PMID- 26735891 OWN - NLM STAT- MEDLINE DCOM- 20170123 LR - 20221207 IS - 1949-2553 (Electronic) IS - 1949-2553 (Linking) VI - 7 IP - 6 DP - 2016 Feb 9 TI - Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outcome from the Chinese patient subset of the GIDEON study. PG - 6639-48 LID - 10.18632/oncotarget.6781 [doi] AB - 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. FAU - Ye, Sheng-Long AU - Ye SL AD - Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Chen, Xiaoping AU - Chen X AD - Department of Surgery, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - Yang, Jiamei AU - Yang J AD - Department of Special Treatment, Eastern Hepatobiliary Surgery Hospital, Shanghai, China. FAU - Bie, Ping AU - Bie P AD - Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing, China. FAU - Zhang, Shuijun AU - Zhang S AD - Department of General Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Liu, Fengyong AU - Liu F AD - Department of Interventional Radiology, Chinese PLA General Hospital, Beijing, China. FAU - Liu, Luming AU - Liu L AD - Shanghai Cancer Center, Fudan University, Shanghai, China. FAU - Zhou, Jie AU - Zhou J AD - Department of Hepatobiliary Surgery, Nanfang Hospital of Southern Medical University, Guangzhou, China. FAU - Dou, Kefeng AU - Dou K AD - Department of Hepatobiliary Surgery, Xijing Hospital, Xi'an, China. FAU - Hao, Chunyi AU - Hao C AD - Department of Hepato-Pancreato-Biliary Surgery, Beijing Cancer Hospital, Peking University, Beijing, China. FAU - Shao, Guoliang AU - Shao G AD - Department of Radiology, Zhejiang Cancer Hospital, Hangzhou, China. FAU - Xia, Qiang AU - Xia Q AD - Department of Liver Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. FAU - Chen, Yajin AU - Chen Y AD - Department of Hepatobiliary Surgery, Second Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China. FAU - Yang, Jijin AU - Yang J AD - Department of Nuclear Medicine, Changhai Hospital, Second Military Medical University, Shanghai, China. FAU - Deng, Xiaxing AU - Deng X AD - Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. FAU - Liu, Yunpeng AU - Liu Y AD - Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China. FAU - Yuan, Yunfei AU - Yuan Y AD - Department of Hepatobiliary, Cancer Center, Sun Yat-sen University, Guangzhou, China. FAU - Fu, Zhiren AU - Fu Z AD - Department of Liver Transplantation, Shanghai Changzheng Hospital, Shanghai, China. FAU - Nakajima, Keiko AU - Nakajima K AD - Global Medical Affairs, Bayer Healthcare Pharmaceuticals, Montville, NJ, USA. FAU - Yip, Christina S M AU - Yip CS AD - Medical Affairs Oncology, Bayer Healthcare Company Ltd., Beijing, China. FAU - Lu, Zhengguang AU - Lu Z AD - Medical Affairs Oncology, Bayer Healthcare Company Ltd., Beijing, China. LA - eng PT - Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - Oncotarget JT - Oncotarget JID - 101532965 RN - 0 (Antineoplastic Agents) RN - 0 (Phenylurea Compounds) RN - 25X51I8RD4 (Niacinamide) RN - 9ZOQ3TZI87 (Sorafenib) SB - IM MH - Antineoplastic Agents/administration & dosage/adverse effects MH - Asian People MH - Carcinoma, Hepatocellular/*drug therapy/pathology MH - Drug Administration Schedule MH - Female MH - Humans MH - Liver Neoplasms/*drug therapy/pathology MH - Male MH - Middle Aged MH - Niacinamide/administration & dosage/adverse effects/*analogs & derivatives MH - Phenylurea Compounds/*administration & dosage/*adverse effects MH - Sorafenib MH - Treatment Outcome PMC - PMC4872739 OTO - NOTNLM OT - Child-Pugh OT - Chinese subset OT - GIDEON OT - sorafenib OT - unresectable hepatocellular carcinoma COIS- CONFLICTS OF INTEREST The authors have provided signed confirmations to the publisher of their compliance with all applicable legal and ethical obligations in respect to declaration of conflicts of interest, funding, authorship, and contributorship, as well as compliance with ethical requirements with respect to treatment of human and animal test subjects. All the authors-Sheng-Long Ye, Xiaoping Chen, Jiamei Yang, Ping Bie, Shuijun Zhang, Fengyong Liu, Luming Liu, Jie Zhou, Kefeng Dou, Chunyi Hao, Guoliang Shao, Qiang Xia, Yajin Chen, Jijin Yang, Xiaxing Deng, Yunpeng Liu, Yunfei Yuan, Zhiren Fu, Keiko Nakajima, Christina Sm Yip, and Zhengguang LU-declared that they have no conflicts of interest to disclose. EDAT- 2016/01/07 06:00 MHDA- 2017/01/24 06:00 PMCR- 2016/02/09 CRDT- 2016/01/07 06:00 PHST- 2015/09/16 00:00 [received] PHST- 2015/12/07 00:00 [accepted] PHST- 2016/01/07 06:00 [entrez] PHST- 2016/01/07 06:00 [pubmed] PHST- 2017/01/24 06:00 [medline] PHST- 2016/02/09 00:00 [pmc-release] AID - 6781 [pii] AID - 10.18632/oncotarget.6781 [doi] PST - ppublish SO - Oncotarget. 2016 Feb 9;7(6):6639-48. doi: 10.18632/oncotarget.6781.