Therasse P, Eisenhauer E A, Verweij J
EORTC Data center, Avenue E. Mounier, 83 Box 11, 1200 Brussels, Belgium.
Eur J Cancer. 2006 May;42(8):1031-9. doi: 10.1016/j.ejca.2006.01.026. Epub 2006 Apr 17.
The response evaluation criteria in solid tumours (RECIST) was developed in the late 1990s to replace the WHO criteria for response evaluation. The new criteria included important changes such as unidimensional tumour measurement, selection of target lesions with a minimum size, details concerning imaging modalities and a new threshold for assignment of objective progression. RECIST was published in February 2000 and very quickly came into operation first in clinical trials performed under the auspices of EORTC, US NCI or NCI Canada Clinical Trials Group but was adopted quickly thereafter by the entire cancer clinical research community. As several key features of RECIST were based on analysis of retrospective clinical data, it was felt important to carefully monitor the implementation of the guidelines and stimulate prospective validation studies. This paper reviews the literature that has been published on RECIST from 2000 up to November 2005. In total 60 papers and ASCO, abstracts directly refer to research studies or reviews related to RECIST and its implementation. Amongst the 60 references identified for this review, 11 papers refer to validation studies (seven prospective and four retrospective), six papers refer to the comparison of unidimensional measurements versus bi or tri-dimensional measurements, 12 papers address issues raised with the implementation of RECIST in Mesothelioma and Gastro-Intestinal Stromal Tumours and four papers report on an adaptation of RECIST for specific tumour types. In general, RECIST has been well received by the scientific community and most validation studies fully support the implementation of the new criteria. As expected, however, some issues have been identified. In keeping with the mathematical differences in definition of progression, RECIST delays the identification of progression as compared to WHO criteria in some instances. RECIST criteria are not easily applicable in some types of trials such as those in paediatric tumours and in mesothelioma. Furthermore, anatomical changes in the tumour as described by RECIST may be detected later than functional changes in some circumstances, as for example in Gastro-Intestinal Stromal Tumours treated with Imatinib. However, there is no other universal method of tumour assessment as yet and functional imaging methods have not been validated and will not be widely available for some time. The findings of this review, together with experience acquired thus far and the results of some ongoing research projects, have paved the way for RECIST 2.0 to be hopefully announced later this year.
实体瘤疗效评价标准（RECIST）于20世纪90年代末制定，以取代世界卫生组织的疗效评价标准。新的标准包括一些重要变化，如一维肿瘤测量、选择最小尺寸的靶病灶、有关成像方式的细节以及客观进展判定的新阈值。RECIST于2000年2月发布，并很快首先在欧洲癌症研究与治疗组织（EORTC）、美国国立癌症研究所（US NCI）或加拿大国立癌症研究所临床试验组主持的临床试验中实施，此后很快被整个癌症临床研究界采用。由于RECIST的几个关键特征基于回顾性临床数据分析，因此认为仔细监测该指南的实施并推动前瞻性验证研究很重要。本文回顾了2000年至2005年11月间发表的关于RECIST的文献。共有60篇论文和美国临床肿瘤学会（ASCO）摘要直接涉及与RECIST及其实施相关的研究或综述。在本次综述确定的60篇参考文献中，11篇论文涉及验证研究（7篇前瞻性和4篇回顾性），6篇论文涉及一维测量与二维或三维测量的比较，12篇论文讨论了在间皮瘤和胃肠道间质瘤中实施RECIST时出现的问题，4篇论文报告了针对特定肿瘤类型对RECIST的调整。总体而言，RECIST受到了科学界的好评，大多数验证研究完全支持新标准的实施。然而，正如预期的那样，也发现了一些问题。与世界卫生组织标准相比，由于进展定义在数学上的差异，RECIST在某些情况下会延迟进展的判定。RECIST标准在某些类型的试验中不易应用，如儿科肿瘤和间皮瘤试验。此外，在某些情况下，如用伊马替尼治疗的胃肠道间质瘤，RECIST所描述的肿瘤解剖学变化可能比功能变化检测得晚。然而，目前还没有其他通用的肿瘤评估方法，功能成像方法尚未得到验证，在一段时间内也不会广泛应用。本次综述的结果，连同迄今获得的经验以及一些正在进行的研究项目的结果，为有望在今年晚些时候宣布的RECIST 2.0铺平了道路。
