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

Abstract

// Sheng-Long Ye 1 , Xiaoping Chen 2 , Jiamei Yang 3 , Ping Bie 4 , Shuijun Zhang 5 , Fengyong Liu 6 , Luming Liu 7 , Jie Zhou 8 , Kefeng Dou 9 , Chunyi Hao 10 , Guoliang Shao 11 , Qiang Xia 12 , Yajin Chen 13 , Jijin Yang 14 , Xiaxing Deng 15 , Yunpeng Liu 16 , Yunfei Yuan 17 , Zhiren Fu 18 , Keiko Nakajima 19 , Christina S.M. Yip 20 , Zhengguang Lu 20 1 Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China 2 Department of Surgery, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China 3 Department of Special Treatment, Eastern Hepatobiliary Surgery Hospital, Shanghai, China 4 Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing, China 5 Department of General Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China 6 Department of Interventional Radiology, Chinese PLA General Hospital, Beijing, China 7 Shanghai Cancer Center, Fudan University, Shanghai, China 8 Department of Hepatobiliary Surgery, Nanfang Hospital of Southern Medical University, Guangzhou, China 9 Department of Hepatobiliary Surgery, Xijing Hospital, Xi’an, China 10 Department of Hepato-Pancreato-Biliary Surgery, Beijing Cancer Hospital, Peking University, Beijing, China 11 Department of Radiology, Zhejiang Cancer Hospital, Hangzhou, China 12 Department of Liver Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China 13 Department of Hepatobiliary Surgery, Second Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China 14 Department of Nuclear Medicine, Changhai Hospital, Second Military Medical University, Shanghai, China 15 Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China 16 Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China 17 Department of Hepatobiliary, Cancer Center, Sun Yat-sen University, Guangzhou, China 18 Department of Liver Transplantation, Shanghai Changzheng Hospital, Shanghai, China 19 Global Medical Affairs, Bayer Healthcare Pharmaceuticals, Montville, NJ, USA 20 Medical Affairs Oncology, Bayer Healthcare Company Ltd., Beijing, China Correspondence to: Sheng-Long Ye, e-mail: slye@shmu.edu.cn Keywords: sorafenib, unresectable hepatocellular carcinoma, GIDEON, Child-Pugh, Chinese subset Received: September 16, 2015     Accepted: December 07, 2015     Published: December 28, 2015 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.