RECIST (Response Evaluation Criteria in Solid Tumours) 实体瘤反应评价标准提供了一种简单和实用的方法来评估新肿瘤治疗实体肿瘤的活性和有效性,使用验证和一致的标准来评估肿瘤负担的变化。RECIST工作组 由欧洲癌症研究和治疗组织(EORTC)、美国国家癌症研究所(NCI)和加拿大癌症试验小组(CCTG)以及几家制药公司的代表组成。它的任务是确保RECIST继续进行测试、验证和更新。 RECIST疾病评估对靶向治疗(targeted treatment)和经典化疗都是有效的
Assessing tumour growth and cancer cell proliferation in patients is important both for judging the effectiveness of individual treatment and for the evaluation of therapies in clinical trials.
评估患者的肿瘤生长和癌细胞增殖对于判断个体治疗的有效性和临床试验中的治疗方法的评估都很重要。
EORTC was among the international organisations that developed RECIST (Response Evaluation Criteria in Solid Tumours), a method of determining whether tumour measurement data can allow the conclusion that a patient’s disease has improved, stayed about the same, or worsened。
EORTC是开发RECIST(实体肿瘤反应评估标准)国际组织,主要目标是确定肿瘤测量数据的方法是否可以让病人的疾病改善,保持不变,或恶化。
First published in 2000, the RECIST criteria for disease assessment are now used across the world. 首次发表于2000年,RECIST疾病评估标准现世界各地在使用。
But today cancer patients are increasingly treated with targeted cancer agents (TCAs), a relatively new class of drug that block the growth and spread of cancer by interfering with specific molecules involved in tumour growth.
但如今,癌症患者越来越多地接受靶向癌症药物(targeted cancer agents,TCAs)的治疗,这是一种相对较新的药物,通过干扰参与肿瘤生长的特定分子来阻断癌症的生长和传播。
They differ from classical chemotherapy in that they interact with a specific target to block the proliferation of tumours, while classic chemotherapy kills all rapidly dividing cells.
它们与经典化疗的不同之处在于,它们与特定的靶点相互作用,以阻止肿瘤的增殖,而经典化疗可以杀死所有快速分裂的细胞。
Would the latest version of RECIST (1.1) be equally effective in evaluating response to TCAs ?
将是最新版本的RECIST(1.1)在评估对tca的反应方面也同样有效吗?
The EORTC RECIST Working Group set out to find out.
EORTCRECIST工作组开始寻找答案。
«RECIST is a very important yardstick and gives us good reliability in the comparison and assessment of clinical trial results, as well as a common understanding of the terms used to describe disease improvement, stability, and progression, » says Dr Jan Bogaerts, Scientific Director at the EORTC headquarters.
EORTC总部的科学主任Jan·博加尔茨博士说“ RECIST是一个非常重要的衡量标准,它使我们对临床试验结果的比较和评估具有良好的可靠性,以及对用来描述疾病改善、稳定性和进展的术语的共同理解。”
It was therefore important for us to know whether it would give us reliable results for patients who are treated with TCAs.
因此,对我们来说,知道它是否能给我们提供 - 对接受TACs治疗的患者可靠的结果是很重要的。
Because the mechanism of action of TCAs is different, researchers were concerned that RECIST evaluations might not be appropriate in such treatment because, for example, different tumours within the same patient could react differently to the TCA due to heterogeneous characteristics.
由于TCAs的作用机制不同,研究人员担心RECIST评估可能不适用于这种治疗,因为,例如,同一患者内的不同肿瘤可能由于异质性特征对TCAs有不同的反应。
A large database was therefore necessary in order to be sure of robust conclusions in any investigation.
因此,为了确保在任何调查中得出可靠的结论,都需要一个大型数据库。
The EORTC RECIST Working Group compiled a database on the basis of 50 Phase II and Phase III trials containing data from patients treated with TCAs alone or in combination with chemotherapy.
EORTCRECIST工作组根据50个II期和III期试验编制了一个数据库,这些试验包含单独或联合化疗的患者的数据。
Our study looked at the data of over 23,000 patients with cancer, more than 17,000 of whom received treatment with TCAs.
我们的研究着眼了超过23000名癌症患者的数据,其中超过17000人接受了TCAs治疗。
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