Randomized trial of vinorelbine compared with fluorouracil plus leucovorin in patients with stage IV non-small-cell lung cancer.

• DOI: 10.1200/jco.1996.14.10.2774
• Publication Date: 2017-02-24T09:46:54Z
• Authors: J Crawford; M O'Rourke; J H Schiller; C H Spiridonidis; S Yanovich; H Ozer; A Langleben; L Hutchins; A Koletsky; G Clamon; S Burman; R White; J Hohneker; C H Spiridonitis
• Keywords: Vinorelbine; Regimen

PURPOSE This prospective randomized trial was performed to compare the effectiveness of intravenous vinorelbine tartrate with fluorouracil and leucovorin (5-FU/LV) on primary end points survival, quality life (QOL), relief cancer-related symptoms in patients advanced non-small-cell lung cancer (NSCLC). Secondary included tumor response rates time treatment failure. In addition, safety both regimens evaluated this multicenter study. PATIENTS AND METHODS Two hundred sixteen stage IV NSCLC were enrolled onto study from 18 centers. Vinorelbine administered at a dose 30 mg/m2/wk. 5-FU/LV 425 mg/m2 20 mg/m2, respectively, for 5 consecutive days every 4 weeks. Patients progressive disease or toxicity removed while responding stable continued therapy. RESULTS The median survival who received weeks, 25% alive 1 year, compared 22 weeks 16% year those treated (P = .03, log-rank test). improvement associated higher objective rate (12% v 3%) failure (10 8 weeks) versus 5-FU/LV. dose-limiting granulocytopenia, 54% experiencing grade 3/4 granulocytopenia. Nonhematologic generally 2. most common 3 toxicities related injection-site reactions. CONCLUSION confirms efficacy NSCLC. clinical activity relatively favorable profile agent make it reasonable useful option management disease.