Randomized Phase III Study of Surgery Alone or Surgery Plus Preoperative Cisplatin and Gemcitabine in Stages IB to IIIA Non-Small-Cell Lung Cancer
Randomized Phase III Study of Surgery Alone or Surgery Plus Preoperative Cisplatin and Gemcitabine in Stages IB to IIIA Non-Small-Cell Lung Cancer
复制标题
DOI：
10.1200/jco.2010.33.7089
复制
发表时间：
2012-01-10
影响因子：
45.3
通讯作者：
Torri, Valter
中科院分区：
文献类型：
--
作者：
Scagliotti, Giorgio V.;Pastorino, Ugo;Torri, Valter
目的本研究旨在确定与单纯手术相比，术前3个周期的吉西他滨联合顺铂联合根治性手术是否能降低IB至IIIA期非小细胞肺癌（NSCLC）患者的进展风险。（IB、II或IIIA期）随机分配接受三个周期的吉西他滨1，250 mg/m2（第1天和第8天，每3周一次）+顺铂75 mg/m2（第1天，每3周一次），随后进行手术，或者手术按照中心和疾病分期（IB/IIA v IIB/IIIA）对随机化进行分层。主要终点是无进展生存期（PFS）。结果研究提前关闭后，随机分配的270例患者：129化疗加手术和141单独手术。中位年龄为61.8岁，83.3%为男性。单纯手术组中疾病分期为IB/IIA的患者略多（55.3% vs 48.8%）。化疗有效率为35.4%。PFS和总生存期的风险比分别为0.70（95%CI，0.50 - 0.97; P = 0.003）和0.63（95%CI，0.43 - 0.92; P = 0.02），均支持化疗加手术。在IIB/IIIA期亚组中观察到术前化疗对结局的统计学显著影响（3年PFS率：36.1% vs 55.4%; P = 0.002）。最常见的3级或4级化疗相关不良事件是中性粒细胞减少症和血小板减少症。没有治疗的组织学相互作用的影响是apparent.ConclusionAlthough研究提前终止，术前吉西他滨加顺铂，其次是根治性手术提高生存期的临床阶段IIB/IIIA NSCLC患者。J Clin Oncol 30：172-178. (C)2011年美国临床肿瘤学会
PurposeThis study aimed to determine whether three preoperative cycles of gemcitabine plus cisplatin followed by radical surgery provides a reduction in the risk of progression compared with surgery alone in patients with stages IB to IIIA non-small-cell lung cancer (NSCLC).Patients and MethodsPatients with chemotherapy-naive NSCLC (stages IB, II, or IIIA) were randomly assigned to receive either three cycles of gemcitabine 1,250 mg/m(2) days 1 and 8 every 3 weeks plus cisplatin 75 mg/m2 day 1 every 3 weeks followed by surgery, or surgery alone. Randomization was stratified by center and disease stage (IB/IIA v IIB/IIIA). The primary end point was progression-free survival (PFS).ResultsThe study was prematurely closed after the random assignment of 270 patients: 129 to chemotherapy plus surgery and 141 to surgery alone. Median age was 61.8 years and 83.3% were male. Slightly more patients in the surgery alone arm had disease stage IB/IIA (55.3% v 48.8%). The chemotherapy response rate was 35.4%. The hazard ratios for PFS and overall survival were 0.70 (95% CI, 0.50 to 0.97; P = .003) and 0.63 (95% CI, 0.43 to 0.92; P = .02), respectively, both in favor of chemotherapy plus surgery. A statistically significant impact of preoperative chemotherapy on outcomes was observed in the stage IIB/IIIA subgroup (3-year PFS rate: 36.1% v 55.4%; P = .002). The most common grade 3 or 4 chemotherapy-related adverse events were neutropenia and thrombocytopenia. No treatment-by-histology interaction effect was apparent.ConclusionAlthough the study was terminated early, preoperative gemcitabine plus cisplatin followed by radical surgery improved survival in patients with clinical stage IIB/IIIA NSCLC. J Clin Oncol 30:172-178. (C) 2011 by American Society of Clinical Oncology