Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON

Abstract

BackgroundGIDEON was a prospective, global, non-interventional study evaluating the safety of sorafenib in patients with unresectable hepatocellular carcinoma in real-world practice. The aim of this subgroup analysis was to assess the safety and efficacy of sorafenib as used by Japanese patients.MethodsIn Japan, 508 patients were valid for safety analysis. Efficacy and safety were evaluated by the Child-Pugh score.ResultsThe number of patients with Child-Pugh A and B was 432 (85.0 %) and 58 (11.4 %), respectively. The median overall survival time and time to progression in patients with Child-Pugh A and Child-Pugh B were 17.4 and 4.9 months, 3.7 and 2.3 months, respectively. The most common drug-related adverse events (AEs) included hand-foot skin reaction (47.8 %), diarrhea (35.8 %) and hypertension (24.2 %). The incidences of all or drug-related AEs were similar between patients with Child-Pugh A and B. However, all or drug-related serious AEs, AEs resulting in permanent discontinuation of sorafenib and deaths were observed more frequently in patients with Child-Pugh B compared with Child-Pugh A. Duration of treatment tended to be shorter as the Child-Pugh score worsened.ConclusionsSorafenib was well tolerated by Japanese HCC patients in clinical settings. Patients with Child-Pugh B had shorter duration of treatment and higher incidence of SAEs. It is important to carefully evaluate patients’ conditions and assess the benefit and risk before making a decision to treat patients with sorafenib.Electronic supplementary materialThe online version of this article (doi:10.1007/s00535-016-1204-2) contains supplementary material, which is available to authorized users.

Hand-Foot Syndrome and Post-Progression Treatment Are the Good Predictors of Better Survival in Advanced Hepatocellular Carcinoma Treated with Sorafenib: A Multicenter Study

“…Regarding liver function at the start of therapy, in the GIDEON (Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment with Sorafenib) trial the group of Child-Pugh class A patients had better OS than the group that started at ChildPugh class B [28] ; this was also observed in the present study. In the present study, even among the Child-Pugh class A patients, the group that started at class A-5 points had a significantly better OS than the group that started at class A-6 points; however, the OS of the group that started at class A-6 points was not significantly different from that of the Child-Pugh class B group.…”

Serum HMGB1 concentrations at 4 weeks is a useful predictor of extreme poor prognosis for advanced hepatocellular carcinoma treated with sorafenib and hepatic arterial infusion chemotherapy

“…The median survival time (MST) is 40 and 17 months among complete and partial responders, respectively [6][7][8][9][10][11][12][13]. Several studies show the effectiveness of sorafenib in Japanese patients [14,15]. However, not all HCC patients respond to these treatments.…”

Genetic basis of hepatitis virus-associated hepatocellular carcinoma: linkage between infection, inflammation, and tumorigenesis

“…It is currently the second leading cause of cancer-related deaths, with an estimated 500,000-600,000 deaths/year [1][2][3]. To date, multidisciplinary strategies for HCC treatment include surgery, radiofrequency ablation, transarterial chemoembolization, and molecular targeting therapy [4][5][6][7][8][9]. The multi-centric manner of tumorigenesis that is characteristic of HCC development, however, makes it extremely difficult to achieve curative therapy for HCC.…”