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Phase III Comparative Study of Vinorelbine Combined With Doxorubicin Versus Doxorubicin Alone in Disseminated Metastatic/Recurrent Breast Cancer: National Cancer Institute of Canada Clinical Trials Group Study MA8

From the Fraser Valley Cancer Centre, British Columbia Cancer Agency, Surrey; Vancouver Cancer Centre, British Columbia Cancer Agency, Vancouver, British Columbia. Toronto-Sunnybrook Regional Cancer Centre; University of Toronto; Toronto Hospital; Humber Memorial Hospital; Women’s College Hospital, Toronto; National Cancer Institute of Canada Clinical Trials Group; Kingston Regional Cancer Centre, Kingston; Hotel-Dieu Hospital, St. Catherine’s; London Regional Cancer Centre; University of Western Ontario, London; Glaxo-Wellcome Inc, Mississauga, Ontario; Nova Scotia Cancer Centre; Dalhousie University, Halifax, Nova Scotia; and Hotel-Dieu Hospital, Montreal, Quebec, Canada.

Address reprint requests to Brian Norris, MD, Fraser Valley Cancer Centre, British Columbia Cancer Agency, 13750 96th Ave, Surrey, British Columbia, Canada V3V 1Z2.

PURPOSE: This phase III study was performed to determine the superiority of doxorubicin (DOX) and vinorelbine (VNB) (arm 1) versus DOX alone (arm 2) in metastatic breast cancer (MBC) for overall survival (OS), time to treatment failure (TTF), toxicity, and quality of life (QOL).

PATIENTS AND METHODS: Three hundred three patients were randomized to DOX 50 mg/m² intravenously (IV) on day 1 and VNB 25 mg/m² IV on days 1 and 8 (arm 1) or DOX 70 mg/m² IV on day 1 (arm 2). Both regimens were given every 3 weeks until a cumulative DOX dose of 450 mg/m². After 16 of the first 65 randomized patients experienced febrile neutropenia (FN), the doses were reduced to DOX 40 mg/m² on day 1 and VNB 20 mg/m² on days 1 and 8 versus DOX 60 mg/m² on day 1. Eligible patients were vinca alkaloid and anthracycline naive. Chemotherapy was first-line or second-line for MBC.

RESULTS: Three patients were ineligible. Thus, 300 patients were assessable for toxicity and to determine time to disease progression (TTP), TTF, and OS. Two hundred eighty-nine patients were assessable for response, and 99 responders were assessable for response duration (RD). The response rates, QOL, and median RD, TTP, and TTF were not significantly different between the arms. Median OS was 13.8 months for arm 1 versus 14.4 months for arm 2 (P = .4). Grade 3 or 4 granulocytopenia was equivalent in both arms but more grade 3/4 neurotoxicity, mild venous toxicity, and FN were seen on arm 1.

CONCLUSION: The survival with DOX and VNB is not superior to DOX alone in MBC.

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