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Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch Syndrome

Burn, John, Bishop, D.Timothy, Mecklin, Jukka-Pekka, Macrae, Finlay, Möslein, Gabriela, Olschwang, Sylviane, Bisgaard, Marie-Luise, Ramesar, Raj, Eccles, Diana, Maher, Eamonn, Bertario, Lucio, Jarvinen, Heikki J., Lindblom, Annika, Evans, D.Gareth, Lubinski, Jan, Morrison, Patrick J., Ho, Judy W.C., Vasen, Hans F.A., Side, Lucy, Thomas, Huw J.W., Scott, Rodney J., Dunlop, Malcolm, Barker, Gail, Elliott, Faye, Jass, Jeremy R., Fodde, Ricardo, Lynch, Henry T. and Mathers, John C. CAPP2 Investigators (2008) Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch Syndrome New England Journal of Medicine, 359, (24), pp. 2567-2578. (doi:10.1056/NEJMoa0801297). (PMID:19073976).

Record type: Article


BACKGROUND: Observational and epidemiologic data indicate that the use of aspirin reduces the risk of colorectal neoplasia; however, the effects of aspirin in the Lynch syndrome (hereditary nonpolyposis colon cancer) are not known. Resistant starch has been associated with an antineoplastic effect on the colon.

METHODS: In a randomized, placebo-controlled trial, we used a two-by-two design to investigate the effects of aspirin, at a dose of 600 mg per day, and resistant starch (Novelose), at a dose of 30 g per day, in reducing the risk of adenoma and carcinoma among persons with the Lynch syndrome.

RESULTS: Among 1071 persons in 43 centers, 62 were ineligible to participate in the study, 72 did not enter the study, and 191 withdrew from the study. These three categories were equally distributed across the study groups. Over a mean period of 29 months (range, 7 to 74), colonic adenoma or carcinoma developed in 141 participants. Of 693 participants randomly assigned to receive aspirin or placebo, neoplasia developed in 66 participants receiving aspirin (18.9%), as compared with 65 receiving placebo (19.0%) (relative risk, 1.0; 95% confidence interval [CI], 0.7 to 1.4). There were no significant differences between the two groups with respect to the development of advanced neoplasia (7.4% and 9.9%, respectively; P=0.33). Among the 727 participants receiving resistant starch or placebo, neoplasia developed in 67 participants receiving starch (18.7%), as compared with 68 receiving placebo (18.4%) (relative risk, 1.0; 95% CI, 0.7 to 1.4). Advanced adenomas and colorectal cancers were evenly distributed in the two groups. The prevalence of serious adverse events was low, and the events were evenly distributed.

CONCLUSIONS: The use of aspirin, resistant starch, or both for up to 4 years has no effect on the incidence of colorectal adenoma or carcinoma among carriers of the Lynch syndrome. (Current Controlled Trials number, ISRCTN59521990.)
2008 Massachusetts Medical Society

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Published date: 11 December 2008
Organisations: Cancer Sciences, Community Clinical Sciences


Local EPrints ID: 76228
PURE UUID: 541ca2fa-3329-48cc-a0dc-f95497d35531

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Date deposited: 15 Mar 2010
Last modified: 18 Jul 2017 23:41

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Author: John Burn
Author: D.Timothy Bishop
Author: Jukka-Pekka Mecklin
Author: Finlay Macrae
Author: Gabriela Möslein
Author: Sylviane Olschwang
Author: Marie-Luise Bisgaard
Author: Raj Ramesar
Author: Diana Eccles
Author: Eamonn Maher
Author: Lucio Bertario
Author: Heikki J. Jarvinen
Author: Annika Lindblom
Author: D.Gareth Evans
Author: Jan Lubinski
Author: Patrick J. Morrison
Author: Judy W.C. Ho
Author: Hans F.A. Vasen
Author: Lucy Side
Author: Huw J.W. Thomas
Author: Rodney J. Scott
Author: Malcolm Dunlop
Author: Gail Barker
Author: Faye Elliott
Author: Jeremy R. Jass
Author: Ricardo Fodde
Author: Henry T. Lynch
Author: John C. Mathers

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