Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non-small-cell lung cancer
Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non-small-cell lung cancer
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DOI：
10.1200/jco.2000.18.1.122
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发表时间：
2000-01-01
影响因子：
45.3
通讯作者：
Einhorn, LH
中科院分区：
文献类型：
--
作者：
Sandler, AB;Nemunaitis, J;Einhorn, LH
目的：Hoosier肿瘤学小组此前报道了顺铂加吉西他滨联合治疗的II期试验结果。在该研究中，27例可评估的晚期或转移性非小细胞肺癌（NSCLC）患者的缓解率为33%，中位生存期为8.4个月。基于这些有利的结果，Hoosier肿瘤组设计了这项随机III期研究，将吉西他滨加顺铂与单用顺铂在未接受化疗的晚期NSCLC患者中进行比较。患者和方法：患者被随机分配接受顺铂（100 mg/m(2)静脉注射，28天周期的第1天）或顺铂（100 mg/m静脉注射，第1天）加吉西他滨（1000 mg/m(2)静脉注射，28天周期的第1、8和15天）的联合治疗。结果：1995年8月至1997年2月，随机抽取522例可评估的首次化疗患者。毒性主要是血液学方面的，在联合治疗组中更为明显，35.3%的患者发生4级中性粒细胞减少，而顺铂单药治疗组的患者发生4级中性粒细胞减少的比例为1.2%。两组中性粒细胞减少性发热发生率均小于5%。4级血小板减少发生率在联合治疗组中为25.4%，而在顺铂单药治疗组中为0.8%。两组均未报告与血小板减少症相关的严重出血事件。吉西他滨联合顺铂在缓解率（分别为30.4%和11.1%,P < 0.0001）、疾病进展的中位时间（分别为5.6个月和3.7个月，P = 0.0013）和总生存期（分别为9.1个月和7.6个月，P = 0.004）方面比单药顺铂有显著改善。结论：对于NSCLC的一线治疗，吉西他滨联合顺铂方案在缓解率、疾病进展时间和总生存期方面优于单用顺铂方案。(C) 2000年由美国临床肿瘤学会出版。
Purpose: The Hoosier Oncology Group has previously reported the results of its phase II trial of the combination of cisplatin plus gemcitabine. In that study of 27 assessable patients with advanced or metastatic non-small-cell lung cancer (NSCLC), the response rate was 33%, with a median survival of 8.4 months. Based on such favorable results, the Hoosier Oncology Group designed this randomized phase III study of gemcitabine plus cisplatin compared with cisplatin alone in chemotherapy-naive patients with advanced NSCLC.Patients and Methods: Patients were randomized to receive either cisplatin (100 mg/m(2) intravenously on day 1 of a 28-day cycle) or the combination of cisplatin (100 mg/m2 intravenously on day 1) plus gemcitabine (1,000 mg/m(2) administered intravenously on days 1, 8, and 15 of a 28-day cycle).Results: From August 1995 to February 1997, 522 assessable chemotherapy-naive patients were randomized. Toxicity was predominantly hematologic and was more pronounced in the combination arm, with grade 4 neutropenia occurring in 35.3% of patients compared with 1.2% of patients on the cisplatin monotherapy arm. The incidence of neutropenic fevers was less than 5% in both arms. Grade 4 thrombocytopenia occurred in 25.4% of patients on the combination arm compared with 0.8% of patients on the cisplatin monotherapy arm. No serious hemorrhagic events related to thrombocytopenia were reported for either arm. The combination of gemcitabine plus cisplatin demonstrated a significant improvement over single-agent cisplatin with regard to response rate (30.4% compared with 11.1%, respectively; P < .0001), median time to progressive disease (5.6 months compared with 3.7 months, respectively; P = .0013), and overall survival (9.1 months compared with 7.6 months, respectively; P = .004).Conclusions: For the first-line treatment of NSCLC, the regimen of gemcitabine plus cisplatin is superior to cisplatin alone in terms of response rate, time to disease progression, and overall survival. (C) 2000 by American Society of Clinical Oncology.