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; Rodney J Scott; Malcolm Dunlop; Gail Barker; Faye Elliott; Jeremy R Jass; Ricardo Fodde; Henry T Lynch; John C Mathers; CAPP2 Investigators

doi:10.1056/NEJMoa0801297

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 ThomasRodney J Scott, Malcolm Dunlop, Gail Barker, Faye Elliott, Jeremy R Jass, Ricardo Fodde, Henry T Lynch, John C Mathers, CAPP2 Investigators

Department of Cellular and Molecular Medicine

214 Citations (Scopus)

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 language	English
Journal	New England Journal of Medicine
Volume	359
Issue number	24
Pages (from-to)	2567-78
Number of pages	11
ISSN	0028-4793
DOIs	https://doi.org/10.1056/NEJMoa0801297
Publication status	Published - 2008

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10.1056/NEJMoa0801297

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Burn, J., Bishop, D. T., Mecklin, J-P., Macrae, F., Möslein, G., Olschwang, S., Bisgaard, M-L., Ramesar, R., Eccles, D., Maher, E. R., Bertario, L., Jarvinen, H. J., Lindblom, A., Evans, D. G., Lubinski, J., Morrison, P. J., Ho, J. W. C., Vasen, H. F. A., Side, L., ... CAPP2 Investigators (2008). Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch syndrome. New England Journal of Medicine, 359(24), 2567-78. https://doi.org/10.1056/NEJMoa0801297

Burn, J, Bishop, DT, Mecklin, J-P, Macrae, F, Möslein, G, Olschwang, S, Bisgaard, M-L, 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 & CAPP2 Investigators 2008, 'Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch syndrome', New England Journal of Medicine, vol. 359, no. 24, pp. 2567-78. https://doi.org/10.1056/NEJMoa0801297

@article{823da0400c0911df825d000ea68e967b,

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 Jukka-Pekka Mecklin and Finlay Macrae and Gabriela M{\"o}slein and Sylviane Olschwang and Marie-Luise Bisgaard 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} and {CAPP2 Investigators}",

note = "Keywords: Adenoma; Adult; Aged; Aspirin; Carcinoma; Colorectal Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis; DNA Mismatch Repair; Drug Therapy, Combination; Female; Humans; Incidence; Male; Middle Aged; Proportional Hazards Models; Risk; Starch; Treatment Failure",

year = "2008",

doi = "10.1056/NEJMoa0801297",

language = "English",

volume = "359",

pages = "2567--78",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "24",

}

TY - JOUR

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

AU - CAPP2 Investigators

N1 - Keywords: Adenoma; Adult; Aged; Aspirin; Carcinoma; Colorectal Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis; DNA Mismatch Repair; Drug Therapy, Combination; Female; Humans; Incidence; Male; Middle Aged; Proportional Hazards Models; Risk; Starch; Treatment Failure

PY - 2008

Y1 - 2008

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.)

U2 - 10.1056/NEJMoa0801297

DO - 10.1056/NEJMoa0801297

M3 - Journal article

C2 - 19073976

SN - 0028-4793

VL - 359

SP - 2567

EP - 2578

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 24

ER -

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

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