Wednesday, January 14, 2009

Yet Another Failed Chemoprevention Trial

Vitamins E and C in the Prevention of Prostate and Total Cancer in Men : The Physicians' Health Study II Randomized Controlled Trial
J. Michael Gaziano, MD, MPH; Robert J. Glynn, ScD; William G. Christen, ScD; Tobias Kurth, MD, ScD; Charlene Belanger, MA; Jean MacFadyen, BA; Vadim Bubes, PhD; JoAnn E. Manson, MD, DrPH; Howard D. Sesso, ScD, MPH; Julie E. Buring, ScD
JAMA. 2009;301(1):52-62.

Context Many individuals take vitamins in the hopes of preventing chronic diseases such as cancer, and vitamins E and C are among the most common individual supplements. A large-scale randomized trial suggested that vitamin E may reduce risk of prostate cancer; however, few trials have been powered to address this relationship. No previous trial in men at usual risk has examined vitamin C alone in the prevention of cancer.
Objective To evaluate whether long-term vitamin E or C supplementation decreases risk of prostate and total cancer events among men.
Design, Setting, and Participants The Physicians' Health Study II is a randomized, double-blind, placebo-controlled factorial trial of vitamins E and C that began in 1997 and continued until its scheduled completion on August 31, 2007. A total of 14 641 male physicians in the United States initially aged 50 years or older, including 1307 men with a history of prior cancer at randomization, were enrolled.
Intervention Individual supplements of 400 IU of vitamin E every other day and 500 mg of vitamin C daily.
Main Outcome Measures Prostate and total cancer.
Results During a mean follow-up of 8.0 years, there were 1008 confirmed incident cases of prostate cancer and 1943 total cancers. Compared with placebo, vitamin E had no effect on the incidence of prostate cancer (active and placebo vitamin E groups, 9.1 and 9.5 events per 1000 person-years; hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.85-1.09; P = .58) or total cancer (active and placebo vitamin E groups, 17.8 and 17.3 cases per 1000 person-years; HR, 1.04; 95% CI, 0.95-1.13; P = .41). There was also no significant effect of vitamin C on total cancer (active and placebo vitamin C groups, 17.6 and 17.5 events per 1000 person-years; HR, 1.01; 95% CI, 0.92-1.10; P = .86) or prostate cancer (active and placebo vitamin C groups, 9.4 and 9.2 cases per 1000 person-years; HR, 1.02; 95% CI, 0.90-1.15; P = .80). Neither vitamin E nor vitamin C had a significant effect on colorectal, lung, or other site-specific cancers. Adjustment for adherence and exclusion of the first 4 or 6 years of follow-up did not alter the results. Stratification by various cancer risk factors demonstrated no significant modification of the effect of vitamin E on prostate cancer risk or either agent on total cancer risk.
Conclusions In this large, long-term trial of male physicians, neither vitamin E nor C supplementation reduced the risk of prostate or total cancer. These data provide no support for the use of these supplements for the prevention of cancer in middle-aged and older men.
BrooklynDodger(s) comment: The Dodger(s) continue to kick sand in the face of chemoprevention (silica exposure?) At least this study only cost us for 16,000 subjects, not 35,000. The abstract yields a heuristic - a bit more than 10% of these 50 year old men got cancer over the next 8 years from enrollment.

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