Does a patient qualify for liver transplantation after the down‐staging of hepatocellular carcinoma?

SUMMARY Our review of the literature suggests that uniform cri-teria are needed for future studies investigating fur-ther the efficacy and safety of HCC down-stagingbefore LT. Our recommendations are as follows:1. We define HCC down-staging as reducing the tu-mor size with locoregional therapy specifically tomeet acceptable criteria for LT (grade D).2. The tumor response to down-staging treatmentsshould be based on radiological measurementsof the sizes of viable tumors, and the measure-ment should not include the areas of necrosisresulting from locoregional therapy (grade D).3. We propose a goal of achieving a 5-year post-transplant survival rate of 60% to 70% after tu-mor down-staging. Whether intention-to-treatsurvival rates should be compared for thosemeeting the Milan criteria and those undergoingdown-staging remains a debatable issue(grade D).4. We propose using the Milan criteria as the end-point for down-staging, and more data aboutlong-term outcomes are needed (grade C).5. Well-defined upper limits for the tumor size andnumber should be used to determine the eligibil-ity for down-staging before LT (grade D). Otherfactors to be considered include an upper limitfor the AFP level; beyond this limit, down-stagingtreatments are not likely to be successful, andposttransplant outcomes may be significantlyworse.6. TACE is the most commonly used treatment mo-dality, but there is no evidence that one treat-ment is superior to others in achieving down-staging (grade D). More data on the safety ofdown-staging are needed.7. A minimal observation period of 3 monthsbetween successful down-staging and LT is rec-ommended (grade D).8. We propose the following criteria for treatmentfailure for down-staging: (1) tumor progression toone or more of the endpoints resulting in perma-nent removal from the waiting list (vascular inva-sion, extrahepatic spread, or tumor sizes andnumbers beyond the inclusion criteria), (2) deathdue to any cause before LT, and (3) the recur-rence of HCC after LT (grade D).