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Journal of Clinical Oncology, Vol 21, Issue 6 (March), 2003: 968-975
© 2003 American Society for Clinical Oncology

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 for the TAX 306 Study Group

From the University of California at Los Angeles, CA; University of Pretoria, Pretoria, and Sandton Oncology Centre, Johannesburg, South Africa; Hospital de San Isidro, Buenos Aires, Argentina; Szt Margit Hospital, Budapest, and County Hospital, Gyor, Hungary; Hospital Clinico San Carlos, Madrid, Spain; City Hospital Trust, Nottingham, and Western General Hospital, Edinburgh, United Kingdom; Oncology Center, Warsaw, and Oncology Center, Poznan, Poland; Waikato Hospital, Hamilton, New Zealand; and Aventis Pharma, Antony, and Institut Curie, Paris, France.

Address reprint requests to Jean-Marc Nabholtz, MD, University of California, Los Angeles, Peter Ueberroth Building Suite 3360B, Los Angeles, CA 90095-7077; email: jmnabholtz{at}hotmail.com.

Purpose: This 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 Methods: Patients (n = 429) were randomly assigned to receive doxorubicin 50 mg/m2 plus docetaxel 75 mg/m2 (n = 214) or doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (n = 215) on day 1, every 3 weeks for up to eight cycles.

Results: Time 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%).

Conclusion: AT 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.

Supported by Aventis Pharma, Antony, France.




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