Combination of vinorelbine, epirubicin, and cyclophosphamide as neoadjuvant chemotherapy for locally advanced breast cancer: phase II study.

Achievement of a pathologic complete response after primary chemotherapy in breast cancer can predict long-term outcome. We have investigated a combination of epirubicin, cyclophosphamide, and vinorelbine as neoadjuvant chemotherapy in locally advanced breast cancer (LABC). From January 1997 to May 1999, 30 chemonaive patients were treated (T2 or T3 histologically proven invasive breast carcinoma). Treatment was vinorelbine 25 mg/m2 day 1 and day 3, epirubicin 30 mg/m2/d, days 1 to 3, cyclophosphamide 350 mg/m2/d, days 1 to 3, every 14 days for 4 courses. Twenty-nine patients were evaluable. Median age: 48 years (range: 28-66 years); 26 had ductal invasive carcinoma and 4 lobular invasive carcinoma; median tumor size: 7 cm; median number of induction cycles: four. Clinical objective response was seen in 24 patients (relative risk: 86%), 14 complete responses, 10 partial responses, four stable disease (no significant changes). Twenty-nine patients had surgical treatment. Pathologic response rate was complete response in 32% (no residual tumor), in situ carcinoma: 11%, invasive or unchanged tumor remaining: 57%. Ninety-eight cycles were administered; major toxicities were hematologic: grade IV Hb in 5% and grade IV neutropenia in 60% of cycles. Ten patients required hospitalization for febrile neutropenia. Other toxicities were mild to moderate. The vinorelbine/epirubicin/cyclophosphamide regimen resulted in a high pathologic complete response rate in LABC with a good tolerance profile, and warrants further evaluation.