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Long-Term Effects of Everolimus-Facilitated Tacrolimus Reduction in Living-Donor Liver Transplant Recipients with Hepatocellular Carcinoma

 Gonzalo Sapisochin  ;  Wei Chen Lee  ;  Dong Jin Joo  ;  Jae-Won Joh  ;  Koichiro Hata  ;  Arvinder Singh Soin  ;  Uday Kiran Veldandi  ;  Shuhei Kaneko  ;  Matthias Meier  ;  Denise Leclair  ;  Gangadhar Sunkara  ;  Long Bin Jeng 
 ANNALS OF TRANSPLANTATION, Vol.27 : e937988, 2022-11 
Journal Title
Issue Date
Carcinoma, Hepatocellular* / drug therapy ; Carcinoma, Hepatocellular* / surgery ; Everolimus / therapeutic use ; Follow-Up Studies ; Humans ; Liver Neoplasms* / drug therapy ; Liver Neoplasms* / surgery ; Liver Transplantation* ; Living Donors ; Retrospective Studies ; Tacrolimus / therapeutic use
BACKGROUND The study objective was to evaluate the effect of everolimus (EVR) in combination with reduced tacrolimus (rTAC) compared with a standard TAC (sTAC) regimen on hepatocellular carcinoma (HCC) recurrence in de novo living-donor liver transplantation recipients (LDLTRs) with primary HCC at liver transplantation through 5 years after transplantation. MATERIAL AND METHODS In this multicenter, non-interventional study, LDLTRs with primary HCC, who were previously randomized to either everolimus plus reduced tacrolimus (EVR+rTAC) or standard tacrolimus (sTAC), and who completed the 2-year core H2307 study, were followed up. Data were collected retrospectively (end of core to the start of follow-up study), and prospectively (during the 3-year follow-up study). RESULTS Of 117 LDLTRs with HCC at LT in the core H2307 study (EVR+rTAC, N=56; sTAC, N=61), 86 patients (EVR+rTAC, N=41; sTAC, N=45) entered the follow-up study. Overall HCC recurrence was lower but statistically non-significant in the EVR+rTAC group (3.6% vs 11.5% in sTAC; P=0.136) at 5 years after LT. There was no graft loss or chronic rejection. Acute rejection and death were comparable between treatment groups. Higher mean estimated glomerular filtration rate in the EVR+rTAC group (76.8 vs 65.8 mL/min/1.73 m² in sTAC) was maintained up to 5 years. Reported adverse events were numerically lower in the EVR+rTAC group (41.0% vs 53.5% sTAC) but not statistically significant. CONCLUSIONS Although statistically not significant, early EVR initiation reduced HCC recurrence, with comparable efficacy and safety, and better long-term renal function, than that of sTAC treatment.
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Joo, Dong Jin(주동진) ORCID logo https://orcid.org/0000-0001-8405-1531
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