Long-term chemoprevention in patients with adenomatous polyposis coli: an observational study.
Chemoprevention
FAP
NSAIDs
Polyposis
Journal
Familial cancer
ISSN: 1573-7292
Titre abrégé: Fam Cancer
Pays: Netherlands
ID NLM: 100898211
Informations de publication
Date de publication:
10 2022
10 2022
Historique:
received:
12
04
2021
accepted:
10
03
2022
pubmed:
16
5
2022
medline:
9
11
2022
entrez:
15
5
2022
Statut:
ppublish
Résumé
Prospective short-term studies on effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) point towards a decrease in the number and size of polyps. Effectiveness and safety in the prevention of progression in familial polyposis with NSAIDs in long-term use, which is the prerequisite for therapeutic evaluation in prospective studies, is unknown. The total absolute observation period of 54 patients under sulindac was 399 patient years with a mean of 7.4 (2-19) years per patient. 36 patients (66.7%) showed a fast decrease of polyp burden, 8 (14.8%) were slow responders, and 9 (16.7%) had stable disease; one patient had a slow progression. Upper gastrointestinal (GI) polyp burden remained stable in 47% patients, increased in 31%, and improved in 22%. Advanced adenomas were found in 8 patients only within the first 5 years of chemoprevention, no patient developed desmoid disease, anamnestically evaluated on every follow-up. There were no life-threatening side-effects. Dosage and delivery pattern were essential for effectiveness. This study provides evidence that chemoprevention with sulindac is effective and safe and can, either alone or in combination with other drugs, become a long-term management option in cases of adenomatous polyposis. These results justify further long-term prospective chemoprevention studies to elaborate treatment protocols and guidelines.
Identifiants
pubmed: 35570229
doi: 10.1007/s10689-022-00292-2
pii: 10.1007/s10689-022-00292-2
doi:
Substances chimiques
Sulindac
184SNS8VUH
Anti-Inflammatory Agents, Non-Steroidal
0
Types de publication
Observational Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
463-472Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature B.V.
Références
Bertagnolli MM, Eagle CJ, Zauber AG et al (2006) Celecoxib for the prevention of sporadic colorectal adenomas. N Engl J Med 355:873–884. https://doi.org/10.1056/NEJMoa061355
doi: 10.1056/NEJMoa061355
pubmed: 16943400
Cruz-Correa M, Hylind LM, Romans KE et al (2002) Long-term treatment with sulindac in familial adenomatous polyposis: a prospective cohort study. Gastroenterology 122:641–645
doi: 10.1053/gast.2002.31890
pubmed: 11874996
Giardiello FM, Yang VW, Hylind LM et al (2002) Primary chemoprevention of familial adenomatous polyposis with sulindac. N Engl J Med 346:1054–1059. https://doi.org/10.1056/NEJMoa012015
doi: 10.1056/NEJMoa012015
pubmed: 11932472
pmcid: 2225537
Nugent KP, Farmer KC, Spigelman AD et al (1993) Randomized controlled trial of the effect of sulindac on duodenal and rectal polyposis and cell proliferation in patients with familial adenomatous polyposis. Br J Surg 80:1618–1619
doi: 10.1002/bjs.1800801244
pubmed: 8298943
Eberhart CE, Coffey RJ, Radhika A et al (1994) Up-regulation of cyclooxygenase 2 gene expression in human colorectal adenomas and adenocarcinomas. Gastroenterology 107:1183–1188. https://doi.org/10.1016/0016-5085(94)90246-1
doi: 10.1016/0016-5085(94)90246-1
pubmed: 7926468
Kargman SL, O’Neill GP, Vickers PJ et al (1995) Expression of prostaglandin G/H synthase-1 and -2 protein in human colon cancer. Cancer Res 55:2556–2559
pubmed: 7780968
Kemp Bohan PM, Mankaney G, Vreeland TJ et al (2020) Chemoprevention in familial adenomatous polyposis: past, present and future. Fam Cancer. https://doi.org/10.1007/s10689-020-00189-y
doi: 10.1007/s10689-020-00189-y
pubmed: 32507936
pmcid: 7276278
Steinbach G, Lynch PM, Phillips RK et al (2000) The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis. N Engl J Med 342:1946–1952. https://doi.org/10.1056/NEJM200006293422603
doi: 10.1056/NEJM200006293422603
pubmed: 10874062
Phillips RKS, Wallace MH, Lynch PM et al (2002) A randomised, double blind, placebo controlled study of celecoxib, a selective cyclooxygenase 2 inhibitor, on duodenal polyposis in familial adenomatous polyposis. Gut 50:857–860. https://doi.org/10.1136/gut.50.6.857
doi: 10.1136/gut.50.6.857
pubmed: 12010890
pmcid: 1773237
Bresalier RS, Sandler RS, Quan H et al (2005) Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 352:1092–1102. https://doi.org/10.1056/NEJMoa050493
doi: 10.1056/NEJMoa050493
pubmed: 15713943
Solomon SD, McMurray JJV, Pfeffer MA et al (2005) Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 352:1071–1080. https://doi.org/10.1056/NEJMoa050405
doi: 10.1056/NEJMoa050405
pubmed: 15713944
Burn J, Bishop DT, Chapman PD et al (2011) A randomized placebo-controlled prevention trial of aspirin and/or resistant starch in young people with familial adenomatous polyposis. Cancer Prev Res (Phila) 4:655–665. https://doi.org/10.1158/1940-6207.CAPR-11-0106
doi: 10.1158/1940-6207.CAPR-11-0106
Meyskens FL, McLaren CE, Pelot D et al (2008) Difluoromethylornithine plus sulindac for the prevention of sporadic colorectal adenomas: a randomized placebo-controlled, double-blind trial. Cancer Prev Res (Phila) 1:32–38. https://doi.org/10.1158/1940-6207.CAPR-08-0042
doi: 10.1158/1940-6207.CAPR-08-0042
Lynch PM, Burke CA, Phillips R et al (2015) An international randomised trial of celecoxib versus celecoxib plus difluoromethylornithine in patients with familial adenomatous polyposis. Gut. https://doi.org/10.1136/gutjnl-2014-307235
doi: 10.1136/gutjnl-2014-307235
pubmed: 25792707
Samadder NJ, Neklason DW, Boucher KM et al (2016) Effect of sulindac and erlotinib vs placebo on duodenal neoplasia in familial adenomatous polyposis: a randomized clinical trial. JAMA 315:1266. https://doi.org/10.1001/jama.2016.2522
doi: 10.1001/jama.2016.2522
pubmed: 27002448
pmcid: 5003411
Samadder NJ, Kuwada SK, Boucher KM et al (2018) Association of sulindac and erlotinib vs placebo with colorectal neoplasia in familial adenomatous polyposis: secondary analysis of a randomized clinical trial. JAMA Oncol. https://doi.org/10.1001/jamaoncol.2017.5431
doi: 10.1001/jamaoncol.2017.5431
pubmed: 29710287
pmcid: 5885170
Burke CA, Dekker E, Lynch P et al (2020) Eflornithine plus sulindac for prevention of progression in familial adenomatous polyposis. N Engl J Med 383:1028–1039. https://doi.org/10.1056/NEJMoa1916063
doi: 10.1056/NEJMoa1916063
pubmed: 32905675
Burke CA, Dekker E, Samadder NJ et al (2016) Efficacy and safety of eflornithine (CPP-1X)/sulindac combination therapy versus each as monotherapy in patients with familial adenomatous polyposis (FAP): design and rationale of a randomized, double-blind, Phase III trial. BMC Gastroenterol. https://doi.org/10.1186/s12876-016-0494-4
doi: 10.1186/s12876-016-0494-4
pubmed: 27480131
pmcid: 4969736
West NJ, Clark SK, Phillips RKS et al (2010) Eicosapentaenoic acid reduces rectal polyp number and size in familial adenomatous polyposis. Gut 59:918–925. https://doi.org/10.1136/gut.2009.200642
doi: 10.1136/gut.2009.200642
pubmed: 20348368
Bussey HJ, DeCosse JJ, Deschner EE et al (1982) A randomized trial of ascorbic acid in polyposis coli. Cancer 50:1434–1439. https://doi.org/10.1002/1097-0142(19821001)50:7%3c1434::aid-cncr2820500733%3e3.0.co;2-f
doi: 10.1002/1097-0142(19821001)50:7<1434::aid-cncr2820500733>3.0.co;2-f
pubmed: 7049351
Yuksekkaya H, Yucel A, Gumus M et al (2016) Familial adenomatous polyposis; succesful use of sirolimus. Am J Gastroenterol 111:1040–1041. https://doi.org/10.1038/ajg.2016.159
doi: 10.1038/ajg.2016.159
pubmed: 27356835
Campos FG (2014) Surgical treatment of familial adenomatous polyposis: dilemmas and current recommendations. World J Gastroenterol 20:16620–16629. https://doi.org/10.3748/wjg.v20.i44.16620
doi: 10.3748/wjg.v20.i44.16620
pubmed: 25469031
pmcid: 4248206
Agüera-González S, Burton OT, Vázquez-Chávez E et al (2017) Adenomatous polyposis coli defines treg differentiation and anti-inflammatory function through microtubule-mediated NFAT localization. Cell Rep 21:181–194. https://doi.org/10.1016/j.celrep.2017.09.020
doi: 10.1016/j.celrep.2017.09.020
pubmed: 28978472
Gounaris E, Blatner NR, Dennis K et al (2009) T-regulatory cells shift from a protective anti-inflammatory to a cancer-promoting proinflammatory phenotype in polyposis. Cancer Res 69:5490–5497. https://doi.org/10.1158/0008-5472.CAN-09-0304
doi: 10.1158/0008-5472.CAN-09-0304
pubmed: 19570783
pmcid: 2881579
Cassani LS, Lanke G, Chen H-C et al (2017) Comparison of nonampullary duodenal adenomas in patients with familial adenomatous polyposis versus patients with sporadic adenomas. Gastrointest Endosc 85:803–812. https://doi.org/10.1016/j.gie.2016.08.005
doi: 10.1016/j.gie.2016.08.005
pubmed: 27530072
Nieuwenhuis MH, Vasen HFA (2007) Correlations between mutation site in APC and phenotype of familial adenomatous polyposis (FAP): a review of the literature. Crit Rev Oncol Hematol 61:153–161. https://doi.org/10.1016/j.critrevonc.2006.07.004
doi: 10.1016/j.critrevonc.2006.07.004
pubmed: 17064931
Giardiello FM, Offerhaus GJ, DuBois RN (1995) The role of nonsteroidal anti-inflammatory drugs in colorectal cancer prevention. Eur J Cancer 31A:1071–1076. https://doi.org/10.1016/0959-8049(95)00137-8
doi: 10.1016/0959-8049(95)00137-8
pubmed: 7576994
Labayle D, Boyer J, Drouhin F et al (1994) Sulindac in familial adenomatous polyposis. Lancet 343:417–418. https://doi.org/10.1016/s0140-6736(94)91253-x
doi: 10.1016/s0140-6736(94)91253-x
pubmed: 7905570
Lynch PM, Ayers GD, Hawk E et al (2010) The safety and efficacy of celecoxib in children with familial adenomatous polyposis. Am J Gastroenterol 105:1437–1443. https://doi.org/10.1038/ajg.2009.758
doi: 10.1038/ajg.2009.758
pubmed: 20234350
Higuchi T, Iwama T, Yoshinaga K et al (2003) A randomized, double-blind, placebo-controlled trial of the effects of rofecoxib, a selective cyclooxygenase-2 inhibitor, on rectal polyps in familial adenomatous polyposis patients. Clin Cancer Res 9:4756–4760
pubmed: 14581346
Iwama T, Akasu T, Utsunomiya J, Muto T (2006) Does a selective cyclooxygenase-2 inhibitor (tiracoxib) induce clinically sufficient suppression of adenomas in patients with familial adenomatous polyposis? A randomized double-blind placebo-controlled clinical trial. Int J Clin Oncol 11:133–139. https://doi.org/10.1007/s10147-005-0548-z
doi: 10.1007/s10147-005-0548-z
pubmed: 16622748
Waddell WR, Ganser GF, Cerise EJ, Loughry RW (1989) Sulindac for polyposis of the colon. Am J Surg 157:175–179
doi: 10.1016/0002-9610(89)90442-X
pubmed: 2535920
Rigau J, Piqué JM, Rubio E et al (1991) Effects of long-term sulindac therapy on colonic polyposis. Ann Intern Med 115:952–954. https://doi.org/10.7326/0003-4819-115-12-952
doi: 10.7326/0003-4819-115-12-952
pubmed: 1659272
Spagnesi MT, Tonelli F, Dolara P et al (1994) Rectal proliferation and polyp occurrence in patients with familial adenomatous polyposis after sulindac treatment. Gastroenterology 106:362–366. https://doi.org/10.1016/0016-5085(94)90593-2
doi: 10.1016/0016-5085(94)90593-2
pubmed: 8299902
Ishikawa H (2004) Chemoprevention of carcinogenesis in familial tumors. Int J Clin Oncol 9:299–303. https://doi.org/10.1007/s10147-004-0417-1
doi: 10.1007/s10147-004-0417-1
pubmed: 15375706
Winde G, Schmid KW, Brandt B et al (1997) Clinical and genomic influence of sulindac on rectal mucosa in familial adenomatous polyposis. Dis Colon Rectum 40:1156–1168. https://doi.org/10.1007/bf02055161 (discussion 1168–1169)
doi: 10.1007/bf02055161
pubmed: 9336110
Tonelli F, Valanzano R, Messerini L, Ficari F (2000) Long-term treatment with sulindac in familial adenomatous polyposis: is there an actual efficacy in prevention of rectal cancer? J Surg Oncol 74:15–20. https://doi.org/10.1002/1096-9098(200005)74:1%3c15::aid-jso4%3e3.0.co;2-z
doi: 10.1002/1096-9098(200005)74:1<15::aid-jso4>3.0.co;2-z
pubmed: 10861602
Fernández-López F, Conde-Freire R, Cadarso-Suárez C et al (2001) Sulindac in familial adenomatous polyposis: evaluation by nuclear morphometry. Eur J Surg 167:375–381. https://doi.org/10.1080/110241501750215285
doi: 10.1080/110241501750215285
pubmed: 11419555
Guldenschuh I, Hurlimann R, Muller A et al (2001) Relationship between APC genotype, polyp distribution, and oral sulindac treatment in the colon and rectum of patients with familial adenomatous polyposis. Dis Colon Rectum 44:1090–1097. https://doi.org/10.1007/bf02234627 (discussion 1097–1099)
doi: 10.1007/bf02234627
pubmed: 11535846
Matsumoto T, Nakamura S, Esaki M et al (2006) Effect of the non-steroidal anti-inflammatory drug sulindac on colorectal adenomas of uncolectomized familial adenomatous polyposis. J Gastroenterol Hepatol 21:251–257. https://doi.org/10.1111/j.1440-1746.2006.04181.x
doi: 10.1111/j.1440-1746.2006.04181.x
pubmed: 16460482
Akasu T, Yokoyama T, Sugihara K et al (2002) Peroral sustained-release indomethacin treatment for rectal adenomas in familial adenomatous polyposis: a pilot study. Hepatogastroenterology 49:1259–1261
pubmed: 12239919
Hirota C, Iida M, Aoyagi K et al (1996) Effect of indomethacin suppositories on rectal polyposis in patients with familial adenomatous polyposis. Cancer 78:1660–1665
doi: 10.1002/(SICI)1097-0142(19961015)78:8<1660::AID-CNCR4>3.0.CO;2-I
pubmed: 8859177
Dolara P, Caderni G, Tonelli F (1999) Nimesulide, a selective anti-inflammatory cyclooxygenase-2 inhibitor, does not affect polyp number and mucosal proliferation in familial adenomatous polyposis. Scand J Gastroenterol 34:1168. https://doi.org/10.1080/003655299750025002
doi: 10.1080/003655299750025002
pubmed: 10582771
van Stolk R, Stoner G, Hayton WL et al (2000) Phase I trial of exisulind (sulindac sulfone, FGN-1) as a chemopreventive agent in patients with familial adenomatous polyposis. Clin Cancer Res 6:78–89
pubmed: 10656435
Kim B, Giardiello FM (2011) Chemoprevention in familial adenomatous polyposis. Best Pract Res Clin Gastroenterol 25:607–622. https://doi.org/10.1016/j.bpg.2011.08.002
doi: 10.1016/j.bpg.2011.08.002
pubmed: 22122775
pmcid: 3569729
Giardiello FM, Hamilton SR, Krush AJ et al (1993) Treatment of colonic and rectal adenomas with sulindac in familial adenomatous polyposis. N Engl J Med 328:1313–1316. https://doi.org/10.1056/NEJM199305063281805
doi: 10.1056/NEJM199305063281805
pubmed: 8385741
Giardiello FM, Spannhake EW, DuBois RN et al (1998) Prostaglandin levels in human colorectal mucosa: effects of sulindac in patients with familial adenomatous polyposis. Dig Dis Sci 43:311–316
doi: 10.1023/A:1018898120673
pubmed: 9512123
pmcid: 2700288
Niv Y, Fraser GM (1994) Adenocarcinoma in the rectal segment in familial polyposis coli is not prevented by sulindac therapy. Gastroenterology 107:854–857. https://doi.org/10.1016/0016-5085(94)90136-8
doi: 10.1016/0016-5085(94)90136-8
pubmed: 8076772
Lynch HT, Thorson AG, Smyrk T (1995) Rectal cancer after prolonged sulindac chemoprevention. A case report. Cancer 75:936–938. https://doi.org/10.1002/1097-0142(19950215)75:4%3c936::aid-cncr2820750407%3e3.0.co;2-q
doi: 10.1002/1097-0142(19950215)75:4<936::aid-cncr2820750407>3.0.co;2-q
pubmed: 7842414
Ishikawa H, Akedo I, Suzuki T et al (1997) Adverse effects of sulindac used for prevention of colorectal cancer. J Natl Cancer Inst 89:1381. https://doi.org/10.1093/jnci/89.18.1381
doi: 10.1093/jnci/89.18.1381
pubmed: 9308710
Solomon SD, Wittes J, Finn PV et al (2008) Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation 117:2104–2113. https://doi.org/10.1161/CIRCULATIONAHA.108.764530
doi: 10.1161/CIRCULATIONAHA.108.764530
pubmed: 18378608
pmcid: 2965408