RANDOMIZED TRIAL OF VINORELBINE COMPARED WITH FLUOROURACIL PLUS LEUCOVORIN IN PATIENTS WITH STAGE-IV NON-SMALL-CELL LUNG-CANCER

Purpose: This prospective randomized trial was performed to compare th e effectiveness of intravenous vinorelbine tartrate with intravenous f luorouracil and leucovorin (5-FU/LV) on the primary end points of surv ival, quality of life (QOL), and relief of cancer-related symptoms in patients with advanced non-small-cell lung cancer (NSCLC). Secondary e nd points included tumor response rates and time to treatment failure. In addition, the safety of both treatment regimens was evaluated in t his multicenter study. Patients and Methods: Two hundred sixteen patie nts with stage IV NSCLC were enrolled onto this study from 18 centers. Vinorelbine was administered at a dose of 30 mg/m(2)/wk. 5-FU/LV was administered ata dose of 425 mg/m(2) and 20 mg/m(2), respectively, for 5 consecutive days every 4 weeks, Patients with progressive disease o r toxicity were removed from study while responding and stable patient s were continued on therapy. Results: The median survival time of pati ents who received vinorelbine was 30 weeks, with 25% of patients alive at 1 year, compared with a median survival time of 22 weeks and 16% o f patients alive at 1 year for those treated with 5-FU/LV (P = .03, lo g-rank test). This improvement in survival was associated with a highe r objective response rate (12% v 3%) and time to treatment failure (10 weeks v 8 weeks) for vinorelbine versus 5-FU/LV. The dose-limiting to xicity of vinorelbine was granulocytopenia, with 54% of patients exper iencing grade 3/4 granulocytopenia. Nonhematologic toxicity of vinorel bine was generally grade 1 or 2. The most common grade 3 toxicities we re related to injection-site reactions. Conclusion: This trial confirm s the efficacy of vinorelbine in patient; with advanced NSCLC, The cli nical activity and relatively favorable toxicity profile of this agent make it a reasonable and useful treatment option in the management of patients with this disease. (C) 1996 by American Society of Clinical Oncology.