Background:It is unclear whether the reported benefit of mTORi in LT for HCC is from direct effect of mTOR inhibitors. We aimed to compare directly sirolimus versus sirolimus free regimen in LDLT for HCC beyond Milan criteria.

Methods: Forty-two LDLT recipients having HCC beyond Milan pathologically from two centers were prospectively randomized one month after LT into two groups [sirolimus or CNI group]. Sirolimus and MMF were used in sirolimus group. CNI and MMF were used in CNI group. The primary and secondary objects were recurrence free survival (RFS) and patient survival respectively for 3 years.

Results: Twenty patients were sirolimus group and 22 were CNI group. There were total 13 patients with recurrence (sirolimus; 8, CNI;5). There was no difference in RFS and patient survival in univariate analysis. ]. Sirolimus didn't affect on the recurrence even in multivariate analysis. AFP>150 and PET SUV ratio (tumor/background liver) >1.15 were significant risk factors for recurrence. However, sirolimus prolonged survival significantly in multivariate analysis. CNI group (HR:15.0(CI:1.302-172.8), p<0.001), AFP>150 and PET SUV ratio > 1.15 were significant risk factors for survival. The sirolimus group showed better survival among 13 recurred cases (p= long Rank 0.07, Breslow 0.02). Conclusion: sirolimus didn't decrease the incidence of recurrence in patients outside Milan. However, it prolonged survival, especially in patients with recurrence. Therefore, in high risk of recurrence patients such as high AFP or high PET SUV ratio, sirolimus should be considered.

CITATION INFORMATION: Lee K.-W, Kim S.-H, Yi N.-J, Hong S.-K, Yoon G, Kim H, Oh D, Han S.-S, Park S.-J, Suh K.-S. Sirolimus Prolonged Survival After Living Donor Liver Transplantation for HCC Beynd Milan Criteria; Outcome of a Multicenter Prospective Randomized Phase II Trial (ClinicalTrials.gov Identifier: NCT01374750). Am J Transplant. 2017;17 (suppl 3).

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