Effect of Aspirin or Resistant Starch on Colorectal Neoplasia in the Lynch Syndrome

J. Burn; T. Bishop; J-P. Mecklin; F. Macrae; G. Moslein; S. Olschwang; M-L. Bisgaard; R. Ramesar; D. Eccles; E.R. Maher; L. Bertario; H. Jarvinen; A. Lindbom; D.G. Evans; J. Lubinski; P.J. Morrison; J.W.C. Ho; H.F.A. Vasen; L. Side; H.J.W. Thomas; R.J. Scott; M. Dunlop; G. Barker; F. Elliott; J.R. Jass; R. Fodde; H.T. Lynch; J.C. Mathews; P. Adamson; O. Armstrong; J. Ball; L. Baxter; A. Birkett; A. Boussioutas; N. Bradshaw; C. Brewer; M. Broughton; B. Bulman; M. Castiglione; R. Ching; C. Chu; J. Coaker; S. Cina; J. Cook; J. Coxhead; G. Crawford; C. Cummings; R. Davies; T. Debniak; C. De Moncuit; S. Drummond; T. Ellis; K. Farthing; P. Fidalgo; S. Gallinger; J. Gascoyne; J. Gilroy; S. Goff; P. Goldberg; S. Goodman; C. Harocopos; S. Hodgson; R. Jeffcoat; L. Jeffers; S. Jordan; P. Killick; C. Krauss; J. Kristensen; C. Langman; J. Leite; A. Liljegren; G. Lindren; L. Lynagh; C. Oliani; C. Marks; J. Miller; T. Miles; V. Murday; P. Perez Segura; E. Pietersen; U. Platten; L. Reed; G. Rossi; P. Sala; J. Sampson; B. Schmocker; J. Shaw; A. Spigelman; A. Tempesta; R. Toes; M. Velthuizen; P. Wakelen; Ian Walpole; J. Mathers; D. Kerr; S. Perkins; J. Cuzik; L. Faulds Wood; R. Steele; D. Altman; C. Paraskeva; W. Atkin; M. Hulls

doi:10.1056/NEJMoa0801297

Effect of Aspirin or Resistant Starch on Colorectal Neoplasia in the Lynch Syndrome

J. Burn, T. Bishop, J-P. Mecklin, F. Macrae, G. Moslein, S. Olschwang, M-L. Bisgaard, R. Ramesar, D. Eccles, E.R. Maher, L. Bertario, H. Jarvinen, A. Lindbom, D.G. Evans, J. Lubinski, P.J. Morrison, J.W.C. Ho, H.F.A. Vasen, L. Side, H.J.W. ThomasR.J. Scott, M. Dunlop, G. Barker, F. Elliott, J.R. Jass, R. Fodde, H.T. Lynch, J.C. Mathews, P. Adamson, O. Armstrong, J. Ball, L. Baxter, A. Birkett, A. Boussioutas, N. Bradshaw, C. Brewer, M. Broughton, B. Bulman, M. Castiglione, R. Ching, C. Chu, J. Coaker, S. Cina, J. Cook, J. Coxhead, G. Crawford, C. Cummings, R. Davies, T. Debniak, C. De Moncuit, S. Drummond, T. Ellis, K. Farthing, P. Fidalgo, S. Gallinger, J. Gascoyne, J. Gilroy, S. Goff, P. Goldberg, S. Goodman, C. Harocopos, S. Hodgson, R. Jeffcoat, L. Jeffers, S. Jordan, P. Killick, C. Krauss, J. Kristensen, C. Langman, J. Leite, A. Liljegren, G. Lindren, L. Lynagh, C. Oliani, C. Marks, J. Miller, T. Miles, V. Murday, P. Perez Segura, E. Pietersen, U. Platten, L. Reed, G. Rossi, P. Sala, J. Sampson, B. Schmocker, J. Shaw, A. Spigelman, A. Tempesta, R. Toes, M. Velthuizen, P. Wakelen, Ian Walpole, J. Mathers, D. Kerr, S. Perkins, J. Cuzik, L. Faulds Wood, R. Steele, D. Altman, C. Paraskeva, W. Atkin, M. Hulls

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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 language	English
Pages (from-to)	2567-2578
Journal	New England Journal of Medicine
Volume	359
Issue number	24
DOIs	https://doi.org/10.1056/NEJMoa0801297
Publication status	Published - 2008

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Burn, J., Bishop, T., Mecklin, J-P., Macrae, F., Moslein, G., Olschwang, S., Bisgaard, M-L., Ramesar, R., Eccles, D., Maher, E. R., Bertario, L., Jarvinen, H., Lindbom, A., Evans, D. G., Lubinski, J., Morrison, P. J., Ho, J. W. C., Vasen, H. F. A., Side, L., ... Hulls, M. (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

@article{c8bab1ea426b4724ae3d2cc7046e98f3,

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 = "J. Burn and T. Bishop and J-P. Mecklin and F. Macrae and G. Moslein and S. Olschwang and M-L. Bisgaard and R. Ramesar and D. Eccles and E.R. Maher and L. Bertario and H. Jarvinen and A. Lindbom and D.G. Evans and J. Lubinski and P.J. Morrison and J.W.C. Ho and H.F.A. Vasen and L. Side and H.J.W. Thomas and R.J. Scott and M. Dunlop and G. Barker and F. Elliott and J.R. Jass and R. Fodde and H.T. Lynch and J.C. Mathews and P. Adamson and O. Armstrong and J. Ball and L. Baxter and A. Birkett and A. Boussioutas and N. Bradshaw and C. Brewer and M. Broughton and B. Bulman and M. Castiglione and R. Ching and C. Chu and J. Coaker and S. Cina and J. Cook and J. Coxhead and G. Crawford and C. Cummings and R. Davies and T. Debniak and {De Moncuit}, C. and S. Drummond and T. Ellis and K. Farthing and P. Fidalgo and S. Gallinger and J. Gascoyne and J. Gilroy and S. Goff and P. Goldberg and S. Goodman and C. Harocopos and S. Hodgson and R. Jeffcoat and L. Jeffers and S. Jordan and P. Killick and C. Krauss and J. Kristensen and C. Langman and J. Leite and A. Liljegren and G. Lindren and L. Lynagh and C. Oliani and C. Marks and J. Miller and T. Miles and V. Murday and {Perez Segura}, P. and E. Pietersen and U. Platten and L. Reed and G. Rossi and P. Sala and J. Sampson and B. Schmocker and J. Shaw and A. Spigelman and A. Tempesta and R. Toes and M. Velthuizen and P. Wakelen and Ian Walpole and J. Mathers and D. Kerr and S. Perkins and J. Cuzik and {Faulds Wood}, L. and R. Steele and D. Altman and C. Paraskeva and W. Atkin and M. Hulls",

year = "2008",

doi = "10.1056/NEJMoa0801297",

language = "English",

volume = "359",

pages = "2567--2578",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOC",

number = "24",

}

Burn, J, Bishop, T, Mecklin, J-P, Macrae, F, Moslein, G, Olschwang, S, Bisgaard, M-L, Ramesar, R, Eccles, D, Maher, ER, Bertario, L, Jarvinen, H, Lindbom, 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, Mathews, JC, Adamson, P, Armstrong, O, Ball, J, Baxter, L, Birkett, A, Boussioutas, A, Bradshaw, N, Brewer, C, Broughton, M, Bulman, B, Castiglione, M, Ching, R, Chu, C, Coaker, J, Cina, S, Cook, J, Coxhead, J, Crawford, G, Cummings, C, Davies, R, Debniak, T, De Moncuit, C, Drummond, S, Ellis, T, Farthing, K, Fidalgo, P, Gallinger, S, Gascoyne, J, Gilroy, J, Goff, S, Goldberg, P, Goodman, S, Harocopos, C, Hodgson, S, Jeffcoat, R, Jeffers, L, Jordan, S, Killick, P, Krauss, C, Kristensen, J, Langman, C, Leite, J, Liljegren, A, Lindren, G, Lynagh, L, Oliani, C, Marks, C, Miller, J, Miles, T, Murday, V, Perez Segura, P, Pietersen, E, Platten, U, Reed, L, Rossi, G, Sala, P, Sampson, J, Schmocker, B, Shaw, J, Spigelman, A, Tempesta, A, Toes, R, Velthuizen, M, Wakelen, P, Walpole, I, Mathers, J, Kerr, D, Perkins, S, Cuzik, J, Faulds Wood, L, Steele, R, Altman, D, Paraskeva, C, Atkin, W & Hulls, M 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

TY - JOUR

T1 - Effect of Aspirin or Resistant Starch on Colorectal Neoplasia in the Lynch Syndrome

AU - Burn, J.

AU - Bishop, T.

AU - Mecklin, J-P.

AU - Macrae, F.

AU - Moslein, G.

AU - Olschwang, S.

AU - Bisgaard, M-L.

AU - Ramesar, R.

AU - Eccles, D.

AU - Maher, E.R.

AU - Bertario, L.

AU - Jarvinen, H.

AU - Lindbom, A.

AU - Evans, D.G.

AU - Lubinski, J.

AU - Morrison, P.J.

AU - Ho, J.W.C.

AU - Vasen, H.F.A.

AU - Side, L.

AU - Thomas, H.J.W.

AU - Scott, R.J.

AU - Dunlop, M.

AU - Barker, G.

AU - Elliott, F.

AU - Jass, J.R.

AU - Fodde, R.

AU - Lynch, H.T.

AU - Mathews, J.C.

AU - Adamson, P.

AU - Armstrong, O.

AU - Ball, J.

AU - Baxter, L.

AU - Birkett, A.

AU - Boussioutas, A.

AU - Bradshaw, N.

AU - Brewer, C.

AU - Broughton, M.

AU - Bulman, B.

AU - Castiglione, M.

AU - Ching, R.

AU - Chu, C.

AU - Coaker, J.

AU - Cina, S.

AU - Cook, J.

AU - Coxhead, J.

AU - Crawford, G.

AU - Cummings, C.

AU - Davies, R.

AU - Debniak, T.

AU - De Moncuit, C.

AU - Drummond, S.

AU - Ellis, T.

AU - Farthing, K.

AU - Fidalgo, P.

AU - Gallinger, S.

AU - Gascoyne, J.

AU - Gilroy, J.

AU - Goff, S.

AU - Goldberg, P.

AU - Goodman, S.

AU - Harocopos, C.

AU - Hodgson, S.

AU - Jeffcoat, R.

AU - Jeffers, L.

AU - Jordan, S.

AU - Killick, P.

AU - Krauss, C.

AU - Kristensen, J.

AU - Langman, C.

AU - Leite, J.

AU - Liljegren, A.

AU - Lindren, G.

AU - Lynagh, L.

AU - Oliani, C.

AU - Marks, C.

AU - Miller, J.

AU - Miles, T.

AU - Murday, V.

AU - Perez Segura, P.

AU - Pietersen, E.

AU - Platten, U.

AU - Reed, L.

AU - Rossi, G.

AU - Sala, P.

AU - Sampson, J.

AU - Schmocker, B.

AU - Shaw, J.

AU - Spigelman, A.

AU - Tempesta, A.

AU - Toes, R.

AU - Velthuizen, M.

AU - Wakelen, P.

AU - Walpole, Ian

AU - Mathers, J.

AU - Kerr, D.

AU - Perkins, S.

AU - Cuzik, J.

AU - Faulds Wood, L.

AU - Steele, R.

AU - Altman, D.

AU - Paraskeva, C.

AU - Atkin, W.

AU - Hulls, M.

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 - 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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