mRECIST for HCC: Performance and novel refinements

Abstract

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.

CT volume of enhancement of disease (VED) can predict the early response to treatment and overall survival in patients with advanced HCC treated with sorafenib

“…Then, to classify CB vs. PD patients, we could not use LI-RADS v2018 (not dealing with the evaluation of the response to systemic treatment). Thus, we chose mRECIST [14], even if we were conscious of some bias related to these criteria (nonvolumetric evaluation, non-percentage assessment of the enhancement, incomplete evaluation reliability for systemic therapy) [8,14,16,[46][47][48][49], and that a revision of this system has been recently published by the same authors [50]. Furthermore, in this series, the VED was calculated for a maximum of 2 target lesions, which accounted for more than 80% of the overall disease burden.…”

Comparison between Y90 Radioembolization Plus Sorafenib and Y90 Radioembolization alone in the Treatment of Hepatocellular Carcinoma: A Propensity Score Analysis

“…Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 [24] and modified RECIST (mRECIST) criteria [34]. Objective response (OR) was defined as partial response plus complete response, while the disease control rate (DCR) was defined as stable disease plus partial response plus complete response.…”

Embolotherapy for Hepatic Oncology: Current Perspectives and Future Directions

“…BCLC intermediate stage accounts for 20% of HCC patients with a 2-year survival of approximately 50%. 65 It is important to note the extensive heterogeneity of this patient subcohort given the potential range of tumor numbers and sizes as well as range of hepatic function. Patients in the intermediate stage are stratified according to these parameters, with therapeutic indication either as a means of downstaging to potential surgery or as palliative therapy to delay progression and prolong OS.…”