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 -
