PMID- 17405999
OWN - NLM
STAT- MEDLINE
DCOM- 20070427
LR  - 20220309
IS  - 1460-2105 (Electronic)
IS  - 0027-8874 (Print)
IS  - 0027-8874 (Linking)
VI  - 99
IP  - 7
DP  - 2007 Apr 4
TI  - Secondary chemoprevention of Barrett's esophagus with celecoxib: results of a 
      randomized trial.
PG  - 545-57
AB  - BACKGROUND: Barrett's esophagus is a premalignant condition that is a risk factor 
      for the development of esophageal adenocarcinoma, a disease whose incidence is 
      rapidly increasing. Because aspirin and other nonsteroidal anti-inflammatory 
      drugs, such as celecoxib, may decrease the risk of developing esophageal cancer, 
      we investigated the effect of long-term administration of celecoxib in patients 
      with Barrett's esophagus with dysplasia. METHODS: Chemoprevention for Barrett's 
      Esophagus Trial (CBET) is a phase IIb multicenter randomized placebo-controlled 
      trial of celecoxib in patients with Barrett's esophagus and low- or high-grade 
      dysplasia. Patients were randomly assigned to treatment with 200 mg of celecoxib 
      or placebo, both administered orally twice daily, and then stratified by grade of 
      dysplasia. The primary outcome was the change from baseline to 48 weeks of 
      treatment in the proportion of biopsy samples with dysplasia between the 
      celecoxib and placebo arms. Secondary and tertiary outcomes included evaluation 
      of changes in histology and expression levels of relevant biomarkers. All 
      statistical tests were two-sided. RESULTS: From April 1, 2000, through June 30, 
      2003, 222 patients were registered into CBET, and 100 of them with low- or 
      high-grade Barrett's dysplasia were randomly assigned to treatment (49 to 
      celecoxib and 51 to placebo). After 48 weeks of treatment, no difference was 
      observed in the median change in the proportion of biopsy samples with dysplasia 
      or cancer between treatment groups in either the low-grade (median change with 
      celecoxib = -0.09, interquartile range [IQR] = -0.32 to 0.14 and with placebo = 
      -0.07, IQR = -0.26 to 0.12; P = .64) or high-grade (median change with celecoxib 
      = 0.12, IQR = -0.31 to 0.55, and with placebo = 0.02, IQR = -0.24 to 0.28; P = 
      .88) stratum. No statistically significant differences in total surface area of 
      the Barrett's esophagus; in prostaglandin levels; in cyclooxygenase-1/2 mRNA 
      levels; or in methylation of tumor suppressor genes p16, adenomatous polyposis 
      coli, and E-cadherin were found with celecoxib compared with placebo. 
      CONCLUSIONS: Administration of 200 mg of celecoxib twice daily for 48 weeks of 
      treatment does not appear to prevent progression of Barrett's dysplasia to 
      cancer.
FAU - Heath, Elisabeth I
AU  - Heath EI
AD  - Barbara Ann Karmanos Cancer Institute, Wayne State University School of Medicine, 
      Detroit, MI, USA. heathe@karmanos.org
FAU - Canto, Marcia Irene
AU  - Canto MI
FAU - Piantadosi, Steven
AU  - Piantadosi S
FAU - Montgomery, Elizabeth
AU  - Montgomery E
FAU - Weinstein, Wilfred M
AU  - Weinstein WM
FAU - Herman, James G
AU  - Herman JG
FAU - Dannenberg, Andrew J
AU  - Dannenberg AJ
FAU - Yang, Vincent W
AU  - Yang VW
FAU - Shar, Albert O
AU  - Shar AO
FAU - Hawk, Ernest
AU  - Hawk E
FAU - Forastiere, Arlene A
AU  - Forastiere AA
CN  - Chemoprevention for Barrett's Esophagus Trial Research Group
LA  - eng
GR  - R01 CA084197/CA/NCI NIH HHS/United States
GR  - R01 DK052230/DK/NIDDK NIH HHS/United States
GR  - N01-CN-85185/CN/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Natl Cancer Inst
JT  - Journal of the National Cancer Institute
JID - 7503089
RN  - 0 (Cadherins)
RN  - 0 (Cyclooxygenase Inhibitors)
RN  - 0 (Placebos)
RN  - 0 (Pyrazoles)
RN  - 0 (RNA, Messenger)
RN  - 0 (Sulfonamides)
RN  - EC 1.14.99.1 (Cyclooxygenase 1)
RN  - EC 1.14.99.1 (Cyclooxygenase 2)
RN  - JCX84Q7J1L (Celecoxib)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Barrett Esophagus/genetics/pathology/*prevention & control
MH  - Cadherins/genetics
MH  - Celecoxib
MH  - Cyclooxygenase 1/genetics
MH  - Cyclooxygenase 2/genetics
MH  - Cyclooxygenase Inhibitors/*therapeutic use/toxicity
MH  - DNA Methylation
MH  - Esophageal Neoplasms/*prevention & control
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Placebos
MH  - Precancerous Conditions/*prevention & control
MH  - Pyrazoles/*therapeutic use/toxicity
MH  - RNA, Messenger/genetics
MH  - Sulfonamides/*therapeutic use/toxicity
PMC - PMC3755596
MID - NIHMS502090
EDAT- 2007/04/05 09:00
MHDA- 2007/04/28 09:00
PMCR- 2013/08/28
CRDT- 2007/04/05 09:00
PHST- 2007/04/05 09:00 [pubmed]
PHST- 2007/04/28 09:00 [medline]
PHST- 2007/04/05 09:00 [entrez]
PHST- 2013/08/28 00:00 [pmc-release]
AID - 99/7/545 [pii]
AID - 10.1093/jnci/djk112 [doi]
PST - ppublish
SO  - J Natl Cancer Inst. 2007 Apr 4;99(7):545-57. doi: 10.1093/jnci/djk112.