中晚期非小细胞肺癌维持治疗的对比研究

The comparative study on maintenance therapy for moderate or advanced non-small cell lung cancer

目的了解中晚期非小细胞肺癌(NSCLC)维持治疗的必要性和有效性及不同维持治疗的疗效。方法采用多中心、随机、空白对照的研究方法以SAS6.12软件模拟产生随机数据分为3组(靶向治疗组、常规治疗组、对照组),通过对NSCLC进行常规治疗方案和靶向治疗方案作为维持治疗,两两对比分析,然后再与对照观察组做两两对比分析,分析不同维持治疗的疗效、中位生存时间、有效生存率及不良反应等。结果靶向治疗组与常规治疗组治疗有效率和疾病控制率比较差异有统计学意义(P<0.05),靶向治疗组和常规治疗组与对照观察组治疗有效率和疾病控制率比较差异有统计学意义(P<0.01);中位生存时间:靶向治疗组18.3个月,常规治疗组17.8个月,对照观察组10.8个月。生存率:靶向治疗组和常规治疗组的生存率差异无统计学意义(P>0.05),两组生存率与对照组的生存率比较差异有统计学意义(P<0.05);在不良反应方面,常规组的皮疹发生率高于靶向治疗组(P<0.05),两组间的其他不良反应发生率差异无统计学意义(P>0.05)。结论维持治疗能明显提高中晚期NSCLC的有效生存率和中位生存时间,患者在接受常规治疗后继续进行维持治疗是十分必要的。

Objective To understand the necessity and effectiveness of maintenance therapy in advanced non-small cell lung cancer（NSCLC）,as well as the efficacy of different types maintenance therapy.Methods We designed a multicenter,randomized,placebo-controlled study.Based on random numbers generated by SAS6.12,the subjects were divided into 3 maintenance therapy groups,which were the targeted therapy group,conventional treatment group,control group.We analyzed efficacy,median survival time,survival rate and side effects of these 3 groups.Results The differences of efficiency and disease control rate were statistically significant between targeted therapy group and conventional treatment group（P0.05）.Between targeted therapy group,conventional treatment group and control group,the differences of treatment efficiency and disease control rate were statistically significant（P0.01）;median survival time of different groups was as following：targeted therapy group：18.3 months,conventional treatment group：17.8 months,control group：10.8 months.Survival rate：the survival rate of the targeted therapy group and conventional treatment group was not statistically significant different（P0.05）,the survival rate was statistically significant different in targeted therapy group,conventional treatment group and control group（P0.05）;side effects：Incidence of rash in conventional group was higher than the targeted therapy group（P0.05）,the other side effects were not statistically significant between the two groups（P0.05）.Conclusion For patients with NSCLC,maintenance therapy can significantly improve the survival rate and median survival time,it is necessary for patients who had received conventional treatment to take maintenance therapy.