recist1.1中英文校准完整版.pdfVIP

1.Background 1 背景 1.1. History of RECIST criteria 1.1RECIST 标准的历史 Assessment of the change intumour burden is an important feature of the clinicalevaluation of cancertherapeutics.Bothtumourshrinkage (objective response)andtimetothe development of disease progressionare important endpoints incancer clinicaltrials.The use of tumour regressionas the endpoint for phase IItrials screening new agentsforevidence of anti-tumour effect is supported by years of evidence suggesting that,for many solid tumours,agentswhich produce tumourshrinkage ina proportionof patients have a reasonable (albeit imperfect)chance of subsequently demonstrating an improvement inoverallsurvivalorothertime to event measures in randomised phase IIIstudies (reviewed in [1], [2], [3] and [4]).At the current time objective response carrieswith it a body of evidence greaterthanforany other biomarkersupporting its utility as a measure of promising treatment effect in phase IIscreening trials.Furthermore,at boththe phase IIand phase IIIstage of drug development, clinicaltrials inadvanced disease settings are increasingly utilising time to progression (or progression-free survival) as anendpoint uponwhichefficacy conclusions are drawn,which is also based onanatomical measurement of tumoursize. 评价肿瘤负荷的改变是癌症治疗的临床评价的一个重要特征。肿瘤缩小 （客观缓解）和疾病进展时间 都是癌症临床试验中的重要终点。为了筛查新的抗肿瘤药物，肿瘤缩小作为II期试验重点被多年研究的证 据所支持。这些研究提示对于多种实体肿瘤来说，促使部分病人肿瘤缩小的药物以后都有可能 （尽管不完 美）被证实可提高在随机Ⅲ期试验中病人的总体生存期或进入其他事件评价的可能。目前在Ⅱ期筛查试验 中评价治疗效果的指标中，客观缓解比任何其他生物标记更可靠。而且，在Ⅱ和Ⅲ期药物试验中，进展期 疾病中的临床试验正越来越利用疾病进展的时间 （无进展生存）作为得出有治疗效果结论的终点，而这些 也是建立在肿瘤大小的解剖学测量基础上。 However, bothof these tumourendpoints,objective response and time to disease progression,are usefulonly if based onwidely accepted and readily applied standardcriteria based onanatomicaltumour burden.In 1981theWorld Health Organisation (WHO)first published tumour response criteria, mainly for use intrialswhere tumour response was the primary endpoint.T