De novo sirolimus-based immunosuppression after liver transplantation for hepatocellular carcinoma: Long-term outcomes and side effects

Background. We report long-term outcomes and side effects after transplantation for hepatocellular carcinoma (HCC) using de novo, sirolimus-based immunosuppression (IS). Methods. A total of 70 patients with HCC (mean age: 54.4 +/- 7 years, female/male: 12/58) were transplanted and included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids. Results. After 49 months-median follow-up, eight patients have experienced an HCC recurrence, 2 of 34 when Milan criteria were respected (6%) and 6 of 36 when beyond Milan criteria (17%). One- and 4-year tumor-free survivals were 85 and 73%, when Milan criteria were respected and 82% and 75% when they were not, respectively. (P=0.9). After recurrence, mean survival was 23 28 months. Half (35 of 70) of the patients experienced a rejection. Incisional hernia (24 of 70,34%), wound infection (12 of 70,17%), anemia (39 of 70,56%), leucopenia (39 of 70,56%), high triglyceride (43 of 70,61%), and cholesterol (28 of 70,40%) levels and mouth ulcers (20 of 70,29%) were among the most frequent complications. No hepatic artery thrombosis was observed. Conclusions. These data suggest that de novo sirolimus-based immunosuppression is associated with satisfactory outcomes after transplantation, even in selected patients beyond Milan criteria. The protocol has proven safe, with an acceptable side-effect profile. This study supports the conduct of larger randomized trials investigating sirolimus after transplantation for HCC.