Sorafenib as adjuvant therapy for high-risk hepatocellular carcinoma in liver transplant recipients: feasibility and efficacy.

OBJECTIVES

Liver transplant can be a definitive treatment for hepatocellular carcinoma. However, recurrence limits long-term survival. Sorafenib is the first agent to improve survival for patients with advanced hepatocellular carcinoma.

MATERIALS AND METHODS

A retrospective, case-control match analysis was performed, along with assessment of safety and tolerability. The endpoints of the study were recurrence incidence, episodes of rejection, and disease-free overall survival. Eight patients who underwent liver transplant for hepatocellular carcinoma between May 2007 and April 2009, and tolerated adjuvant therapy with sorafenib were matched with patients who did not receive sorafenib according to age, sex, year of transplant, tumor burden, and presence of vascular invasion.

RESULTS

During follow-up, there were no episodes of rejection in either group. Eight patients were able to tolerate a predetermined duration of therapy. During a mean (± standard deviation [SD]) follow-up of 17.75 ± 6.26 months, 1 of 8 patients (12.5%) treated with sorafenib developed hepatocellular carcinoma recurrence. During a mean (± SD) follow-up of 31.63 months (± 22.30 months), 4 of 8 matched controls (50.0%) developed hepatocellular carcinoma recurrence. Disease-free 1-year survival for sorafenib and control group was 85.7% and 57.1%. Overall, 1-year survival for sorafenib and control group was 87.5% and 62.5%.

CONCLUSIONS

Our study demonstrates the safety and potential benefit of sorafenib in reducing the incidence of hepatocellular carcinoma recurrence and in extending disease-free and overall survival for high-risk liver transplant recipients. A prospective trial is needed to fully assess the role sorafenib as prophylaxis against hepatocellular carcinoma recurrence.