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• W2279073885 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, respectively. Two pts died after the first cycle of treatment and 1 pt had only received 1 cycle of treatment at the time of evaluation. Overall response rates were 70% and 64% for docetaxel and EC, respectively (p=ns). Median time to response was significantly shorter for docetaxel compared with EC (3.0 vs 5.7 weeks, p=0.044) and median time to progression was similar for both groups (35.9 vs 39.9 weeks, respectively). To facilitate the comparison of toxicity between treatments, we calculated the mean incidence per cycle of WHO grade toxicities. Grade 1–3 neurotoxicity was reported by significantly more pts receiving docetaxel compared with EC (p=0.028). There were no reports of clinical grade 4 toxicity for either regimen. Conclusions: These preliminary phase II data suggest that docetaxel is as effective and well tolerated as EC when used as first-line treatment for MBC. More mature data for 42 pts, including hematotoxity results, will be available by ASCO. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis" @default.
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• W2279073885 date "2004-07-15" @default.
• W2279073885 modified "2023-09-27" @default.
• W2279073885 title "Docetaxel versus epirubicin/cyclophosphamide (EC) as first-line therapy in metastatic breast cancer (MBC): Results from the randomized phase II TIPP study" @default.
• W2279073885 doi "https://doi.org/10.1200/jco.2004.22.14_suppl.823" @default.
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