免疫相关疗效评价标准在中医药治疗晚期非小细胞肺癌的临床应用

Clinical Application of Immune-related Response Criteria in Evaluating Chinese Medical Treatment for Advanced Non-small Cell Lung Cancer

目的评价免疫相关疗效评价标准(immune-related response criteria,irRC)在中医药治疗晚期非小细胞肺癌疗效中的适用性。方法选择97例Ⅲa-Ⅳ期非小细胞肺癌患者,以中医药综合治疗为主,采用实体瘤的疗效评价标准(response evaluation criteria in solid tumors,RECIST)、实体瘤的中医肿瘤疗效评定标准(草案,以下简称中医标准)及irRC 3种方法评价其临床疗效。分析比较irRC与RECIST及中医标准的对应性与一致性,评价irRC在中医药治疗晚期非小细胞肺癌疗效评价应用上的客观性。结果 irRC与RECIST对应率为59.79%,Kappa值为0.379,经U检验P<0.01,两者有一定的对应性,但一致性不理想。irRC与中医标准对应率为83.51%,Kappa值为0.751,经U检验P<0.01,两者有良好的对应性及一致性。结论以irRC评价中医药治疗晚期非小细胞肺癌疗效与中医标准具有良好的一致性,其结果能客观地反映中医药治疗晚期非小细胞肺癌的疗效特点和优势。

Objective To evaluate the applicability of immune-related response criteria（irRC） in treating non-small cell lung cancer（NSCLC） by Chinese medicine（CM）.Methods Totally 97 stage Ⅲa-Ⅳ NSCLC patients were predominantly treated with comprehensive CM.Curative effects were evaluated by three methods such as Response Evaluation Criteria in Solid Tumors（RECIST）,Oncologic Curative Effect Evaluation Criteria of Chinese Medicine in Solid Tumor（draft,abbreviated as CM criteria）,and irRC.The correspondency and consistency between irRC,RECIST and CM criteria were analyzed and compared.The objectivity of irRC in evaluating curative effect of Chinese medical treatment for NSCLC was assessed.Results The correspondency rate of irRC to RECIST was 59.79%with Kappa value of 0.379（U test,P0.01）.The two criteria had certain correspondence,but with an unsatisfactory consistency.The correspondency rate of irRC to CM criteria rate was 83.51%with Kappa value of 0.751（U test,P0.01）.The two criteria had good correspondence and consistency.Conclusions CM criteria had good consistency with CM criteria in evaluating curative effect for Chinese medical treatment of advanced NSCLC.Its results could objectively reflect features and advantages of CM for treating advanced NSCLC.