Adjuvant docetaxel for node-positive breast cancer

Miguel Martin, 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 ColwellCatherine Prady, Louise Provencher, David Walde, Alvaro Rodriguez-Lescure, Judith Hugh, Camille Loret, Matthieu Rupin, Sandra Blitz, Philip Jacobs, Michael Murawsky, Alessandro Riva, Charles Vogel

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872 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)2302-2313
Number of pages12
JournalNew England Journal of Medicine
Issue number22
StatePublished - Jun 2 2005
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)


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