埃克替尼联合胸部放疗与单独埃克替尼比较治疗EGFR突变阳性Ⅲ/Ⅳ期NSCLC的临床对照研究  

Icotinib Combined with Thoracic Radiotherapy Versus Icotinib Alone in Treatment of EGFR Mutation Positive StageⅢ/ⅣNSCLC:A Retrospective Clinical Controlled Study

作　　者：刘锐锋 魏世鸿[2] 罗宏涛[1,2,3] 张学良 宋海侠[2] 董玉梅[2] 李征[1] 张秋宁[1,3] 王小虎 LIU Rui-feng;WEI Shi-hong;LUO Hong-tao;ZHANG Xue-liang;SONG Hai-xia;DONG Yu-mei;LI Zheng;ZHANG Qiu-ning;WANG Xiao-hu(Institute of Modern Physics,Chinese Academy of Sciences,Lanzhou 730000,China;Gansu Provincial Cancer Hospital,Lanzhou 730050,China;Lanzhou Heavy Ion Hospital,Lanzhou 730000,China)

机构地区：[1]中国科学院近代物理研究所,甘肃兰州730000 [2]甘肃省肿瘤医院,甘肃兰州730050 [3]兰州重离子医院,甘肃兰州730000

出　　处：《中国肿瘤》2020年第6期463-475,共13页China Cancer

基　　金：兰州市人才创新创业项目(2017-RC-23)。

摘　　要：[目的]比较埃克替尼联合胸部放疗与单独埃克替尼治疗Ⅲ/Ⅳ期EGFR突变阳性NSCLC的临床有效性及安全性。[方法]按照纳入排除标准,选择2012年1月至2017年12月在甘肃省肿瘤医院首次采用埃克替尼联合胸部放疗或单独埃克替尼治疗的EGFR突变阳性NSCLC患者,比较两种治疗模式在胸部原发灶的近期缓解率、无进展生存时间(PFS)、总生存时间(OS)、埃克替尼耐药时间及毒副反应发生方面的差异,并分析各临床因素对患者生存的影响。[结果]共纳入76例患者,其中埃克替尼联合胸部放疗组28例,单药埃克替尼组48例。两组比较,近期疗效方面存在统计学差异(P=0.009),特别是ORR方面埃克替尼+TRT组显著优于单独埃克替尼组(P=0.002);生存情况方面,1、2年PFS和OS两组差异均无统计学意义(P>0.05),但在中位OS(40.3个月vs 25.7个月)和中位PFS(34.2个月vs 19.9个月)方面,埃克替尼+TRT组均优于单独埃克替尼组;多因素分析显示,埃克替尼耐药时间及总应用时间与PFS和OS均成正相关(P=0.000),患者近期疗效与患者PFS和OS也密切相关(P=0.000)。毒副反应方面,急性放射性肺炎、放射性食管炎、白细胞减少、恶心呕吐两组间存在统计学差异(P<0.05),埃克替尼+TRT组高于单独埃克替尼组;而埃克替尼相关的皮疹、腹泻、口腔溃疡、肝功能异常、血栓形成以及贫血、血小板减少方面两组差异均无统计学意义(P>0.05)。[结论]埃克替尼联合胸部放疗与单独埃克替尼比较在治疗局部晚期或晚期EGFR突变阳性NSCLC中,能提高肺部原发灶的近期缓解率,改善无进展生存期和总生存期,且未增加TKI药物相关的毒副反应发生,是一种有效且安全的治疗模式。[Purpose]To compare the clinical efficacy and safety of icotinib combined with thoracic radiotherapy(Icotinib+TRT)versus icotinib alone in the treatment of stageⅢ/ⅣEGFR mutation-positive non-small cell lung cancer(NSCLC).[Methods]Clinical data of 76 patients with EGFR mutation positive NSCLC admitted in Gansu Provincial Hospital from Jan 2012 to Dec 2017 were retrospectively analyzed.Among them 28 patients were treated with icotinib+TRT(icotinib+TRT group)and 48 patients were treated with icotinib alone(icotinib alone group).The primary lesion response rate,progression-free survival(PFS),overall survival(OS),icotinib resistance and application time,adverse events were compared between two groups;and influencing factors on survival were analyzed.[Results]There was a significant difference in primary lesion response rate between two groups(P=0.009),especially in objective response rate(ORR),the icotinib+TRT group was superior to icotinib alone group(P=0.002).There were no statistical differences in 1-and 2-years OS and PFS(P>0.05),while the median OS of icotinib+TRT group and icotinib alone group was 40.8 months vs 27.3 months,and the median PFS was 34.2 months vs 19.9 months,respectively.Multivatiate analysis showed that the icotinib resistance duration(r=0.666,P=0.000 and r=0.849,P=0.000)and total application time(r=0.886,P=0.000 and r=0.774,P=0.000)were positively correlated with PFS and OS;and the primary lesion response rate was also closely correlated with PFS and OS(P=0.000).The incidence of adverse events,including acute radiation pneumonia,radiation esophagitis,leukopenia,nausea and vomiting in icotinib+TRT group was higher than that in icotinib alone group(P<0.05);but there were significant differences in icotinib-related adverse responses between two groups(P>0.05).[Conclusion]Comparing icotinib alone,icotinib+TRT can increase the primary lesions response rate,improve PFS and OS,and do not increase icotinib-related adverse events in the treatment of locally advanced or metastatic EGFR mutant positive

关 键 词：非小细胞肺癌 放射治疗 靶向治疗 盐酸埃克替尼 

分 类 号：R734.2[医药卫生—肿瘤]