非小细胞肺癌EGFR基因突变与吉非替尼疗效的相关性研究

摘要

目的 探索铜陵地区非小细胞肺癌EGFR基因突变率,观察EGFR基因的突变与吉非替尼的疗效的关系.方法 2009年1月至2010年12月安徽省铜陵市人民医院诊治的符合入组条件的晚期NSCLC 34例,对其病理标本使用ARMS法进行EGFR基因突变18~21外显子的检测.所有病例均给予口服吉非替尼250 mg/d,1次/d,持续服用直到疾病进展或出现不可耐受的毒副反应.观察症状的控制、临床疗效、无疾病进展生存时间(PFS)、总生存时间(OS)和不良反应.结果 铜陵地区34例NSCLC患者EGFR基因突变的检出阳性率59.09%.34例吉非替尼治疗NSCLC疗效总有效率(16/34)47.06%,经Fisher精确检验显示无吸烟史、EGFR突变、肺内有播散有效率高,与有吸烟史、无EGFR突变、无肺内有播散者相比,差异有统计学意义(P<0.05).Logistic多因素回归分析显示仅EGFR突变、肺内有播散为独立影响因素.Cox模型回归分析显示EGFR基因突变使肿瘤进展的风险降低了70%.结论 铜陵地区NSCLC EGFR基因突变率较高,EGFR突变可以较好地预测吉非替尼治疗晚期NSCLC的疗效,降低了肿瘤进展的风险,且安全性好.%Objective To investigate the mutation rate of EGFR gene in non - small - cell lung cancer ( NSCLC ) in Tongling city, and observe the correlation between EGFR gene mutation and the effect of gefitinib. Methods Form Jan. 2009 to Feb. 2010, gefitinib was orally administered at a dose of 250 mg once a day for 34 advanced stage NSCLC patients until occurrence of disease progression or intolerable toxicity. The mutations in the exons 18 to 21 of EGFR gene were detected in the tumor tissues of the 34 patients before the treatment of gefitinib by ARMS method. The control of the symptom, curative effect, PFS,overall survival ( OS ), and adverse effects were observed. Results EGFR mutation occurred in 59. 09% of the 34 NSCLC patients. Response rate to gefitinib in the 34 NSCLC patients was 47. 06% ( 16/34 ). Compared with the patients with history of cigarette smoking, EGFR mutation, andlung dissemination, those without these history were more sensitive to gefitinib by Fisher method( P < 0. 05 ). It suggested that EGFR mutation and lung dissemination were independent influential factor by multinomial logistic regression analysis, EGFR mutation decreased the risk of tumor progression by 70% with Cox's proportional hazards regression model analysis. Conclusion The mutation rate of EGFR gene was high in the NSCLC patients in Tongling city. EGFR mutation,which may be positively correlated with the response in advanced stage NSCLC patients treated with gefitinib, can decrease the risk of tumor progression, and has positively security.