Background: A new national policy has adopted the UNOS Region 5 down-staging protocol for liver transplant (LT) in HCC meeting the following inclusion criteria – 1 lesion >5 and ≤8 cm, 2-3 lesions at least one >3 cm and ≤5 cm with total tumor diameter ≤8 cm, or 4-5 lesions each ≤3 cm with total tumor diameter ≤8 cm. Therefore, we aimed to evaluate the application of down-staging nationally across wait-time regions as well as post-LT outcomes following successful down-staging to Milan criteria in patients with initial tumor burden within and beyond the Region 5 down-staging criteria. Methods: We identified 3,754 HCC patients in the UNOS database who received priority listing and underwent LT between 2012-2015, of whom 3,276 (87%) were always within Milan, 367 (10%) met Region 5 down-staging criteria, and 111 (3%) exceeded these criteria (“all-comers”). Results: Median time from priority listing to LT was 12.6 months in long wait regions (LWR-1,5,9; 21% of the cohort), 6.5 months in mid wait regions (MWR-2,4,6,7,8; 43%), and 2.6 months in short wait regions (SWR-3,10,11; 36%). In the explant, the probability of under-staging to beyond Milan was significantly higher in the Region 5 down-staging group (35%) and all-comers (41%) compared to Milan group (14%) (p<0.001). Vascular invasion was found in 21% of all-comers compared to 17% of Region 5 down-staging and 14% of Milan group (p=0.09). Poorly differentiated tumor grade was similar among groups (p=0.31). Kaplan-Meier 3-year post-LT survival was 83% for Milan, 78% for Region 5 down-staging group (p=0.05 versus Milan), and 69% for all-comers (p=0.002 versus Milan). Post-LT survival at 3-years was similar across wait regions for Milan but within Region 5 down-staging group was significantly lower in MWR (73%) and SWR (79%) compared to LWR (90%) (p=0.03). The probability of HCC recurrence at 3-years post-LT was 6.9% for Milan, 13% for Region 5 down-staging, and 18% for all-comers (p<0.001). Post-LT recurrence at 3-years was numerically higher for Region 5 down-staging group in MWR (15%) and SWR (13%) compared to LWR (8.0%), though not significant (p values >0.2). Conclusions: We observed worse post-LT survival and HCC recurrence in all-comers compared to the Milan and Region 5 down-staging groups in the UNOS database. Within the Region 5 down-staging group, patients from MWR and SWR had worse post-LT outcomes compared to LWR, suggesting an influence of longer wait-time in the selection of better candidates for LT after tumor down-staging.

CITATION INFORMATION: Mehta N., Dodge J., Yao F. Influence of Initial Tumor Burden and Wait Times on Post-Transplant Outcomes after Down-Staging of Hepatocellular Carcinoma (HCC) Am J Transplant. 2017;17 (suppl 3).

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