title: Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outcome from the Chinese patient subset of the GIDEON study.
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.
authors.affiliation: Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Sheng-Long
authors.initials: SL
authors.lastname: Ye
authors.affiliation: Department of Surgery, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Chen
authors.affiliation: Department of Special Treatment, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
authors.forename: Jiamei
authors.initials: J
authors.lastname: Yang
authors.affiliation: Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Bie
authors.affiliation: Department of General Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
authors.forename: Shuijun
authors.initials: S
authors.lastname: Zhang
authors.affiliation: Department of Interventional Radiology, Chinese PLA General Hospital, Beijing, China.
authors.forename: Fengyong
authors.initials: F
authors.lastname: Liu
authors.affiliation: Shanghai Cancer Center, Fudan University, Shanghai, China.
authors.forename: Luming
authors.initials: L
authors.lastname: Liu
authors.affiliation: Department of Hepatobiliary Surgery, Nanfang Hospital of Southern Medical University, Guangzhou, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Zhou
authors.affiliation: Department of Hepatobiliary Surgery, Xijing Hospital, Xi'an, China.
authors.forename: Kefeng
authors.initials: K
authors.lastname: Dou
authors.affiliation: Department of Hepato-Pancreato-Biliary Surgery, Beijing Cancer Hospital, Peking University, Beijing, China.
authors.forename: Chunyi
authors.initials: C
authors.lastname: Hao
authors.affiliation: Department of Radiology, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Guoliang
authors.initials: G
authors.lastname: Shao
authors.affiliation: Department of Liver Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Xia
authors.affiliation: Department of Hepatobiliary Surgery, Second Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
authors.forename: Yajin
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Nuclear Medicine, Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Jijin
authors.initials: J
authors.lastname: Yang
authors.affiliation: Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Xiaxing
authors.initials: X
authors.lastname: Deng
authors.affiliation: Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China.
authors.forename: Yunpeng
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Hepatobiliary, Cancer Center, Sun Yat-sen University, Guangzhou, China.
authors.forename: Yunfei
authors.initials: Y
authors.lastname: Yuan
authors.affiliation: Department of Liver Transplantation, Shanghai Changzheng Hospital, Shanghai, China.
authors.forename: Zhiren
authors.initials: Z
authors.lastname: Fu
authors.affiliation: Global Medical Affairs, Bayer Healthcare Pharmaceuticals, Montville, NJ, USA.
authors.forename: Keiko
authors.initials: K
authors.lastname: Nakajima
authors.affiliation: Medical Affairs Oncology, Bayer Healthcare Company Ltd., Beijing, China.
authors.forename: Christina S M
authors.initials: CS
authors.lastname: Yip
authors.affiliation: Medical Affairs Oncology, Bayer Healthcare Company Ltd., Beijing, China.
authors.forename: Zhengguang
authors.initials: Z
authors.lastname: Lu
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D044466:Asian People; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010671:Phenylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects*; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib
keywords: Child-Pugh; Chinese subset; GIDEON; sorafenib; unresectable hepatocellular carcinoma