iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.
iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.
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DOI：
10.1016/s1470-2045(17)30074-8
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发表时间：
2017-03
期刊：
影响因子：
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通讯作者：
RECIST working group
中科院分区：
文献类型：
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作者：
Seymour L;Bogaerts J;Perrone A;Ford R;Schwartz LH;Mandrekar S;Lin NU;Litière S;Dancey J;Chen A;Hodi FS;Therasse P;Hoekstra OS;Shankar LK;Wolchok JD;Ballinger M;Caramella C;de Vries EGE;RECIST working group
与化疗药物相比，肿瘤对免疫疗法的反应不同，这引发了对肿瘤负荷变化评估的疑问——这是癌症治疗评估的支柱，提供了有关客观反应和疾病进展的关键信息。 RECIST 工作组制定了共识指南 iRECIST，用于在癌症免疫治疗试验中使用修改后的实体瘤疗效评估标准（RECIST 1.1 版），以确保设计和数据收集的一致性，促进试验数据的持续收集以及指南的最终验证。本指南描述了实体瘤测量的标准方法和肿瘤大小客观变化的定义，用于免疫疗法的试验。此外，它还定义了未来试验和当前正在开发的试验所需的最小数据点，以促进数据仓库的编译，以便稍后用于验证 iRECIST。已经完成、启动或计划进行数量空前的试验，以使用各种修改后的反应标准来测试用于癌症治疗的新免疫调节剂。该指南将允许对免疫疗法试验进行一致的实施、解释和分析。
Tumours respond differently to immunotherapies compared with chemotherapeutic drugs, raising questions about the assessment of changes in tumour burden—a mainstay of evaluation of cancer therapeutics that provides key information about objective response and disease progression. A consensus guideline—iRECIST—was developed by the RECIST working group for the use of modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials, to ensure consistent design and data collection, facilitate the ongoing collection of trial data, and ultimate validation of the guideline. This guideline describes a standard approach to solid tumour measurements and definitions for objective change in tumour size for use in trials in which an immunotherapy is used. Additionally, it defines the minimum datapoints required from future trials and those currently in development to facilitate the compilation of a data warehouse to use to later validate iRECIST. An unprecedented number of trials have been done, initiated, or are planned to test new immune modulators for cancer therapy using a variety of modified response criteria. This guideline will allow consistent conduct, interpretation, and analysis of trials of immunotherapies.