Vinorelbine in Combination with Leucovorin and 5-Fluorouracil Vs Single Agent Docetaxel as First- Line Therapy in Metastatic Breast Cancer Pre-Treated With Anthracyclines

Objective: The purpose of the study is to compare the efficacy and tolerability of vinorelbine (VNB) plus 5- fluorouracil (5-FU) and leucovorin (LV) combination chemo-therapy (VLF) with single agent docetaxel given as first-line therapy to patients with metastatic breast cancer (MBC) after failure of anthracycline based chemotherapy. Patients and methods: Sixty patients with MBC previously treated with an adjuvant anthracycline were enrolled. Thirty one patients were treated with docetaxel 100mg/m2 every 3 weeks and 29 patients were treated with a combination of VNB 25mg/m2 plus LV 30mg/m2 followed by 5-FU 600 mg/m2 infused over 24h on days 1 and 8 of each 3-week cycle. Results: The overall response rate was 51.6% and 44.8% (p=0.6) in the docetaxel and VLF groups respectively. Three (9.7%) complete responses and 13 (41.9%) partial responses occurred with docetaxel, while 2 (6.9%) complete responses and 11 (37.9%) partial responses occurred with VLF. Median time to disease progression (9Vs 8.5 months) and median overall survival (18 Vs 16 months) did not differ significantly between the docetaxel and VLF arms respectively. Sever toxicity was uncommon with higher incidence of neutropenia, skin disorders and peripheral edema with docetaxel, whereas VLF combination resulted in more thrombocytopenia and gastrointestinal disorders. Conclusions: These two regimens were active for MBC, while there appeared to be evidence in favor of docetaxel not reaching statistical significance. The safety profiles of both therapies are manageable and tolerable.