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Phase II to III Study Comparing Doxorubicin and Docetaxel With Fluorouracil, Doxorubicin, and Cyclophosphamide As First-Line Chemotherapy in Patients With Metastatic Breast Cancer: Results of a Dutch Community Setting Trial for the Clinical Trial Group of the Comprehensive Cancer Centre

From the Departments of Medical Oncology and Statistics, Erasmus University Medical Center, Daniel den Hoed Cancer Center; Ijsselland Hospital; Sint Clara Hospital, Rotterdam; Catharina Hospital, Eindhoven; Vlietland Hospital, Schiedam; Sint Franciscus Hospital, Roosendaal; Vlietland Hospital, Vlaardingen; Twee Steden Hospital, Tilburg; Van Weel Bethesda Hospital, Dirksland; Hospital Walcheren, Vlissingen; and Aventis Pharma, Hoevelaken, the Netherlands

Address reprint requests to Marijke Bontenbal, MD, PhD, Medical Oncologist, Erasmus University Medical Center, Daniel den Hoed Cancer Center, Groene Hilledijk 301, 3075 EA Rotterdam, the Netherlands; e-mail: m.bontenbal{at}erasmusmc.nl

PURPOSE: To compare the efficacy and safety of doxorubicin and docetaxel (AT) with fluorouracil, doxorubicin, and cyclophosphamide (FAC) as first-line chemotherapy for metastatic breast cancer (MBC).

PATIENTS AND METHODS: Patients (n = 216) were randomly assigned to either AT (doxorubicin 50 mg/m² and docetaxel 75 mg/m²) or FAC (fluorouracil 500 mg/m², doxorubicin 50 mg/m², and cyclophosphamide 500 mg/m²); both regimens were administered on day 1, every 3 weeks.

RESULTS: A median number of six cycles was delivered in both arms, with a median relative dose-intensity of more than 98%. Median time to progression (TTP) and median overall survival (OS) were significantly longer for patients on AT compared with FAC (TTP: 8.0 v 6.6 months, respectively; P = .004; and OS: 22.6 v 16.2 months, respectively; P = .019). The overall response rate (ORR) was significantly higher in patients on AT compared with FAC (58% v 37%, respectively; P = .003). The ORR on AT was also higher in patients with visceral disease compared with FAC patients with visceral disease (59% v 36%, respectively; P = .003). There were no differences in grade 3 to 4 neutropenia and infections (AT 89% v FAC 84% and AT 12% v FAC 9%, respectively). Neutropenic fever was more common in AT-treated patients than FAC-treated patients (33% v 9%, respectively; P < .001). Grade 3 to 4 nonhematologic toxicity was infrequent in both arms. Congestive heart failure was observed in 3% and 6% of patients on AT and FAC, respectively.

CONCLUSION: In this phase II to III study, AT resulted in a significantly longer TTP and OS and a higher objective ORR than FAC. First-line AT is a valid treatment option for patients with MBC.

Supported by Aventis Pharma, Hoevelaken, the Netherlands.

Presented in part at the 12th European Conference of Clinical Oncology, Copenhagen, Denmark, September 21-25, 2003.

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

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