A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer

New England Journal of Medicine

Volumn 348, Issue 10, 2003, Pages 883-890

  Sandler, Robert S ^a,l   Halabi, Susan ^b   Baron, John A ^c   Budinger, Susan ^b   Paskett, Electra ^e   Keresztes, Roger ^f   Petrelli, Nicholas ^g   Pipas, J Marc ^d   Karp, Daniel D ^h   Loprinzi, Charles L ^j   Steinbach, Gideon ⁱ   Schilsky, Richard ^k  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c Department of Medicine ^*  (United States)

^d DARTMOUTH MEDICAL SCHOOL   (United States)

^e WAKE FOREST SCHOOL OF MEDICINE   (United States)

^f WEILL CORNELL MEDICAL COLLEGE   (United States)

^g ROSWELL PARK CANCER INSTITUTE   (United States)

^h Eastern Cooperative Oncology Group   (United States)

ⁱ UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^j North Central Cancer Treatment Group Rochester   (United States)

^k Central Office of the Chairman   (United States)

^l UNIVERSITY OF NORTH CAROLINA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; HISTAMINE H2 RECEPTOR ANTAGONIST; MISOPROSTOL; OMEPRAZOLE; PARACETAMOL; PLACEBO; SUCRALFATE;

ADULT; AGE; AGED; ARTICLE; CANCER RISK; CANCER STAGING; CHEMOPROPHYLAXIS; CLINICAL TRIAL; COLON ADENOMA; COLORECTAL CANCER; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIGESTIVE SYSTEM ULCER; DISEASE ASSOCIATION; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG SAFETY; DYSPEPSIA; EARLY DIAGNOSIS; FEMALE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HUMAN; HUMAN TISSUE; INCIDENCE; MAJOR CLINICAL STUDY; MALE; PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RANK SUM TEST; RECURRENT CANCER; RISK; SEX; SIDE EFFECT; STATISTICAL SIGNIFICANCE; TRANSIENT ISCHEMIC ATTACK; TREATMENT OUTCOME;

ADENOMA; ADULT; AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ASPIRIN; COLONIC POLYPS; COLONOSCOPY; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; RECURRENCE; RISK;

EID: 0037421984     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMoa021633     Document Type: Article

References (44)

1. Sandler RS. Aspirin and other nonsteroidal anti-inflammatory agents in the prevention of colorectal cancer. Important Adv Oncol 1996:123-37.
2. Thun MJ, Henley SJ, Patrono C. Nonsteroidal anti-inflammatory drugs as anticancer agents: mechanistic, pharmacologic, and clinical issues. J Natl Cancer Inst 2002;94:252-66.
3. Jänne PA, Mayer RJ. Chemoprevention of colorectal cancer. N Engl J Med 2000;342:1960-8.
4. Pollard M, Luckert PH. Indomethacin treatment of rats with dimethylhydrazine-induced intestinal tumors. Cancer Treat Rep 1980;64:1323-7.
5. Kune GA, Kune S, Watson LF. Colorectal cancer risk, chronic illnesses, operations, and medications: case control results from the Melbourne Colorectal Cancer Study. Cancer Res 1988;48:4399-404.
6. Rosenberg L, Palmer JR, Zauber AG, Warshauer ME, Stolley PD, Shapiro S. A hypothesis: nonsteroidal anti-inflammatory drugs reduce the incidence of large-bowel cancer. J Natl Cancer Inst 1991;83:355-8.
7. Thun MJ, Namboodiri MM, Heath CW Jr. Aspirin use and reduced risk of fatal colon cancer. N Engl J Med 1991;325:1593-6.
8. Giovannucci E, Rimm EB, Stampfer MJ, Colditz GA, Ascherio A, Willett WC. Aspirin use and the risk for colorectal cancer and adenoma in male health professionals. Ann Intern Med 1994;121:241-6.
9. Giovannucci E, Egan KM, Hunter DJ, et al. Aspirin and the risk of colorectal cancer in women. N Engl J Med 1995;333:609-14.
10. Steinbach G, Lynch PM, Philips RKS, et al. The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis. N Engl J Med 2000;342:1946-52.
11. Giardiello FM, Hamilton SR, Krush AJ, et al. Treatment of colonic and rectal adenomas with sulindac in familial adenomatous polyposis. N Engl J Med 1993;328:1313-6.
12. Greenberg ER, Baron JA, Tosteson TD, et al. A clinical trial of antioxidant vitamins to prevent colorectal adenoma. N Engl J Med 1994;331:141-7.
13. Alberts DS, Martínez ME, Roe DJ, et al. Lack of effect of a high-fiber cereal supplement on the recurrence of colorectal adenomas. N Engl J Med 2000;342:1156-62.
14. Schatzin A, Lanza E, Corle D, et al. Lack of effect of a low-fat, high-fiber diet on the recurrence of colorectal adenomas. N Engl J Med 2000;342:1149-55.
15. Baron JA, Beach M, Mandel JS, et al. Calcium supplements for the prevention of colorectal adenomas. N Engl J Med 1999;340:101-7.
16. Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous outcomes. Biometrics 1986;42:121-30.
17. McCullagh P, Nelder JA. Generalized linear models. 2nd ed. London: Chapman & Hall, 1989.
18. Smalley W, Ray WA, Daugherty J, Griffin MR. Use of nonsteroidal anti-inflammatory drugs and incidence of colorectal cancer: a population-based study. Arch Intern Med 1999;159:161-6.
19. Schreinemachers DM, Everson RB. Aspirin use and lung, colon, and breast cancer incidence in a prospective study. Epidemiology 1994;5:138-46.
20. Paganini-Hill A, Chao A, Ross RK, Henderson BE. Aspirin use and chronic diseases: a cohort study of the elderly. BMJ 1989;299:1247-50.
21. Collet JP, Sharpe C, Belzile E, Boivin JF, Hanley J, Abenhaim L. Colorectal cancer prevention by non-steroidal anti-inflammatory drugs: effects of dosage and timing. Br J Cancer 1999;81:62-8.
22. Garcia-Rodriguez LA, Huerta-Alvarez C. Reduced risk of colorectal cancer among long-term users of aspirin and nonaspirin nonsteroidal antiinflammatory drugs. Epidemiology 2001;12:88-93.
23. Greenberg ER, Baron JA, Freeman DH Jr, Mandel JS, Haile R. Reduced risk of large-bowel adenomas among aspirin users. J Natl Cancer Inst 1993;85:912-6.
24. La Vecchia C, Negri E, Franceschi S, et al. Aspirin and colorectal cancer. Br J Cancer 1997;76:675-7.
25. Logan RF, Little J, Hawtin PG, Hardcastle JD. Effect of aspirin and non-steroidal antiinflammatory drugs on colorectal adenomas: case-control study of subjects participating in the Nottingham faecal occult blood screening programme. BMJ 1993;307:285-9.
26. Martinez ME, McPherson RS, Levin B, Annegers JF. Aspirin and other nonsteroidal anti-inflammatory drugs and risk of colorectal adenomatous polyps among endoscoped individuals. Cancer Epidemiol Biomarkers Prev 1995;4:703-7.
27. Muscat JE, Stellman SD, Wynder EL. Nonsteroidal antiinflammatory drugs and colorectal cancer. Cancer 1994;74:1847-54.
28. Peleg II, Maibach HT, Brown SH, Wilcox CM. Aspirin and nonsteroidal anti-inflammatory drug use and the risk of subsequent colorectal cancer. Arch Intern Med 1994;154:394-9.
29. Sandler RS, Galanko JC, Murray SC, Helm JF, Woosley JT. Aspirin and nonsteroidal anti-inflammatory agents and risk for colorectal adenomas. Gastroenterology 1998;114:441-7.
30. Suh O, Mettlin C, Petrelli NJ. Aspirin use, cancer, and polyps of the large bowel. Cancer 1993;72:1171-7.
31. Shaheen NJ, Straus WL, Sandler RS. Chemoprevention of gastrointestinal malignancies with nonsteroidal antiinflammatory drugs. Cancer 2002;94:950-63.
32. Labayle D, Fischer D, Vielh P, etal. Sulindac causes regression of rectal polyps in familial adenomatous polyposis. Gastroenterology 1991;101:635-9.
33. Cruz-Correa M, Hylind LM, Romans KE, Booker SV, Giardiello FM. Long-term treatment with sulindac in familial adenomatous polyposis: a prospective cohort study. Gastroenterology 2002;122:641-5.
34. Winawer SJ, Fletcher RH, Miller L, et al. Colorectal cancer screening: clinical guidelines and rationale. Gastroenterology 1997; 112:594-642. [Errata, Gastroenterology 1997; 112:1060, 1998;114:625.]
35. McKeown-Eyssen GE, Bright-See E, Bruce WR, et al. A randomized trial of a low fat high fibre diet in the recurrence of colorectal polyps. J Clin Epidemiol 1994;47:525-36. [Erratum, J Clin Epidemiol 1995;48:i.]
36. MacLennan R, Macrae F, Bain C, et al. Randomized trial of intake of fat, fiber, and beta carotene to prevent colorectal adenomas: the Australian Polyp Prevention Project. J Natl Cancer Inst 1995;87:1760-6.
37. O'Shaughnessy JA, Kelloff GJ, Gordon GB, et al. Treatment and prevention of intraepithelial neoplasia: an important target for accelerated new agent development. Clin Cancer Res 2002;8:314-46.
38. Sample D, Wargovich M, Fischer SM, et al. A dose-finding study of aspirin for chemoprevention utilizing rectal mucosal prostaglandin E(2) levels as a biomarker. Cancer Epidemiol Biomarkers Prev 2002;11:275-9.
39. Baron JA, Cole BF, Sandier RS, et al. A randomized trial of aspirin to prevent colorectal adenomas. N Engl J Med 2003; 348:891-9.
40. Green RJ, Metlay JP, Propert K, etal. Surveillance for second primary colorectal cancer after adjuvant chemotherapy: an analysis of Intergroup 0089. Ann Intern Med 2002;136:261-9.
41. Cooper GS, Yuan Z, Chak A, Rimm AA. Geographic and patient variation among Medicare beneficiaries in the use of follow-up testing after surgery for nonmetastatic colorectal carcinoma. Cancer 1999;85:2124-31.
42. Pocock SJ, Hughes MD. Practical problems in interim analyses, with particular regard to estimation. Control Clin Trials 1989; 10:Suppl:209S-221S.
43. Ladabaum U, Chopra CL, Huang G, Scheiman JM, Chernew ME, Fendrick AM. Aspirin as an adjunct to screening for prevention of sporadic colorectal cancer: a cost-effectiveness analysis. Ann Intern Med 2001;135:769-81.
44. Suleiman S, Rex DK, Sonnenberg A. Chemoprevention of colorectal cancer by aspirin: a cost-effectiveness analysis. Gastroenterology 2002;122:78-84.