PMID- 27783997
OWN - NLM
STAT- MEDLINE
DCOM- 20170801
LR  - 20220408
IS  - 1949-2553 (Electronic)
IS  - 1949-2553 (Linking)
VI  - 8
IP  - 10
DP  - 2017 Mar 7
TI  - Effectiveness and safety of sorafenib in the treatment of unresectable and 
      advanced intrahepatic cholangiocarcinoma: a pilot study.
PG  - 17246-17257
LID - 10.18632/oncotarget.12825 [doi]
AB  - Patients with unresectable and advanced intrahepatic cholangiocarcinoma (ICC) 
      usually have short survival due to a lack of effective treatment. This 
      multicenter, single arm, open labeled, prospective study was conducted to 
      evaluate the effectiveness and safety of sorafenib combined with best supportive 
      care (BSC) in these patients. We enrolled 44 patients with unresectable and 
      advanced ICC who were treated with sorafenib (400 mg, twice daily) and BSC. The 
      primary endpoint was disease control rate (DCR) at week 12, and the secondary 
      endpoints included time to progression (TTP), progression-free survival (PFS), 
      overall survival (OS), duration of therapy (DOT), and adverse events (AEs). Our 
      results showed that the DCR was 15.9%, the median TTP was 5.6 months, and the 
      median PFS and OS were 3.2 and 5.7 months (95% confidence interval [CI]: 2.4-4.1 
      months; 3.7-8.5 months), respectively. The median DOT was 1.8 months (95% CI: 
      1.9-3.9 months). AEs of grades 1 and 2 events occurred in 75% of patients, and AE 
      of grade 4 (severe) was observed in 1 patient. Therefore, sorafenib in 
      combination with BSC had an acceptable DCR and safety profile in patients with 
      unresectable and advanced ICC.
FAU - Luo, Xiangji
AU  - Luo X
AD  - Department of Biliary Surgery, The Eastern Hepatobiliary Surgery Hospital, Second 
      Military Medical University, Shanghai, China.
FAU - Jia, Weidong
AU  - Jia W
AD  - Department of Hepatobiliary Surgery, The Anhui Provincial Hospital, Hefei, China.
FAU - Huang, Zhiyong
AU  - Huang Z
AD  - Department of Hepatobiliary Surgery, The Tongji Hospital, Huazhong University of 
      Science and Technology, Wuhan, China.
FAU - Li, Xiangcheng
AU  - Li X
AD  - Department of Hepatobiliary Surgery, The Jiangsu Provincial People's Hospital, 
      Nanjing, China.
FAU - Xing, Baocai
AU  - Xing B
AD  - Department of Hepatobiliary Surgery, The Beijing Cancer Hospital, Beijing, China.
FAU - Jiang, Xiaoqing
AU  - Jiang X
AD  - Department of Biliary Surgery, The Eastern Hepatobiliary Surgery Hospital, Second 
      Military Medical University, Shanghai, China.
FAU - Li, Jun
AU  - Li J
AD  - Department of Hepatic Surgery, The Eastern Hepatobiliary Surgery Hospital, Second 
      Military Medical University, Shanghai, China.
FAU - Si, Anfeng
AU  - Si A
AD  - Department of Hepatic Surgery, The Eastern Hepatobiliary Surgery Hospital, Second 
      Military Medical University, Shanghai, China.
FAU - Yang, Tian
AU  - Yang T
AD  - Department of Hepatic Surgery, The Eastern Hepatobiliary Surgery Hospital, Second 
      Military Medical University, Shanghai, China.
FAU - Gao, Chunfang
AU  - Gao C
AD  - Department of Laboratory Diagnosis, The Eastern Hepatobiliary Surgery Hospital, 
      Second Military Medical University, Shanghai, China.
FAU - Lau, Wan Yee
AU  - Lau WY
AD  - Department of Hepatic Surgery, The Eastern Hepatobiliary Surgery Hospital, Second 
      Military Medical University, Shanghai, China.
AD  - Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong, SAR, 
      China.
FAU - Shen, Feng
AU  - Shen F
AD  - Department of Hepatic Surgery, The Eastern Hepatobiliary Surgery Hospital, Second 
      Military Medical University, Shanghai, China.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - United States
TA  - Oncotarget
JT  - Oncotarget
JID - 101532965
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
MH  - Aged
MH  - Bile Duct Neoplasms/*drug therapy
MH  - Bile Ducts, Intrahepatic/*drug effects/pathology
MH  - Cholangiocarcinoma/*drug therapy
MH  - Diarrhea/chemically induced
MH  - Drug Administration Schedule
MH  - Exanthema/chemically induced
MH  - Fatigue/chemically induced
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Niacinamide/adverse effects/*analogs & derivatives/therapeutic use
MH  - Palliative Care
MH  - Phenylurea Compounds/adverse effects/*therapeutic use
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Protein Kinase Inhibitors/adverse effects/therapeutic use
MH  - Sorafenib
MH  - Treatment Outcome
PMC - PMC5370037
OTO - NOTNLM
OT  - adverse events
OT  - disease control rate
OT  - intrahepatic cholangiocarcinoma
OT  - sorafenib
COIS- CONFLICTS OF INTEREST The authors declare no conflicts of interest.
EDAT- 2016/10/27 06:00
MHDA- 2017/08/02 06:00
PMCR- 2017/03/07
CRDT- 2016/10/27 06:00
PHST- 2016/04/12 00:00 [received]
PHST- 2016/10/14 00:00 [accepted]
PHST- 2016/10/27 06:00 [pubmed]
PHST- 2017/08/02 06:00 [medline]
PHST- 2016/10/27 06:00 [entrez]
PHST- 2017/03/07 00:00 [pmc-release]
AID - 12825 [pii]
AID - 10.18632/oncotarget.12825 [doi]
PST - ppublish
SO  - Oncotarget. 2017 Mar 7;8(10):17246-17257. doi: 10.18632/oncotarget.12825.