Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outcome from the Chinese patient subset of the GIDEON study.

Sheng Long Ye ,Yunpeng Liu,Xiaxing Deng,Shuijun Zhang,Luming Liu,Jiamei Yang,Jie Zhou,Chunyi Hao,Yajin Chen,Fengyong Liu,Qiang Xia,Yunfei Yuan,Keiko Nakajima,Ping Bie,Zhengguang Lu,Kefeng Dou,Guoliang Shao,Xiaoping Chen,Junjie Yang ,Christina Sze Man Yip ,Zhi-Ren Fu

doi:10.18632/oncotarget.6781

Abstract

We report data from the final analysis of the Chinese subset of the GIDEON (the Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib) study, which evaluated the safety and efficacy of sorafenib in Child-Pugh A, B and C patients with unresectable hepatocellular carcinoma (uHCC) in real-life clinical practice. Patient demographics, disease characteristics and treatment history were recorded at enrollment; dose, adverse events (AEs) and efficacy were recorded at follow-up. Of the 338 evaluable patients, 98.5% started on 800 mg/day sorafenib, regardless of their Child-Pugh status. The median treatment duration (21.1 vs. 18.8 weeks) and median overall survival (322 vs 240 days) were longer in patients with Child-Pugh A compared with the Child-Pugh B, progression-free survival were 183 vs. 208 days, respectively). AEs (all grades) were comparable in the Child-Pugh B vs A group (56.3% vs. 50.4%, respectively), moreover, the Child-Pugh B group also had comparable rates of drug-related AEs (35.4% vs. 27.2%, respectively) and serious AEs (25.0% vs. 23.0%, respectively) compared with the Child-Pugh A group. The overall dosing strategy was consistent in Chinese patients across Child-Pugh subgroups. Tolerability and safety data suggest that Child-Pugh B patients might be safely treated with sorafenib. The findings from our study showed that safety profile of sorafenib in terms of rate and type of AEs is similar to the global international GIDEON study as well as other pivotal studies.

Highlights

Primary liver cancer (PLC) represents the sixth most common malignancy worldwide and is the third leading cause of cancer-related deaths [1]
We report data from the final analysis of the Chinese subset of the GIDEON study, which evaluated the safety and efficacy of sorafenib in Child-Pugh A, B and C patients with unresectable hepatocellular carcinoma in real-life clinical practice
Majority of the patients belonged to Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 (Child-Pugh A: 90%; Child-Pugh B: 66.7%; Child-Pugh C: 50%)

Summary

Introduction

Primary liver cancer (PLC) represents the sixth most common malignancy worldwide and is the third leading cause of cancer-related deaths [1]. ~75% of the deaths occurring due to HCC worldwide is expected to rise, due partly to the increasing incidence of hepatitis C [2]. Data from various studies have reflected that China has the highest prevalence of hepatitis B virus (HBV) carriers in the world and an increasing trend in the rate of hepatitis C virus (HCV) infection. All these factors contribute to a heavy disease burden in China. The Ministry of Health of China has taken several measures to control the disease, but it still remains a health issue of major concern [4,5,6,7,8]

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Results

Conclusion