Research Papers:
Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outcome from the Chinese patient subset of the GIDEON study
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Abstract
Sheng-Long Ye1, Xiaoping Chen2, Jiamei Yang3, Ping Bie4, Shuijun Zhang5, Fengyong Liu6, Luming Liu7, Jie Zhou8, Kefeng Dou9, Chunyi Hao10, Guoliang Shao11, Qiang Xia12, Yajin Chen13, Jijin Yang14, Xiaxing Deng15, Yunpeng Liu16, Yunfei Yuan17, Zhiren Fu18, Keiko Nakajima19, Christina S.M. Yip20, Zhengguang Lu20
1Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China
2Department of Surgery, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
3Department of Special Treatment, Eastern Hepatobiliary Surgery Hospital, Shanghai, China
4Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing, China
5Department of General Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
6Department of Interventional Radiology, Chinese PLA General Hospital, Beijing, China
7Shanghai Cancer Center, Fudan University, Shanghai, China
8Department of Hepatobiliary Surgery, Nanfang Hospital of Southern Medical University, Guangzhou, China
9Department of Hepatobiliary Surgery, Xijing Hospital, Xi’an, China
10Department of Hepato-Pancreato-Biliary Surgery, Beijing Cancer Hospital, Peking University, Beijing, China
11Department of Radiology, Zhejiang Cancer Hospital, Hangzhou, China
12Department of Liver Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
13Department of Hepatobiliary Surgery, Second Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China
14Department of Nuclear Medicine, Changhai Hospital, Second Military Medical University, Shanghai, China
15Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
16Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China
17Department of Hepatobiliary, Cancer Center, Sun Yat-sen University, Guangzhou, China
18Department of Liver Transplantation, Shanghai Changzheng Hospital, Shanghai, China
19Global Medical Affairs, Bayer Healthcare Pharmaceuticals, Montville, NJ, USA
20Medical Affairs Oncology, Bayer Healthcare Company Ltd., Beijing, China
Correspondence to:
Sheng-Long Ye, e-mail: [email protected]
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.
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