• J. Clin. Oncol. · Mar 2003

    Randomized Controlled Trial Multicenter Study Clinical Trial

    Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial.

    • Jean-Marc Nabholtz, Carla Falkson, Daniel Campos, Janos Szanto, Miguel Martin, Stephen Chan, Tadeuz Pienkowski, Jerzy Zaluski, Tamas Pinter, Maciej Krzakowski, Daniel Vorobiof, Robert Leonard, Ian Kennedy, Nacer Azli, Michael Murawsky, Alessandro Riva, Pierre Pouillart, and TAX 306 Study Group.
    • University of California at Los Angeles, CA 90095-7077, USA. jmnabholtz@hotmail.com
    • J. Clin. Oncol. 2003 Mar 15; 21 (6): 968-75.

    PurposeThis randomized, multicenter, phase III study compared doxorubicin and docetaxel (AT) with doxorubicin and cyclophosphamide (AC) as first-line chemotherapy (CT) in metastatic breast cancer (MBC).Patients And MethodsPatients (n = 429) were randomly assigned to receive doxorubicin 50 mg/m(2) plus docetaxel 75 mg/m(2) (n = 214) or doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) (n = 215) on day 1, every 3 weeks for up to eight cycles.ResultsTime to progression (TTP; primary end point) and time to treatment failure (TTF) were significantly longer with AT than AC (median TTP, 37.3 v 31.9 weeks; log-rank P =.014; median TTF, 25.6 v 23.7 weeks; log-rank P =.048). The overall response rate (ORR) was significantly greater for patients taking AT (59%, with 10% complete response [CR], 49% partial response [PR]) than for those taking AC (47%, with 7% CR, 39% PR) (P =.009). The ORR was also higher with AT in patients with visceral involvement (58% v 41%; liver, 62% v 42%; lung, 58% v 35%), three or more organs involved (59% v 40%), or prior adjuvant CT (53% v 41%). Overall survival (OS) was comparable in both arms. Grade 3/4 neutropenia was frequent in both groups, although febrile neutropenia and infections were more frequent for patients taking AT (respectively, 33% v 10%, P <.001; 8% v 2%, P =.01). Severe nonhematologic toxicity was infrequent in both groups, including grade 3/4 cardiac events (AT, 3%; AC, 4%).ConclusionAT significantly improves TTP and ORR compared with AC in patients with MBC, but there is no difference in OS. AT represents a valid option for the treatment of MBC.

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