title: Celecoxib for the Prevention of Colorectal Adenomas: Results of a Suspended Randomized Controlled Trial.
abstract: Cyclooxygenase (COX)-2 inhibitors such as celecoxib were designed to preserve anti-inflammatory activity without inhibiting COX-1. Downregulation of COX-2 inhibits colorectal carcinogenesis.
  
  
  
  The Selenium and Celecoxib Trial was a randomized, placebo-controlled trial of once-daily selenium 200 µg and celecoxib 400 mg, alone or together, for colorectal adenoma prevention. Men and women between age 40 and 80 years were eligible following colonoscopic removal of adenomas. The primary outcome was development of new adenomas. Celecoxib was suspended early because of cardiovascular toxicity in other trials. Accrual to selenium or placebo continued. Before suspension, 824 participants were randomly assigned to celecoxib or placebo, of whom 712 (86.4%) were available for analysis. All statistical tests were two-sided.
  
  
  
  In the placebo and celecoxib arms of 356 participants each, adenoma detection was 47.5% and 49.7% (relative risk [RR] = 1.04, 95% confidence interval [CI] = 0.90 to 1.21, P = .58), respectively, after median periods of 13.6 and 14.2 months on intervention. Among participants colonoscoped within 12 months of discontinuing intervention (n = 244), overall adenoma recurrence (RR = 0.69, 95% CI = 0.48 to 0.98, P = .04) and recurrence with advanced adenomas (RR = 0.23, 95% CI = 0.07 to 0.80, P = .02) were reduced with celecoxib. Reduction of adenoma recurrence was greatest in participants with previous advanced adenomas. Celecoxib increased risk of hypertension in participants with pre-existing cardiovascular risk factors compared with placebo (hazard ratio = 2.19, 95% CI = 1.07 to 4.50, P = .03).
  
  
  
  Limited-duration celecoxib prevents adenoma recurrence in patients with prior high-risk adenomas, in whom strategies to minimize cardiovascular toxicity might be feasible.
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Thompson
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Erin L
authors.initials: EL
authors.lastname: Ashbeck
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Denise J
authors.initials: DJ
authors.lastname: Roe
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Liane
authors.initials: L
authors.lastname: Fales
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Julie
authors.initials: J
authors.lastname: Buckmeier
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Fang
authors.initials: F
authors.lastname: Wang
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Achyut
authors.initials: A
authors.lastname: Bhattacharyya
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Chiu-Hsieh
authors.initials: CH
authors.lastname: Hsu
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Sherry H H
authors.initials: SH
authors.lastname: Chow
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Dennis J
authors.initials: DJ
authors.lastname: Ahnen
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: C Richard
authors.initials: CR
authors.lastname: Boland
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Russell I
authors.initials: RI
authors.lastname: Heigh
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: David E
authors.initials: DE
authors.lastname: Fay
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Stanley R
authors.initials: SR
authors.lastname: Hamilton
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Elizabeth T
authors.initials: ET
authors.lastname: Jacobs
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: Elena Maria
authors.initials: EM
authors.lastname: Martinez
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT).
authors.forename: David S
authors.initials: DS
authors.lastname: Alberts
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ (PAT, ELA, DJR, LF, JB, FW, CHH, HHSC, ETJ, DSA, PL); Department of Pathology, University of Arizona, Tucson, AZ (AB); Denver Department of Veterans Affairs Medical Center and University of Colorado, Denver, CO (DJA); GI Cancer Research Laboratory, Baylor University Medical Center, Dallas, TX (CRB); Division of Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ (RIH); Endoscopy Center of Western New York, Buffalo, NY (DEF); Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX (SRH); Moores UCSD Cancer Center, San Diego, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT). plance@uacc.arizona.edu.
authors.forename: Peter
authors.initials: P
authors.lastname: Lance
mesh_terms: D000236:Adenoma / Q000000981:diagnostic imaging / Q000517:prevention & control* / Q000601:surgery; D000368:Aged; D002318:Cardiovascular Diseases / Q000139:chemically induced; D000068579:Celecoxib / Q000009:adverse effects / Q000627:therapeutic use*; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000000981:diagnostic imaging / Q000517:prevention & control* / Q000601:surgery; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D057239:Early Termination of Clinical Trials; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016609:Neoplasms, Second Primary / Q000000981:diagnostic imaging / Q000517:prevention & control*
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D000068579:Celecoxib