Adjuvant Docetaxel for Node-Positive Breast Cancer
Miguel Martin, M.D., Tadeusz Pienkowski, M.D., John Mackey, M.D., Marek Pawlicki, M.D., Jean-Paul Guastalla, M.D., Charles Weaver, M.D., Eva Tomiak, M.D., Taher Al-Tweigeri, M.D., Linnea Chap, M.D., Eva Juhos, M.D., Raymond Guevin, M.D., Anthony Howell, M.D., Tommy Fornander, M.D., John Hainsworth, M.D., Robert Coleman, M.D., Jeferson Vinholes, M.D., Manuel Modiano, M.D., Tamas Pinter, M.D., Shou C. Tang, M.D., Bruce Colwell, M.D., Catherine Prady, M.D., Louise Provencher, M.D., David Walde, M.D., Alvaro Rodriguez-Lescure, M.D., Judith Hugh, M.D., Camille Loret, Ph.D., Matthieu Rupin, M.Sc., Sandra Blitz, M.Sc., Philip Jacobs, Ph.D., Michael Murawsky, M.Sc., Alessandro Riva, M.D., Charles Vogel, M.D., for the Breast Cancer International Research Group 001 Investigators
Background We compared docetaxel plus doxorubicin and cyclophosphamide(TAC) with fluorouracil plus doxorubicin and cyclophosphamide(FAC) as adjuvant chemotherapy for operable node-positive breastcancer.
Methods We randomly assigned 1491 women with axillary node-positivebreast cancer to six cycles of treatment with either TAC orFAC as adjuvant chemotherapy after surgery. The primary endpoint was disease-free survival.
Results At a median follow-up of 55 months, the estimated ratesof disease-free survival at five years were 75 percent amongthe 745 patients randomly assigned to receive TAC and 68 percentamong the 746 randomly assigned to receive FAC, representinga 28 percent reduction in the risk of relapse (P=0.001) in theTAC group. The estimated rates of overall survival at five yearswere 87 percent and 81 percent, respectively. Treatment withTAC resulted in a 30 percent reduction in the risk of death(P=0.008). The incidence of grade 3 or 4 neutropenia was 65.5percent 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 occurredin 3.9 percent of the patients who received TAC and 2.2 percentof those who received FAC (P=0.05); no deaths occurred as aresult of infection. Two patients in each group died duringtreatment. Congestive heart failure and acute myeloid leukemiaoccurred in less than 2 percent of the patients in each group.Quality-of-life scores decreased during chemotherapy but returnedto baseline levels after treatment.
Conclusions Adjuvant chemotherapy with TAC, as compared withFAC, significantly improves the rates of disease-free and overallsurvival among women with operable node-positive breast cancer.
Source Information
From Hospital Universitario San Carlos, Madrid (M. Martin); Maria Sklodowska-Curie Cancer Center, Warsaw, Poland (T. Pienkowski); Cross Cancer Institute, Edmonton, Canada (J.M., J. Hugh); Maria Sklodowska-Curie Memorial Institute, Krakow, Poland (M.P.); Centre Léon Bérard, Lyon, France (J.-P.G.); Response Oncology, Memphis, Tenn. (C.W.); Ottawa Regional Cancer Center, Ottawa (E.T.); Saskatoon Cancer Center, Saskatoon, Canada (T.A.-T.); UCLA School of Medicine, Los Angeles (L.C.); National Institute of Oncology, Budapest, Hungary (E.J.); Hôpital Saint Luc, Montreal (R.G.); Christie Hospital, Manchester, United Kingdom (A.H.); Onkologkliniken Södersjukhuset, Stockholm (T.F.); Cannon Cancer Center, Nashville (J. Hainsworth); Weston Park Hospital, Sheffield, United Kingdom (R.C.); Hospital Santa Casa de Misericordia, Porto Alegre, Brazil (J.V.); Arizona Clinical Research Center, Tucson (M. Modiano); Petz Aladár County Teaching Hospital, Gyor, Hungary (T. Pinter); Murphy Cancer Centre, Saint John, Canada (S.C.T.); Nova Scotia Cancer Center, Halifax, Canada (B.C.); Dumont Hospital, Moncton, Canada (C.P.); Hôpital du Saint Sacrement, Quebec, Canada (L.P.); Plummer Memorial Hospital, Sault Ste. Marie, Canada (D.W.); Hospital General, Elche, Spain (A.R.-L.); Breast Cancer International Research Group, Paris (C.L., M.R., S.B., A.R.); Institute of Health Economics, Edmonton, Canada (P.J.); Aventis Pharma, Antony, France (M. Murawsky); and Cancer Research Network, Plantation, Fla. (C.V.).
Address reprint requests to Dr. Martin at Servicio de Oncologia Medica, Hospital Universitario San Carlos, 28040 Madrid, Spain, or at mmartin{at}geicam.org.
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