240P - Hepatic reserve and the other conditions for regorafenib as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib in Japanese practical setting

Abstract

Background: In RESORCE trial, which revealed that regorafenib has improved survival of the patients with advanced hepatocellular carcinoma (aHCC) after sorafenib, only patients with preserved hepatic reserve were included. We investigated change of hepatic reserve and the other conditions for proven benefit of regorafenib after sorafenib treatment in Japanese practical setting. Methods: We retrospectively reviewed change of Child-Pugh score and the other conditions at commencement and cessation of sorafenib, and evaluated the effect of change in Child-Pugh scores on second line treatment and outcomes in patients with aHCC. Results: Of the 120 patients whose aHCC were treated with sorafenib, 87 patients (73%) and 67 patients (56%) had sufficient hepatic reserve that is Child-Pugh A. After median 2.4 months of sorafenib treatment, hepatic reserve remained Child-Pugh A in 57 of 87 (66%) patients with Child-Pugh A before sorafenib, and it improved to Child-Pugh A in 10 of 33 (33%) patients with Child-Pugh B before sorafenib. At cessation of sorafenib treatment, only 50 patients (42%) fulfilled key inclusion criteria of RESORCE trial (Child-Pugh A, ECOG PS 0 or 1, tumor progression on imaging and administration of ≥ 400mg of sorafenib for at least 20 of the last 28 days before discontinuation; 67 patients (56%), 103 patients (86%), 90 patients (75%), and 86 patients (72%) fulfilled each criterion, respectively). Multivariate analysis revealed that only Child-Pugh score of 5 before sorafenib was contributing factor to Child-Pugh A at cessation of sorafenib. Significantly more patients with Child-Pugh A at cessation of sorafenib treated by any subsequent therapies compared to patients with Child-Pugh B (86.6 vs 52.8%; P < 0.001) and had better outcome (median overall survival of 13.7 vs 7.1 months; P = 0.004). Conclusions: Sorafenib treatment can deteriorate hepatic reserves even if the patients have sufficient hepatic reserve before treatment. Maintaining hepatic reserve during sorafenib treatment should be taken care because it contributes to treatment of subsequent therapies such as regorafenib treatment and longer survival of patients with aHCC. Legal entity responsible for the study: Kanazawa University Hospital Funding: None Disclosure: All authors have declared no conflicts of interest.