吉非替尼治疗复治、晚期非小细胞肺癌的临床分析

Clinical efficiency of gefitinib in the treatment of patients with advanced non-small cell lung cancer

目的：观察晚期非小细胞肺癌（NSCLC）患者接受吉非替尼（gefitinib）治疗后的生存期、缓解率、疗效。方法：分析2000年12月-2003年10月美国M．D．Anderson癌症治疗中心与上海市胸科医院接受吉非替尼250mg／d口服治疗的共175例晚期NSCLC患者。用Kaplan-Meier及logrank进行生存分析和比较，并用Cox多因素回归分析生存相关因素。用x^2检验比较不同因素在缓解率及疾病控制方面有无差异，logistic多因素回归分析疾病控制率、缓解率的相关因素。结果：175名患者的中位生存期（MST）为6．9个月（95％CI：4．19～9．61）；中位无疾病进展时间（PFS）为3．47个月（95％CI：2．67～4．27）。Cox多因素分析显示性别（P=0．002）、年龄（P〈0．001）、治疗前血红蛋白水平（P=0．034）、PS评分（P=0．019）、既往化疗方案次数（P=0．013）、病理类型（P=0．030）是影响生存的独立因素。性别（P=0．002）、PS评分（P=0．013）是影响PFS的独立因素。所有患者的缓解率为10．14％；疾病控制率为40．54％。影响缓解率与疾病控制率的多因素分析提示性别（P=0．041）、年龄（P=0．035）、吸烟情况（P=0．038）是影响缓解率的独立因素，而性别是影响疾病控制率的独立因素（P=0．036）。结论：吉非替尼治疗复治、晚期NSCLC患者是安全、有效的。

Objective： To observe the survival rate, complete remission rate, and therapeutic efficacy of patients with advanced non-small cell lung cancer （NSCLC） after gefitinib （ZD1839, IRESSA） treatment. Methods： We analyzed 175 patients who received gefitinib treatment （250 mg/d, po） in MD Anderson Cancer Center and Shanghai Chest Hospital from 2000 Sep to 2003 Oct. Survival curves were plotted by Kaplan-Meier method and compared by log-rank test. Cox multivariate regression was used to examine the prognostic significance of covariates. The influence of different factors on complete remission rate and disease controlling rate was analyzed by X^2 test. Logistic multiple regression was used for multivariate analysis. Results： The median survival time （MST） of 175 patients with advanced NSCLC was 6.9 months（95 % CI：4. 19-9.61 ）and median progression-free survival time （PFS） was 3.47 months. Cox multivariate analysis showed that gender （P= 0. 002）, age （P〈0. 001 ）, hemoglobin level before treatment （P=0. 034）, PS score （P=0. 019）, the times of former chemotherapy （P=0. 013）, pathological classification （P=0. 030） were the independent factors in predicting survival time; gender （P=0. 002） and PS score （P=0. 013） were the independent factors in predicting PFS. The complete remission rate of all the patients was 10.14 %, the disease controlling rate was 40. 54%. Multivariate analysis suggested that gender （P=0. 041）, age （P=0. 035）, smoking status （P=0. 038） were independent factors in predicting complete remission rate; gender was the independent factor in predicting disease controlling rate. Conclusion：Gefitinib is safe and effective in the treatment of patients who have advanced NSCLC or need re-treatment.