Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-celllung cancer: A Southwest Oncology Group trial

Purpose: This randomized trial was designed to determine whether paclitaxel plus carboplatin (PC) offered a survival advantage over vinorelbine plus c isplatin (VC) for patients with advanced non-small-cell lung cancer. Second ary objectives were to compare toxicity, tolerability, quality of life (QOL ), and resource utilization, Patients and Methods: Two hundred two patients received VC (vinorelbine 25 mg/m(2)/wk and cisplatin 100 mg/m(2)/d, day 1 every 28 days) and 206 patien ts received PC (paclitaxel 225 mg/m(2) over 3 hours with carboplatin area u nder the curve of 6, day 1 every 21 days). Patients completed QOL questionn aires at baseline, 13 weeks, and 25 weeks. Resource utilization forms were completed at five time points through 24 months. Results: Patient characteristics were similar between the groups. The objec tive response rate was 28% in the VC arm and 25% in the PC arm. Median surv ival was 8 months in both arms, with 1-year survival rates of 36% and 38%, respectively. Grade 3 and 4 leukopenia (P = .002) and neutropenia (P =.008) occurred more frequently on the VC arm, Grade 3 nausea and vomiting were h igher on the VC arm (P = .001, P = .007), and grade 3 peripheral neuropathy was higher on the PC arm (P < .001). More patients on the VC arm discontin ued therapy because of toxicity (P = .001), No difference in QOL was observ ed. Overall costs on the PC arm were higher than on the VC arm because of d rug costs. Conclusion: PC is equally efficacious as VC for the treatment of advanced n on-small-cell lung cancer. PC is less toxic and better tolerated but more e xpensive than VC. New treatment strategies should be pursued. (C) 2001 by A merican Society of Clinical Oncology.