Patricia A Thompson1, Erin L Ashbeck1, Denise J Roe1, Liane Fales1, Julie Buckmeier1, Fang Wang1, Achyut Bhattacharyya1, Chiu-Hsieh Hsu1, H H Sherry Chow1, Dennis J Ahnen1, C Richard Boland1, Russell I Heigh1, David E Fay1, Stanley R Hamilton1, Elizabeth T Jacobs1, Maria Elena Martinez1, David S Alberts1, Peter Lance2. 1. 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); University of California, San Diego, Moores Cancer Center, La Jolla, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT). 2. 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); University of California, San Diego, Moores Cancer Center, La Jolla, CA (MEM). Current affiliation: Stony Brook University, Stony Brook, New York, NY (PAT) plance@uacc.arizona.edu.
Abstract
BACKGROUND:Selenium supplementation may help to prevent colorectal cancer; as precursors of colorectal cancer, colorectal adenomas are a surrogate for colorectal cancer. Selenium supplementation may increase risk of type 2 diabetes (T2D). METHODS: The Selenium and Celecoxib (Sel/Cel) Trial was a randomized, placebo controlled trial of selenium 200 µg daily as selenized yeast and celecoxib 400 mg once daily, alone or together, for colorectal adenoma prevention. Men and women between age 40 and 80 years were eligible following colonoscopic removal of colorectal adenomas. The primary outcome was adenoma development. Celecoxib was suspended because of cardiovascular toxicity in other trials, but accrual continued to selenium and placebo. A total of 1621 participants were randomly assigned to selenium or placebo, of whom 1374 (84.8%) were available for analysis. All statistical tests were two-sided. RESULTS: In the respective placebo and selenium arms of 689 and 685 participants, adenoma detection after medians of 33.6 (range = 0.0-85.1 months) and 33.0 months (range = 0.0-82.6 months) were 42.8% and 44.1% (relative risk [RR] = 1.03, 95% confidence interval [CI] = 0.91 to 1.16, P = .68). In participants with baseline advanced adenomas, adenoma recurrence was reduced by 18% with selenium (RR = 0.82, 95% CI = 0.71 to 0.96, P = .01). In participants receiving selenium, the hazard ratio for new-onset T2D was 1.25 (95% CI = 0.74 to 2.11, P = .41), with a statistically significantly increased risk of selenium-associated T2D among older participants (RR = 2.21; 95% CI = 1.04 to 4.67, P = .03). CONCLUSIONS: Overall, selenium did not prevent colorectal adenomas and showed only modest benefit in patients with baseline advanced adenomas. With limited benefit and similar increases in T2D to other trials, selenium is not recommended for preventing colorectal adenomas in selenium-replete individuals.
RCT Entities:
BACKGROUND:Selenium supplementation may help to prevent colorectal cancer; as precursors of colorectal cancer, colorectal adenomas are a surrogate for colorectal cancer. Selenium supplementation may increase risk of type 2 diabetes (T2D). METHODS: The Selenium and Celecoxib (Sel/Cel) Trial was a randomized, placebo controlled trial of selenium 200 µg daily as selenized yeast and celecoxib 400 mg once daily, alone or together, for colorectal adenoma prevention. Men and women between age 40 and 80 years were eligible following colonoscopic removal of colorectal adenomas. The primary outcome was adenoma development. Celecoxib was suspended because of cardiovascular toxicity in other trials, but accrual continued to selenium and placebo. A total of 1621 participants were randomly assigned to selenium or placebo, of whom 1374 (84.8%) were available for analysis. All statistical tests were two-sided. RESULTS: In the respective placebo and selenium arms of 689 and 685 participants, adenoma detection after medians of 33.6 (range = 0.0-85.1 months) and 33.0 months (range = 0.0-82.6 months) were 42.8% and 44.1% (relative risk [RR] = 1.03, 95% confidence interval [CI] = 0.91 to 1.16, P = .68). In participants with baseline advanced adenomas, adenoma recurrence was reduced by 18% with selenium (RR = 0.82, 95% CI = 0.71 to 0.96, P = .01). In participants receiving selenium, the hazard ratio for new-onset T2D was 1.25 (95% CI = 0.74 to 2.11, P = .41), with a statistically significantly increased risk of selenium-associated T2D among older participants (RR = 2.21; 95% CI = 1.04 to 4.67, P = .03). CONCLUSIONS: Overall, selenium did not prevent colorectal adenomas and showed only modest benefit in patients with baseline advanced adenomas. With limited benefit and similar increases in T2D to other trials, selenium is not recommended for preventing colorectal adenomas in selenium-replete individuals.
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