Abstract
Familial adenomatous polyposis (FAP) is a rare genetic disease. Without treatment, FAP patients have a 100% lifetime risk of developing colorectal cancer. This study was conducted to evaluate the effect of celecoxib treatment in prolonging the time to FAP-related events and to document the safety profile of the long-term use of celecoxib (≥6 months) in FAP patients. FAP patients receiving celecoxib in routine clinical practice were individually matched with historical/concurrent FAP patients not receiving celecoxib. The study population included patients aged 12 years or older registered in national and regional FAP registries in Denmark, the United States, Spain, and Canada. Descriptive statistics were used to summarize dose and duration among celecoxib treated patients. The primary study endpoints, time-to-next-FAP events, were examined with Kaplan–Meier method. Fifty four celecoxib-treated patients were recruited and a matched control was identified for 13 of these patients. The Kaplan–Meier estimated probability of not having a polypectomy 12 and 60 months post- ileorectal anastomosis in the celecoxib-treated patients (n = 33) was 60.6% and 42.2%, respectively. The estimated probability of not having a polypectomy 6–60 months post-ileal pouch-anal anastomosis the celecoxib-treated patients (n = 24) was 100%. The median total daily dose of celecoxib was 698.9 mg with the majority treated more than 24 months. Five celecoxib-treated patients experienced 6 serious adverse events with one of these events (rash) considered related to celecoxib. Long term celecoxib treatment appeared to be well tolerated in FAP patients with or without FAP-related surgeries.
Similar content being viewed by others
References
Kinzler KW, Vogelstein B (1996) Lessons from hereditary colorectal cancer. Cell 87(2):159–170
Macrae F, du Sart D, Nasioulas S (2009) Familial adenomatous polyposis. Best Pract Res Clin Gastroenterol 23(2):197–207
Bulow S (2003) Results of national registration of familial adenomatous polyposis. Gut 52(5):742–746
Lotfi AM, Dozois RR, Gordon H et al (1989) Mesenteric fibromatosis complicating familial adenomatous polyposis: predisposing factors and results of treatment. Int J Colorectal Dis 4(1):30–36
Spigelman AD, Talbot IC, Penna C et al (1994) Evidence for adenoma-carcinoma sequence in the duodenum of patients with familial adenomatous polyposis. The Leeds Castle Polyposis Group (Upper Gastrointestinal Committee). J Clin Pathol 47(8):709–710
Vasen HF, Moslein G, Alonso A et al (2008) Guidelines for the clinical management of familial adenomatous polyposis (FAP). Gut 57(5):704–713
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(26):1946–1952
Church J, Burke C, McGannon E, Pastean O, Clark B (2001) Predicting polyposis severity by proctoscopy: how reliable is it? Dis Colon Rectum 44(9):1249–1254
Acknowledgments
This study was sponsored by Pfizer, Inc. The authors would like to sincerely acknowledge Dr. Bohdana Ratitch who conducted data analysis and the FAP patients who agreed to participate in this study.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Huang, K., Gutierrez, L.P., Bülow, S. et al. Clinical characteristics and outcomes in familial adenomatous polyposis patients with a long-term treatment of celecoxib: a matched cohort study. Familial Cancer 10, 303–308 (2011). https://doi.org/10.1007/s10689-011-9423-4
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10689-011-9423-4