Endocrine therapy (ET) has long been the therapeutic backbone for the treatment of HR+/HER2- breast cancer. However, for patients who already have advanced HR+/HER2- disease at the time of diagnosis, studies have shown that addition of a CDK4/6 inhibitor significantly improves outcomes compared with ET alone.

In this ReCAP, Dr Kevin Kalinsky, director of the Glenn Family Breast Center at Winship Cancer Institute in Atlanta, Georgia, examines important considerations in the frontline treatment of HR+/HER2- advanced breast cancer.

First, he reviews the PALOMA-2 data, which looked at the overall survival of the CDK4/6 inhibitor palbociclib plus letrozole. He then compares that data with the overall survival data of other CDK4/5 inhibitors.

Dr Kalinsky then examines the findings of MONALEESA-7, which looked at premenopausal patients with HR+/HER2- advanced breast cancer treated with ET plus or minus ribociclib. In that study population, the combination of ET and ribociclib showed an overall survival advantage.

Finally, he discusses data from the Right Choice trial, which found that patients did better when given hormonal therapy plus a CDK4/6 inhibitor as opposed to doublet chemotherapy.

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Kevin Kalinsky, MD, Director, Glenn Family Breast Center, Winship Cancer Institute, Atlanta, Georgia

Kevin Kalinsky, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Pfizer; Eli Lilly; Novartis ; Eisai; AstraZeneca; Daiichi Sankyo; Puma; 4D Pharma; Oncosec; Immunomedics; Merck; Seattle Genetics

Spouse holds stock in: Grail; Array Biopharma; Pfizer (prior employee)

Endocrine therapy (ET) has long been the therapeutic backbone for the treatment of HR+/HER2- breast cancer. However, for patients who already have advanced HR+/HER2- disease at the time of diagnosis, studies have shown that addition of a CDK4/6 inhibitor significantly improves outcomes compared with ET alone.

In this ReCAP, Dr Kevin Kalinsky, director of the Glenn Family Breast Center at Winship Cancer Institute in Atlanta, Georgia, examines important considerations in the frontline treatment of HR+/HER2- advanced breast cancer.

First, he reviews the PALOMA-2 data, which looked at the overall survival of the CDK4/6 inhibitor palbociclib plus letrozole. He then compares that data with the overall survival data of other CDK4/5 inhibitors.

Dr Kalinsky then examines the findings of MONALEESA-7, which looked at premenopausal patients with HR+/HER2- advanced breast cancer treated with ET plus or minus ribociclib. In that study population, the combination of ET and ribociclib showed an overall survival advantage.

Finally, he discusses data from the Right Choice trial, which found that patients did better when given hormonal therapy plus a CDK4/6 inhibitor as opposed to doublet chemotherapy.

--

Kevin Kalinsky, MD, Director, Glenn Family Breast Center, Winship Cancer Institute, Atlanta, Georgia

Kevin Kalinsky, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Pfizer; Eli Lilly; Novartis ; Eisai; AstraZeneca; Daiichi Sankyo; Puma; 4D Pharma; Oncosec; Immunomedics; Merck; Seattle Genetics

Spouse holds stock in: Grail; Array Biopharma; Pfizer (prior employee)

Endocrine therapy (ET) has long been the therapeutic backbone for the treatment of HR+/HER2- breast cancer. However, for patients who already have advanced HR+/HER2- disease at the time of diagnosis, studies have shown that addition of a CDK4/6 inhibitor significantly improves outcomes compared with ET alone.

In this ReCAP, Dr Kevin Kalinsky, director of the Glenn Family Breast Center at Winship Cancer Institute in Atlanta, Georgia, examines important considerations in the frontline treatment of HR+/HER2- advanced breast cancer.

First, he reviews the PALOMA-2 data, which looked at the overall survival of the CDK4/6 inhibitor palbociclib plus letrozole. He then compares that data with the overall survival data of other CDK4/5 inhibitors.

Dr Kalinsky then examines the findings of MONALEESA-7, which looked at premenopausal patients with HR+/HER2- advanced breast cancer treated with ET plus or minus ribociclib. In that study population, the combination of ET and ribociclib showed an overall survival advantage.

Finally, he discusses data from the Right Choice trial, which found that patients did better when given hormonal therapy plus a CDK4/6 inhibitor as opposed to doublet chemotherapy.

--

Kevin Kalinsky, MD, Director, Glenn Family Breast Center, Winship Cancer Institute, Atlanta, Georgia

Kevin Kalinsky, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Pfizer; Eli Lilly; Novartis ; Eisai; AstraZeneca; Daiichi Sankyo; Puma; 4D Pharma; Oncosec; Immunomedics; Merck; Seattle Genetics

Spouse holds stock in: Grail; Array Biopharma; Pfizer (prior employee)

Key clinical point: Patients with estrogen receptor-negative (ER−) primary breast cancer (BC) have a higher risk of developing secondary BC during the first 5 years after treatment than patients with ER-positive (ER+) primary BC.

Major finding: In women with ER− vs ER+ primary BC, the rates of secondary BCs were higher during the first 5 years of follow-up (16.0/1000 person-years [PY]; 95% CI 14.2-17.9/1000 PY vs 7.8/1000 PY; 95% CI 7.3-8.4/1000 PY) but were similar after 5 years (12.1/1000 PY; 95% CI 9.9-14.7/1000 PY vs 9.3/1000 PY; 95% CI 8.4-10.3/1000 PY).

Study details: Findings are from a study including 36,165 women with stage I-III primary BC who underwent breast‐conserving surgery or mastectomy.

Disclosures: This study was funded by the US National Cancer Institute. Some authors declared receiving grants, personal fees, payments, or travel support from several sources.

Source: Lowry KP et al. Variation in second breast cancer risk after primary invasive cancer by time since primary cancer diagnosis and estrogen receptor status. Cancer. 2023 (Feb 15). Doi: 10.1002/cncr.34679

Key clinical point: Patients with estrogen receptor-negative (ER−) primary breast cancer (BC) have a higher risk of developing secondary BC during the first 5 years after treatment than patients with ER-positive (ER+) primary BC.

Major finding: In women with ER− vs ER+ primary BC, the rates of secondary BCs were higher during the first 5 years of follow-up (16.0/1000 person-years [PY]; 95% CI 14.2-17.9/1000 PY vs 7.8/1000 PY; 95% CI 7.3-8.4/1000 PY) but were similar after 5 years (12.1/1000 PY; 95% CI 9.9-14.7/1000 PY vs 9.3/1000 PY; 95% CI 8.4-10.3/1000 PY).

Study details: Findings are from a study including 36,165 women with stage I-III primary BC who underwent breast‐conserving surgery or mastectomy.

Disclosures: This study was funded by the US National Cancer Institute. Some authors declared receiving grants, personal fees, payments, or travel support from several sources.

Source: Lowry KP et al. Variation in second breast cancer risk after primary invasive cancer by time since primary cancer diagnosis and estrogen receptor status. Cancer. 2023 (Feb 15). Doi: 10.1002/cncr.34679

Key clinical point: Patients with estrogen receptor-negative (ER−) primary breast cancer (BC) have a higher risk of developing secondary BC during the first 5 years after treatment than patients with ER-positive (ER+) primary BC.

Major finding: In women with ER− vs ER+ primary BC, the rates of secondary BCs were higher during the first 5 years of follow-up (16.0/1000 person-years [PY]; 95% CI 14.2-17.9/1000 PY vs 7.8/1000 PY; 95% CI 7.3-8.4/1000 PY) but were similar after 5 years (12.1/1000 PY; 95% CI 9.9-14.7/1000 PY vs 9.3/1000 PY; 95% CI 8.4-10.3/1000 PY).

Study details: Findings are from a study including 36,165 women with stage I-III primary BC who underwent breast‐conserving surgery or mastectomy.

Disclosures: This study was funded by the US National Cancer Institute. Some authors declared receiving grants, personal fees, payments, or travel support from several sources.

Source: Lowry KP et al. Variation in second breast cancer risk after primary invasive cancer by time since primary cancer diagnosis and estrogen receptor status. Cancer. 2023 (Feb 15). Doi: 10.1002/cncr.34679

Key clinical point: Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors plus endocrine therapy (ET) led to a significantly higher improvement in overall survival than ET alone in older patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC).

Major finding: ET+CDK4/6 inhibitor vs ET alone reduced mortality rate by 41% in the first-line treatment setting (adjusted hazard ratio [aHR] 0.590; 95% CI 0.423-0.823) and by 58% in the second-line setting (aHR 0.422; 95% CI 0.238-0.746).

Study details: This retrospective cohort study included 630 female patients aged ≥65 years with HR+/HER2− metastatic BC from the Survey Epidemiology and End Results (SEER)‐Medicare database, of which 461 and 169 patients received first‐line treatment with ET alone and ET+CDK4/6 inhibitor, respectively.

Disclosures: The acquisition of SEER‐Medicare data was supported by the University of Houston,  Texas,College of Pharmacy. The authors declared no conflicts of interest.

Source: Goyal RK et al. Overall survival associated with CDK4/6 inhibitors in patients with HR+/HER2− metastatic breast cancer in the United States: A SEER-Medicare population-based study. Cancer. 2023;129(7):1051-1063 (Feb 9). Doi: 10.1002/cncr.34675

Key clinical point: Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors plus endocrine therapy (ET) led to a significantly higher improvement in overall survival than ET alone in older patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC).

Major finding: ET+CDK4/6 inhibitor vs ET alone reduced mortality rate by 41% in the first-line treatment setting (adjusted hazard ratio [aHR] 0.590; 95% CI 0.423-0.823) and by 58% in the second-line setting (aHR 0.422; 95% CI 0.238-0.746).

Study details: This retrospective cohort study included 630 female patients aged ≥65 years with HR+/HER2− metastatic BC from the Survey Epidemiology and End Results (SEER)‐Medicare database, of which 461 and 169 patients received first‐line treatment with ET alone and ET+CDK4/6 inhibitor, respectively.

Disclosures: The acquisition of SEER‐Medicare data was supported by the University of Houston,  Texas,College of Pharmacy. The authors declared no conflicts of interest.

Source: Goyal RK et al. Overall survival associated with CDK4/6 inhibitors in patients with HR+/HER2− metastatic breast cancer in the United States: A SEER-Medicare population-based study. Cancer. 2023;129(7):1051-1063 (Feb 9). Doi: 10.1002/cncr.34675

Key clinical point: Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors plus endocrine therapy (ET) led to a significantly higher improvement in overall survival than ET alone in older patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC).

Major finding: ET+CDK4/6 inhibitor vs ET alone reduced mortality rate by 41% in the first-line treatment setting (adjusted hazard ratio [aHR] 0.590; 95% CI 0.423-0.823) and by 58% in the second-line setting (aHR 0.422; 95% CI 0.238-0.746).

Study details: This retrospective cohort study included 630 female patients aged ≥65 years with HR+/HER2− metastatic BC from the Survey Epidemiology and End Results (SEER)‐Medicare database, of which 461 and 169 patients received first‐line treatment with ET alone and ET+CDK4/6 inhibitor, respectively.

Disclosures: The acquisition of SEER‐Medicare data was supported by the University of Houston,  Texas,College of Pharmacy. The authors declared no conflicts of interest.

Source: Goyal RK et al. Overall survival associated with CDK4/6 inhibitors in patients with HR+/HER2− metastatic breast cancer in the United States: A SEER-Medicare population-based study. Cancer. 2023;129(7):1051-1063 (Feb 9). Doi: 10.1002/cncr.34675

Key clinical point: The rate of pathological complete response (pCR) was significantly higher in patients with early-stage breast cancer (BC) who received neoadjuvant treatment with pegylated liposomal doxorubicin-cyclophosphamide followed by docetaxel (LC-T) vs epirubicin-cyclophosphamide followed by docetaxel (EC-T).

Major finding: The pCR rate was significantly higher with LC-T vs EC-T in the overall cohort (25.3% vs 15.5%; P = .026) and in the subgroup of patients with triple-negative BC (47.1% vs 15.4%; P = .013).

Study details: Findings are from a retrospective study including 359 patients with stage I-III BC who received neoadjuvant treatment with LC-T (n = 178) or EC-T (n = 181) followed by surgery.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Tsai J-H et al. Neoadjuvant pegylated liposomal doxorubicin- and epirubicin-based combination therapy regimens for early breast cancer: A multicenter retrospective case-control study. Breast Cancer Res Treat. 2023 (Mar 4). Doi: 10.1007/s10549-023-06867-6

Key clinical point: The rate of pathological complete response (pCR) was significantly higher in patients with early-stage breast cancer (BC) who received neoadjuvant treatment with pegylated liposomal doxorubicin-cyclophosphamide followed by docetaxel (LC-T) vs epirubicin-cyclophosphamide followed by docetaxel (EC-T).

Major finding: The pCR rate was significantly higher with LC-T vs EC-T in the overall cohort (25.3% vs 15.5%; P = .026) and in the subgroup of patients with triple-negative BC (47.1% vs 15.4%; P = .013).

Study details: Findings are from a retrospective study including 359 patients with stage I-III BC who received neoadjuvant treatment with LC-T (n = 178) or EC-T (n = 181) followed by surgery.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Tsai J-H et al. Neoadjuvant pegylated liposomal doxorubicin- and epirubicin-based combination therapy regimens for early breast cancer: A multicenter retrospective case-control study. Breast Cancer Res Treat. 2023 (Mar 4). Doi: 10.1007/s10549-023-06867-6

Key clinical point: The rate of pathological complete response (pCR) was significantly higher in patients with early-stage breast cancer (BC) who received neoadjuvant treatment with pegylated liposomal doxorubicin-cyclophosphamide followed by docetaxel (LC-T) vs epirubicin-cyclophosphamide followed by docetaxel (EC-T).

Major finding: The pCR rate was significantly higher with LC-T vs EC-T in the overall cohort (25.3% vs 15.5%; P = .026) and in the subgroup of patients with triple-negative BC (47.1% vs 15.4%; P = .013).

Study details: Findings are from a retrospective study including 359 patients with stage I-III BC who received neoadjuvant treatment with LC-T (n = 178) or EC-T (n = 181) followed by surgery.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Tsai J-H et al. Neoadjuvant pegylated liposomal doxorubicin- and epirubicin-based combination therapy regimens for early breast cancer: A multicenter retrospective case-control study. Breast Cancer Res Treat. 2023 (Mar 4). Doi: 10.1007/s10549-023-06867-6

Key clinical point: Contrary to women who received bilateral oophorectomy, women who underwent hysterectomy and concurrent estrogen plus progestin therapy had a significantly higher risk of developing breast cancer (BC).

Major finding: Bilateral oophorectomy (hazard ratio [HR] 0.91; 95% CI 0.83-1.00) did not increase the risk for BC irrespective of the use of hormone therapy. However, hysterectomy alone was positively associated with an increased risk for BC (HR 1.12; 95% CI 1.02-1.23), especially among those receiving estrogen plus progestin therapy (HR 1.25; 95% CI 1.01-1.55).

Study details: Findings are from a prospective cohort study, The Sister Study, including 50,701 women without BC who had a biological sister with BC, of which 13.8% and 18.1% of participants underwent hysterectomy only and bilateral oophorectomy with or without hysterectomy, respectively.

Disclosures: This study was funded by the Intramural Research Program at the US National Institutes of Health and other sources. The authors declared no conflicts of interest.

Source: Lovett SM et al. Hysterectomy, bilateral oophorectomy, and breast cancer risk in a racially diverse prospective cohort study. J Natl Cancer Inst. 2023 (Feb 20). Doi: 10.1093/jnci/djad038

Key clinical point: Contrary to women who received bilateral oophorectomy, women who underwent hysterectomy and concurrent estrogen plus progestin therapy had a significantly higher risk of developing breast cancer (BC).

Major finding: Bilateral oophorectomy (hazard ratio [HR] 0.91; 95% CI 0.83-1.00) did not increase the risk for BC irrespective of the use of hormone therapy. However, hysterectomy alone was positively associated with an increased risk for BC (HR 1.12; 95% CI 1.02-1.23), especially among those receiving estrogen plus progestin therapy (HR 1.25; 95% CI 1.01-1.55).

Study details: Findings are from a prospective cohort study, The Sister Study, including 50,701 women without BC who had a biological sister with BC, of which 13.8% and 18.1% of participants underwent hysterectomy only and bilateral oophorectomy with or without hysterectomy, respectively.

Disclosures: This study was funded by the Intramural Research Program at the US National Institutes of Health and other sources. The authors declared no conflicts of interest.

Source: Lovett SM et al. Hysterectomy, bilateral oophorectomy, and breast cancer risk in a racially diverse prospective cohort study. J Natl Cancer Inst. 2023 (Feb 20). Doi: 10.1093/jnci/djad038

Key clinical point: Contrary to women who received bilateral oophorectomy, women who underwent hysterectomy and concurrent estrogen plus progestin therapy had a significantly higher risk of developing breast cancer (BC).

Major finding: Bilateral oophorectomy (hazard ratio [HR] 0.91; 95% CI 0.83-1.00) did not increase the risk for BC irrespective of the use of hormone therapy. However, hysterectomy alone was positively associated with an increased risk for BC (HR 1.12; 95% CI 1.02-1.23), especially among those receiving estrogen plus progestin therapy (HR 1.25; 95% CI 1.01-1.55).

Study details: Findings are from a prospective cohort study, The Sister Study, including 50,701 women without BC who had a biological sister with BC, of which 13.8% and 18.1% of participants underwent hysterectomy only and bilateral oophorectomy with or without hysterectomy, respectively.

Disclosures: This study was funded by the Intramural Research Program at the US National Institutes of Health and other sources. The authors declared no conflicts of interest.

Source: Lovett SM et al. Hysterectomy, bilateral oophorectomy, and breast cancer risk in a racially diverse prospective cohort study. J Natl Cancer Inst. 2023 (Feb 20). Doi: 10.1093/jnci/djad038

Key clinical point: Patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC) who achieved pathological complete response (pCR) after 12 weeks of conventional chemotherapy-free, de-escalated, neoadjuvant anti-HER2 treatment can forgo adjuvant chemotherapy.

Major finding: Risk for invasive disease-free survival (iDFS) was significantly lower in patients who did vs did not achieve pCR (unadjusted hazard ratio [HR] 0.40; 95% CI 0.18-0.85). Among patients who achieved pCR, iDFS rates were similar in those who did vs did not receive adjuvant chemotherapy (unadjusted HR 1.15; 95% CI 0.27-4.81).

Study details: Findings are from the phase 2, WSG-ADAPT-TP trial including 375 patients with HR+/HER2+ early BC who were randomly assigned to receive 12 weeks of trastuzumab-emtansine with or without endocrine therapy (ET) or trastuzumab+ET in a neoadjuvant setting.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors declared serving in consulting or advisory roles, receiving research funding, travel and accommodation expenses, or honoraria, or having other ties with several sources, including Roche.

Source: Harbeck N et al on behalf of the WSG-ADAPT investigators. De-escalated neoadjuvant trastuzumab-emtansine with or without endocrine therapy versus trastuzumab with endocrine therapy in HR+/HER2+ early breast cancer: 5-year survival in the WSG-ADAPT-TP trial. J Clin Oncol. 2023 (Feb 21). Doi: 10.1200/JCO.22.01816

Key clinical point: Patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC) who achieved pathological complete response (pCR) after 12 weeks of conventional chemotherapy-free, de-escalated, neoadjuvant anti-HER2 treatment can forgo adjuvant chemotherapy.

Major finding: Risk for invasive disease-free survival (iDFS) was significantly lower in patients who did vs did not achieve pCR (unadjusted hazard ratio [HR] 0.40; 95% CI 0.18-0.85). Among patients who achieved pCR, iDFS rates were similar in those who did vs did not receive adjuvant chemotherapy (unadjusted HR 1.15; 95% CI 0.27-4.81).

Study details: Findings are from the phase 2, WSG-ADAPT-TP trial including 375 patients with HR+/HER2+ early BC who were randomly assigned to receive 12 weeks of trastuzumab-emtansine with or without endocrine therapy (ET) or trastuzumab+ET in a neoadjuvant setting.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors declared serving in consulting or advisory roles, receiving research funding, travel and accommodation expenses, or honoraria, or having other ties with several sources, including Roche.

Source: Harbeck N et al on behalf of the WSG-ADAPT investigators. De-escalated neoadjuvant trastuzumab-emtansine with or without endocrine therapy versus trastuzumab with endocrine therapy in HR+/HER2+ early breast cancer: 5-year survival in the WSG-ADAPT-TP trial. J Clin Oncol. 2023 (Feb 21). Doi: 10.1200/JCO.22.01816

Key clinical point: Patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (BC) who achieved pathological complete response (pCR) after 12 weeks of conventional chemotherapy-free, de-escalated, neoadjuvant anti-HER2 treatment can forgo adjuvant chemotherapy.

Major finding: Risk for invasive disease-free survival (iDFS) was significantly lower in patients who did vs did not achieve pCR (unadjusted hazard ratio [HR] 0.40; 95% CI 0.18-0.85). Among patients who achieved pCR, iDFS rates were similar in those who did vs did not receive adjuvant chemotherapy (unadjusted HR 1.15; 95% CI 0.27-4.81).

Study details: Findings are from the phase 2, WSG-ADAPT-TP trial including 375 patients with HR+/HER2+ early BC who were randomly assigned to receive 12 weeks of trastuzumab-emtansine with or without endocrine therapy (ET) or trastuzumab+ET in a neoadjuvant setting.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors declared serving in consulting or advisory roles, receiving research funding, travel and accommodation expenses, or honoraria, or having other ties with several sources, including Roche.

Source: Harbeck N et al on behalf of the WSG-ADAPT investigators. De-escalated neoadjuvant trastuzumab-emtansine with or without endocrine therapy versus trastuzumab with endocrine therapy in HR+/HER2+ early breast cancer: 5-year survival in the WSG-ADAPT-TP trial. J Clin Oncol. 2023 (Feb 21). Doi: 10.1200/JCO.22.01816

Key clinical point: Anthracycline+taxane-based regimens demonstrated significantly higher improvement in survival outcomes than non-anthracycline-containing taxane-based regimens in patients with triple-negative breast cancer (TNBC) who were ≥76 years old and had ≥4 positive lymph nodes.

Major finding: Although anthracycline+taxane-based vs taxane-based regimens failed to improve cancer-specific survival (CSS) in the overall cohort of older patients with TNBC (hazard ratio [HR] 0.94; P = .79); they improved CSS in patients aged ≥76 years with ≥4 positive lymph nodes (HR 0.09; P = .02).

Study details: Findings are from a retrospective analysis of 1106 women aged ≥66 years with node-positive TNBC from the Surveillance, Epidemiology, and End Results-Medicare database, of which 661 women received adjuvant chemotherapy with anthracycline+taxane-based regimens (n = 364) or taxane-based regimens (n = 297).

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Clinical outcomes of adjuvant taxane + anthracycline versus taxane-based chemotherapy regimens in older adults with node-positive, triple-negative breast cancer: A SEER-Medicare study. Eur J Cancer. 2023 (Feb 27). Doi: 10.1016/j.ejca.2023.02.014

Key clinical point: Anthracycline+taxane-based regimens demonstrated significantly higher improvement in survival outcomes than non-anthracycline-containing taxane-based regimens in patients with triple-negative breast cancer (TNBC) who were ≥76 years old and had ≥4 positive lymph nodes.

Major finding: Although anthracycline+taxane-based vs taxane-based regimens failed to improve cancer-specific survival (CSS) in the overall cohort of older patients with TNBC (hazard ratio [HR] 0.94; P = .79); they improved CSS in patients aged ≥76 years with ≥4 positive lymph nodes (HR 0.09; P = .02).

Study details: Findings are from a retrospective analysis of 1106 women aged ≥66 years with node-positive TNBC from the Surveillance, Epidemiology, and End Results-Medicare database, of which 661 women received adjuvant chemotherapy with anthracycline+taxane-based regimens (n = 364) or taxane-based regimens (n = 297).

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Clinical outcomes of adjuvant taxane + anthracycline versus taxane-based chemotherapy regimens in older adults with node-positive, triple-negative breast cancer: A SEER-Medicare study. Eur J Cancer. 2023 (Feb 27). Doi: 10.1016/j.ejca.2023.02.014

Key clinical point: Anthracycline+taxane-based regimens demonstrated significantly higher improvement in survival outcomes than non-anthracycline-containing taxane-based regimens in patients with triple-negative breast cancer (TNBC) who were ≥76 years old and had ≥4 positive lymph nodes.

Major finding: Although anthracycline+taxane-based vs taxane-based regimens failed to improve cancer-specific survival (CSS) in the overall cohort of older patients with TNBC (hazard ratio [HR] 0.94; P = .79); they improved CSS in patients aged ≥76 years with ≥4 positive lymph nodes (HR 0.09; P = .02).

Study details: Findings are from a retrospective analysis of 1106 women aged ≥66 years with node-positive TNBC from the Surveillance, Epidemiology, and End Results-Medicare database, of which 661 women received adjuvant chemotherapy with anthracycline+taxane-based regimens (n = 364) or taxane-based regimens (n = 297).

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Clinical outcomes of adjuvant taxane + anthracycline versus taxane-based chemotherapy regimens in older adults with node-positive, triple-negative breast cancer: A SEER-Medicare study. Eur J Cancer. 2023 (Feb 27). Doi: 10.1016/j.ejca.2023.02.014

Key clinical point: Human epidermal growth factor receptor 2-low (ERBB2-low) breast cancer (BC) did not have a prognosis noticeably different from ERBB2-negative BC, thereby contradicting its classification as a unique disease entity.

Major finding: ERBB2-low vs ERBB2-negative BC was associated with slightly higher improvements in overall survival (adjusted hazard ratio [aHR] 0.98; 95% CI 0.97-0.99), especially for stage III (aHR 0.92; 95% CI 0.89-0.96) and stage IV (aHR 0.91; 95% CI 0.87-0.96) triple-negative BC, and a marginally lower likelihood of achieving pathological complete response (adjusted odds ratio 0.89; 95% CI 0.86-0.92).

Study details: Findings are from a retrospective cohort study including 1,136,016 patients with invasive BC that was not ERBB2 positive.

Disclosures: This study was supported by the Breast Cancer Research Foundation, New York, and other sources. Some authors declared receiving grants, personal fees, or research funding from several sources.

Source: Peiffer DS et al. Clinicopathologic characteristics and prognosis of ERBB2-low breast cancer among patients in the National Cancer Database. JAMA Oncol. 2023;e227476 (Feb 23). Doi: 10.1001/jamaoncol.2022.7476

Key clinical point: Human epidermal growth factor receptor 2-low (ERBB2-low) breast cancer (BC) did not have a prognosis noticeably different from ERBB2-negative BC, thereby contradicting its classification as a unique disease entity.

Major finding: ERBB2-low vs ERBB2-negative BC was associated with slightly higher improvements in overall survival (adjusted hazard ratio [aHR] 0.98; 95% CI 0.97-0.99), especially for stage III (aHR 0.92; 95% CI 0.89-0.96) and stage IV (aHR 0.91; 95% CI 0.87-0.96) triple-negative BC, and a marginally lower likelihood of achieving pathological complete response (adjusted odds ratio 0.89; 95% CI 0.86-0.92).

Study details: Findings are from a retrospective cohort study including 1,136,016 patients with invasive BC that was not ERBB2 positive.

Disclosures: This study was supported by the Breast Cancer Research Foundation, New York, and other sources. Some authors declared receiving grants, personal fees, or research funding from several sources.

Source: Peiffer DS et al. Clinicopathologic characteristics and prognosis of ERBB2-low breast cancer among patients in the National Cancer Database. JAMA Oncol. 2023;e227476 (Feb 23). Doi: 10.1001/jamaoncol.2022.7476

Key clinical point: Human epidermal growth factor receptor 2-low (ERBB2-low) breast cancer (BC) did not have a prognosis noticeably different from ERBB2-negative BC, thereby contradicting its classification as a unique disease entity.

Major finding: ERBB2-low vs ERBB2-negative BC was associated with slightly higher improvements in overall survival (adjusted hazard ratio [aHR] 0.98; 95% CI 0.97-0.99), especially for stage III (aHR 0.92; 95% CI 0.89-0.96) and stage IV (aHR 0.91; 95% CI 0.87-0.96) triple-negative BC, and a marginally lower likelihood of achieving pathological complete response (adjusted odds ratio 0.89; 95% CI 0.86-0.92).

Study details: Findings are from a retrospective cohort study including 1,136,016 patients with invasive BC that was not ERBB2 positive.

Disclosures: This study was supported by the Breast Cancer Research Foundation, New York, and other sources. Some authors declared receiving grants, personal fees, or research funding from several sources.

Source: Peiffer DS et al. Clinicopathologic characteristics and prognosis of ERBB2-low breast cancer among patients in the National Cancer Database. JAMA Oncol. 2023;e227476 (Feb 23). Doi: 10.1001/jamaoncol.2022.7476

Key clinical point: In women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC), adjuvant epirubicin+paclitaxel (EP) therapy led to favorable survival outcomes, noninferior to those with epirubicin+cyclophosphamide followed by paclitaxel (EC-P) therapy, and a higher frequency of adverse events (AE).

Major finding: After a median follow-up of 93.6 months, the 5-year disease-free survival with EP was noninferior to that with EC-P in the entire cohort (hazard ratio [HR] 0.82; 95% CI 0.62-1.10; noninferior P  =  .001) and in patients with luminal A BC (HR 0.84; 95% CI 0.45-1.57) and luminal B BC (HR 0.70; 95% CI 0.49-1.00). The AE rate was higher in the EP group.

Study details: This phase 3 study included 813 patients with HR+/ERBB2−, lymph node-positive, operable BC who were randomly assigned to receive adjuvant EP or EC-P.

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Yuan P et al. Effect of epirubicin plus paclitaxel vs epirubicin and cyclophosphamide followed by paclitaxel on disease-free survival among patients with operable ERBB2-negative and lymph node-positive breast cancer: A randomized clinical trial. JAMA Netw Open. 2023;6(2):e230122 (Feb 24). Doi: 10.1001/jamanetworkopen.2023.0122

Key clinical point: In women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC), adjuvant epirubicin+paclitaxel (EP) therapy led to favorable survival outcomes, noninferior to those with epirubicin+cyclophosphamide followed by paclitaxel (EC-P) therapy, and a higher frequency of adverse events (AE).

Major finding: After a median follow-up of 93.6 months, the 5-year disease-free survival with EP was noninferior to that with EC-P in the entire cohort (hazard ratio [HR] 0.82; 95% CI 0.62-1.10; noninferior P  =  .001) and in patients with luminal A BC (HR 0.84; 95% CI 0.45-1.57) and luminal B BC (HR 0.70; 95% CI 0.49-1.00). The AE rate was higher in the EP group.

Study details: This phase 3 study included 813 patients with HR+/ERBB2−, lymph node-positive, operable BC who were randomly assigned to receive adjuvant EP or EC-P.

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Yuan P et al. Effect of epirubicin plus paclitaxel vs epirubicin and cyclophosphamide followed by paclitaxel on disease-free survival among patients with operable ERBB2-negative and lymph node-positive breast cancer: A randomized clinical trial. JAMA Netw Open. 2023;6(2):e230122 (Feb 24). Doi: 10.1001/jamanetworkopen.2023.0122

Key clinical point: In women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC), adjuvant epirubicin+paclitaxel (EP) therapy led to favorable survival outcomes, noninferior to those with epirubicin+cyclophosphamide followed by paclitaxel (EC-P) therapy, and a higher frequency of adverse events (AE).

Major finding: After a median follow-up of 93.6 months, the 5-year disease-free survival with EP was noninferior to that with EC-P in the entire cohort (hazard ratio [HR] 0.82; 95% CI 0.62-1.10; noninferior P  =  .001) and in patients with luminal A BC (HR 0.84; 95% CI 0.45-1.57) and luminal B BC (HR 0.70; 95% CI 0.49-1.00). The AE rate was higher in the EP group.

Study details: This phase 3 study included 813 patients with HR+/ERBB2−, lymph node-positive, operable BC who were randomly assigned to receive adjuvant EP or EC-P.

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Yuan P et al. Effect of epirubicin plus paclitaxel vs epirubicin and cyclophosphamide followed by paclitaxel on disease-free survival among patients with operable ERBB2-negative and lymph node-positive breast cancer: A randomized clinical trial. JAMA Netw Open. 2023;6(2):e230122 (Feb 24). Doi: 10.1001/jamanetworkopen.2023.0122

SAN FRANCISCO – Gastroenterologists are uniquely positioned to treat obesity, according to a panel of experts convened by the American Gastroenterological Association.

“We see this as a field that GI should own,” said Naresh T. Gunaratnam, MD, a gastroenterologist at Huron Gastro in Ypsilanti, Mich., who has made obesity treatment an important part of his practice.

Gastroenterologists are uniquely qualified in endoscopic sleeve gastroplasty and in the placement of intragastric balloons and can also bring their internal medicine training to bear in patient education and medical prescription, Dr. Gunaratnam said in an interview.

He and three colleagues spoke about innovation in obesity and metabolism at the 2023 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Significant hurdles remain to launching new endoscopic devices for treating obesity, but evidence shows that the existing treatments are effective when combined with medication and other treatments, said panelist Reem Z. Sharaiha, MD, MSc, a gastroenterologist with expertise in obesity at Weill Cornell Medicine in New York. “You can never find just one cure for obesity, you should always think about a combination.”

Obesity rates continue to spiral worldwide, with over 100 million adults in the United States weighing in at over 30 kg/m², said Dr. Sharaiha, but less than 5% per year receive adequate treatment. The condition is driving upticks in diabetes and nonalcoholic fatty liver disease and contributing to cancer, heart disease, stroke, and COVID-19 infections.

Even small reductions in body weight can significantly improve these conditions, she said. Less than a 5% in total body weight on average results in significant reductions in HbA1c, triglycerides, blood pressure and steatosis.

In recent years, the Food and Drug Administration has several devices that gastroenterologists can use to treat obesity, Dr. Sharaiha said, including three brands of intragastric balloon used to reduce appetite by filling the stomach. The AGA now recommends such an intragastric balloon for people with obesity who have “failed a trial of conventional weight-loss strategies.”

But many devices have been withdrawn from the market, including two of the balloon systems. Why do so many devices fail? Sometimes the FDA demands trials that are too expensive, Dr. Sharaiha said. The COVID-19 pandemic put financial pressure on some companies that have already secured FDA approval. Some insurance companies are not willing to pay for the devices, even after the FDA has approved them. Some are not cost effective.

And sometimes patients don’t accept them. That may have been one challenge with Aspire’s AspireAssist, which allowed patients to empty their stomachs into the toilet using a surgically implanted tube, though the company cited “the financial impact of the COVID-19 pandemic” when it withdrew the device from the market last year.

More devices are in the pipeline, but they face an uncertain path forward, Dr. Sharaiha said. “Device companies are usually startups that need funding. With the economic downturn, venture capital funding is hard to get.”

In the meantime, patients with class 3 obesity in particular may benefit from surgery, she said.

For others, medications are playing a more important role in the obesity epidemic, with an average 10%-15% body weight loss, Dr. Sharaiha said. Injections with semaglutide (Ozempic), a glucagon-like peptide 1 (GLP-1) receptor agonist that is approved to improve glycemic control in adults with type 2 diabetes mellitus, is leading the charge.

Tirzepatide (Mounjaro) may be even more effective, Dr. Sharaiha said. The FDA approved the drug last year to improve blood sugar control in adults with type 2 diabetes and was fast-tracked in October for the treatment of adults with obesity, or who are overweight with weight-related comorbidities.

Medications provide add-on benefits to many patients who have been treated with intragastric balloons or endoscopic sleeve gastroplasty, Dr. Sharaiha said.

Also lifestyle and education should not be neglected, said Dr. Gunaratnam, who lost 50 pounds by changing his diet. He urged gastroenterologists to take on the challenge of treating obesity. It’s not the part of his practice with the best reimbursement, but it is the most satisfying. “I get more hugs, cards, and tears by doing this because when you change weight, you’re impacting every part of their lives,” he said.

Dr. Gunaratnam is the founder of Lean Medical LLC and Satya Health Sciences. Dr. Sharaiha has served as a consultant for Boston Scientific Corporation and Cook Medical Inc.

SAN FRANCISCO – Gastroenterologists are uniquely positioned to treat obesity, according to a panel of experts convened by the American Gastroenterological Association.

“We see this as a field that GI should own,” said Naresh T. Gunaratnam, MD, a gastroenterologist at Huron Gastro in Ypsilanti, Mich., who has made obesity treatment an important part of his practice.

Gastroenterologists are uniquely qualified in endoscopic sleeve gastroplasty and in the placement of intragastric balloons and can also bring their internal medicine training to bear in patient education and medical prescription, Dr. Gunaratnam said in an interview.

He and three colleagues spoke about innovation in obesity and metabolism at the 2023 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Significant hurdles remain to launching new endoscopic devices for treating obesity, but evidence shows that the existing treatments are effective when combined with medication and other treatments, said panelist Reem Z. Sharaiha, MD, MSc, a gastroenterologist with expertise in obesity at Weill Cornell Medicine in New York. “You can never find just one cure for obesity, you should always think about a combination.”

Obesity rates continue to spiral worldwide, with over 100 million adults in the United States weighing in at over 30 kg/m², said Dr. Sharaiha, but less than 5% per year receive adequate treatment. The condition is driving upticks in diabetes and nonalcoholic fatty liver disease and contributing to cancer, heart disease, stroke, and COVID-19 infections.

Even small reductions in body weight can significantly improve these conditions, she said. Less than a 5% in total body weight on average results in significant reductions in HbA1c, triglycerides, blood pressure and steatosis.

In recent years, the Food and Drug Administration has several devices that gastroenterologists can use to treat obesity, Dr. Sharaiha said, including three brands of intragastric balloon used to reduce appetite by filling the stomach. The AGA now recommends such an intragastric balloon for people with obesity who have “failed a trial of conventional weight-loss strategies.”

But many devices have been withdrawn from the market, including two of the balloon systems. Why do so many devices fail? Sometimes the FDA demands trials that are too expensive, Dr. Sharaiha said. The COVID-19 pandemic put financial pressure on some companies that have already secured FDA approval. Some insurance companies are not willing to pay for the devices, even after the FDA has approved them. Some are not cost effective.

And sometimes patients don’t accept them. That may have been one challenge with Aspire’s AspireAssist, which allowed patients to empty their stomachs into the toilet using a surgically implanted tube, though the company cited “the financial impact of the COVID-19 pandemic” when it withdrew the device from the market last year.

More devices are in the pipeline, but they face an uncertain path forward, Dr. Sharaiha said. “Device companies are usually startups that need funding. With the economic downturn, venture capital funding is hard to get.”

In the meantime, patients with class 3 obesity in particular may benefit from surgery, she said.

For others, medications are playing a more important role in the obesity epidemic, with an average 10%-15% body weight loss, Dr. Sharaiha said. Injections with semaglutide (Ozempic), a glucagon-like peptide 1 (GLP-1) receptor agonist that is approved to improve glycemic control in adults with type 2 diabetes mellitus, is leading the charge.

Tirzepatide (Mounjaro) may be even more effective, Dr. Sharaiha said. The FDA approved the drug last year to improve blood sugar control in adults with type 2 diabetes and was fast-tracked in October for the treatment of adults with obesity, or who are overweight with weight-related comorbidities.

Medications provide add-on benefits to many patients who have been treated with intragastric balloons or endoscopic sleeve gastroplasty, Dr. Sharaiha said.

Also lifestyle and education should not be neglected, said Dr. Gunaratnam, who lost 50 pounds by changing his diet. He urged gastroenterologists to take on the challenge of treating obesity. It’s not the part of his practice with the best reimbursement, but it is the most satisfying. “I get more hugs, cards, and tears by doing this because when you change weight, you’re impacting every part of their lives,” he said.

Dr. Gunaratnam is the founder of Lean Medical LLC and Satya Health Sciences. Dr. Sharaiha has served as a consultant for Boston Scientific Corporation and Cook Medical Inc.

SAN FRANCISCO – Gastroenterologists are uniquely positioned to treat obesity, according to a panel of experts convened by the American Gastroenterological Association.

“We see this as a field that GI should own,” said Naresh T. Gunaratnam, MD, a gastroenterologist at Huron Gastro in Ypsilanti, Mich., who has made obesity treatment an important part of his practice.

Gastroenterologists are uniquely qualified in endoscopic sleeve gastroplasty and in the placement of intragastric balloons and can also bring their internal medicine training to bear in patient education and medical prescription, Dr. Gunaratnam said in an interview.

He and three colleagues spoke about innovation in obesity and metabolism at the 2023 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Significant hurdles remain to launching new endoscopic devices for treating obesity, but evidence shows that the existing treatments are effective when combined with medication and other treatments, said panelist Reem Z. Sharaiha, MD, MSc, a gastroenterologist with expertise in obesity at Weill Cornell Medicine in New York. “You can never find just one cure for obesity, you should always think about a combination.”

Obesity rates continue to spiral worldwide, with over 100 million adults in the United States weighing in at over 30 kg/m², said Dr. Sharaiha, but less than 5% per year receive adequate treatment. The condition is driving upticks in diabetes and nonalcoholic fatty liver disease and contributing to cancer, heart disease, stroke, and COVID-19 infections.

Even small reductions in body weight can significantly improve these conditions, she said. Less than a 5% in total body weight on average results in significant reductions in HbA1c, triglycerides, blood pressure and steatosis.

In recent years, the Food and Drug Administration has several devices that gastroenterologists can use to treat obesity, Dr. Sharaiha said, including three brands of intragastric balloon used to reduce appetite by filling the stomach. The AGA now recommends such an intragastric balloon for people with obesity who have “failed a trial of conventional weight-loss strategies.”

But many devices have been withdrawn from the market, including two of the balloon systems. Why do so many devices fail? Sometimes the FDA demands trials that are too expensive, Dr. Sharaiha said. The COVID-19 pandemic put financial pressure on some companies that have already secured FDA approval. Some insurance companies are not willing to pay for the devices, even after the FDA has approved them. Some are not cost effective.

And sometimes patients don’t accept them. That may have been one challenge with Aspire’s AspireAssist, which allowed patients to empty their stomachs into the toilet using a surgically implanted tube, though the company cited “the financial impact of the COVID-19 pandemic” when it withdrew the device from the market last year.

More devices are in the pipeline, but they face an uncertain path forward, Dr. Sharaiha said. “Device companies are usually startups that need funding. With the economic downturn, venture capital funding is hard to get.”

In the meantime, patients with class 3 obesity in particular may benefit from surgery, she said.

For others, medications are playing a more important role in the obesity epidemic, with an average 10%-15% body weight loss, Dr. Sharaiha said. Injections with semaglutide (Ozempic), a glucagon-like peptide 1 (GLP-1) receptor agonist that is approved to improve glycemic control in adults with type 2 diabetes mellitus, is leading the charge.

Tirzepatide (Mounjaro) may be even more effective, Dr. Sharaiha said. The FDA approved the drug last year to improve blood sugar control in adults with type 2 diabetes and was fast-tracked in October for the treatment of adults with obesity, or who are overweight with weight-related comorbidities.

Medications provide add-on benefits to many patients who have been treated with intragastric balloons or endoscopic sleeve gastroplasty, Dr. Sharaiha said.

Also lifestyle and education should not be neglected, said Dr. Gunaratnam, who lost 50 pounds by changing his diet. He urged gastroenterologists to take on the challenge of treating obesity. It’s not the part of his practice with the best reimbursement, but it is the most satisfying. “I get more hugs, cards, and tears by doing this because when you change weight, you’re impacting every part of their lives,” he said.

Dr. Gunaratnam is the founder of Lean Medical LLC and Satya Health Sciences. Dr. Sharaiha has served as a consultant for Boston Scientific Corporation and Cook Medical Inc.