Docetaxel versus epirubicin/cyclophosphamide (EC) as first-line therapy in metastatic breast cancer (MBC): Results from the randomized phase II TIPP study

Abstract

823 Background: Docetaxel is one of the most active single-agent therapies for MBC and may produce higher response rates than current standard regimens. This two-centre randomized, phase II study of docetaxel vs EC was initiated to investigate the therapeutic potential of single-agent docetaxel as first-line therapy for MBC. Methods: Patients (pts) with MBC (no prior chemotherapy for metastatic disease) and WHO performance status 0–1 are eligible for the study. Accrual of 60 patients is planned. Pts are randomized to either docetaxel 100mg/m2 as a 1-hour intravenous infusion (with standard oral dexamethasone premedication) or epirubicin 90mg/m2 followed by cyclophosphamide 600mg/m2, each administered as an intravenous bolus. Both regimens are repeated every 3 weeks for a maximum of 6 cycles. Results: To date, interim data are available for 34 patients (docetaxel 14, EC 20) who have completed 6 cycles of therapy. In total, 24, 31, and 34 pts are evaluable for tumor response, efficacy, and toxicity, respect...