© 2003 by Oxford University Press
Journal of the National Cancer Institute, Vol. 95, No. 10, 717-722,
May 21, 2003
© 2003 Oxford University Press
ARTICLE |
Neoplastic and Antineoplastic Effects of 
-Carotene on Colorectal Adenoma Recurrence: Results of a Randomized Trial
Affiliations of authors: J. A. Baron (Departments of Medicine and Community and Family Medicine), B. F. Cole, L. Mott, M. Grau, E. R. Greenberg (Department of Community and Family Medicine), Dartmouth Medical School, Lebanon, NH; R. Haile, Department of Preventive Medicine, University of Southern California, Los Angeles; T. R. Church, Department of Occupational and Environmental Health, University of Minnesota, Minneapolis; G. J. Beck, Department of Biostatistics and Epidemiology, Cleveland Clinic Foundation, Cleveland, OH.
Correspondence to: John Baron, M.D., Dartmouth Medical School, Section of Biostatistics and Epidemiology, Evergreen Center, 46 Centerra Pkwy., Ste. 300, Lebanon, NH 03766 (e-mail: john.a.baron{at}dartmouth.edu).
Background: In two large, randomized prevention trials, supplementation with 
-carotene increased the risk of lung cancer. Subjects in these studies were predominantly cigarette smokers, and the adverse effects were concentrated among those who also drank alcohol. Although -carotene supplementation appeared not to increase the risk of cancer generally, it is not clear if smoking and/or alcohol use alters the effect of -carotene on carcinogenesis at sites outside the lung. Methods: We studied the effect of -carotene supplementation on colorectal adenoma recurrence among subjects in a multicenter double-blind, placebo-controlled clinical trial of antioxidants for the prevention of colorectal adenomas. A total of 864 subjects who had had an adenoma removed and were polyp-free were randomly assigned (in a factorial design) to receive -carotene (25 mg or placebo) and/or vitamins C and E in combination (1000 mg and 400 mg, respectively, or placebo), and were followed with colonoscopy for adenoma recurrence 1 year and 4 years after the qualifying endoscopy. A total of 707 subjects had two follow-up examinations and provided smoking and alcohol use data. Adjusted multivariate risk ratios (RRs) and 95% confidence intervals (CIs) were used to assess the effects of -carotene on adenoma recurrence. Results: Among subjects who neither smoked cigarettes nor drank alcohol, -carotene was associated with a marked decrease in the risk of one or more recurrent adenomas (RR = 0.56, 95% CI = 0.35 to 0.89), but -carotene supplementation conferred a modest increase in the risk of recurrence among those who smoked (RR = 1.36, 95% CI = 0.70 to 2.62) or drank (RR = 1.13, 95% CI = 0.89 to 1.43). For participants who smoked cigarettes and also drank more than one alcoholic drink per day, -carotene doubled the risk of adenoma recurrence (RR = 2.07, 95% CI = 1.39 to 3.08; P for difference from nonsmoker/nondrinker RR < .001). Conclusion: Alcohol intake and cigarette smoking appear to modify the effect of -carotene supplementation on the risk of colorectal adenoma recurrence.
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