Efficacy and Safety of a Steroid-Free Immunosuppressive Regimen after Liver Transplantation for Hepatocellular Carcinoma

Abstract

Background/AimsWe aimed to evaluate the efficacy and safety of an immunosuppressive regimen without steroids after liver transplantation (LT) for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC).MethodsSixty-six HCC patients who underwent an immunosuppressive regimen without steroids after LT were enrolled in the steroid-free group. The preoperative characteristics and postoperative outcomes of these patients were compared with those of 132 HCC recipients who were placed on an immunosuppressive regimen using steroids (steroid group). The incidence of acute rejection, HBV recurrence, infection, and new-onset diabetes mellitus and the overall and tumor-free survival rates were compared between the two groups.ResultsDifferences were not observed in the 1-year (83.3% vs 97.0%, p=0.067), 3-year (65.4% vs 75.8%, p=0.067) or 5-year (56.3% vs 70.7%, p=0.067) patient survival rates or in the 1-year (62.1% vs 72.7%, p=0.067), 3-year (49.8% vs 63.6%, p=0.067) or 5-year (48.6% vs 63.6%, p=0.067) tumor-free survival rates between the two groups, respectively. In the steroid-free group, the patients who fulfilled the Milan criteria had higher overall and tumor-free survival rates than those in the steroid group (p<0.001). The prevalence of HBV recurrence (3.0% vs 13.6%, p=0.02) was significantly lower in the steroid-free group compared with the steroid group.ConclusionsAfter LT, an immunosuppressive regimen without steroids could be a safe and feasible treatment for HBV-related HCC patients, thus resulting in the reduction of HBV recurrence. Based on the observed survival rates, patients who fulfill the Milan criteria may derive benefits from steroid-free immunosuppression.

Liver transplantation for Hepatitis‐B‐associated liver disease ‐ Three decades of experience

“…HBV‐infections might also occur in secrecy despite seronegative HBs‐Ag . It is supposed to be the result of immunosuppression, enhanced virus replication, extrahepatic reservoirs of HBV as well as direct stimulatory effects of prednisolone therapy on the HBV genome . Recent studies could show significantly fewer HBV‐recurrence in patients with steroid‐free regimens after LT .…”

“…It is supposed to be the result of immunosuppression, enhanced virus replication, extrahepatic reservoirs of HBV as well as direct stimulatory effects of prednisolone therapy on the HBV genome . Recent studies could show significantly fewer HBV‐recurrence in patients with steroid‐free regimens after LT . The most important issue is the advent of effective NUC‐based prophylaxis, so that the impact of immunosuppression including corticosteroids is less dominant as it used to be.…”

A national report from China Liver Transplant Registry: steroid avoidance after liver transplantation for hepatocellular carcinoma

“…Increasing attention has been focused on the side effects associated with steroid-based IS regimens (6). Long-term steroids can facilitate the host immunity, which maybe the cause of HCC recurrence (7)(8)(9)(10). In addition, the numerous side effects of steroids, such as infections, obesity, lipid profile imbalances, hypertension and diabetes mellitus, have emphasized the need to avoid or limit steroid usage (11,12).…”

Safety and Efficacy of Budesonide for Liver Transplant Immune Suppression: Results of a Pilot Phase 2a Trial

“…(4,6,8) The majority of the studies using steroid-free regimens augmented their immune suppression with antibody induction therapy. (3,9,(19)(20)(21)(22)(23) Randomized trials that have used similar methodology and patient selection have provided conflicting evidence in regard to risk of ACR between cohorts using steroid versus steroid-free regimens. (5,7,15,24) Multiple meta-analyses and literature reviews have concluded that steroid-free immune suppression regimens lower the risk of NODAT, CMV infections, and hypercholesterolemia while having similar efficacy to steroid-based regimens in preventing ACR only when steroids were replaced with antibody induction treatments.…”