First-line chemotherapy with vinorelbine and paclitaxel as simultaneous infusion in advanced breast cancer

Based on preclinical data showing a synergistic activity of simultaneous ad ministration of vinorelbine and paclitaxel, we carried out a phase II trial in previously untreated advanced breast cancer patients. Treatment consist ed of vinorelbine 25 mg/m(2) and paclitaxel 150 mg/m(2), both drugs given b y intravenous infusion over 3 h on day 1, with cycles repeated every 3 week s. Granulocyte colony-stimulating factor, 300 mu g subcutaneously, was give n on days 7-12 to the first 10 patients. From October 1995 to January 1997, 43 patients with advanced breast cancer entered the study, and 41 were eva luable for response. We obtained 2 complete responses (5%) and 18 partial r esponses (44%), for an overall response rate of 49% (95% CI 34-64%). Median time to response, time to progression and survival were 2, 7 and 22 months , respectively. Myelosuppression was the dose-limiting toxicity, with G4 ne utropenia in 21% and neutropenic fever in 7% of the patients. Other toxicit ies were mild. Simultaneous infusion of vinorelbine and paclitaxel is a wel l-tolerated and active regimen in metastatic breast cancer, with overall re sults similar to those reported with more toxic regimens; furthermore, it m ay be a good option in patients with anthracycline contraindications. Copyr ight (C) 2000 S. Karger AG. Basel.