Adjuvant Docetaxel for Node-Positive Breast Cancer

作者：Miguel Martín, Tadeusz Pieńkowski, John Robert Mackey, Marek Pawlicki, Jean‐Paul Guastalla, Charles H. Weaver, Eva M. Tomiak, Taher Al‐Tweigeri, Linnea I. Chap, Éva Juhos, Raymond Guevin, Anthony Howell, Tommy G. Fornander, John Daniel Hainsworth, Robert Edward Coleman, J. Vinholes, Manuel Modiano, Tamás Pintér, Shou Ching Tang, Bruce Colwell, Catherine C. M. Prady, Louise Provencher, David Walde, Álvaro Rodríguez-Lescure, Judith C. Hugh, Camille Loret, Matthieu Rupin, Sandra Blitz, Philip Jacobs, Michael Murawsky, Alessandro Riva, Charles L. Vogel · 发表于：New England Journal of Medicine · 年份：2005 · DOI：10.1056/nejmoa043681 · 被引用次数：958 · 研究领域：Breast Cancer Treatment Studies、Breast Lesions and Carcinomas、Breast Implant and Reconstruction

BACKGROUND: We compared docetaxel plus doxorubicin and cyclophosphamide (TAC) with fluorouracil plus doxorubicin and cyclophosphamide (FAC) as adjuvant chemotherapy for operable node-positive breast cancer. METHODS: We randomly assigned 1491 women with axillary node-positive breast cancer to six cycles of treatment with either TAC or FAC as adjuvant chemotherapy after surgery. The primary end point was disease-free survival. RESULTS: At a median follow-up of 55 months, the estimated rates of disease-free survival at five years were 75 percent among the 745 patients randomly assigned to receive TAC and 68 percent among the 746 randomly assigned to receive FAC, representing a 28 percent reduction in the risk of relapse (P=0.001) in the TAC group. The estimated rates of overall survival at five years were 87 percent and 81 percent, respectively. Treatment with TAC resulted in a 30 percent reduction in the risk of death (P=0.008). The incidence of grade 3 or 4 neutropenia was 65.5 percent in the TAC group and 49.3 percent in the FAC group (P<0.001); rates of febrile neutropenia were 24.7 percent and 2.5 percent, respectively (P<0.001). Grade 3 or 4 infections occurred in 3.9 percent of the patients who received TAC and 2.2 percent of those who received FAC (P=0.05); no deaths occurred as a result of infection. Two patients in each group died during treatment. Congestive heart failure and acute myeloid leukemia occurred in less than 2 percent of the patients in each group. Quality...