Sorafenib for recurrent hepatocellular carcinoma after liver transplantation.

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e14669 Background: Sorafenib is the only drug that has shown a survival benefit in patients with hepatocellular carcinoma (HCC) in randomized phase III trials. The efficacy and safety of sorafenib in the treatment of recurrent HCC after liver transplantation, however, has not been determined. Methods: We retrospectively analyzed 13 patients who were treated with sorafenib for recurrent HCC after liver transplantation. Results: All 13 patients underwent living-donor liver transplantation for HCC with underlying liver cirrhosis caused by hepatitis B virus (HBV) infection. The median model for end-stage liver disease (MELD) score at transplantation was 7.6 (range, 4.2-25.2). The median time from liver transplantation to detection of recurrent HCC was 12.3 months (range, 0.5-33.4 months). The median serum alpha-fetoprotein (AFP) concentration before sorafenib administration was 193 ng/mL (range, 1-20,500 ng/mL). Eleven of 13 patients had a starting dose of 400mg twice daily and two had a starting dose of 200 mg twice daily at the discretion of the attending physician. The median duration of sorafenib treatment was 2.4 months (range, 0.3-9.9 months). Single or multiple immunosuppressants were coadministered in these patients during sorafenib treatment. Six of 10 evaluable patients showed stable disease, which was the best response and the median duration of stabilization was 3.9 months (95% confidence interval [CI], 1.6–6.2 months). At a median follow-up duration of 3.7 months (range, 0.3-10.9 months) in living patients, the median progression-free survival and the median overall survival from commencement of sorafenib were 2.9 months (95% CI, 1.2-4.6 months) and 5.4 months (95% CI, 3.7-7.0 months), respectively. Grade 3 neutropenia was observed in one patient, which was the only high grade hematologic toxicity observed. Grade 3 hand-foot skin reactions were observed in three patients. Adverse events could be managed with dose adjustment. Conclusions: These findings suggest that the efficacy of sorafenib for recurrent HCC after liver transplantation may not be inferior to that observed in phase 3 trials conducted in non- transplant patients and the drug may be safely administered with careful monitoring in these patients. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bayer Bayer

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