PMID- 32509392
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2156-6976 (Print)
IS  - 2156-6976 (Electronic)
IS  - 2156-6976 (Linking)
VI  - 10
IP  - 5
DP  - 2020
TI  - Preventive effect of celecoxib in sorafenib-related hand-foot syndrome in 
      hepatocellular carcinoma patients, a single-center, open-label, randomized, 
      controlled clinical phase III trial.
PG  - 1467-1476
AB  - Skin toxicity, especially hand-foot syndrome (HFS), is one of the most common 
      sorafenib-induced adverse events (AEs) in hepatocellular carcinoma (HCC) 
      patients, leading to treatment interruption and failure. Mucocutaneous 
      inflammation may cause HFS; therefore, we investigated whether celecoxib can 
      alleviate HFS, improve patients' quality of life and increase survival when 
      administered in conjunction with active therapy. Our randomized, open-label study 
      prospectively enrolled 116 advanced HCC patients receiving sorafenib as targeted 
      therapy from July 2015 to July 2016. All patients were randomly assigned (1:1) 
      via a computer-generated sequence to receive sorafenib with or without celecoxib. 
      Sorafenib-related AEs were recorded, Survival was compared between the two 
      groups. Compared to the Sorafenib group, the SoraCele group had lower incidence 
      rates of >/= grade 2 and grade 3 HFS (63.8% vs 29.3%, P < 0.001; 19.0% vs 3.4%, P = 
      0.008, respectively), hair loss, rash and abdominal pain. Kaplan-Meier analysis 
      revealed a lower risk of >/= grade 2 HFS (HR, 0.384; P = 0.002) and a lower dose 
      reduction/interruption rate (46.6% to 15.5%, P < 0.001) in the SoraCele group. 
      Cox proportional hazards regression analysis demonstrated that celecoxib was the 
      only independent predictive factor of developing >/= grade 2 HFS (HR, 0.414; P = 
      0.004). Longer progression-free survival (PFS) was also observed in the SoraCele 
      group (P = 0.039), although overall survival was not prolonged (P = 0.305). These 
      results suggest that sorafenib + Celecoxib administration alleviated 
      sorafenib-related skin toxicity. Longer PFS was achieved in clinical practice, 
      although overall survival was not prolonged (ClinicalTrials.gov: NCT02961998).
CI  - AJCR Copyright (c) 2020.
FAU - Chen, Jian-Cong
AU  - Chen JC
AD  - Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. 
      R. China.
AD  - Department of Pancreato-Biliary Surgery, The First Affiliated Hospital, Sun 
      Yat-sen University Guangzhou, P. R. China.
FAU - Wang, Jun-Cheng
AU  - Wang JC
AD  - Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. 
      R. China.
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. 
      China.
FAU - Pan, Yang-Xun
AU  - Pan YX
AD  - Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. 
      R. China.
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. 
      China.
FAU - Yi, Min-Jiang
AU  - Yi MJ
AD  - Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. 
      R. China.
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. 
      China.
FAU - Chen, Jin-Bin
AU  - Chen JB
AD  - Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. 
      R. China.
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. 
      China.
FAU - Wang, Xiao-Hui
AU  - Wang XH
AD  - Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. 
      R. China.
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. 
      China.
FAU - Fu, Yi-Zhen
AU  - Fu YZ
AD  - Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. 
      R. China.
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. 
      China.
FAU - Zhang, Yao-Jun
AU  - Zhang YJ
AD  - Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. 
      R. China.
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. 
      China.
FAU - Xu, Li
AU  - Xu L
AD  - Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. 
      R. China.
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. 
      China.
FAU - Chen, Min-Shan
AU  - Chen MS
AD  - Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. 
      R. China.
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. 
      China.
FAU - Zhang, Rong-Xin
AU  - Zhang RX
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. 
      China.
AD  - Department of Colorectal Cancer, Sun Yat-sen University Cancer Center Guangzhou, 
      P. R. China.
FAU - Zhou, Zhong-Guo
AU  - Zhou ZG
AD  - Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. 
      R. China.
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. 
      China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02961998
PT  - Journal Article
DEP - 20200501
PL  - United States
TA  - Am J Cancer Res
JT  - American journal of cancer research
JID - 101549944
PMC - PMC7269790
OTO - NOTNLM
OT  - Hand-foot syndrome
OT  - celecoxib
OT  - hepatocellular carcinoma
OT  - sorafenib
COIS- None.
EDAT- 2020/06/09 06:00
MHDA- 2020/06/09 06:01
PMCR- 2020/05/01
CRDT- 2020/06/09 06:00
PHST- 2020/03/13 00:00 [received]
PHST- 2020/04/04 00:00 [accepted]
PHST- 2020/06/09 06:00 [entrez]
PHST- 2020/06/09 06:00 [pubmed]
PHST- 2020/06/09 06:01 [medline]
PHST- 2020/05/01 00:00 [pmc-release]
PST - epublish
SO  - Am J Cancer Res. 2020 May 1;10(5):1467-1476. eCollection 2020.