A Randomized Trial of Aspirin to Prevent Colorectal Adenomas
John A. Baron, M.D., Bernard F. Cole, Ph.D., Robert S. Sandler, M.D., Robert W. Haile, Dr.Ph., Dennis Ahnen, M.D., Robert Bresalier, M.D., Gail McKeown-Eyssen, Ph.D., Robert W. Summers, M.D., Richard Rothstein, M.D., Carol A. Burke, M.D., Dale C. Snover, M.D., Timothy R. Church, Ph.D., John I. Allen, M.D., Michael Beach, M.D., Ph.D., Gerald J. Beck, Ph.D., John H. Bond, M.D., Tim Byers, M.D., E. Robert Greenberg, M.D., Jack S. Mandel, Ph.D., Norman Marcon, M.D., Leila A. Mott, M.S., Loretta Pearson, M.Phil., Fred Saibil, M.D., and Rosalind U. van Stolk, M.D.
Background Laboratory and epidemiologic data suggest that aspirinhas an antineoplastic effect in the large bowel.
Methods We performed a randomized, double-blind trial of aspirinas a chemopreventive agent against colorectal adenomas. We randomlyassigned 1121 patients with a recent history of histologicallydocumented adenomas to receive placebo (372 patients), 81 mgof aspirin (377 patients), or 325 mg of aspirin (372 patients)daily. According to the protocol, follow-up colonoscopy wasto be performed approximately three years after the qualifyingendoscopy. We compared the groups with respect to the risk ofone or more neoplasms (adenomas or colorectal cancer) at leastone year after randomization using generalized linear modelsto compute risk ratios and 95 percent confidence intervals.
Results Reported adherence to study medications and avoidanceof nonsteroidal antiinflammatory drugs were excellent. Follow-upcolonoscopy was performed at least one year after randomizationin 1084 patients (97 percent). The incidence of one or moreadenomas was 47 percent in the placebo group, 38 percent inthe group given 81 mg of aspirin per day, and 45 percent inthe group given 325 mg of aspirin per day (global P=0.04). Unadjustedrelative risks of any adenoma (as compared with the placebogroup) were 0.81 in the 81-mg group (95 percent confidence interval,0.69 to 0.96) and 0.96 in the 325-mg group (95 percent confidenceinterval, 0.81 to 1.13). For advanced neoplasms (adenomas measuringat least 1 cm in diameter or with tubulovillous or villous features,severe dysplasia, or invasive cancer), the respective relativerisks were 0.59 (95 percent confidence interval, 0.38 to 0.92)and 0.83 (95 percent confidence interval, 0.55 to 1.23).
Conclusions Low-dose aspirin has a moderate chemopreventiveeffect on adenomas in the large bowel.
Source Information
From the Norris Cotton Cancer Center, Dartmouth–Hitchcock Medical Center, Lebanon, N.H. (J.A.B., B.F.C., E.R.G.); Dartmouth Medical School, Hanover, N.H. (J.A.B., R.R., M.B., E.R.G., L.A.M., L.P.); the University of North Carolina School of Medicine, Chapel Hill (R.S.S.); the University of Southern California School of Medicine, Los Angeles (R.W.H.); the Veterans Affairs Medical Center, Denver (D.A.); the University of Colorado School of Medicine, Denver (D.A., T.B.); Henry Ford Health Sciences Center, Detroit (R.B.); the University of Toronto, Toronto (G.M.-E., N.M., F.S.); the Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City (R.W.S.); the Cleveland Clinic Foundation, Cleveland (C.A.B., R.U.S., G.J.B.); Fairview Southdale Hospital, Minneapolis (D.C.S.); the University of Minnesota, Minneapolis (T.R.C.); the University of Minnesota School of Medicine, Minneapolis ( J.I.A., J.H.B.); Minnesota Gastroenterology, Minneapolis (J.I.A.); the Veterans Affairs Medical Center, Minneapolis ( J.H.B.); and the Rollins School of Public Health, Emory University, Atlanta (J.S.M.).
Address reprint requests to Dr. Baron at Biostatistics and Epidemiology, Evergreen Center, 46 Centerra Pkwy., Lebanon, NH 03766, or at john.a.baron{at}dartmouth.edu.
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66: 6877-6883
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(2006). High Dry Bean Intake and Reduced Risk of Advanced Colorectal Adenoma Recurrence among Participants in the Polyp Prevention Trial. J. Nutr.
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Kelloff, G. J., Lippman, S. M., Dannenberg, A. J., Sigman, C. C., Pearce, H. L., Reid, B. J., Szabo, E., Jordan, V. C., Spitz, M. R., Mills, G. B., Papadimitrakopoulou, V. A., Lotan, R., Aggarwal, B. B., Bresalier, R. S., Kim, J., Arun, B., Lu, K. H., Thomas, M. E., Rhodes, H. E., Brewer, M. A., Follen, M., Shin, D. M., Parnes, H. L., Siegfried, J. M., Evans, A. A., Blot, W. J., Chow, W.-H., Blount, P. L., Maley, C. C., Wang, K. K., Lam, S., Lee, J. J., Dubinett, S. M., Engstrom, P. F., Meyskens, F. L. Jr., O'Shaughnessy, J., Hawk, E. T., Levin, B., Nelson, W. G., Hong, W. K., for the AACR Task Force on Cancer Prevention,
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Castells, A., Paya, A., Alenda, C., Rodriguez-Moranta, F., Agrelo, R., Andreu, M., Pinol, V., Castellvi-Bel, S., Jover, R., Llor, X., Pons, E., Elizalde, J. I., Bessa, X., Alcedo, J., Salo, J., Medina, E., Naranjo, A., Esteller, M., Pique, J. M., for the Gastrointestinal Oncology Group of the Spa,
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