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Docetaxel Plus Epirubicin Is A Highly Active, Well-tolerated, First-line Chemotherapy For Metastatic Breast Cancer: Results Of A Large, Multicentre Phase II Study

S. Morales, Antonio Lorenzo, M. Ramos, P. Ballesteros, M. Méndez, C. Almanza, J. Castellanos, J. A. Moreno-Nogueira, J. Casal, J. Lizón, A. Oltra, A. Frau, I. Machengs, A. Galán, J. Belón, C. Llorca
Published 2003 · Medicine

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PurposeIn this multicentre phase II study, the efficacy and safety profile of the combination of docetaxel and epirubicin as first-line chemotherapy for metastatic breast cancer (MBC) were evaluated.MethodsEpirubicin (75 mg/m2) and docetaxel (75 mg/m2) were given intravenously once every 3 weeks for six cycles to 133 patients with MBC.ResultsThe overall clinical response rate was 67% (complete and partial responses were 23% and 44%, respectively). The median time to progression was 10.8 months (95% CI 9.7–12.6) and the median overall survival was 19.5 months. Granulocyte colony-stimulating factor support was administered to 32% of patients and in 22% of cycles. Grade 3/4 neutropenia occurred in 35% of patients and febrile neutropenia in 19%. The most frequent grade 3/4 non-haematological toxicities (as percent of patients) were asthenia (6%), vomiting (5%) and nausea (5%). No patients developed congestive heart failure.ConclusionsThe combination of docetaxel and epirubicin was highly active as first-line treatment for MBC and showed a manageable toxicity profile.
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