Adjuvant docetaxel for node-positive breast cancer - PubMed (original) (raw)

Clinical Trial

. 2005 Jun 2;352(22):2302-13.

doi: 10.1056/NEJMoa043681.

Tadeusz Pienkowski, John Mackey, Marek Pawlicki, Jean-Paul Guastalla, Charles Weaver, Eva Tomiak, Taher Al-Tweigeri, Linnea Chap, Eva Juhos, Raymond Guevin, Anthony Howell, Tommy Fornander, John Hainsworth, Robert Coleman, Jeferson Vinholes, Manuel Modiano, Tamas Pinter, Shou C Tang, Bruce Colwell, Catherine Prady, Louise Provencher, David Walde, Alvaro Rodriguez-Lescure, Judith Hugh, Camille Loret, Matthieu Rupin, Sandra Blitz, Philip Jacobs, Michael Murawsky, Alessandro Riva, Charles Vogel; Breast Cancer International Research Group 001 Investigators

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Clinical Trial

Adjuvant docetaxel for node-positive breast cancer

Miguel Martin et al. N Engl J Med. 2005.

Free article

Abstract

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.

Copyright 2005 Massachusetts Medical Society.

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