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
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
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DOI：
10.1200/jco.2001.19.13.3210
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发表时间：
2001-07-01
影响因子：
45.3
通讯作者：
Gandara, DR
中科院分区：
文献类型：
--
作者：
Kelly, K;Crowley, J;Gandara, DR
目的：这项随机试验旨在确定紫杉醇联合卡铂（PC）治疗晚期非小细胞肺癌患者是否优于长春瑞滨联合顺铂（VC）。次要目标是比较毒性、耐受性、生活质量（QOL）和资源利用、患者和方法：202例患者接受VC治疗长春瑞滨25 mg/m2/wk+顺铂100 mg/m2/d，第1天，每28天1次（紫杉醇225 mg/m2，3小时，卡铂曲线下面积为6，第1天，每21天）。患者在基线、13周和25周时完成QOL问卷。通过24 months.Results的五个时间点完成资源利用的形式：患者的特点是相似的组之间。VC组和PC组的客观缓解率分别为28%和25%，中位生存期均为8个月，1年生存率分别为36%和38%。VC组3级和4级白细胞减少症（P = .002）和中性粒细胞减少症（P =.008）的发生率更高，VC组3级恶心和呕吐的发生率更高（P = .001，P = .007），PC组3级周围神经病变的发生率更高（P < .001）。VC组更多患者因毒性而停止治疗（P = .001），未观察到QOL差异。PC组的总费用高于VC组，因为药物costs.Conclusion：PC是同样有效的VC治疗晚期非小细胞肺癌。PC毒性较小，耐受性更好，但比VC更昂贵。应采取新的治疗策略。(C)2001年，美国临床肿瘤学会。
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 = .002) and neutropenia (P =.008) occurred more frequently on the VC arm, Grade 3 nausea and vomiting were higher 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 discontinued therapy because of toxicity (P = .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. (C) 2001 by American Society of Clinical Oncology.