The
therapeutic effect of
regorafenib was previously demonstrated in patients with advanced
hepatocellular carcinoma (HCC) and Child-Pugh classification A (CP-A) whose disease progressed during
sorafenib treatment in a phase III trial. However, treatment options are limited for patients with advanced HCC other than CP-A. In this study, we aimed to evaluate the
therapeutic effect of
regorafenib on advanced HCC patients including those with Child-Pugh classification B (CP-B).We retrospectively analyzed the medical records of 21 patients with advanced HCC who were treated with
regorafenib after
sorafenib monotherapy at our hospital from July 2017 to April 2018 and were followed up until September 2019. Patients were classified according to liver function and adverse events experienced during
sorafenib treatment and were started on
regorafenib with a pre-defined reduced starting dose along with a
dose reduction and schedule change based on the judgement of the attending physician.At
regorafenib initiation, 13 and 8 patients were classified as CP-A and CP-B, respectively. In all patients with CP-B, the starting dose of
regorafenib was reduced, and the pre-defined starting-dose sets were applied to 17 (81%) patients. The median duration of
regorafenib treatment in patients with CP-A and CP-B were 4.1 months and 2.0 months, respectively, with no significant difference. The median overall survival from
regorafenib initiation (OS-r) and
sorafenib initiation (OS-s) was 13.2 months and 30.9 months, respectively. In subgroup analysis, OS-r was 16.3 months in patients with CP-A and 10.1 months with CP-B with no significant difference (Pā=ā.44), whereas OS-r was 16.3 months in patients with modified
albumin-
bilirubin Grade 1/2a and 13.2 months in patients with Grade 2b, with no significant difference. There was no clear difference in the incidence rate of ≥grade 3 adverse events between CP-A and CP-B. OS-r and OS-s were significantly correlated.Even patients with impaired liver function achieved the desired
therapeutic effects by safely reducing the starting dose of
regorafenib according to both impaired liver function and adverse events during pretreatment.
Regorafenib may be considered to be an effective treatment after
sorafenib monotherapy in patients with impaired liver function.