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

John Burn, D. Timothy Bishop, Jukka Pekka Mecklin, Finlay Macrae, Gabriela Möslein, Sylviane Olschwang, Marie Luise Bisgaard, Raj Ramesar, Diana Eccles, Eamonn R. Maher, Lucio Bertario, Heikki J. Jarvinen, Annika Lindblom, D. Gareth Evans, Jan Lubinski, Patrick J. Morrison, Judy W C Ho, Hans F A Vasen, Lucy Side, Huw J W Thomas & 8 others Rodney J. Scott, Malcolm Dunlop, Gail Barker, Faye Elliott, Jeremy R. Jass, Ricardo Fodde, Henry T. Lynch, John C. Mathers

Research output: Contribution to journalArticle

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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.)

Original languageEnglish
Pages (from-to)2567-2578
Number of pages12
JournalNew England Journal of Medicine
Volume359
Issue number24
DOIs
StatePublished - Dec 11 2008

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Hereditary Nonpolyposis Colorectal Neoplasms
Starch
Aspirin
Adenoma
Placebos
Neoplasms
Carcinoma
Confidence Intervals
Antineoplastic Agents
Colorectal Neoplasms
Colon
Randomized Controlled Trials
Incidence

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Burn, J., Bishop, D. T., Mecklin, J. P., Macrae, F., Möslein, G., Olschwang, S., ... Mathers, J. C. (2008). Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch syndrome. New England Journal of Medicine, 359(24), 2567-2578. https://doi.org/10.1056/NEJMoa0801297

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 R.; 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.; Mathers, John C.

In: New England Journal of Medicine, Vol. 359, No. 24, 11.12.2008, p. 2567-2578.

Research output: Contribution to journalArticle

Burn, J, Bishop, DT, Mecklin, JP, Macrae, F, Möslein, G, Olschwang, S, Bisgaard, ML, Ramesar, R, Eccles, D, Maher, ER, Bertario, L, Jarvinen, HJ, Lindblom, A, Evans, DG, Lubinski, J, Morrison, PJ, Ho, JWC, Vasen, HFA, Side, L, Thomas, HJW, Scott, RJ, Dunlop, M, Barker, G, Elliott, F, Jass, JR, Fodde, R, Lynch, HT & Mathers, JC 2008, 'Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch syndrome', New England Journal of Medicine, vol. 359, no. 24, pp. 2567-2578. https://doi.org/10.1056/NEJMoa0801297
Burn J, Bishop DT, Mecklin JP, Macrae F, Möslein G, Olschwang S et al. Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch syndrome. New England Journal of Medicine. 2008 Dec 11;359(24):2567-2578. https://doi.org/10.1056/NEJMoa0801297
Burn, John ; Bishop, D. Timothy ; Mecklin, Jukka Pekka ; Macrae, Finlay ; Möslein, Gabriela ; Olschwang, Sylviane ; Bisgaard, Marie Luise ; Ramesar, Raj ; Eccles, Diana ; Maher, Eamonn R. ; 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. ; Mathers, John C. / Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch syndrome. In: New England Journal of Medicine. 2008 ; Vol. 359, No. 24. pp. 2567-2578.
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title = "Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch syndrome",
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.)",
author = "John Burn and Bishop, {D. Timothy} and Mecklin, {Jukka Pekka} and Finlay Macrae and Gabriela M{\"o}slein and Sylviane Olschwang and Bisgaard, {Marie Luise} and Raj Ramesar and Diana Eccles and Maher, {Eamonn R.} and Lucio Bertario and Jarvinen, {Heikki J.} and Annika Lindblom and Evans, {D. Gareth} and Jan Lubinski and Morrison, {Patrick J.} and Ho, {Judy W C} and Vasen, {Hans F A} and Lucy Side and Thomas, {Huw J W} and Scott, {Rodney J.} and Malcolm Dunlop and Gail Barker and Faye Elliott and Jass, {Jeremy R.} and Ricardo Fodde and Lynch, {Henry T.} and Mathers, {John C.}",
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T1 - Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch syndrome

AU - Burn, John

AU - Bishop, D. Timothy

AU - Mecklin, Jukka Pekka

AU - Macrae, Finlay

AU - Möslein, Gabriela

AU - Olschwang, Sylviane

AU - Bisgaard, Marie Luise

AU - Ramesar, Raj

AU - Eccles, Diana

AU - Maher, Eamonn R.

AU - Bertario, Lucio

AU - Jarvinen, Heikki J.

AU - Lindblom, Annika

AU - Evans, D. Gareth

AU - Lubinski, Jan

AU - Morrison, Patrick J.

AU - Ho, Judy W C

AU - Vasen, Hans F A

AU - Side, Lucy

AU - Thomas, Huw J W

AU - Scott, Rodney J.

AU - Dunlop, Malcolm

AU - Barker, Gail

AU - Elliott, Faye

AU - Jass, Jeremy R.

AU - Fodde, Ricardo

AU - Lynch, Henry T.

AU - Mathers, John C.

PY - 2008/12/11

Y1 - 2008/12/11

N2 - 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.)

AB - 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.)

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