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Final results of ERASME-4: a randomized trial of first-line docetaxel plus either capecitabine or epirubicin for metastatic breast cancer.

Author(s): Bachelot T, Bajard A, Ray-Coquard I, Provencal J, Coeffic D, Agostini C, Boisseau M, Kaphan R, Dramais D, Oprea C, Ferri-Dessens RM, Guastalla JP, Perol D

Affiliation(s): Departement de Cancerologie Medicale et Unite INSERM U590Centre Leon Berard, 28 rue LaennecFR-69373 Lyon Cedex 08, France. bachelot@lyon.fnclcc.fr

Publication date & source: 2011, Oncology., 80(3-4):262-8. Epub 2011 Jul 6.

Publication type: Clinical Trial, Phase II; Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: To assess the efficacy of capecitabine plus docetaxel (XT) versus epirubicin plus docetaxel (ET) as first-line therapy for metastatic breast cancer (MBC). PATIENTS AND METHODS: Patients with no prior chemotherapy for MBC were randomized to 3-weekly cycles of either XT (capecitabine 1,000 mg/m(2) twice daily, days 1-14; docetaxel 75 mg/m(2), day 1) or ET (epirubicin 75 mg/m(2), day 1; docetaxel 75 mg/m(2), day 1). The primary endpoint was non-progression rate 6 months after randomization. The planned sample size was 106 patients based on a randomized, phase II selection design. RESULTS: Between April 2004 and January 2007, 68 patients were randomized, giving 82% power to select the best regimen according to a 6-month non-progression rate. Slow accrual led to premature study termination. Baseline characteristics were generally well balanced between arms. The 6-month non-progression rates were 75.8% with XT versus 65.7% with ET (p = 0.36). After 42 months' median follow-up, median progression-free survival was 12.4 versus 6.8 months, respectively (p = 0.040). The safety profiles were consistent with previous experience. CONCLUSION: Further larger studies are warranted to validate these results. Despite more grade 3 hand-foot syndrome, first-line XT may be a valid alternative to ET, potentially improving efficacy. Copyright (c) 2011 S. Karger AG, Basel.

Page last updated: 2011-12-09

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