Publications (2)60.05 Total impact
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Article: Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT).
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ABSTRACT: The initial report of the Selenium and Vitamin E Cancer Prevention Trial (SELECT) found no reduction in risk of prostate cancer with either selenium or vitamin E supplements but a statistically nonsignificant increase in prostate cancer risk with vitamin E. Longer follow-up and more prostate cancer events provide further insight into the relationship of vitamin E and prostate cancer. To determine the long-term effect of vitamin E and selenium on risk of prostate cancer in relatively healthy men. A total of 35,533 men from 427 study sites in the United States, Canada, and Puerto Rico were randomized between August 22, 2001, and June 24, 2004. Eligibility criteria included a prostate-specific antigen (PSA) of 4.0 ng/mL or less, a digital rectal examination not suspicious for prostate cancer, and age 50 years or older for black men and 55 years or older for all others. The primary analysis included 34,887 men who were randomly assigned to 1 of 4 treatment groups: 8752 to receive selenium; 8737, vitamin E; 8702, both agents, and 8696, placebo. Analysis reflect the final data collected by the study sites on their participants through July 5, 2011. Oral selenium (200 μg/d from L-selenomethionine) with matched vitamin E placebo, vitamin E (400 IU/d of all rac-α-tocopheryl acetate) with matched selenium placebo, both agents, or both matched placebos for a planned follow-up of a minimum of 7 and maximum of 12 years. Prostate cancer incidence. This report includes 54,464 additional person-years of follow-up and 521 additional cases of prostate cancer since the primary report. Compared with the placebo (referent group) in which 529 men developed prostate cancer, 620 men in the vitamin E group developed prostate cancer (hazard ratio [HR], 1.17; 99% CI, 1.004-1.36, P = .008); as did 575 in the selenium group (HR, 1.09; 99% CI, 0.93-1.27; P = .18), and 555 in the selenium plus vitamin E group (HR, 1.05; 99% CI, 0.89-1.22, P = .46). Compared with placebo, the absolute increase in risk of prostate cancer per 1000 person-years was 1.6 for vitamin E, 0.8 for selenium, and 0.4 for the combination. Dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men. Clinicaltrials.gov Identifier: NCT00006392.JAMA The Journal of the American Medical Association 10/2011; 306(14):1549-56. · 30.03 Impact Factor -
Article: Vitamin E and the Risk of Prostate CancerThe Selenium and Vitamin E Cancer Prevention Trial (SELECT)
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ABSTRACT: Context The initial report of the Selenium and Vitamin E Cancer Prevention Trial (SELECT) found no reduction in risk of prostate cancer with either selenium or vitamin E supplements but a statistically nonsignificant increase in prostate cancer risk with vitamin E. Longer follow-up and more prostate cancer events provide further insight into the relationship of vitamin E and prostate cancer.Objective To determine the long-term effect of vitamin E and selenium on risk of prostate cancer in relatively healthy men.Design, Setting, and Participants A total of 35 533 men from 427 study sites in the United States, Canada, and Puerto Rico were randomized between August 22, 2001, and June 24, 2004. Eligibility criteria included a prostate-specific antigen (PSA) of 4.0 ng/mL or less, a digital rectal examination not suspicious for prostate cancer, and age 50 years or older for black men and 55 years or older for all others. The primary analysis included 34 887 men who were randomly assigned to 1 of 4 treatment groups: 8752 to receive selenium; 8737, vitamin E; 8702, both agents, and 8696, placebo. Analysis reflect the final data collected by the study sites on their participants through July 5, 2011.Interventions Oral selenium (200 μg/d from L-selenomethionine) with matched vitamin E placebo, vitamin E (400 IU/d of all rac-α-tocopheryl acetate) with matched selenium placebo, both agents, or both matched placebos for a planned follow-up of a minimum of 7 and maximum of 12 years.Main Outcome Measures Prostate cancer incidence.Results This report includes 54 464 additional person-years of follow-up and 521 additional cases of prostate cancer since the primary report. Compared with the placebo (referent group) in which 529 men developed prostate cancer, 620 men in the vitamin E group developed prostate cancer (hazard ratio [HR], 1.17; 99% CI, 1.004-1.36, P = .008); as did 575 in the selenium group (HR, 1.09; 99% CI, 0.93-1.27; P = .18), and 555 in the selenium plus vitamin E group (HR, 1.05; 99% CI, 0.89-1.22, P = .46). Compared with placebo, the absolute increase in risk of prostate cancer per 1000 person-years was 1.6 for vitamin E, 0.8 for selenium, and 0.4 for the combination.Conclusion Dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men.Trial Registration Clinicaltrials.gov Identifier: NCT00006392 Figures in this Article Lifetime risk of prostate cancer in the United States is currently estimated to be 16%.1 Although most cases are found at an early, curable stage, treatment is costly and urinary, sexual, and bowel-related adverse effects are common.2 Even men who choose active surveillance as an initial management strategy face anxiety, uncertain prognosis, and a measurable risk of sepsis with follow-up biopsies,3 and more than one-third of those who initially defer therapy are ultimately treated.4- 5 With such a high prevalence, risk of morbidity from treatment, and treatment-related costs, primary prevention of prostate cancer is an attractive option. With considerable preclinical and epidemiological evidence that selenium and vitamin E may reduce prostate cancer risk, we conducted and reported the results of a prospective randomized trial examining the effect of these 2 agents for prostate cancer prevention.6 Coordinated by SWOG, a federally funded cancer research cooperative group, the Selenium and Vitamin E Cancer Prevention Trial (SELECT) began accrual on August 22, 2001, and randomized 35 533 men into 4 groups: selenium with matching placebo, vitamin E with matching placebo, both agents, or placebo. Based on a preplanned interim analysis, the independent data and safety monitoring committee met on September 15, 2008, and recommended the early discontinuation of study supplements because of lack of efficacy for risk reduction and because futility analysis demonstrated no possibility of benefit to the planned degree with additional follow-up.6 As reported in the initial article,6 with a median follow-up of 5.5 years, the numbers of prostate cancers detected were 473 (hazard ratio [HR], 1.13; 99% CI, 0.95-1.35) for vitamin E; 432 (HR, 1.04; 99% CI, 0.87-1.24) for selenium; 437 (HR, 1.05; 99% CI, 0.88-1.25) for selenium plus vitamin E; and 416 (HR, 1.0) for placebo. Although these results were not statistically significant, the data and safety monitoring committee expressed concern about the increased risk of prostate cancer observed in the vitamin E plus placebo group, which approached statistical significance (P = .06) and a statistically nonsignificant increased risk of type 2 diabetes mellitus in the selenium plus placebo group (P = .16). Since that time, participant follow-up has continued, allowing observation of additional events. On May 20, 2011, the data and safety monitoring committee reviewed trial data and recommended reporting the finding regarding increased risk of prostate cancer with vitamin E. This recommendation was based on final data collection from the study sites and coincided with the preplanned final analysis at 7 years after the last participant was randomized.JAMA The Journal of the American Medical Association 306(14):1549-1556. · 30.03 Impact Factor
