Sirolimus-Based Immunosuppression Therapy in Liver Transplantation for Patients With Hepatocellular Carcinoma Exceeding the Milan Criteria

Aim. Sirolimus (SRL) acts as a primary immunosuppressant or antitumor agent. The aim of the present study was to evaluate the influence of SRL on the recurrence rate and survival of patients after orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC) exceeding the Milan criteria. Materials and Methods. We retrospectively examined 73 consecutive patients who underwent OLT for HCC exceeding the Milan criteria from March 2004 through December 2005. Among them, 27 patients were treated with SRL-based immunosuppressive protocols after OLT, and 46 patients by an FK506-based protocol. Statistical analysis was based on the intent-to-treat method. Results. The 2 groups were comparable in ail clinicopathologic parameters. The mean overall survival was 594 35 days in the SRL group and 480 42 days in the FK506 group (P =.011); the mean disease-free survival period was 519 43 days in the SRL group and 477 48 days in the FK506 group (P =.234). Multivariate analysis revealed Child's status (P.004) and immunosuppressive protocol (P =.015) were the significant factors affecting overall survival. Only microvascular invasion (P =.004) was significantly associated with disease-free survival. Among 24 surviving patient in the SRL group, 2 patients had SRL discontinued for toxicity; 10 had SRL monotherapy immunosuppression. Conclusion. The SRL-based immunosuppressive protocol improved the overall survival of patients after OLT for HCC exceeding the Milan criteria, probably by postponing recurrence and with better tolerability.