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HR+/HER2− metastatic BC: Greater survival benefit observed with ET+CDK4/6 inhibitor vs ET
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
Neoadjuvant pegylated liposomal doxorubicin-based treatment shows potential in early-stage BC
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
Hysterectomy combined with hormone therapy increases BC risk
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
pCR: An excellent prognostic marker in HR+/HER2+ early BC treated with de-escalated chemotherapy-free anti-HER2 therapy
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
Anthracycline+taxane regimens benefit older TNBC patients with higher lymph node involvement
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
Minimal prognostic differences exist between ERBB2-low and ERBB2-negative BC2- BC
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
Epirubicin+paclitaxel noninferior to epirubicin+cyclophosphamide followed by paclitaxel in HR+/ERBB2- BC
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
Omitting radiotherapy increases local recurrence risk without affecting other survival outcomesin HR+ early BC
Key clinical point: Omission of radiotherapy after breast-conserving surgery (BCS) increased local recurrence rates but did not affect distant recurrence rates or overall survival (OS) outcomes in women aged ≥65 years with low-risk, hormone receptor-positive (HR+), early breast cancer (BC).
Major finding: In patients who did not vs did receive radiotherapy, the cumulative incidence of local recurrence within 10 years was significantly higher (9.5% vs 0.9%; hazard ratio, 10.4; P < .001), but the 10-year cumulative incidence of distant recurrence (1.6% vs 3.0%) and OS (80.8% vs 80.7%) were not worsened.
Study details: Findings are from the phase 3, PRIME II trial including 1326 older patients with HR+, early BC who received adjuvant endocrine therapy after BCS and were randomly assigned to receive whole breast irradiation or no irradiation.
Disclosures: This study was supported by the Chief Scientist Office of the Scottish Government and other sources. DA Cameron declared serving as a consultant for several sources.
Source: Kunkler IH et al. Breast-conserving surgery with or without irradiation in early breast cancer. N Engl J Med. 2023;388(7):585-594 (Feb 16). Doi: 10.1056/NEJMoa2207586
Key clinical point: Omission of radiotherapy after breast-conserving surgery (BCS) increased local recurrence rates but did not affect distant recurrence rates or overall survival (OS) outcomes in women aged ≥65 years with low-risk, hormone receptor-positive (HR+), early breast cancer (BC).
Major finding: In patients who did not vs did receive radiotherapy, the cumulative incidence of local recurrence within 10 years was significantly higher (9.5% vs 0.9%; hazard ratio, 10.4; P < .001), but the 10-year cumulative incidence of distant recurrence (1.6% vs 3.0%) and OS (80.8% vs 80.7%) were not worsened.
Study details: Findings are from the phase 3, PRIME II trial including 1326 older patients with HR+, early BC who received adjuvant endocrine therapy after BCS and were randomly assigned to receive whole breast irradiation or no irradiation.
Disclosures: This study was supported by the Chief Scientist Office of the Scottish Government and other sources. DA Cameron declared serving as a consultant for several sources.
Source: Kunkler IH et al. Breast-conserving surgery with or without irradiation in early breast cancer. N Engl J Med. 2023;388(7):585-594 (Feb 16). Doi: 10.1056/NEJMoa2207586
Key clinical point: Omission of radiotherapy after breast-conserving surgery (BCS) increased local recurrence rates but did not affect distant recurrence rates or overall survival (OS) outcomes in women aged ≥65 years with low-risk, hormone receptor-positive (HR+), early breast cancer (BC).
Major finding: In patients who did not vs did receive radiotherapy, the cumulative incidence of local recurrence within 10 years was significantly higher (9.5% vs 0.9%; hazard ratio, 10.4; P < .001), but the 10-year cumulative incidence of distant recurrence (1.6% vs 3.0%) and OS (80.8% vs 80.7%) were not worsened.
Study details: Findings are from the phase 3, PRIME II trial including 1326 older patients with HR+, early BC who received adjuvant endocrine therapy after BCS and were randomly assigned to receive whole breast irradiation or no irradiation.
Disclosures: This study was supported by the Chief Scientist Office of the Scottish Government and other sources. DA Cameron declared serving as a consultant for several sources.
Source: Kunkler IH et al. Breast-conserving surgery with or without irradiation in early breast cancer. N Engl J Med. 2023;388(7):585-594 (Feb 16). Doi: 10.1056/NEJMoa2207586
Severe atopic dermatitis linked with significant overall morbidity
Key clinical point: Compared with mild atopic dermatitis (AD), severe AD results in an increased risk for overall morbidity.
Major finding: Patients with severe vs mild AD had a significantly increased risk for other dermatitis, extragenital herpes, urticaria, impetigo, cellulitis, varicella zoster virus, abscess, sepsis, conjunctivitis, alopecia areata, asthma, allergic rhinitis and conjunctivitis, stress-related and somatoform diseases, intervertebral disc disorders, osteoporosis, and lymphomas (all P < .001), as well as condylomas, rosacea, certain psychiatric disorders, migraine, sleep apnea, other sleep disorders, hypertension, atherosclerosis, enthesopathies, and drug-induced cataract (all P < .05). However, patients with moderate or severe vs mild AD had a lower risk for prostate cancer (P < .05).
Study details: The data come from a retrospective real-world cohort study including 124,038 patients with mild (n = 53,046), moderate (n = 46,296), or severe (n = 24,696) AD.
Disclosures: This study was sponsored by AbbVie. Some authors reported ties, including employment and stock ownership, with AbbVie and others.
Source: Kiiski V et al. Effect of disease severity on comorbid conditions in atopic dermatitis: Nationwide registry-based investigation in Finnish adults. Acta Derm Venereol. 2023;103:adv00882 (Mar 8). Doi: 10.2340/actadv.v103.4447
Key clinical point: Compared with mild atopic dermatitis (AD), severe AD results in an increased risk for overall morbidity.
Major finding: Patients with severe vs mild AD had a significantly increased risk for other dermatitis, extragenital herpes, urticaria, impetigo, cellulitis, varicella zoster virus, abscess, sepsis, conjunctivitis, alopecia areata, asthma, allergic rhinitis and conjunctivitis, stress-related and somatoform diseases, intervertebral disc disorders, osteoporosis, and lymphomas (all P < .001), as well as condylomas, rosacea, certain psychiatric disorders, migraine, sleep apnea, other sleep disorders, hypertension, atherosclerosis, enthesopathies, and drug-induced cataract (all P < .05). However, patients with moderate or severe vs mild AD had a lower risk for prostate cancer (P < .05).
Study details: The data come from a retrospective real-world cohort study including 124,038 patients with mild (n = 53,046), moderate (n = 46,296), or severe (n = 24,696) AD.
Disclosures: This study was sponsored by AbbVie. Some authors reported ties, including employment and stock ownership, with AbbVie and others.
Source: Kiiski V et al. Effect of disease severity on comorbid conditions in atopic dermatitis: Nationwide registry-based investigation in Finnish adults. Acta Derm Venereol. 2023;103:adv00882 (Mar 8). Doi: 10.2340/actadv.v103.4447
Key clinical point: Compared with mild atopic dermatitis (AD), severe AD results in an increased risk for overall morbidity.
Major finding: Patients with severe vs mild AD had a significantly increased risk for other dermatitis, extragenital herpes, urticaria, impetigo, cellulitis, varicella zoster virus, abscess, sepsis, conjunctivitis, alopecia areata, asthma, allergic rhinitis and conjunctivitis, stress-related and somatoform diseases, intervertebral disc disorders, osteoporosis, and lymphomas (all P < .001), as well as condylomas, rosacea, certain psychiatric disorders, migraine, sleep apnea, other sleep disorders, hypertension, atherosclerosis, enthesopathies, and drug-induced cataract (all P < .05). However, patients with moderate or severe vs mild AD had a lower risk for prostate cancer (P < .05).
Study details: The data come from a retrospective real-world cohort study including 124,038 patients with mild (n = 53,046), moderate (n = 46,296), or severe (n = 24,696) AD.
Disclosures: This study was sponsored by AbbVie. Some authors reported ties, including employment and stock ownership, with AbbVie and others.
Source: Kiiski V et al. Effect of disease severity on comorbid conditions in atopic dermatitis: Nationwide registry-based investigation in Finnish adults. Acta Derm Venereol. 2023;103:adv00882 (Mar 8). Doi: 10.2340/actadv.v103.4447
Skin biomarkers in infants aged 2 months predictive of future atopic dermatitis onset
Key clinical point: Stratum corneum (SC) lipid and cytokine levels in infants aged 2 months can predict the future onset of atopic dermatitis (AD) up to 2 years of age.
Major finding: The SC levels of protein-bound ceramides were decreased (P = .0058), whereas those of unsaturated sphingomyelin (P < .0001), thymic stromal lymphopoietin (P = .0032), and interleukin-13 (IL13; P < .0001) increased in infants with vs without a family history of atopic diseases. A combination of family history and high IL13, high 26:1-sphingomyelin, and low O30:0(C22S)-ceramide levels had a strong predictive power for AD onset by 2 years of age (adjusted odds ratio 54.0; 95% CI 9.2-317.5).
Study details: This observational study included 111 asymptomatic infants with or without a family history of atopic diseases who underwent skin tape strip analysis at 2 months of age.
Disclosures: This study was funded by Edelstein Family Chair of Pediatric Allergy-Immunology at National Jewish Health, Denver, Colorado, and the Korea Environment Industry and Technology Institute (KEITI) through Environmental Health Action Program, funded by Korea Ministry of Environment. Some authors reported ties with various organizations.
Source: Berdyshev E et al. Stratum corneum lipid and cytokine biomarkers at two months of age predict the future onset of atopic dermatitis. J Allergy Clin Immunol. 2023 (Feb 22). Doi: 10.1016/j.jaci.2023.02.013
Key clinical point: Stratum corneum (SC) lipid and cytokine levels in infants aged 2 months can predict the future onset of atopic dermatitis (AD) up to 2 years of age.
Major finding: The SC levels of protein-bound ceramides were decreased (P = .0058), whereas those of unsaturated sphingomyelin (P < .0001), thymic stromal lymphopoietin (P = .0032), and interleukin-13 (IL13; P < .0001) increased in infants with vs without a family history of atopic diseases. A combination of family history and high IL13, high 26:1-sphingomyelin, and low O30:0(C22S)-ceramide levels had a strong predictive power for AD onset by 2 years of age (adjusted odds ratio 54.0; 95% CI 9.2-317.5).
Study details: This observational study included 111 asymptomatic infants with or without a family history of atopic diseases who underwent skin tape strip analysis at 2 months of age.
Disclosures: This study was funded by Edelstein Family Chair of Pediatric Allergy-Immunology at National Jewish Health, Denver, Colorado, and the Korea Environment Industry and Technology Institute (KEITI) through Environmental Health Action Program, funded by Korea Ministry of Environment. Some authors reported ties with various organizations.
Source: Berdyshev E et al. Stratum corneum lipid and cytokine biomarkers at two months of age predict the future onset of atopic dermatitis. J Allergy Clin Immunol. 2023 (Feb 22). Doi: 10.1016/j.jaci.2023.02.013
Key clinical point: Stratum corneum (SC) lipid and cytokine levels in infants aged 2 months can predict the future onset of atopic dermatitis (AD) up to 2 years of age.
Major finding: The SC levels of protein-bound ceramides were decreased (P = .0058), whereas those of unsaturated sphingomyelin (P < .0001), thymic stromal lymphopoietin (P = .0032), and interleukin-13 (IL13; P < .0001) increased in infants with vs without a family history of atopic diseases. A combination of family history and high IL13, high 26:1-sphingomyelin, and low O30:0(C22S)-ceramide levels had a strong predictive power for AD onset by 2 years of age (adjusted odds ratio 54.0; 95% CI 9.2-317.5).
Study details: This observational study included 111 asymptomatic infants with or without a family history of atopic diseases who underwent skin tape strip analysis at 2 months of age.
Disclosures: This study was funded by Edelstein Family Chair of Pediatric Allergy-Immunology at National Jewish Health, Denver, Colorado, and the Korea Environment Industry and Technology Institute (KEITI) through Environmental Health Action Program, funded by Korea Ministry of Environment. Some authors reported ties with various organizations.
Source: Berdyshev E et al. Stratum corneum lipid and cytokine biomarkers at two months of age predict the future onset of atopic dermatitis. J Allergy Clin Immunol. 2023 (Feb 22). Doi: 10.1016/j.jaci.2023.02.013