New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)
New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)
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DOI：
10.1016/j.ejca.2008.10.026
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发表时间：
2009-01-01
影响因子：
8.4
通讯作者：
Verweij, J.
中科院分区：
文献类型：
--
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
背景资料：肿瘤负荷变化的评估是癌症治疗临床评价的一个重要特征：肿瘤缩小（客观缓解）和疾病进展都是临床试验中有用的终点。自2000年RECIST发表以来，许多研究者、合作团体、行业和政府当局都采用了这些标准来评估治疗结果。然而，出现了一些问题和问题，导致了修订版RECIST指南（1.1版）的制定。变化的证据来自于对一个大型数据仓库的评估，这些证据在这期特刊的单独文章中进行了总结（>6500例患者）、模拟研究和文献综述。修订后的RECIST 1.1的亮点：主要变化包括：待评估的病变数量：根据为分析目的而合并到数据仓库的大量试验数据库的证据，评估肿瘤负荷以确定缓解所需的病变数量已从最多10个减少到最多总共5个（每个器官最多从5个减少到2个）。现在纳入了病理淋巴结的评估：短轴>= 15 mm的淋巴结被视为可测量和可评估的靶病变。在计算肿瘤缓解时，应将短轴测量值纳入病变总和中。节点缩小到
Background: Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews.Highlights of revised RECIST 1.1: Major changes include: Number of lesions to be assessed: based on evidence from numerous trial databases merged into a data warehouse for analysis purposes, the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total (and from five to two per organ, maximum). Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of >= 15 mm are considered measurable and assessable as target lesions. The short axis measurement should be included in the sum of lesions in calculation of tumour response. Nodes that shrink to