肿瘤免疫治疗疗效评价标准—iRECIST解读

近年来，肿瘤免疫治疗迅猛发展，而现有世界卫生组织标准或实体瘤疗效评价标准(response evaluation criteria in solid tumor，RECIST)无法对免疫治疗疗效进行准确的解读和确切的评估，尤其是反映肿瘤缓解或进展的关键问题—肿瘤负荷的变化。基于此，RECIST工作组结合临床肿瘤免疫治疗实践改良的实体肿瘤疗效评价标准（RECIST版本1.1）制定了一个新的肿瘤免疫治疗疗效评价标准—实体瘤免疫治疗疗效评价标准（immune response evaluation criteria in solid tumor,iRECIST），并在2017年第18期的The Lancet Oncology上发表。该标准详细定义了实体瘤测量及肿瘤大小评价的标准方法，以期在后续肿瘤免疫治疗临床试验中得以验证。作者对这一新的标准作一介绍。

Interpretation of response criteria in solid tumor for trials testing immunotherapeutics

Tumor immunotherapy has been progressing rapidly in recent years. However, the existing World Health Organization (WHO) criteria or response evaluation criteria in solid tumor (RECIST) could not accurately interpret and evaluate the effect of immunotherapy, especially the key issue that reflects tumor remission or progression-the change of tumor burden. In view of this phenomenon, the RECIST working group developed the new tumor response evaluation criteria for immunotherapy-iRECIST, based on the modified response evaluation criteria for solid tumors (RECIST version 1.1) used in clinical practice of tumor immunotherapy, and published in the 18th issue of The Lancet Oncology in 2017. This criteria defines standard methods for solid tumor measurement and tumor size evaluation in detail, which allows it to be further validated in the following tumor immunotherapy clinical trials. This paper gives an introduction to the new criteria.