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1、New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) 新版实体瘤疗效评价标准：修订的RECIST指南（1.1版本）Abstract摘要Background背景介绍Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective respon
2、se) 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 ari
3、sen 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.临床上评价肿瘤治疗效果最重要的一点就是对肿瘤负荷变化的评估：瘤体
4、皱缩（目标疗效）和病情恶化在临床试验中都是有意义的判断终点。自从2000年RECIST出版以来，许多研究人员、企业团体、行业和政府当局都采纳了这一标准来评价治疗效果。但是，随之涌现出的一些问题导致了本修订版的出版（1.1版）。修正之处（请见各章的专题）源自于对大型数据库（超过6500例患者）、模拟研究以及文献综述的评估。Highlights of revised RECIST 1.11.1版RECIST的重要修订之处Major changes include: Number of lesions to be assessed: based on evidence from numerous t
5、rial 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 n
6、ow 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 10 mm short axis are considered normal. Confirmation of response i
7、s required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disea
8、se of 20% increase in sum, a 5 mm absolute increase is now required as well to guard against over calling PD when the total sum is very small. Furthermore, there is guidance offered on what constitutes unequivocal progression of non-measurable/non-target disease, a source of confusion in the origina
9、l RECIST guideline. Finally, a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included. Imaging guidance: the revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions.主要的修订之处有：病灶数目的判定：
10、为了方便分析，很多小型试验数据库的证据被合并成一个大型数据库。根据该数据库，为判断疗效对肿瘤负荷进行评估所需病灶的总数由原来的最多10个减至现在的5个（每个器官由最多5个减至2个）。病理性淋巴结的判定现在也合并为：短轴值15mm的淋巴结现在也被认为是可检测和评估的目标病灶。计算肿瘤疗效时，（结节性病灶的）短轴值必须包括在病灶（半径的）总和中。结节皱缩至短轴值10mm时可以认为是正常的。疗效的确认因为控制限已用作解释数据的合适均值，试验所必需的疗效最初的终点值在现在的随机化研究中已不再必需。病情恶化根据以下几个方面分类：除了原先的定义目标病灶（半径）的总和增加20%外，若总数很小，为预防过高估计
11、恶化程度，（病灶短轴的）绝对值增加5mm也必须具备。另外，还提供了关于构成不可测量或非目标病灶“明确恶化”的指南即初版RECIST指南中容易混淆的地方。最后还有一节专门介绍新损害的检测，包括解释FDG-PET的扫描结果。影像学指南：修订后的RECIST包含了新的影像学附录，内有更新了的病灶最佳解剖学评估的推荐。Future work 下一步工作A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anat
12、omic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI. It was concluded that, at present, there is not sufficient standardisation or evidence to abandon anatomical assessment of tumour burden. The only exception to this
13、 is in the use of FDG-PET imaging as an adjunct to determination of progression. As is detailed in the final paper in this special issue, the use of these promising newer approaches requires appropriate clinical validation studies.工作组在修订RECIST 1.1时考虑到的一个关键问题是：评估肿瘤负荷从一维的解剖学评估修改为三维的解剖学评估或用PET和MRI作出的功能
14、评估是否恰当。目前的结论是缺乏足够的标准或证据放弃对肿瘤负荷的解剖学评估。对此唯一的解释是使用FDG-PET成像作为病情恶化判断的辅助手段。正如最后一章的专题中详细讨论的那样，使用这些最新的、前景诱人的技术需要有相应的临床验证研究。 Keywords: Response criteria; Solid tumours; Guidelines关键词：疗效评估标准；实体瘤；指南编译：摘要背景介绍临床上评价肿瘤治疗效果最重要的一点就是对肿瘤负荷变化的评估：瘤体皱缩（目标疗效）和病情恶化在临床试验中都是有意义的判断终点。自从2000年RECIST出版以来，许多研究人员、企业团体、行业和政府当局都采纳了
15、这一标准来评价治疗效果。但是，随之涌现出的一些问题导致了本修订版的出版（1.1版）。修正之处（请见各章的专题）源自于对大型数据库（超过6500例患者）、模拟研究以及文献综述的评估。1.1版RECIST的重要修订之处主要的修订之处有：病灶数目的判定：为了方便分析，很多小型试验数据库的证据被合并成一个大型数据库。根据该数据库，为判断疗效对肿瘤负荷进行评估所需病灶的总数由原来的最多10个减至现在的5个（每个器官由最多5个减至2个）。病理性淋巴结的判定现在也合并为：短轴值15mm的淋巴结现在也被认为是可检测和评估的目标病灶。计算肿瘤疗效时，（结节性病灶的）短轴值必须包括在病灶（半径的）总和中。结节皱缩
16、至短轴值10mm时可以认为是正常的。疗效的确认因为控制限已用作解释数据的合适均值，试验所必需的疗效最初的终点值在现在的随机化研究中已不再必需。病情恶化根据以下几个方面分类：除了原先的定义目标病灶（半径）的总和增加20%外，若总数很小，为预防过高估计恶化程度，（病灶短轴的）绝对值增加5mm也必须具备。另外，还提供了关于构成不可测量或非目标病灶“明确恶化”的指南即初版RECIST指南中容易混淆的地方。最后还有一节专门介绍新损害的检测，包括解释FDG-PET的扫描结果。影像学指南：修订后的RECIST包含了新的影像学附录，内有更新了的病灶最佳解剖学评估的推荐。下一步工作工作组在修订RECIST 1.1时考虑到的一个关键问题是：评估肿瘤负荷从一维的解剖学评估修改为三维的解剖学评估或用PET和MRI作出的功能评估是否恰当。目前的结论是缺乏足够的标准或证据放弃对肿瘤负荷的解剖学评估。对此唯一的解释是使用FDG-PET成像作为病情恶化判断的辅助手段。正如最后
