Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Vinorelbine Plus Cisplatin in the Treatment of Patients With Advanced Non–Small-Cell Lung Cancer: A Southwest Oncology Group Trial

摘要: PURPOSE: This randomized trial was designed to determine whether paclitaxel plus carboplatin (PC) offered a survival advantage over vinorelbine cisplatin (VC) for patients with advanced non–small-cell lung cancer. Secondary objectives were compare toxicity, tolerability, quality of life (QOL), and resource utilization. PATIENTS AND METHODS: Two hundred two received VC (vinorelbine 25 mg/m2/wk 100 mg/m2/d, day 1 every 28 days) 206 PC (paclitaxel 225 mg/m2 3 hours area under the curve 6, 21 days). Patients completed QOL questionnaires at baseline, 13 weeks, weeks. Resource utilization forms five time points through 24 months. RESULTS: Patient characteristics similar between groups. The objective response rate 28% in arm 25% arm. Median 8 months both arms, 1-year rates 36% 38%, respectively. Grade 4 leukopenia (P = .002...