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Adjuvant Docetaxel For Node-positive Breast Cancer.

M. Martín, T. Pieńkowski, John Mackey, M. Pawlicki, J. Guastalla, Charles T. Weaver, E. Tomiak, T. Al-Tweigeri, L. Chap, É. Juhos, R. Guévin, A. Howell, T. Fornander, J. Hainsworth, R. Coleman, J. Vinholes, M. Modiano, T. Pintér, S. C. Tang, B. Colwell, C. Prady, L. Provencher, D. Walde, Á. Rodríguez-Lescure, J. Hugh, C. Loret, M. Rupin, S. Blitz, P. Jacobs, M. Murawsky, A. Riva, C. Vogel
Published 2005 · Medicine

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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-of-life scores decreased during chemotherapy but returned to baseline levels after treatment. CONCLUSIONS Adjuvant chemotherapy with TAC, as compared with FAC, significantly improves the rates of disease-free and overall survival among women with operable node-positive breast cancer.
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