Vinorelbine and paclitaxel as first-line chemotherapy in metastatic breastcancer

Purpose: To evaluate the efficacy and toxicity of a combination of vinorelb ine (VNB) and paclitaxel (PTX) as first-line chemotherapy in metastatic bre ast carcinoma (MBC). Patients and Methods:: Between August 1995 and August 1997, 49 patients wit h untreated MBC received a regimen that consisted of VNB 30 mg/m(2) in a 20 -minute intravenous (IV) infusion on days 1 and 8 and PTX 135 mg/m(2) in a 3-hour IV infusion (starting 1 hour after VNB) on day 1. Cycles were repeat ed every 28 days. The median age of the patients was 52 years, and 59% of p atients were postmenopausal. Median performance status was 1. Dominant site s of disease were soft tissue in 6%, bone in 29%, and viscera in 65%. Results: Objective responses were recorded in 27 of 45 assessable patients (60%; 95% confidence interval, 46% to 74%). Complete remissions occurred in three patients (7%), and partial remissions occurred in 24 patients (53%). No change was recorded in 12 patients (27%), and progressive disease occur red in six patients (13%). The median time to treatment failure was 7 month s, and median survival duration was 17 months. The limiting toxicity was my elosuppression, mainly leukopenia in 49 patients (100%) (grade 1 to grade 2 , four patients; grade 3, 30 patients; and grade 4, 15 patients). Neutropen ia was observed in 100% of patients (grade 1 to grade 2, three patients; gr ade 3, 11 patients; grade 4, 35 patients). Two treatment-related deaths due to febrile neutropenia were observed in patients with massive liver involv ement. Peripheral neurotoxicity developed in 33 patients (67%) (grade 1, 25 patients; grade 2, eight patients); there were no grade 3 or grade 4 episo des. Conclusion: The combination of VNB-PTX showed significant activity as first -line chemotherapy for patients with MBC. Myelosuppression was the dose-lim iting side effect, whereas neurotoxicity was mild to moderate. J Clin Oncol 17:74-81. (C) 1999 by American Society of Clinical Oncology.