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《肝癌疗效评价标准(RECICL)》(2015年修订版)

Response Evaluation Criteria in Cancer of the Liver (RECICL) (2015 Revised version).

作者信息

Kudo Masatoshi, Ueshima Kazuomi, Kubo Shoji, Sakamoto Michiie, Tanaka Masatoshi, Ikai Iwao, Furuse Junji, Murakami Takamichi, Kadoya Masumi, Kokudo Norihiro

机构信息

Committee for Response Evaluation Criteria in Cancer of the Liver, Liver Cancer Study Group of Japan, Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka-Sayama, Japan.

出版信息

Hepatol Res. 2016 Jan;46(1):3-9. doi: 10.1111/hepr.12542. Epub 2015 Aug 4.

Abstract

The Response Evaluation Criteria in Solid Tumors (RECIST) is inappropriate to assess the direct effects of treatment on hepatocellular carcinoma (HCC) by locoregional therapies such as radiofrequency ablation (RFA) and transarterial chemoembolization (TACE). Therefore, establishment of response evaluation criteria solely devoted to HCC is needed urgently in clinical practice as well as in clinical trials of HCC treatment, such as molecular-targeted therapies, which cause necrosis of the tumor. The Response Evaluation Criteria in Cancer of the Liver (RECICL) was revised in 2015 by the Liver Cancer Study Group of Japan based on the 2009 version of RECICL, which was commonly used in Japan. Major revised points of the RECICL 2015 is to define the target lesions of two lesions per organ or three lesions per liver, up to a maximum of five lesions. The second revised point is that setting the timing at which the overall treatment response has been changed. The third point is that the definition of treatment effect 1 has been changed to more than 50% tumor enlargement, excluding the area of necrosis after treatment. Overall evaluation of treatment response has been amended to make it possible to evaluate the overall response including extrahepatic lesions by systemic therapy, which is similar to RECIST or modified RECIST. We hope this new treatment response criteria, RECICL, proposed by the Liver Cancer Study Group of Japan will benefit HCC treatment response evaluation in the setting of daily clinical practice and clinical trials, not only in Japan, but also internationally.

摘要

实体瘤疗效评价标准(RECIST)不适用于评估诸如射频消融(RFA)和经动脉化疗栓塞(TACE)等局部区域治疗对肝细胞癌(HCC)的直接治疗效果。因此,在临床实践以及HCC治疗的临床试验(如导致肿瘤坏死的分子靶向治疗)中,迫切需要建立专门针对HCC的疗效评价标准。日本肝癌研究组在2009年版日本常用的《肝癌疗效评价标准》(RECICL)基础上,于2015年对其进行了修订。RECICL 2015的主要修订点包括:将每个器官的靶病灶定义为2个,或每个肝脏3个,最多不超过5个;第二点修订是设定总体治疗反应发生变化的时间点;第三点是将治疗效果1的定义改为肿瘤增大超过50%,不包括治疗后坏死区域。对治疗反应的总体评估进行了修订,以便能够评估包括全身治疗引起的肝外病灶在内的总体反应,这与RECIST或改良RECIST类似。我们希望日本肝癌研究组提出的这个新的治疗反应标准RECICL,不仅能在日本,而且能在国际上的日常临床实践和临床试验中,对HCC治疗反应评估有所助益。

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