PMID- 29499662
OWN - NLM
STAT- MEDLINE
DCOM- 20180830
LR  - 20181202
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 18
IP  - 1
DP  - 2018 Mar 2
TI  - Safety assessment of sorafenib in Chinese patients with unresectable 
      hepatocellular carcinoma: subgroup analysis of the GIDEON study.
PG  - 247
LID - 10.1186/s12885-018-4144-9 [doi]
LID - 247
AB  - BACKGROUND: This study aimed to investigate the safety of sorafenib for the 
      treatment of unresectable hepatocellular carcinoma in Chinese patients. METHODS: 
      A subgroup of 345 Chinese patients from the international database of the Global 
      Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its 
      treatment with sorafeNib (GIDEON) study was included in this analysis. Safety 
      assessment measures were adverse events (AEs) and serious adverse events (SAEs) 
      graded using the National Cancer Institute Common Terminology Criteria version 
      3.0. RESULTS: Of 331 evaluable patients, 98% started sorafenib at 800 mg/day. The 
      median treatment duration was 22 weeks (range, 0.1-116 weeks), and median overall 
      survival (OS) was 322 days (10.7 months). Approximately 50% of patients had at 
      least one adverse event, and 6% had grade 3-4 adverse events. Drug-related 
      adverse events were experienced by 29% of patients, and 3.6% had grade 3-4 
      drug-related adverse events. Overall, 23% of patients (n = 77) experienced 
      serious adverse events, among which only 1 event was drug-related (0.3%). No 
      differences in overall adverse events, serious adverse events, and deaths were 
      observed between Child-Pugh A and Child-Pugh B patients. The most frequent 
      drug-related adverse events were dermatological/skin (24%), hand-foot skin 
      reaction (20%), gastrointestinal (11%), and diarrhea (11%). The majority of 
      adverse events occurred within 30 days of beginning sorafenib. CONCLUSION: 
      Sorafenib has satisfactory efficacy and safety in Chinese Child-Pugh A and B 
      patients with unresectable HCC using the recommended dosage of 800 mg/day, and 
      the safety of sorafenib is not affected by liver function. Prophylaxis for 
      gastrointestinal adverse events may help to decrease dose interruptions or 
      discontinuation. TRIAL REGISTRATION: ClinicalTrials.gov ; Identifier: 
      NCT00812175. Date of registration: December 19, 2008.
FAU - Ye, Sheng-Long
AU  - Ye SL
AD  - Liver Cancer Institute, Zhongshan Hospital, Fudan University, 136 Yixueyuan Rd, 
      Shanghai, 200032, China. slye@shmu.edu.cn.
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 - Chen, Xiaoping
AU  - Chen X
AD  - Department of Surgery, Tongji Medical College, Huazhong University of Science and 
      Technology, Wuhan, 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  - Bayer Healthcare Pharmaceuticals, Whippany, NJ, USA.
FAU - Lv, Zhengguang
AU  - Lv Z
AD  - Bayer Healthcare Company Ltd., Beijing, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT00812175
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180302
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Phenylurea Compounds)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
MH  - Aged
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Carcinoma, Hepatocellular/*drug therapy/pathology
MH  - Drug-Related Side Effects and Adverse Reactions/*etiology
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Liver Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Niacinamide/adverse effects/*analogs & derivatives/therapeutic use
MH  - Phenylurea Compounds/adverse effects/*therapeutic use
MH  - Retrospective Studies
MH  - Safety
MH  - Sorafenib
MH  - Treatment Outcome
PMC - PMC5834849
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This study was approved by the ethics 
      committee of Zhongshan Hospital Fudan University (certification number: 2009-15). 
      Written informed consent was obtained from all the patients involved. The GIDEON 
      study was an international prospective, open-label, multi-centered, 
      non-interventional study of patients with unresectable HCC who had indications 
      for systemic therapy and received sorafenib. All patients met the inclusion and 
      exclusion criteria, were treated with sorafenib at least once. The duration of 
      observation was from the initiation of sorafenib therapy to withdrawal from the 
      study, last follow-up, or death. The GIDEON study protocol [NCT00812175] is 
      available at: https://www.clinicaltrials.gov/ct2/show/NCT00812175). CONSENT FOR 
      PUBLICATION: Not applicable. COMPETING INTERESTS: This trial was financially 
      supported by Bayer HealthCare Pharmaceutical Company, Ltd., China. PUBLISHER'S 
      NOTE: Springer Nature remains neutral with regard to jurisdictional claims in 
      published maps and institutional affiliations.
EDAT- 2018/03/04 06:00
MHDA- 2018/08/31 06:00
PMCR- 2018/03/02
CRDT- 2018/03/04 06:00
PHST- 2016/11/09 00:00 [received]
PHST- 2018/02/19 00:00 [accepted]
PHST- 2018/03/04 06:00 [entrez]
PHST- 2018/03/04 06:00 [pubmed]
PHST- 2018/08/31 06:00 [medline]
PHST- 2018/03/02 00:00 [pmc-release]
AID - 10.1186/s12885-018-4144-9 [pii]
AID - 4144 [pii]
AID - 10.1186/s12885-018-4144-9 [doi]
PST - epublish
SO  - BMC Cancer. 2018 Mar 2;18(1):247. doi: 10.1186/s12885-018-4144-9.