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

Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch Syndrome
Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch Syndrome
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
2567-2578
Burn, John
455f5bd0-3b49-4784-a924-de7861508290
Bishop, D.Timothy
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Mecklin, Jukka-Pekka
5e4b3d86-d108-401b-9199-39e97c1c333e
Macrae, Finlay
1563da0e-d7e9-4f37-8095-041739cf4e09
Möslein, Gabriela
2130db23-3edb-4705-b48a-c98bfa12b4ff
Olschwang, Sylviane
b5ecf044-8db1-499c-bd4a-f53e3a606443
Bisgaard, Marie-Luise
008a7597-657d-4e0c-ac40-64ed33a1759a
Ramesar, Raj
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Eccles, Diana
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Maher, Eamonn
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Bertario, Lucio
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Jarvinen, Heikki J.
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Lindblom, Annika
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Evans, D.Gareth
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Lubinski, Jan
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Morrison, Patrick J.
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Ho, Judy W.C.
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Vasen, Hans F.A.
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Side, Lucy
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Thomas, Huw J.W.
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Scott, Rodney J.
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Dunlop, Malcolm
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Barker, Gail
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Elliott, Faye
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Jass, Jeremy R.
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Fodde, Ricardo
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Lynch, Henry T.
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Mathers, John C.
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CAPP2 Investigators
Burn, John
455f5bd0-3b49-4784-a924-de7861508290
Bishop, D.Timothy
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Mecklin, Jukka-Pekka
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Macrae, Finlay
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Möslein, Gabriela
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Olschwang, Sylviane
b5ecf044-8db1-499c-bd4a-f53e3a606443
Bisgaard, Marie-Luise
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Ramesar, Raj
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Eccles, Diana
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Maher, Eamonn
6540cdd4-e308-4bd4-bd77-bed4677b6a4a
Bertario, Lucio
4e19d5e5-a4f2-4797-b305-56a6c8e6ca96
Jarvinen, Heikki J.
c88292a6-ed82-4321-be97-bf0c59806949
Lindblom, Annika
855a20de-8712-44cb-9a0a-01d4176a666f
Evans, D.Gareth
141c5f82-b4c6-4d79-a5b4-ed24e98c4979
Lubinski, Jan
e7a9709c-36b3-44ed-a5e0-675177ca3d51
Morrison, Patrick J.
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Ho, Judy W.C.
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Vasen, Hans F.A.
127a09fd-e091-45dd-90a8-dc6c9ae777cf
Side, Lucy
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Thomas, Huw J.W.
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Scott, Rodney J.
260625d6-e0c1-40df-92c3-cac44df0f612
Dunlop, Malcolm
424299ca-55a1-4eb1-9bc7-d126c3cd7ca1
Barker, Gail
1e1854bb-1eb9-42c0-a715-294a2fbd692d
Elliott, Faye
ebf9247f-1916-4e36-90ff-adf98a0192d3
Jass, Jeremy R.
cb6415b4-d42d-498f-91be-72041711c935
Fodde, Ricardo
8f1792a8-fe1f-4ff6-b912-bf8eab05f23a
Lynch, Henry T.
4515a3de-428a-476c-ad48-621c7928e874
Mathers, John C.
4dfcad8f-65ea-46f8-a219-3573b131be52

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), 2567-2578. (doi:10.1056/NEJMoa0801297). (PMID:19073976)

Record type: Article

Abstract

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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More information

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

Identifiers

Local EPrints ID: 76228
URI: http://eprints.soton.ac.uk/id/eprint/76228
PURE UUID: 541ca2fa-3329-48cc-a0dc-f95497d35531
ORCID for Diana Eccles: ORCID iD orcid.org/0000-0002-9935-3169

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Date deposited: 15 Mar 2010
Last modified: 14 Mar 2024 02:34

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Contributors

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 ORCID iD
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
Corporate Author: CAPP2 Investigators

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