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Gemcitabine, Epirubicin, and Paclitaxel Versus Fluorouracil, Epirubicin, and Cyclophosphamide As First-Line Chemotherapy in Metastatic Breast Cancer: A Central European Cooperative Oncology Group International, Multicenter, Prospective, Randomized Phase III Trial

From the University Hospital Vienna, Vienna, Austria; Institute of Oncology, Sarajevo, Bosnia; University Hospital, Zagreb, Croatia; Medical University, Gdansk; Jagiellonian University, Krakow, Poland; Onkotherápiás Klinika, Szeged; Debrecen Medical University, Debrecen, Hungary; University Hospital "Queen Joanna"; National Oncological Center, Sofia, Bulgaria; Sourasky Medical Center, Tel Aviv, Israel; Institute of Oncology, Ljubljana, Slovenia; Nemocnica Saetes Alzbety, Bratislava; Fakultna Nemocnica Luisa Pasteura, Kosice, Slovakia; Institute of Oncology, Cluj, Romania; and InnoPharm, Smolensk, Russia

Address reprint requests to Christoph C. Zielinski, MD, Department of Medicine I, University Hospital, 18-20 Waehringer Guertel, A-1090 Vienna, Austria; e-mail: christoph.zielinski{at}meduniwien.ac.at

BACKGROUND: The objectives of this phase III trial were to compare the time to progressive disease (TtPD), overall response rate (ORR), overall survival, and toxicity of gemcitabine, epirubicin, and paclitaxel (GET) versus fluorouracil (FU), epirubicin, and cyclophosphamide (FEC) as first-line therapy in patients with metastatic breast cancer (MBC).

PATIENTS AND METHODS: Female patients aged 18 to 75 years with stage IV and measurable MBC were enrolled and randomly assigned to either gemcitabine (1,000 mg/m², days 1 and 4), epirubicin (90 mg/m², day 1), and paclitaxel (175 mg/m², day 1) or FU (500 mg/m², day 1), epirubicin (90 mg/m², day 1), and cyclophosphamide (500 mg/m², day 1). Both regimens were administered every 21 days for a maximum of eight cycles.

RESULTS: Between October 1999 and November 2002, 259 patients (GET, n = 124; FEC, n = 135) were enrolled. Baseline characteristics were well balanced across treatment arms. After a median of 20.4 months of follow-up, median TtPD was 9.1 months and 9.0 months in the GET and FEC arms, respectively (P = .557). The ORR was 62.3% in the GET arm (n = 114) and 51.2% in the FEC arm (n = 129; P = .093). Grade 3 and 4 toxicities, including neutropenia, thrombocytopenia, anemia, stomatitis, neurosensory toxicity, and allergy, occurred significantly more often in the GET arm.

CONCLUSION: No significant differences in terms of TtPD and ORR were observed between the two treatment arms. Treatment-related toxicity was higher in the GET arm.

Supported by grants from Eli Lilly and Company, Bristol-Myers Squibb, and Pharmacia Upjohn.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

Statistical analysis was performed by D.K. and V.S. from InnoPharm, Smolensk, Russia.

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

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