ASCO 2014：基于EGFR突变的新辅助治疗IIIA-N2期NSCLC可行

2014-05-31 Ruanancy 译医学论坛网

摘要号：#7572第一作者：钟文昭，广东省人民医院肿瘤外科标题：基于EGFR突变状态对IIIA-N2期非小细胞肺癌生物标志物指导下的新辅助治疗策略进行II期临床研究背景：EGFR-TKI新辅助疗法和个体化辅助疗法是治疗IIIA-N2期非小细胞肺癌的一种既有吸引人又颇具争议的策略。本研究的目的是评估生物标志物指导下的新辅助治疗策略在IIIA-N2期非小细胞肺癌（NSCLC）患者（基于表皮生长因子受体

摘要号：#7572

第一作者：钟文昭，广东省人民医院肿瘤外科

标题：基于EGFR突变状态对IIIA-N2期非小细胞肺癌生物标志物指导下的新辅助治疗策略进行II期临床研究

背景：EGFR-TKI新辅助疗法和个体化辅助疗法是治疗IIIA-N2期非小细胞肺癌的一种既有吸引人又颇具争议的策略。本研究的目的是评估生物标志物指导下的新辅助治疗策略在IIIA-N2期非小细胞肺癌（NSCLC）患者（基于表皮生长因子受体（EGFR）的突变状态进行分类）中的作用。

方法：基于EGFR突变状态（NCT00600587），把可切除性、组织学证实为IIIA-N2期的NSCLC患者分别分配到新辅助疗法埃罗替尼组和吉西他滨/卡铂（GC）组。本II期研究的主要终点是缓解率（RR）；次要终点是无进展生存期（PFS）和总生存期（OS）。

结果：2008年1月至2011年5月期间共有24例IIIA-N2期NSCLC患者参加了试验。总RR为42％，埃罗替尼组突变型EGFR患者的RR为58.3％（7/12）而GC组野生型EGFR患者的RR为25.0％（4/12）（P=0.18）。埃罗替尼组和GC组分别有6例和7例患者接受了手术切除术。埃罗替尼组和GC组的PFS中位值分别为6.9个月和9.0个月（P=0.071），OS中位值分别为14.5个月和29.3个月（P=0.304）；两组中接受切除术的患者的OS中位值分别为28.9个月和55.8个月（P=0.218）。全部受试患者的PFS和OS分别为7.9个月和24.1个月。此外，埃罗替尼组接受切除术的6例患者在疾病进展后接受酪氨酸激酶抑制剂（TKI）再次治疗时都发生了部分缓解，第2个PFS中位值为11个月。

结论：生物标志物指导下的新辅助治疗策略治疗IIIA-N2期非小细胞肺癌患者具有可行性。在本亚组试验中，虽然埃罗替尼可提高患者的反应率，但该效益并没有带来PFS或OS的改善。要确定围手术期TKI疗法在IIIA-N2期非小细胞肺癌患者中的作用，需要对新辅助疗法联合佐剂EGFR-TKI开展深入的随机化对照研究。临床试验信息：NCT00600587。

研究链接：Phase II study of biomarker guided neoadjuvant treatment strategy for IIIA-N2 non-small cell lung cancer based on EGFR-mutation status. (Abstract 7572)

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2014-12-05 一叶知秋

#III#

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2015-02-03 charl1234576

#新辅助#

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2015-03-19 quxin068

#ASC#

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2014-06-02 liuyiping

#GFR#

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