吉非替尼联合胸部同步放疗治疗局部晚期存在敏感基因突变非小细胞肺癌的临床研究  

A randomized clinical study of gefitinib combined with concurrent thoracic radiotherapy in the treatment of local - advanced non - small cell lung cancer with sensitive EGFR mutations

作　　者：朱川[1] 蔡祖艾 李湘宜[1] 熊德明[1] 任必勇[1] 常世川[1] 谭建军[1] 秦岳 程珣[1] Zhu Chuan;Cai Zuai;Li Xiangyi;Xiong Deming;Ren Biyong;Chang Shichuan;Tan Jianjun;Qin Yue;Cheng Xun(Department of Respiratory Oncology, Chongqing Three Gorges Central Hospital, Chongqing 443000, China)

机构地区：[1]重庆三峡中心医院肿瘤防治中心,443000

出　　处：《中国基层医药》2019年第8期943-948,共6页Chinese Journal of Primary Medicine and Pharmacy

基　　金：重庆市卫生和计划生育委员会科研项目(016MSXM116).

摘　　要：目的探讨吉非替尼联合胸部同步放疗在治疗表皮生长因子受体(EGFR)基因突变敏感型局部晚期非鳞肺癌患者中的临床获益及安全性。方法将2015年6月至2016年12月重庆三峡中心医院收治的符合条件的患者56例随机按照1 : 1分入A、B两组,每组28例。A组患者口服吉非替尼联合胸部同步放疗,B组患者接受同步放化疗。按照研究方案记录毒副反应并定期随访。研究指标包括:严重毒性反应;客观反应率(ORR)和疾病控制率(DCR),无进展生存时间(PFS),中位生存时间(0S)o结果 A组有26例完成治疗,明显不良反应包括:间质性肺炎(3/26)、放射性食管炎(4/26)、骨髓抑制、皮疹及胃肠道反应;B组有28例完成治疗,明显毒副反应包括:间质性肺炎(4/26)、放射性食管炎(3/26)、骨髓抑制及胃肠道反应;两组均未出现III级以上严重毒副反应。两组放射性肺炎、食管炎发生率差异均无统计学意义(均P>0.05)。两组ORR 和 DCR 差异均无统计学意义(ORR :61.5%比 39.3%,P =0. 102;DCR :84. 6%比 71.4%,P =0.505)。两组中位PFS分别为12.45个月、10.35个月,组间差异有统计学意义(P=0.036)。而OS尚未达到预期目标,有待后续随访研究。结论初步研究显示,对于EGFR突变敏感型局部晚期非鳞肺癌患者,吉非替尼联合胸部同步放疗方案安全有效。Objective To evaluate the efficacy and safety of gefitinib combined with concurrent thoracic radiotherapy in the treatment of local - advanced non - small cell lung cancer with sensitive EGFR mutations. Methods From June 2015 to December 2016, fifty - six eligible patients in Chongqing Three Gorges Central Hospital were randomly assigned into two groups by one to one ratio, with 28 cases in each group. A group received treatment of gefitinib combined with concurrent thoracic radiotherapy, and B group adopted concurrent chemoradiotherapy. The toxic effects were recorded and all patients were followed up as defined by the study protocol. Primary study endpoints included: severe toxic effects, objective response rate and disease control rate, progression free survival and overall survival. Results Twenty - six patients in A group completed the study, and the severe toxic effects were as followed: interstitial pneumonia( 3/26), radiation esophagitis (4/26), myelosuppression, skin rashes and gastrointestinal disruption. Twenty - eight patients in B group completed the study, and the severe toxicity included: interstitial pneumonia (4/26), radiation esophagitis(3/26), myelosuppression, skin rashes and gastrointestinal disruption. No toxicity higher than grade ID developed in both two groups, and there were no statistically significant differences in incidence rates of interstitial pneumonia and radiation esophagitis between the two groups ( all P > 0. 05 ). Moreover, there were no statistically significant differences in ORR and DCR between the two groups( ORR:61.5% vs. 39. 3%,P = 0. 102;DCR: 84. 6% vs. 71.4%, P = 0. 505 ). A group showed the benefit over B group in PFS ( 12. 45 months vs. 10. 35 months,p=0. 036). However,OS didnt reach and needed further follow - up. Conclusion The modality of gefitinib combined with concurrent thoracic radiotherapy in the treatment of local - advanced non - small cell lung cancer with sensitive EGFR mutations is safe and effective,and it yet needs further follow - up.

关 键 词：癌.非小细胞肺 吉非替尼 放射疗法 抗肿瘤联合化疗方案 疗效比较研究 

分 类 号：R734.2[医药卫生—肿瘤]