TY - JOUR
T1 - Randomized trial of standard adjuvant chemotherapy regimens versus capecitabine in older women with early breast cancer
T2 - 10-year update of the CALGB 49907 trial
AU - Muss, Hyman B.
AU - Polley, Mei Yin C.
AU - Berry, Donald A.
AU - Liu, Heshan
AU - Cirrincione, Constance T.
AU - Theodoulou, Maria
AU - Mauer, Ann M.
AU - Kornblith, Alice B.
AU - Partridge, Ann H.
AU - Dressler, Lynn G.
AU - Cohen, Harvey J.
AU - Kartcheske, Patricia A.
AU - Perez, Edith A.
AU - Wolff, Antonio C.
AU - Gralow, Julie R.
AU - Burstein, Harold J.
AU - Mahmood, Ahmad A.
AU - Sutton, Linda M.
AU - Magrinat, Gustav
AU - Parker, Barbara A.
AU - Hart, Ronald D.
AU - Grenier, Debjani
AU - Hurria, Arti
AU - Jatoi, Aminah
AU - Norton, Larry
AU - Hudis, Clifford A.
AU - Winer, Eric P.
AU - Carey, Lisa
N1 - Publisher Copyright:
© 2019 by American Society of Clinical Oncology
PY - 2019/9/10
Y1 - 2019/9/10
N2 - PURPOSE Older women with breast cancer remain under-represented in clinical trials. The Cancer and Leukemia Group B 49907 trial focused on women age 65 years and older. We previously reported the primary analysis after a median follow-up of 2.4 years. Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine. We now update results at a median follow-up of 11.4 years. PATIENTS AND METHODS Patients age 65 years or older with early breast cancer were randomly assigned to either standard adjuvant chemotherapy (physician's choice of either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide and doxorubicin) or capecitabine. An adaptive Bayesian design was used to determine sample size and test noninferiority of capecitabine. The primary end point was RFS. RESULTS The design stopped accrual with 633 patients at its first sample size assessment. RFS remains significantly longer for patients treated with standard chemotherapy. At 10 years, in patients treated with standard chemotherapy versus capecitabine, the RFS rates were 56% and 50%, respectively (hazard ratio [HR], 0.80; P = .03); breast cancer-specific survival rates were 88% and 82%, respectively (HR, 0.62; P = .03); and overall survival rates were 62% and 56%, respectively (HR, 0.84; P = .16). With longer follow-up, standard chemotherapy remains superior to capecitabine among hormone receptor-negative patients (HR, 0.66; P = .02), but not among hormone receptor-positive patients (HR, 0.89; P = .43). Overall, 43.9% of patients have died (13.1% from breast cancer, 16.4% from causes other than breast cancer, and 14.1% from unknown causes). Second nonbreast cancers occurred in 14.1% of patients. CONCLUSION With longer follow-up, RFS remains superior for standard adjuvant chemotherapy versus capecitabine, especially in patients with hormone receptor-negative disease. Competing risks in this older population dilute overall survival benefits.
AB - PURPOSE Older women with breast cancer remain under-represented in clinical trials. The Cancer and Leukemia Group B 49907 trial focused on women age 65 years and older. We previously reported the primary analysis after a median follow-up of 2.4 years. Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine. We now update results at a median follow-up of 11.4 years. PATIENTS AND METHODS Patients age 65 years or older with early breast cancer were randomly assigned to either standard adjuvant chemotherapy (physician's choice of either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide and doxorubicin) or capecitabine. An adaptive Bayesian design was used to determine sample size and test noninferiority of capecitabine. The primary end point was RFS. RESULTS The design stopped accrual with 633 patients at its first sample size assessment. RFS remains significantly longer for patients treated with standard chemotherapy. At 10 years, in patients treated with standard chemotherapy versus capecitabine, the RFS rates were 56% and 50%, respectively (hazard ratio [HR], 0.80; P = .03); breast cancer-specific survival rates were 88% and 82%, respectively (HR, 0.62; P = .03); and overall survival rates were 62% and 56%, respectively (HR, 0.84; P = .16). With longer follow-up, standard chemotherapy remains superior to capecitabine among hormone receptor-negative patients (HR, 0.66; P = .02), but not among hormone receptor-positive patients (HR, 0.89; P = .43). Overall, 43.9% of patients have died (13.1% from breast cancer, 16.4% from causes other than breast cancer, and 14.1% from unknown causes). Second nonbreast cancers occurred in 14.1% of patients. CONCLUSION With longer follow-up, RFS remains superior for standard adjuvant chemotherapy versus capecitabine, especially in patients with hormone receptor-negative disease. Competing risks in this older population dilute overall survival benefits.
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U2 - 10.1200/JCO.19.00647
DO - 10.1200/JCO.19.00647
M3 - Article
C2 - 31339827
AN - SCOPUS:85071784356
SN - 0732-183X
VL - 37
SP - 2338
EP - 2348
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 26
ER -