PMID- 28765715
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 1178-7023 (Print)
IS  - 1178-7023 (Electronic)
IS  - 1178-7023 (Linking)
VI  - 10
DP  - 2017
TI  - Children's International Polyposis (CHIP) study: a randomized, double-blind, 
      placebo-controlled study of celecoxib in children with familial adenomatous 
      polyposis.
PG  - 177-185
LID - 10.2147/CEG.S121841 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of celecoxib versus placebo in the 
      prevention and treatment of colorectal polyposis in children with familial 
      adenomatous polyposis (FAP). METHODS: In this Phase III, double-blind, 
      randomized, placebo-controlled, multicenter trial patients aged 10-17 years with 
      FAP were randomized to celecoxib (16 mg/kg/day) or placebo for up to 5 years. 
      Patients underwent annual assessments, including colonoscopies, to detect the 
      time from randomization to the earliest occurrence of >/=20 polyps (>2 mm in size) 
      or colorectal malignancy. The study was terminated early due to low rate of 
      observed endpoints combined with a lower than expected enrollment rate. 
      Descriptive results are provided. RESULTS: Of 106 randomized patients, 55 were 
      treated with celecoxib (mean age 12.6 years; 52.7% female) and 51 were given 
      placebo (mean age 12.2 years; 54.9% female). Disease progression (>/=20 polyps, >2 
      mm in size) was observed in seven (12.7%) and 13 (25.5%) patients, respectively. 
      The median time to disease progression was 2.1 years in the celecoxib group and 
      1.1 years for placebo. No patient developed colorectal cancer. The rate of 
      adverse events (AEs) was similar in both groups (75.5% and 72.9%, respectively). 
      Three patients in the celecoxib group (none in the placebo group) experienced 
      serious AEs. CONCLUSION: In children with FAP, celecoxib was a well-tolerated 
      treatment that was associated with a lower rate of colorectal polyposis and a 
      longer time to disease progression compared with placebo. Due to the low rate of 
      observed endpoints, the long-term impact of these results could not be 
      ascertained.
FAU - Burke, Carol A
AU  - Burke CA
AD  - Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH, 
      USA.
FAU - Phillips, Robin
AU  - Phillips R
AD  - Department of Surgery, St Mark's Hospital and Academic Institute, Middlesex, UK.
FAU - Berger, Manuela F
AU  - Berger MF
AD  - Global Clinical Affairs.
FAU - Li, Chunming
AU  - Li C
AD  - Global Clinical Affairs.
FAU - Essex, Margaret Noyes
AU  - Essex MN
AD  - Global Medical Affairs, Pfizer Inc., New York, NY.
FAU - Iorga, Dinu
AU  - Iorga D
AD  - Global Clinical Affairs.
FAU - Lynch, Patrick M
AU  - Lynch PM
AD  - Department of Gastroenterology, Hepatology and Nutrition, The University of Texas 
      MD Anderson Cancer Center, Houston, TX, USA.
LA  - eng
PT  - Journal Article
DEP - 20170719
PL  - New Zealand
TA  - Clin Exp Gastroenterol
JT  - Clinical and experimental gastroenterology
JID - 101532800
PMC - PMC5525455
OTO - NOTNLM
OT  - adenoma
OT  - chemoprevention
OT  - clinical trial
OT  - colorectal
COIS- Disclosure PML has received research support and has served on steering 
      committees for Pfizer. He has also served on external advisory panels and 
      speakers bureau for Myriad Genetics. RP has received research support and has 
      served on steering committees for Pfizer. CAB has served on steering committees 
      for Pfizer and has received research support from Pfizer, Salix, and Cancer 
      Prevention Pharmaceuticals. MB, CL, MNE, and DI are employees of, and hold stock 
      and/or stock options in, Pfizer. ClinicalTrials.gov identifier: NCT00585312. The 
      authors report no other conflicts of interest in this work.
EDAT- 2017/08/03 06:00
MHDA- 2017/08/03 06:01
PMCR- 2017/07/19
CRDT- 2017/08/03 06:00
PHST- 2017/08/03 06:00 [entrez]
PHST- 2017/08/03 06:00 [pubmed]
PHST- 2017/08/03 06:01 [medline]
PHST- 2017/07/19 00:00 [pmc-release]
AID - ceg-10-177 [pii]
AID - 10.2147/CEG.S121841 [doi]
PST - epublish
SO  - Clin Exp Gastroenterol. 2017 Jul 19;10:177-185. doi: 10.2147/CEG.S121841. 
      eCollection 2017.