Sorafenib use for recurrent hepatocellular cancer after resection or transplantation: Observations from a US regional analysis of the GIDEON registry

- With 5-year recurrence rates of approximately 70% for resection and 20% for OLT, treating HCC patients after these procedures is a frequent issue.
- Sorafenib is one choice for treating HCC recurrence, but little is known about its safety/ tolerability prior liver resection/OLT.
- rug-related AEs were higher in patients with prior resection (87%), OLT (100%), than in patients with concomitant OLT (63%) or no surgery (70%).
- Incidence of AEs resulting in permanent discontinuation was similar in all groups (19-38%).
- Safety profile seen in this cohort undergoing prior surgical resection/OLT is consistent with known safety profile of sorafenib.

Treatment of unresectable recurrent hepatocellular carcinoma (HCC) in patients who recur after resection or orthotopic liver transplantation (OLT) remains a clinical challenge. One option is sorafenib, although little is known about its safety and tolerance in this unique patient population; therefore, we analyzed patients who underwent prior surgical resection and/or OLT and were treated with sorafenib in US cohort of GIDEON registry. In US, 645 patients were enrolled; 553 for intent to treat and 563 for safety. Data were analyzed in the safety population of 479 patients no surgery and 56 for resection or OLT. Forty-one patients underwent resection prior to the initiation of sorafenib, 15 patients had previously received an OLT, and 6 patients had both resection and OLT. Initial low starting doses (400 mg/day) were observed for more patients with prior OLT (71%) than prior resection (36%), resection and OLT (50%), concomitant OLT (25%), and no surgery (36%). Most AEs occurred in the first 4 weeks of treatment. Drug-related AEs were higher in patients with prior resection (87%), prior OLT (100%), or both (100%) than in patients with concomitant OLT (63%) or no surgery (70%). However, incidence of AEs resulting in permanent discontinuation were similar in all groups (19-38%).