近几年抗肿瘤靶向药物的研究取得了突破性的进展，基于基因水平的肿瘤分子诊断技术的发展及特异性靶向药物的应用，推动了癌症治疗进入精准医学新时代。传统的肿瘤治疗评价体系如WHO 或RECIST标准不能准确地对靶向药物治疗进行疗效评价,无法准确地反映患者的生存获益，因此，探索并建立适用于肿瘤靶向药物的疗效评价标准迫在眉睫。本文将回顾抗肿瘤药物疗效评价标准发展历史，介绍针对各类肿瘤的不同靶向药物疗效评价标准的发展及演化历程，并重点介绍结合免疫指标评价的新标准，对该新标准的具体定义、指导原则和临床应用进行详细阐述。有理由相信，随着肿瘤靶向药物疗效评价体系的不断完善，会给个体化肿瘤治疗带来新的进展。

In recent years, the breakthroughs of targeting agents for tumor therapies and personalized molecular diagnosis have prompted cancer treatment into the era of precision medicine. However, established assessment for solid tumors treatment such as the WHO or RECIST evaluation criteria could not reflex precisely the efficacy of the targeted therapeutics and the survival benefits they provided to patients. Therefore, it is extremely urgent to explore and establish a new response assessment criteria for targeted tumor therapeutics. This article reviewed the history of the efficacy assessment criteria for anti-tumor drugs and current opinions on the subject. I also introduced the evolution and development of evaluation criteria for various targeted therapeutics toward different tumors, and focused on the new criteria for evaluating immuno-related therapeutics. Finally, I discussed in detail the proposed evaluation criteria, its definition, guiding principle and clinical application. It is conceivable that the continuous improvements in evaluating targeted therapeutics for solid tumors will bring transformation to personalized cancer treatment.

国家高技术研究发展计划(863 计划) 资助项目（No. 2012AA02A204）；国家自然科学基金（地区基金）资助项目（No. 81160245）；云南省科学技术联合专项基金资助项目（No. 2011FB160）