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 (I2 = 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.
Highlights
IntroductionDespite the latest advancements in diagnosis and screening programs in cirrhotics, a great number of patients are still diagnosed in an advanced stage, being unsuitable to curative treatments, such as surgery, orthotopic liver transplantation (OLT), or radiofrequency ablation (RFA) [2,3]
Hepatocellular carcinoma (HCC) represents the most common type of malignancy and the leading cause of death in cirrhotic patients [1].Despite the latest advancements in diagnosis and screening programs in cirrhotics, a great number of patients are still diagnosed in an advanced stage, being unsuitable to curative treatments, such as surgery, orthotopic liver transplantation (OLT), or radiofrequency ablation (RFA) [2,3].For these subjects with unresectable HCC who cannot benefit from loco-regional treatments, the oral multikinase inhibitor sorafenib (Nexavar®, Bayer, Leverkusen, Germany) represents the first-line systemic treatment [2,3,4]
A recent phase III multicenter randomized placebo-controlled trial (RCT) showed evidence of the superiority of regorafenib over placebo in HCC patients that had progressed on sorafenib [9]
Summary
Despite the latest advancements in diagnosis and screening programs in cirrhotics, a great number of patients are still diagnosed in an advanced stage, being unsuitable to curative treatments, such as surgery, orthotopic liver transplantation (OLT), or radiofrequency ablation (RFA) [2,3]. For these subjects with unresectable HCC who cannot benefit from loco-regional treatments, the oral multikinase inhibitor sorafenib (Nexavar® , Bayer, Leverkusen, Germany) represents the first-line systemic treatment [2,3,4]. Several real-life series were published with promising results on the use of regorafenib after sorafenib failure; a pressing need to systematically assess the efficacy of regorafenib in this setting exists, based on available real-life experiences
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