Journal of Clinical Oncology, Vol 17, Issue 8
(August), 1999: 2341
© 1999 American Society for Clinical Oncology
Prospective Randomized Trial of Docetaxel Versus Doxorubicin in Patients With Metastatic Breast Cancer
Stephen Chan,
Kay Friedrichs,
Daniel Noel,
Tamàs Pintér,
Simon Van Belle,
Daniel Vorobiof,
Ricardo Duarte,
Miguel Gil Gil,
Istvan Bodrogi,
Elizabeth Murray,
Louise Yelle,
Gunter von Minckwitz,
Stefan Korec,
Peter Simmonds,
Franco Buzzi,
Rosario González Mancha,
Gary Richardson,
Euan Walpole,
Monica Ronzoni,
Michael Murawsky,
May Alakl,
Alessandro Riva,
John Crown for the 303 Study Group
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 Department, Country Hospital, Gyor, and National Institute of Oncology, Budapest, Hungary; Dienst Medische Oncologie, Universitair Ziekenhuis Gent, Gent, Belgium; The Sandton Oncology Centre, Johannesburg, and Department of Radiation Oncology, Groote Schuur Hospital, Cape Town, South Africa; National Institute of Cancerology, Bogota, Colombia; Servicio Oncología, Instituto Catalán de Oncología, Barcelona, and Servicio Oncología, Hospital Provincial, Cordova, Spain; National Cancer Institute, Bratislava, Slovakia; Servizio Oncologico, Ospedale Civile S. Maria, Terni, and Unita di Radiochemioterapia, Ospedale San Raffaele, Milan, Italy; Department of Medical Oncology and Clinical Haematology, Monash Medical Centre, Clayton, Victoria, and Department of Medical Oncology, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia; Rhône-Poulenc Rorer, Antony, France; and St Vincent Hospital, Dublin, Ireland.
Address reprint requests to Stephen Chan, DM, MRCP, FRCR, Department of Clinical Oncology, City Hospital, Hucknall Rd, Nottingham NG5 1PB, United Kingdom; email ytschan{at}innotts.co.uk
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.
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