Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer
Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer
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DOI：
10.1200/jco.2002.02.068
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发表时间：
2002-11-01
影响因子：
45.3
通讯作者：
Tonato, M
中科院分区：
文献类型：
--
作者：
Scagliotti, GV;De Marinis, F;Tonato, M
目的：评估两种常用的以铂为基础的新方案在晚期非小细胞肺癌（NSCLC）患者的缓解率方面是否比长春瑞滨-顺铂（参考方案）有任何优势。患者和方法：首次化疗的患者随机接受吉西他滨1,250 mg/m(2)第1天和第8天加顺铂75 mg/m(2)第2天每21天（GC组），或紫杉醇225 mg/m(2)（3小时输注）然后卡铂（浓度-时间曲线下面积为6 mg/mL(.)min），均在第1天每21天（PCb组），或长春瑞滨25 mg/m(2)/周，然后每隔一周加顺铂100 mg/m(2)第1天每28天（VC组）。结果：612例患者随机接受治疗（GC 205例，PCb 204例，VC 203例）。GC组（30%）和抗PCb组（32%）的总有效率与VC组（30%）没有显著差异。在总生存期、疾病进展时间或治疗失败时间方面没有差异。GC、PCb和VC组的中位生存期分别为9.8个月、9.9个月和9.5个月。中性粒细胞减少症在VC组明显较高（GC组17%或PCb组35% vs VC组43%，P < 0.001），血小板减少症在GC组（GC组16% vs VC组0.1%,P < 0.001）。脱发和周围神经毒性在PCb组最常见，恶心/呕吐和VC组也最常见（P < 0.05）。结论：实验组与参比组疗效终点无显著差异，但毒副反应存在差异。这些发现表明，非小细胞肺癌的化疗已达到治疗平台期。(C) 2002年由美国临床肿瘤学会出版。
Purpose: To evaluate whether two commonly used newer platinum-based regimens offer any advantage over vinorelbine-cisplatin (reference regimen) in response rate for patients with advanced non-small-cell lung cancer (NSCLC).Patients and Methods: Chemotherapy-naive patients were randomized to receive gemcitabine 1,250 mg/m(2) days 1 and 8 plus cisplatin 75 mg/m(2) day 2 every 21 days (GC arm), or paclitaxel 225 mg/m(2) (3-hour infusion) then carboplatin (area under the concentration-time curve of 6 mg/mL(.)min), both on day 1 every 21 days (PCb arm), or vinorelbine 25 mg/m(2)/wk for 12 weeks then every other week plus cisplatin 100 mg/m(2) day 1 every 28 days (VC arm).Results: Six hundred twelve patients were randomized to treatment (205 GC, 204 PCb, and 203 VC). Overall response rates for the GC (30%) anti PCb (32%) arms were not significantly different from that of the VC arm (30%). There were no differences in overall survival, time to disease progression, or time to treatment failure. Median survival for the GC, PCb, and VC groups was 9.8, 9.9, and 9.5 months, respectively. Neutropenia was significantly higher on the VC arm (GC 17% or PCb 35% v VC 43% of cycles, P < .001), as was thrombocytopenia on the GC arm (GC 16% v VC 0.1% of cycles, P < .001). Alopecia and peripheral neurotoxicity were most common on the PCb arm, as was nausea/vomiting an the VC arm (P < .05).Conclusion: Efficacy end points were not significantly different between experimental and reference arms, although toxicities showed differences. These findings suggest that chemotherapy in NSCLC has reached a therapeutic plateau. (C) 2002 by American Society of Clinical Oncology.