目的：肿瘤免疫治疗近年来发展迅猛，已被越来越多的临床医生所认可，并广泛应用于多种恶性肿瘤的治疗。与传统的化疗不同，免疫治疗发生严重毒性反应的概率更低，患者耐受性更好，尤其对患者生活质量的改善作用更明显。但遗憾的是，目前临床上采用传统的肿瘤治疗评价体系对肿瘤免疫治疗疗效评价时往往不能令人满意，导致部分进入Ⅲ期临床试验的免疫治疗项目最后以失败告终。鉴于现有WHO或RECIST（response evaluation criteria in solid tumor）标准很难对肿瘤免疫治疗的临床疗效进行准确的解读和确切的评价，因此在2009年第23期的Clinical Cancer Research上专门刊载了由纽约Memorial Sloan-Kettering 癌症中心Wolchok 教授等撰写的论文--《针对实体瘤免疫治疗疗效评价指南：免疫相关疗效评价标准》，深入探讨了肿瘤免疫治疗疗效评价新标准的意义和应用前景。本文以该论文为主，结合其他相关文献，对"肿瘤免疫疗效评价的新标准"这一肿瘤学界的热点问题作一介绍。

Cancer immunotherapy has been widely accepted in clinic and has been applied for treatment of multiple malignancies in recent years. Different from chemotherapy, most patients can well tolerate immunotherapy and benefit from the improvement of life quality after immunotherapy; furthermore, immunotherapy shows lower risk of severe toxic side effects. Regrettably, disappointing results always occur when the conventional response evaluation criteria are used to assess the clinical efficiency of cancer immunotherapy, which might be responsible for the failure of quite a number of phase Ⅲ clinical trials of cancer immunotherapy. Since it is very difficult to use the existing WHO and RECIST criteria for accurate elucidation and evaluation of the clinical responses to cancer immunotherapy, Dr. Wolchok of New York Memorial Sloan-Kettering Cancer Center and his colleagues published a paper in Clinical Cancer Research in 2009, entitled "Guidelines for the evaluation of immune therapy activity in solid tumors: Immune-related response criteria", in which a novel response evaluation criterion system was proposed for cancer immunotherapy, and the clinical application of this system was discussed thoroughly. This paper briefly introduces the hot issue in onclology- "new evaluation criteria for efficiency of cancer immunotherapy".

国家自然科学基金资助项目（No. 30872986/H1611）