Randomized P hase I II T rial o f P aclitaxel P lus C arboplatin Versus V inorelbine P lus C isplatin i n t he T reatment o f Patients W ith A dvanced N on-Small-Cell L ung C ancer: A Southwest O ncology G roup T rial

Purpose: This randomized trial was designed to determine whether paclitaxel plus carboplatin (PC) offered a survival advantage over vinorelbine plus cisplatin (VC) for patients with advanced non‐small-cell lung cancer. Secondary 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 patients received PC (paclitaxel 225 mg/m 2 over 3 hours with carboplatin area under the curve of 6, day 1 every 21 days). Patients completed QOL questionnaires 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 objective response rate was 28% in the VC arm and 25% in the PC arm. Median survival was 8 months in both arms, with 1-year survival rates of 36% and 38%, respectively. Grade 3 and 4 leukopenia (P 5 .002) and neutropenia (P 5 .008) occurred more frequently on the VC arm. Grade 3 nausea and vomiting were higher on the VC arm (P 5 .001, P 5 .007), and grade 3 peripheral neuropathy was higher on the PC arm (P < .001). More patients on the VC arm discontinued therapy because of toxicity (P 5 .001). No difference in QOL was observed. Overall costs on the PC arm were higher than on the VC arm because of drug costs. Conclusion: PC is equally efficacious as VC for the treatment of advanced non‐small-cell lung cancer. PC is less toxic and better tolerated but more expensive than VC. New treatment strategies should be pursued. J Clin Oncol 19:3210-3218. © 2001 by American Society of Clinical Oncology.