Pathological and clinical response of a primary chemotherapy regimen combining vinorelbine, epirubicin, and paclitaxel as neoadjuvant treatment in patients with operable breast cancer

This phase II study investigated the efficacy and tolerability of a primary chemotherapy regimen combining vinorelbine, epirubicin, and paclitaxel (VEP protocol) in women with stage II/III operable breast cancer. Patients (n = 50) were treated with six cycles of VEP according to the following schedule: vinorelbine (Navelbine (R); Pierre Fabre, Boulogne, France; http://www.pierre-fabre.com) 20 mg/m(2), epirubicin (Farmorubicin (R); Pharmacia, New York, NY; http:www.pnu.com) 35 mg/m(2) given on days 1 and 8, paclitaxel (Taxol (R); Bristol-Myers Squibb, New York, NY; http://www.bmsoncology.com) 175 mg/m(2) given on day 9, and G-CSF 5 mg/kg/day given on days 10-20 of a 21-day cycle, followed by surgery and radiotherapy. After six cycles of VEP, the pathological response rate (pCR) in breast was confirmed in six patients (12 %; 95 % confidence interval [CI]: 3-21) using Chevallier's classification and in nine patients (18 %; 95 % CI: 7.4-28.6) using Sataloff's classification. The clinical response rate was 42 % (95 % CI: 283-55.7), including 26 % complete responses. Breast conservation was achieved in 68 % of patients. After a median follow-up of 48 months (range, 34-62 months), 16 relapses were observed. The overall and disease-free survivals at 5 years were 54.1 % (95 % CI: 403-67.9) and 38 % (95 % CI: 24.1-51.9), respectively. The principal toxicities of VEP were grade 3/4 neutropenia observed in 30 % of patients and grade 3 anemia observed in 12 % of patients. There was no case of severe cardiac toxicity, thrombocytopenia, or any other serious adverse events. In conclusion, whereas this regimen was relatively well tolerated, it appears inferior to other regimens and its use is not recommended.