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Phase III Study of Intravenous Vinorelbine in Combination With Epirubicin Versus Epirubicin Alone in Patients With Advanced Breast Cancer: A Scandinavian Breast Group Trial (SBG9403)

From the Departments of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen; Vejle County Hospital, Vejle; Aarhus University Hospital; Aalborg County Hospital, Aarhus, Denmark; and Helsinki University Hospital, Helsinki, Finland

Address reprint requests to Bent Ejlertsen, MD, PhD, Department of Oncology, Bldg. 5012 Rigshospitalet, 9 Blegdamsvej, DK-2100 Copenhagen, Denmark; e-mail: ejlertsen{at}rh.dk

PURPOSE: To determine whether the addition of intravenous (IV) vinorelbine to epirubicin increased the progression-free survival in first-line treatment of metastatic breast cancer.

PATIENTS AND METHODS: A total of 387 patients were randomly assigned to receive IV epirubicin 90 mg/m² on day 1 and vinorelbine 25 mg/m² on days 1 and 8, or epirubicin 90 mg/m² IV on day 1. Both regimens were given every 3 weeks for a maximum of 1 year but discontinued prematurely in the event of progressive disease or severe toxicity. In addition, epirubicin was discontinued at a cumulative dose of 1,000 mg/m² (950 mg/m² from June 1999). Prior anthracycline-based adjuvant chemotherapy and prior chemotherapy for metastatic breast cancer was not allowed. Reported results were all based on intent-to-treat analyses.

RESULTS: Overall response rates to vinorelbine and epirubicin, and epirubicin alone, were 50% and 42%, respectively (P = .15). The complete response rate was significantly superior in the combination arm (17% v 10%; P = .048) as was median duration of progression-free survival (10.1 months v 8.2 months; P = .019). Median survival was similar in the two arms (19.1 months v 18.0 months; P = .50). Leukopenia related complications, stomatitis, and peripheral neuropathy were more common in the combination arm. The incidences of cardiotoxicity and constipation were similar in both arms.

CONCLUSION: Addition of vinorelbine to epirubicin conferred a significant advantage in terms of complete response rate and progression-free survival, but not in terms of survival.

Supported in part by Institut de Recherche Pierre Fabre, Boulogne, France; and Medical Affairs Oncology, Pharmacia, Milan, Italy.

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

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