Zhongguo Zhong Xi Yi Jie He Za Zhi. 1999 Jun; 19(6): 340-3.

[Discussion and preliminary application on standard for comprehensive efficacy assessment of traditional Chinese medicine in treating malignant tumor]

Yang Y, Zhu Y, Wu Y.

Xiyuan Hospital, China Academy of TCM, Beijing (100091).

OBJECTIVE: To establish a comprehensive efficacy assessment standard on premise of patients' survival period and referring to the response of tumor and host to traditional Chinese medicine (TCM) therapy. METHODS: A standard was established by taking change of tumor size, tumor related symptoms, Karnofsky scoring and body weight of patient as criteria for evaluation. The standard was used to evaluate the comprehensive effect on advanced tumor patients, received various therapeutic regimen of TCM treatment in Xiyuan Hospital from March 1997 to August 1998, and compared with that evaluated by objective response rate (RR) of tumor. RESULTS: By the new standard, comprehensive therapeutic effect of 55 advanced tumor patients was: effective in 17 cases (30.91%), stable in 10 (18.18%) and exacerbative in 28 (50.91%), while by RR, it was completely response in 0, partial response in 3 (5.45%), no change in 41 (74.55%) and progressive disease in 11 (20.00%). Results of evaluation made by the two standard was different significantly, P < 0.005. The median survival period of 18 cases of advanced lung carcinoma patients was 11.5 months. Patients survived longer than the median survival period, mostly were tumor-bearing survival, were attributed to no change by RR, but were listed as effective by the new standard. CONCLUSION: The new standard laid more stress on quality of life than the RR, it reflects better response of tumor and host to treatment, and the prognosis of patients, and associated with the survival period, therefore, it could be conducted as the standard for comprehensive efficacy assessment in treating advanced malignant tumor in clinical practice after further improving.