Prospective Randomized Trial of Docetaxel Versus Doxorubicin in Patients With Metastatic Breast Cancer
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Published:1999-08
Issue:8
Volume:17
Page:2341-2341
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ISSN:0732-183X
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Container-title:Journal of Clinical Oncology
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language:en
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Short-container-title:JCO
Author:
Chan Stephen1, Friedrichs Kay1, Noel Daniel1, Pintér Tamàs1, Van Belle Simon1, Vorobiof Daniel1, Duarte Ricardo1, Gil Gil Miguel1, Bodrogi Istvan1, Murray Elizabeth1, Yelle Louise1, von Minckwitz Gunter1, Korec Stefan1, Simmonds Peter1, Buzzi Franco1, González Mancha Rosario1, Richardson Gary1, Walpole Euan1, Ronzoni Monica1, Murawsky Michael1, Alakl May1, Riva Alessandro1, Crown John1
Affiliation:
1. From the Department of Clinical Oncology, City Hospital, Nottingham, and CRC Wessex Medical Oncology Unit, Royal South Hants Hospital, Southampton, United Kingdom; Universitäts-Frauenklinik und Poliklinik, Universitäts-Krankenhaus Eppendorf, Hamburg, and Klinik für Gynäkologie und Onkologie, Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt, Germany; Oncology Department, Hôpital du Sacré-Coeur de Montreal, and Oncology Department, Hôpital Notre-Dame, Montreal, Quebec, Canada; Oncoradiology...
Abstract
PURPOSE: This phase III study compared docetaxel and doxorubicin in patients with metastatic breast cancer who had received previous alkylating agent–containing chemotherapy. PATIENTS AND METHODS: Patients were randomized to receive an intravenous infusion of docetaxel 100 mg/m2 or doxorubicin 75 mg/m2 every 3 weeks for a maximum of seven treatment cycles. RESULTS: A total of 326 patients were randomized, 165 to receive doxorubicin and 161 to receive docetaxel. Overall, docetaxel produced a significantly higher rate of objective response than did doxorubicin (47.8% v 33.3%; P = .008). Docetaxel was also significantly more active than doxorubicin in patients with negative prognostic factors, such as visceral metastases (objective response, 46% v 29%) and resistance to prior chemotherapy (47% v 25%). Median time to progression was longer in the docetaxel group (26 weeks v 21 weeks; difference not significant). Median overall survival was similar in the two groups (docetaxel, 15 months; doxorubicin, 14 months). There was one death due to infection in each group, and an additional four deaths due to cardiotoxicity in the doxorubicin group. Although neutropenia was similar in both groups, febrile neutropenia and severe infection occurred more frequently in the doxorubicin group. For severe nonhematologic toxicity, the incidences of cardiac toxicity, nausea, vomiting, and stomatitis were higher among patients receiving doxorubicin, whereas diarrhea, neuropathy, fluid retention, and skin and nail changes were higher among patients receiving docetaxel. CONCLUSION: The observed differences in activity and toxicity profiles provide a basis for therapy choice and confirms the rationale for combination studies in early breast cancer.
Publisher
American Society of Clinical Oncology (ASCO)
Subject
Cancer Research,Oncology
Cited by
570 articles.
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