非小细胞肺癌患者EGFR基因突变与吉非替尼临床疗效关联

目的:评估吉非替尼（Gefitinib）疗效和晚期难治性非小细胞肺癌（NSCLC）患者表皮生长因子受体（EGFR）突变情况的关联。方法:121名晚期难治性非小细胞肺癌患者，均是经过一线化疗方案失败的中晚期非小细胞肺癌患者，每日予以口服吉非替尼250mg治疗，直到疾病进展或出现不可耐受的毒副反应为止。在开始治疗之前检测EGFR18、19、21位点，于治疗期间进行常规检查和规范的随访。分析疗效、突变以及中位生存期之间的关联。结果:在115名有效随访的患者中，13例完全缓解，25例部分缓解，38例稳定，39例病情进展。疾病控制率66.3%。1年和2年生存率分别为59.7%和26.9%。中位生存期16个月。115人中有38例病人存在EGFR突变。EGFR突变的病人表现出对吉非替尼较敏感。不吸烟的女性患者有较好的疗效和较长的生存期。而患者年龄、一线化疗周期、肿瘤分期的组间差异对于生存期的影响都无显著差异。结论:吉非替尼在女性不吸烟非小细胞肺癌患者中疗效是确定的。西部女性肺腺癌患者拥有较高的突变率和较长的生存时间。

Efficacy of Gefitinib and EGFR mutations on patients with non-small cell lung cancer

Objective:To evaluate the efficacy of Gefitinib and EGFR mutations on the west Chinese patients with advanced refractory non-small cell lung cancer.Methods:One hundred and twenty one west Chinese patients who failed previous chemotherapy regimens with stage Ⅲb-Ⅳ non-small cell lung cancer received 250mg/day Gefitinib until disease progression or serious adverse reactions were studied.Mutations in the exons 18,19,21 of EGFR gene in primary tumors from the patients were searched before the treatment.Regular examinations and follow-up visits were performed from the beginning of Gefitinib treatment.The correlations among efficacy，EGFR mutation and median survival time were analyzed.Results:Among 115 evaluable patients，13 cases had complete response，25 cases partial response，38 cases stable disease，39 cases progression.The disease control rate was 66.3%.1- and 2-year cumulative survival rates were 59.7% and 26.9%.The median survival time was 16 months.Thirty-one patients with EGFR mutations were detected in 115 patients.The patients possessed EGFR mutations conferred susceptibility to Gefitinib.Non-smoking female patients possessed better efficacy and longer median survival time.No differences of factors among age，number of previous chemotherapy cycles and tumor staging in clinical outcome and survival term were found.Conclusion:Gefitinib monotherapy has definite efficacy on the west Chinese non-smoking female patients with non-small cell lung cancer.High EGFR mutation rate and long survival time was found in west Chinese female lung adenocarcinoma patients.