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Multicenter Randomized Trial Comparing Sequential With Concomitant Administration of Doxorubicin and Docetaxel As First-Line Treatment of Metastatic Breast Cancer: A Spanish Breast Cancer Research Group (GEICAM-9903) Phase III Study

From the Medical Oncology Department, Complejo Hospitalario Virgen de la Victoria, Málaga; Medical Oncology Department, Hospital Universitario San Carlos, and Medical Oncology Department, Fundación Hospital Alcorcón, Madrid; Medical Oncology Department, Centro Oncológico Regional, La Coruña; Medical Oncology Department, Hospital General Universitario, Alicante; Medical Oncology Department, Hospital Universitario Arnau de Vilanova, Lérida; Medical Oncology Department, Hospital Germans Trias i Pujol, Badalona; Medical Oncology Department, Complejo Hospitalario de Albacete, Albacete; and Medical Oncology Department, Complejo Hospitalario Ciudad de Jaén, Jaén, Spain

Address reprint requests to Emilio Alba, MD, PhD, Medical Oncology Service, Hospital Clínico Universitario Virgen de la Victoria, Colonia Santa Inés S/N, 29010 Málaga, Spain; e-mail: oncologia98{at}yahoo.com

PURPOSE: This randomized, multicenter, phase III trial evaluated whether sequential doxorubicin and docetaxel (AT) reduced hematological toxicity, especially febrile neutropenia, compared with concomitant (AT) administration as first-line chemotherapy in metastatic breast cancer (MBC).

PATIENTS AND METHODS: One hundred forty-four patients were randomly assigned to receive three cycles of doxorubicin 75 mg/m² every 21 days followed by three cycles of docetaxel 100 mg/m², every 21 days (AT) or six cycles of the combination doxorubicin 50 mg/m² and docetaxel 75 mg/m² (AT) every 21 days. Patients previously treated with anthracyclines received two cycles of doxorubicin followed by four cycles of docetaxel (AT), or three cycles of AT followed by three cycles of docetaxel 100 mg/m² every 21 days.

RESULTS: Febrile neutropenia was less common in the AT arm (29.3% of patients, 6.9% of cycles) compared with the AT arm (47.8% of patients, 14.8% of cycles; P = .02 and P = .0004, respectively). Asthenia, diarrhea, and fever occurred more frequently in the AT arm. The overall responses rates were 61% in the AT arm (95% CI, 50% to 72%) and 51% in the AT arm (95% CI, 39% to 63%). The median duration of response was 8.7 months (AT) and 7.6 months (AT); the median time to progression was 10.5 months (AT) and 9.2 months (AT); the median overall survival was 22.3 months (AT) and 21.8 months (AT); and no significant differences were found.

CONCLUSION: AT significantly reduced febrile neutropenia compared with AT in MBC patients and maintains comparable antitumoral efficacy. AT represents a valid option for the treatment of MBC.

Supported by Aventis Pharma SA.

The results of this study were presented as oral communication at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003 (Abstract 27).

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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