Korean J Transplant.  2022 Nov;36(Supple 1):S305. 10.4285/ATW2022.F-4429.

Impact of everolimus versus mycophenolate mofetil in combination with reduced tacrolimus in liver transplantation patients with hepatocellular carcinoma within Milan criteria

• Min EK
• Lee JG
• Choi MC
• Yim SH
• Kim DG
• Joo DJ

• KMID: 2535532
• DOI: http://doi.org/10.4285/ATW2022.F-4429

Abstract

Background
The benefit of using everolimus with reduced tacrolimus (rTAC) in respect of hepatocellular carcinoma (HCC) recurrence is still controversial and whether preventive effect of HCC recurrence resulted from everolimus or from minimization of tacrolimus is not clear. There has been no head-to-head study that compared rTAC+everolimus with rTAC+mycophenolate mofetil (MMF). We describe retrospective intention-to-treat (ITT) analysis comparing outcome of those to regimens, with HCC recurrence as primary endpoint in liver transplant (LT) recipients within Milan criteria.
Methods
Three hundred thirteen patients who received LT for HCC at Severance Hospital, between January 2014 and Decem-ber 2020 were retrospectively reviewed. Pediatrics, retransplants, combined transplants, patients with use of cyclosporine or Rapamune, and above Milan were excluded. Goal of tacrolimus blood level was 4–10 ng/mL in the first month after LT and 3–6 ng/mL thereafter. With the use of Everolimus, target level thereof was 3–5 ng/mL.
Results
ITT population composed of patients receiving at least 1 month of MMF and then continued MMF (rTAC+MMF, n=52) or switched to everolimus (rTAC+Everolimus, n=81). Among them, 105 patients who continued MMF or everolimus without chang-ing regimen thereafter comprised per-protocol (PP) population. In ITT population, there was no difference in sex, age, model for end-stage liver disease (MELD), Child-Turcotte-Pugh score and original liver disease between the two groups. There were no significant differences in acute rejection rate, recurrence-free survival (RFS) and overall survival (OS). In PP population, four patients had recurrence of HCC in rTAC+MMF group and five patients in rTAC+Everolimus group (10.8% vs. 7.4%, P=0.717). There was no significant difference in 5-year RFS nor OS between rTAC+MMF and rTAC+Everolimus group (87.7% vs. 91.3%, P=0.653; 83.2% vs. 94.1%; P=0.351).
Conclusions
There was no significant difference in HCC recurrence rate between patients receiving rTAC+MMF or rTAC+Evero-limus for HCC within Milan. Prospective studies are needed to find best strategy of immunosuppression for prevention of HCC recurrence.