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Journal of Clinical Oncology, Vol 18, Issue 4 (February), 2000: 724
© 2000 American Society for Clinical Oncology

Paclitaxel Versus Doxorubicin as First-Line Single-Agent Chemotherapy for Metastatic Breast Cancer: A European Organization for Research and Treatment of Cancer Randomized Study With Cross-Over

By R. Paridaens, L. Biganzoli, P. Bruning, J. G. M. Klijn, T. Gamucci, S. Houston, R. Coleman, J. Schachter, A. Van Vreckem, R. Sylvester, A. Awada, J. Wildiers, M. Piccart, on behalf of the European Organization for Research and Treatment of Cancer-Investigational Drug Branch for Breast Cancer/Early Clinical Studies Group

From the University Hospital Gasthuisberg, Leuven; and Investigational Drug Branch for Breast Cancer; and European Organization for Research and Treatment of Cancer Data Center; and Institut Jules Bordet, Brussels, Belgium; and Netherlands Cancer Institute, Amsterdam; and Daniel den Hoed Klinik and Academic Hospital, Rotterdam, The Netherlands; and Istituto Regina Helena, Rome, Italy; and Guy’s Hospital, London; and Weston Park Hospital, Sheffield, United Kingdom; and Rabin Medical Centre, Tel Aviv, Israel.

Address reprint requests to Robert Paridaens, MD, Department of Oncology, University Hospital Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium; email Robert.Paridaens{at}uz.kuleuven.oc.be

PURPOSE: To compare the efficacy of paclitaxel versus doxorubicin given as single agents in first-line therapy of advanced breast cancer (primary end point, progression-free survival [PFS]) and to explore the degree of cross-resistance between the two agents.

PATIENTS AND METHODS: Three hundred thirty-one patients were randomized to receive either paclitaxel 200 mg/m2, 3-hour infusion every 3 weeks, or doxorubicin 75 mg/m2, intravenous bolus every 3 weeks. Seven courses were planned unless progression or unacceptable toxicity occurred before the seven courses were finished. Patients who progressed within the seven courses underwent early cross-over to the alternative drug, while a delayed cross-over was optional for the remainder of patients at the time of disease progression.

RESULTS: Objective response in first-line therapy was significantly better (P = .003) for doxorubicin (response rate [RR], 41%) than for paclitaxel (RR, 25%), with doxorubicin achieving a longer median PFS (7.5 months for doxorubicin v 3.9 months for paclitaxel, P < .001). In second-line therapy, cross-over to doxorubicin (91 patients) and to paclitaxel (77 patients) gave response rates of 30% and 16%, respectively. The median survival durations of 18.3 months for doxorubicin and 15.6 months for paclitaxel were not significantly different (P = .38). The doxorubicin arm had greater toxicity, but this was counterbalanced by better symptom control.

CONCLUSION: At the dosages and schedules used in the present study, doxorubicin achieves better disease and symptom control than paclitaxel in first-line treatment. Doxorubicin and paclitaxel are not totally cross-resistant, which supports further investigation of these drugs in combination or in sequence, both in advanced disease and in the adjuvant setting.


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