Objective: While adoption of the Milan Criteria (MC) has improved outcomes following liver transplantation (LT) for hepatocellular carcinoma (HCC), recurrence remains a significant challenge. We sought to develop and validate a pretransplant model incorporating serum biomarkers in addition to radiologic criteria to improve stratification of post-LT HCC recurrence risk.

Methods: A risk score based on multivariate predictors of HCC recurrence from competing-risk Cox regression analysis was used to stratify HCC recurrence risk in 4407 consecutive patients with radiographically apparent HCC from 20 US centers encompassing 10 of the 11 UNOS regions (2002-2013). The model was developed in a randomly selected training set (n=2982) and validated in an independent group (n=1515).

Results: Of 4407 LT recipients, 81.7% were within MC, 10.6% were downstaged (DS) to MC, and 7.7% beyond MC and not DS prior to LT. A pretransplant model (C=0.70) was superior to MC alone (C=0.59, P=0.010) and MC with DS status (C=0.59, P=0.009), with a risk score stratifying patients into low-, moderate-, and high-risk recurrence groups. Excellent discrimination of recurrence risk was observed when applied to LT recipients within MC, beyond MC and DS, and beyond MC and not DS. Conclusions: In a large multicenter cohort, we develop and validate a risk score model incorporating NLR and AFP in addition to radiologic size/number that is superior to Milan alone in predicting HCC recurrence, allowing for identification of both a subset of MC patients at prohibitive risk for post-LT recurrence, and beyond MC patients with acceptable risk. Strong consideration must be made for incorporation of these markers of tumor biology for HCC candidate selection.

CITATION INFORMATION: Agopian V, On Behalf of the US Multicenter HCC Transplant Consortium A Pretransplant Model Incorporating Serum Biomarkers Is Superior to the Milan Criteria in Stratifying Risk of Hepatocellular Carcinoma Recurrence Following Liver Transplantation: Analysis of 4407 Patients from the US Multicenter HCC Transplant Consortium. Am J Transplant. 2017;17 (suppl 3).

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