Efficacy of Regorafenib in Hepatocellular Carcinoma Patients: A Systematic Review and Meta-Analysis

Abstract

Regorafenib showed promising results as a second-line agent after sorafenib failure in hepatocellular carcinoma patients. The aim of this meta-analysis was to evaluate the efficacy and safety of regorafenib in hepatocarcinoma patients. A computerized bibliographic search was performed on the main databases. The primary outcome was overall survival. Secondary outcomes were progression-free survival, tumor response, and the adverse events rate. Outcomes were pooled through a random-effects model and summary estimates were expressed in terms of median and 95% confidence interval or rates, as appropriate. One randomized-controlled trial and seven non-randomized studies with 809 patients were included. The great majority of recruited patients were in Child-Pugh A and ECOG 0 stage. Median overall survival was 11.08 months (9.46-12.71) and sensitivity analyses confirmed this finding, with a median survival ranging from 10.2 to 13.8 months. Duration of regorafenib therapy was 3.58 months, whereas median progression-free survival was 3.24 months (2.68-3.86). The pooled objective response rate was 10.1% (7.8-12.5%) while the disease control rate was 65.5% (61.3-69.7%) with no evidence of heterogeneity (I 2 = 0%; Diarrhea, fatigue, and hand-foot skin reaction were the most frequent adverse events. The current meta-analysis shows that regorafenib represents a valuable and relatively safe therapeutic option in intermediate/advanced hepatocellular carcinomapatients who progress on sorafenib.

Sequential systemic treatment in patients with hepatocellular carcinoma

“…First prospective data on sequential systemic treatment were provided by a post hoc analysis of the III RESORCE study, which showed a mOS of 26.0 months from the start of sorafenib followed by sequential treatment with regorafenib 12 . Accordingly, several small, mostly Asian cohorts with less than 50 patients and one systematic review and meta‐analysis including 809 patients demonstrated a prolonged survival in patients treated with regorafenib following sorafenib compared to historical controls 13‐16,20 . Furthermore, other real‐life studies demonstrated in line with our findings a long mOS particularly for patients receiving even further treatment following regorafenib 13,14 …”

Systemic immune-inflammation index predicts prognosis of sequential therapy with sorafenib and regorafenib in hepatocellular carcinoma

“…Regorafenib demonstrated an objective response rate (ORR) of 11.8%, DCR of 60.9%, a median PFS of 3 months, and a median OS of 8 months. These results are similar to those of previous studies [20]. We investigated the prognostic role of systemic in ammatory markers including SII and found that the SII was an independent predictive factor associated with OS.…”

Systemic immune-inflammation index predicts prognosis of sequential therapy with sorafenib and regorafenib in hepatocellular carcinoma

“…Reforafenib demonstrated an objective response rate (ORR) of 11.8%, DCR of 60.9%, a median PFS of 3 months, and a median OS of 8 months. These results are similar to those of previous studies [19]. We investigated the prognostic role of systemic in ammatory markers including SII and found that the SII was an independent predictive factor associated with OS.…”