work.

Source: Coombes RC et al. JAMA Oncol. 2021 Jul 15 (in press). doi: 10.1001/jamaoncol.2021.2193.

Key clinical point: Adjuvant celecoxib for 2 years vs placebo fails to extend survival in patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Major finding: In patients who received celecoxib vs placebo, no significant difference was observed in the disease-free survival (P = 0.75) and the overall survival (P = 0.78). In the celecoxib vs. placebo group, similar rates of cardiac events (15% vs. 13%) and new primary non-breast cancers (4% vs 4%) were reported.

Study details: A phase 3, randomized, double-blind study of patients with HER2-negative breast cancer who were randomly assigned to adjuvant celecoxib for 2 years or placebo following complete resection.

Disclosures: The study was supported by Pfizer, Cancer Research UK, The Royal Marsden NHS Foundation Trust, and the Institute of Cancer Research, London. The authors reported receiving grants, research funding, personal fees, advisory fees, nonfinancial support, and/or honoraria and/or having patents outside this work.

Source: Coombes RC et al. JAMA Oncol. 2021 Jul 15 (in press). doi: 10.1001/jamaoncol.2021.2193.

Key clinical point: Adding trastuzumab to chemotherapy in patients with early-stage, epidermal growth hormone receptor 2 (HER2)-positive breast cancer lowers the rate of recurrence and mortality from breast cancer.

Major finding: Trastuzumab plus chemotherapy vs chemotherapy alone significantly reduced the rates of breast cancer recurrence (rate ratio [RR], 0.66; P < 0.0001) and death from breast cancer (RR, 0.67; P < 0.0001). The average absolute reduction in 10-year risk of recurrence was 9.0% (P < 0.0001) and in 10-year breast cancer mortality was 6.4% (P < 0.0001).

Study details: This was a meta-analysis of individual patient data from 7 randomized trials including 13,864 patients with early-stage, HER2-positive breast cancer who were randomly assigned to trastuzumab plus chemotherapy or chemotherapy alone.

Disclosures: The study was funded by Cancer Research UK and the UK Medical Research Council. The authors declared grants, contracts, consulting/speaker/advisory fees, patents, royalties, and support for attending meetings and travel. Dr. H Joensuu reported a leadership/fiduciary role and stock or stock options from Orion Pharma.

Source: Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Lancet Oncol. 2021;22(8):1139-1150. doi: 10.1016/S1470-2045(21)00288-6.

Key clinical point: Adding trastuzumab to chemotherapy in patients with early-stage, epidermal growth hormone receptor 2 (HER2)-positive breast cancer lowers the rate of recurrence and mortality from breast cancer.

Major finding: Trastuzumab plus chemotherapy vs chemotherapy alone significantly reduced the rates of breast cancer recurrence (rate ratio [RR], 0.66; P < 0.0001) and death from breast cancer (RR, 0.67; P < 0.0001). The average absolute reduction in 10-year risk of recurrence was 9.0% (P < 0.0001) and in 10-year breast cancer mortality was 6.4% (P < 0.0001).

Study details: This was a meta-analysis of individual patient data from 7 randomized trials including 13,864 patients with early-stage, HER2-positive breast cancer who were randomly assigned to trastuzumab plus chemotherapy or chemotherapy alone.

Disclosures: The study was funded by Cancer Research UK and the UK Medical Research Council. The authors declared grants, contracts, consulting/speaker/advisory fees, patents, royalties, and support for attending meetings and travel. Dr. H Joensuu reported a leadership/fiduciary role and stock or stock options from Orion Pharma.

Source: Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Lancet Oncol. 2021;22(8):1139-1150. doi: 10.1016/S1470-2045(21)00288-6.

Key clinical point: Adding trastuzumab to chemotherapy in patients with early-stage, epidermal growth hormone receptor 2 (HER2)-positive breast cancer lowers the rate of recurrence and mortality from breast cancer.

Major finding: Trastuzumab plus chemotherapy vs chemotherapy alone significantly reduced the rates of breast cancer recurrence (rate ratio [RR], 0.66; P < 0.0001) and death from breast cancer (RR, 0.67; P < 0.0001). The average absolute reduction in 10-year risk of recurrence was 9.0% (P < 0.0001) and in 10-year breast cancer mortality was 6.4% (P < 0.0001).

Study details: This was a meta-analysis of individual patient data from 7 randomized trials including 13,864 patients with early-stage, HER2-positive breast cancer who were randomly assigned to trastuzumab plus chemotherapy or chemotherapy alone.

Disclosures: The study was funded by Cancer Research UK and the UK Medical Research Council. The authors declared grants, contracts, consulting/speaker/advisory fees, patents, royalties, and support for attending meetings and travel. Dr. H Joensuu reported a leadership/fiduciary role and stock or stock options from Orion Pharma.

Source: Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Lancet Oncol. 2021;22(8):1139-1150. doi: 10.1016/S1470-2045(21)00288-6.

Key clinical point: Adding entinostat to exemestane does not improve survival in aromatase inhibitor (AI)-resistant advanced hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Major finding: There were no differences between the entinostat and placebo groups in median progression-free survival (3.3 months vs. 3.1 months; P = 0.30) and median overall survival (23.4 months vs. 21.7 months; P = 0.94). The most common grade 3-4 adverse events in the entinostat group were neutropenia (20%) and hypophosphatemia (14%).

Study details: This was a multicenter, randomized, double-blind, placebo-controlled phase 3 E2112 study of 608 patients with AI-resistant, HR-positive, HER2-negative breast cancer, randomly assigned to entinostat plus exemestane or placebo plus exemestane.

Disclosures: The study was supported by the National Cancer Institute of the National Institutes of Health. The authors reported receiving consulting/advisory/speaker fees, research funding, accommodation/travel/expenses, and royalties from and/or stock ownership and/or other relationship in companies or patents owned/filed.

Source: Connoly RM et al. J Clin Oncol. 2021 Aug 6 (in press). doi: 10.1200/JCO.21.00944.

Key clinical point: Adding entinostat to exemestane does not improve survival in aromatase inhibitor (AI)-resistant advanced hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Major finding: There were no differences between the entinostat and placebo groups in median progression-free survival (3.3 months vs. 3.1 months; P = 0.30) and median overall survival (23.4 months vs. 21.7 months; P = 0.94). The most common grade 3-4 adverse events in the entinostat group were neutropenia (20%) and hypophosphatemia (14%).

Study details: This was a multicenter, randomized, double-blind, placebo-controlled phase 3 E2112 study of 608 patients with AI-resistant, HR-positive, HER2-negative breast cancer, randomly assigned to entinostat plus exemestane or placebo plus exemestane.

Disclosures: The study was supported by the National Cancer Institute of the National Institutes of Health. The authors reported receiving consulting/advisory/speaker fees, research funding, accommodation/travel/expenses, and royalties from and/or stock ownership and/or other relationship in companies or patents owned/filed.

Source: Connoly RM et al. J Clin Oncol. 2021 Aug 6 (in press). doi: 10.1200/JCO.21.00944.

Key clinical point: Adding entinostat to exemestane does not improve survival in aromatase inhibitor (AI)-resistant advanced hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Major finding: There were no differences between the entinostat and placebo groups in median progression-free survival (3.3 months vs. 3.1 months; P = 0.30) and median overall survival (23.4 months vs. 21.7 months; P = 0.94). The most common grade 3-4 adverse events in the entinostat group were neutropenia (20%) and hypophosphatemia (14%).

Study details: This was a multicenter, randomized, double-blind, placebo-controlled phase 3 E2112 study of 608 patients with AI-resistant, HR-positive, HER2-negative breast cancer, randomly assigned to entinostat plus exemestane or placebo plus exemestane.

Disclosures: The study was supported by the National Cancer Institute of the National Institutes of Health. The authors reported receiving consulting/advisory/speaker fees, research funding, accommodation/travel/expenses, and royalties from and/or stock ownership and/or other relationship in companies or patents owned/filed.

Source: Connoly RM et al. J Clin Oncol. 2021 Aug 6 (in press). doi: 10.1200/JCO.21.00944.

Key clinical point: A 10-year vs 7-year treatment with aromatase inhibitors (anastrozole) in patients with hormone receptor (HR)-positive breast cancer does not yield survival benefit but increases the risk for bone fracture.

Major finding: Anastrozole treatment for 10 years vs. 7 years was not associated with a significant difference in disease-free survival (P = 0.90). The risk of clinical bone fracture was higher with 10-year treatment (hazard ratio, 1.35; 95% confidence interval, 1.00-1.84).

Study details: The phase 3 Secondary Adjuvant Long Term Study With Arimidex  (SALSA) trial studied 3,484 postmenopausal women with HR-positive breast cancer who had received anastrozole for 5 years and were randomly assigned to therapy extension by 2 years (for a total of 7 years) or 5 years (for a total of 10 years).

Disclosures: This study was supported by AstraZeneca and the Austrian Breast and Colorectal Cancer Study Group. The authors received grants, honoraria, personal/lecture/advisory/consulting/speaker fees, and/or travel/accommodation/expenses outside this work.

Source: Gnant M et al. New Engl J Med. 2021;385:395-405. doi: 10.1056/NEJMoa2104162.

Key clinical point: A 10-year vs 7-year treatment with aromatase inhibitors (anastrozole) in patients with hormone receptor (HR)-positive breast cancer does not yield survival benefit but increases the risk for bone fracture.

Major finding: Anastrozole treatment for 10 years vs. 7 years was not associated with a significant difference in disease-free survival (P = 0.90). The risk of clinical bone fracture was higher with 10-year treatment (hazard ratio, 1.35; 95% confidence interval, 1.00-1.84).

Study details: The phase 3 Secondary Adjuvant Long Term Study With Arimidex  (SALSA) trial studied 3,484 postmenopausal women with HR-positive breast cancer who had received anastrozole for 5 years and were randomly assigned to therapy extension by 2 years (for a total of 7 years) or 5 years (for a total of 10 years).

Disclosures: This study was supported by AstraZeneca and the Austrian Breast and Colorectal Cancer Study Group. The authors received grants, honoraria, personal/lecture/advisory/consulting/speaker fees, and/or travel/accommodation/expenses outside this work.

Source: Gnant M et al. New Engl J Med. 2021;385:395-405. doi: 10.1056/NEJMoa2104162.

Key clinical point: A 10-year vs 7-year treatment with aromatase inhibitors (anastrozole) in patients with hormone receptor (HR)-positive breast cancer does not yield survival benefit but increases the risk for bone fracture.

Major finding: Anastrozole treatment for 10 years vs. 7 years was not associated with a significant difference in disease-free survival (P = 0.90). The risk of clinical bone fracture was higher with 10-year treatment (hazard ratio, 1.35; 95% confidence interval, 1.00-1.84).

Study details: The phase 3 Secondary Adjuvant Long Term Study With Arimidex  (SALSA) trial studied 3,484 postmenopausal women with HR-positive breast cancer who had received anastrozole for 5 years and were randomly assigned to therapy extension by 2 years (for a total of 7 years) or 5 years (for a total of 10 years).

Disclosures: This study was supported by AstraZeneca and the Austrian Breast and Colorectal Cancer Study Group. The authors received grants, honoraria, personal/lecture/advisory/consulting/speaker fees, and/or travel/accommodation/expenses outside this work.

Source: Gnant M et al. New Engl J Med. 2021;385:395-405. doi: 10.1056/NEJMoa2104162.

Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.

Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.

“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”

According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.

The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.

Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.

From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.

The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.

The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.

Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.

Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.

“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”

Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.

“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”

Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.

“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”

Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.

The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.

Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.

Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.

“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”

According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.

The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.

Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.

From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.

The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.

The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.

Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.

Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.

“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”

Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.

“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”

Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.

“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”

Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.

The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.

Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.

Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.

“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”

According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.

The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.

Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.

From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.

The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.

The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.

Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.

Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.

“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”

Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.

“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”

Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.

“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”

Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.

The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.