In 2010, modified RECIST (mRECIST) criteria were proposed as a way of adapting the RECIST criteria to the particularities of hepatocellular carcinoma (HCC). We intended to overcome some limitations of RECIST in measuring tumour shrinkage with local and systemic therapies, and also to refine the assessment of progression that could be misinterpreted with conventional RECIST 1.1, due to clinical events related to the natural progression of chronic liver disease (development of ascites, enlargement of lymph nodes, etc.). mRECIST has served its purpose since being adopted or included in clinical practice guidelines (European, American and Asian) for the management of HCC; it has also been instrumental for assessing response and time-to-event endpoints in several phase II and III investigations. Nowadays, mRECIST has become the standard tool for measurement of radiological endpoints at early/intermediate stages of HCC. At advanced stages, guidelines recommend both methods. mRECIST has been proven to capture higher objective response rates in tumours treated with molecular therapies and those responses have shown to be independently associated with better survival. With the advent of novel treatment approaches (i.e. immunotherapy) and combination therapies there is a need to further refine and clarify some concepts around the performance of mRECIST. Similarly, changes in the landscape of standard of care at advanced stages of the disease are pointing towards progression-free survival as a potential primary endpoint in some phase III investigations, as effective therapies applied beyond progression might mask overall survival results. Strict recommendations for adopting this endpoint have been reported. Overall, we review the performance of mRECIST during the last decade, incorporating novel clarifications and refinements in light of emerging challenges in the study and management of HCC.

中文翻译：

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HCC 的 mRECIST：性能和新颖的改进

2010 年，提出了修改后的 RECIST (mRECIST) 标准，以使 RECIST 标准适应肝细胞癌 (HCC) 的特殊性。我们打算克服 RECIST 在使用局部和全身治疗测量肿瘤缩小方面的一些局限性，并改进对可能被传统 RECIST 1.1 误解的进展评估，原因是与慢性肝病的自然进展相关的临床事件（发展腹水、淋巴结肿大等）。自 HCC 管理临床实践指南（欧洲、美国和亚洲）采用或纳入 mRECIST 以来，mRECIST 已达到其目的；它还有助于评估几项 II 期和 III 期调查中的反应和事件发生时间终点。如今，mRECIST 已成为测量 HCC 早期/中期放射学终点的标准工具。在高级阶段，指南推荐这两种方法。mRECIST 已被证明可以在用分子疗法治疗的肿瘤中获得更高的客观反应率，并且这些反应已被证明与更好的生存率独立相关。随着新的治疗方法（即免疫疗法）和联合疗法的出现，需要进一步完善和阐明围绕 mRECIST 性能的一些概念。同样，在疾病晚期阶段，护理标准格局的变化表明无进展生存期是一些 III 期研究的潜在主要终点，因为在进展之后应用的有效疗法可能会掩盖总体生存期结果。已经报告了采用此端点的严格建议。总体而言，我们回顾了 mRECIST 在过去十年中的表现，结合新的澄清和改进，以应对 HCC 研究和管理中新出现的挑战。