JCO：辅助化疗可提高非小细胞肺癌患者存活率
2011-12-12 MedSci原创 MedSci原创
近日，意大利的研究人员通过研究发现，辅助化疗可以提高早期非小细胞肺癌患者的存活率，相关的研究成果“Randomized Phase III Study of Surgery Alone or Surgery Plus Preoperative Cisplatin and Gemcitabine in Stages IB to IIIA Non–Small-Cell Lung Cancer。”发表在
近日，意大利的研究人员通过研究发现，辅助化疗可以提高早期非小细胞肺癌患者的存活率，相关的研究成果“Randomized Phase III Study of Surgery Alone or Surgery Plus Preoperative Cisplatin and Gemcitabine in Stages IB to IIIA Non–Small-Cell Lung Cancer。”发表在11月28日的国际著名杂志Journal of Clinical Oncology上。
早期非小细胞肺癌（NSCLC）患者根治手术前接受吉西他滨和顺铂治疗生存期延长，这项欧洲的研究结果在线发表在JCO杂志上。
研究结果来自于一个III期临床试验，被提早终止，因为其他随机临床试验已经得出了辅助化疗的阳性结果。该III期试验的过早终止，也意味着其他试验中相同病人的术前治疗的有效结果。
Giorgio V. Scagliotti教授最初的目的是招募712名病人，NSCLC为IB-IIIA期，对比单独手术和术前接受三个周期的吉西他滨联合顺铂的疗效。当这项研究被关闭时，129名病人被分配到化疗+手术，141被分配到手术组。主要终点是三年无进展生存率，化疗+手术组为52.9%，单独手术组为 47.9%，危险比HR为0.70（p=0.003）,相应的三年总生存率为67.6%和59.8%（HR，0.63；p=0.02）。
几乎在所有的IIB/IIIA期NSCLC患者中都观察到了疗效，三年生存获益率为23.4%，IB/IIA期差异不显著。化疗或程序相关的严重不良事件发生率，联合组为12%，手术组为8%。联合组的3或4级血液学毒性发生率为32%，手术组为0%；3或4级非血液学事件的发生率分别为16%和 11%。
这项随机对照多中心的III期试验表明，早期NSCLC患者术前化疗是可行的和有效的。将来应该着手研究耐受性良好的药物，手机药物基因学的数据以预测治疗结果。但是 Gary M. Strauss教授在一篇评论中说，对于可切除NSCLC病人，支持术后辅助化疗的证据似乎比使用诱导化疗的证据更有说服力。（生物谷Bioon.com）
doi:10.1200/JCO.2010.33.7089
Randomized Phase III Study of Surgery Alone or Surgery Plus Preoperative Cisplatin and Gemcitabine in Stages IB to IIIA Non–Small-Cell Lung Cancer
Giorgio V. Scagliotti⇓, Ugo Pastorino, Johan F. Vansteenkiste,Lorenzo Spaggiari, Francesco Facciolo, Tadeusz M. Orlowski,Luigi Maiorino, Martin Hetzel, Monika Leschinger, Carla Visseren-Gruland Valter Torri
Purpose This 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 Methods Patients with chemotherapy-naive NSCLC (stages IB, II, or IIIA) were randomly assigned to receive either three cycles of gemcitabine 1,250 mg/m2 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). Results The 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. Conclusion Although the study was terminated early, preoperative gemcitabine plus cisplatin followed by radical surgery improved survival in patients with clinical stage IIB/IIIA NSCLC.
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#JCO#
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#存活率#
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#非小细胞#
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#肺癌患者#
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#非小细胞肺癌患者#
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