Xue Nuan-Zhu, Fang Ruo-Ming, Lin Li-Zhu
Guangzhou University of Chinese Medicine, Guangzhou, 510006, China.
Chin J Integr Med. 2014 Dec;20(12):910-6. doi: 10.1007/s11655-014-2022-0. Epub 2014 Nov 27.
To evaluate the objectivity and comprehensiveness of Response Evaluation Criteria of Traditional Chinese Medicine for Solid Tumor (Draft, REC-TCM-ST) in application of Chinese medicine therapeutic effect in patients with advanced non-small cell lung cancer (NSCLC).
A retrospective clinical research was used in 104 NSCLC patients in stages of III-IV, 53 cases were in Chinese medicine (CM) group and 51 cases were in Western medicine (WM) group. The therapeutic effect of the two groups was evaluated with both REC-TCM-ST and Response Evaluation Criteria in Solid Tumor (RECIST). Kaplan-Meier method was used to analyze the survival time. Kappa test method was used to test the consistency of the two kinds of evaluation results.
According to REC-TCM-ST, the effective rate on relieving tumor mass in the CM group was significantly lower than that in the WM group (P<0.05), but there was no significant difference in tumor-mass stable rate (P>0.05); the symptom of weakness in the CM group was improved significantly, indicating better therapeutic effect than that in the WM group (P<0.01). Karnofsky score in the CM group was significantly better than that in the WM group (P<0.01). In terms of survival conditions, the median survival time and the survival rate of 6 months, 1 year and 2 years of the CM group were higher than the WM group. The total effective rate was 9.62%, and the total stable rate was 72.12% for 104 cases according to RECIST; while the total effective rate was 34.62%, and the total stable rate was 84.62% according to REC-TCM-ST, thus there were significant differences between the results of the two criteria (P<0.01), and there was also some consistency between them, but not satisfactory.
REC-TCM-ST was used to evaluate the therapeutic effect of CM in the treatment of advanced NSCLC, which shows that its evaluation results can better reflect the advantages and disadvantages of CM, and the effectiveness of CM is more objective and comprehensive than RECIST, so REC-TCM-ST is worthy of further improvement and clinical expansion.
评价《中药新药治疗实体瘤临床研究指导原则（试行）》（REC-TCM-ST）在评价晚期非小细胞肺癌（NSCLC）患者中医药治疗疗效中的客观性和全面性。
采用回顾性临床研究方法，选取104例Ⅲ-Ⅳ期NSCLC患者，其中中药组53例，西药组51例。分别采用REC-TCM-ST和实体瘤疗效评价标准（RECIST）对两组疗效进行评价。采用Kaplan-Meier法分析生存时间，采用Kappa检验方法检验两种评价结果的一致性。
依据REC-TCM-ST，中药组缓解瘤体有效率显著低于西药组（P<0.05），但瘤体稳定率差异无统计学意义（P>0.05）；中药组乏力症状改善显著，疗效优于西药组（P<0.01）。中药组卡氏评分显著高于西药组（P<0.01）。生存情况方面，中药组中位生存时间及6个月、1年、2年生存率均高于西药组。依据RECIST，104例患者总有效率为9.62%，总稳定率为72.12%；依据REC-TCM-ST，总有效率为34.62%。总稳定率为84.62%，两种标准结果差异有统计学意义（P<0.01），且有一定一致性，但不满意。
采用REC-TCM-ST评价中医药治疗晚期NSCLC的疗效，结果显示其能较好反映中医药的优势与不足，中医药疗效评价较RECIST更客观、全面，REC-TCM-ST值得进一步完善和临床推广。
