Incorporation of protein induced by vitamin K absence or antagonist-II into transplant criteria expands beneficiaries of liver transplantation for hepatocellular carcinoma: A multi-center retrospective cohort study in China.

INTRODUCTION:In order to maximize the utilization of precious donor liver, precisely determining potential hepatocellular carcinoma (HCC) candidates who will benefit from liver transplantation (LT) is essential. As a crucial diagnostic biomarker for HCC, protein induced by vitamin K absence or antagonist-II (PIVKA-II) has become one of the key indicators for assessing tumor recurrence risk after LT. This study aims to investigate the role of PIVKA-II in recipient selection and prognostic stratification. METHODS:The clinicopathologic data of HCC patients undergoing LT from 2015 to 2020 in 6 Chinese transplant centers were collected. Univariate and multivariate analyses were performed to determine risk factors for disease-free survival (DFS). Based on these risk factors, survival analysis was made by Kaplan-Meier method and their value in prognostic stratification was assessed. RESULTS:A total of 522 eligible HCC patients with pre-LT PIVKA-II records were finally included in this study. Tumor burden>8 cm, AFP>400 ng/mL, histopathologic grade III and PIVKA-II>240 mAU/mL were identified as independent risk factors for DFS. DFS of patients with PIVKA-II≤240 mAU/mL (N=288) were significantly higher than those with PIVKA-II>240 mAU/mL (N=234) (1-, 3- and 5-year DFS: 83.2%, 77.3% and 75.9% vs. 75.1%, 58.5% and 50.5%; P<0.001). Compared with Hangzhou criteria (N=305), incorporating PIVKA-II into Hangzhou criteria (including tumor burden, AFP, histopathologic grade) increased the number of patients with eligibility for LT by 21.6% but achieved comparable DFS and OS. CONCLUSIONS:Incorporating PIVKA-II into existing LT criteria could increase the number of eligible HCC patients without compromising post-LT outcomes.