welcome to oneFAPvoice
- a positively charged Familial Adenomatous Polyposis community.- join today!
- login
The Safety and Efficacy of Celecoxib in Children with Familial Adenomatous Polyposis
source: The American journal of gastroenterology
year: 2010
authors: Lynch P M, Ayers G D, Hawk E, Richmond E, Eagle C, Woloj M, Church J, Hasson H, Patterson S, Half E, Burke C A
summary/abstract:OBJECTIVES : Celecoxib is approved as an adjunctive chemopreventive agent in adults with familial adenomatous polyposis (FAP). Its safety and efficacy for colorectal polyps in children is unknown. We evaluated the short-term (3 months) safety and preliminary efficacy of celecoxib in children with FAP.
METHODS : This was a phase I, dose-escalation trial, with three successive cohorts of six children. Children of ages 10-14 years with APC gene mutations and/or adenomas with a family history of FAP were studied at M.D. Anderson Cancer Center and the Cleveland Clinic. Colonoscopy was performed at baseline and month 3. Random assignment was in a 2:1 generic:placebo ratio, escalating from cohort 1 (4 mg/kg/day) to cohort 2 (8 mg/kg/day) to cohort 3 (16 mg/kg/day). Adherence and adverse event (AE) monitoring was conducted at 2-week intervals during drug administration. Safety profile, difference in number, and percent change in colorectal polyps were compared among the four treatments (placebo and the three dose-escalation groups).
RESULTS : Eighteen subjects completed drug dosing and both colonoscopies. Median age was 12.3 years (56% female). No clinically meaningful differences in AEs were seen between placebo subjects and subjects at any of the three celecoxib doses. Median polyp count at baseline was 31. There was a 39.1% increase in the number of polyps in placebo subjects at month 3, whereas in the highest dose celecoxib group, 16 mg/kg/day, a 44.2% reduction was seen (P=0.01).
CONCLUSIONS : Celecoxib at a dose of 16 mg/kg/day, corresponding to the adult dose of 400 mg BID, is safe, well tolerated, and significantly reduced the number of colorectal polyps in children with FAP.
organization: University of Texas M.D. Anderson Cancer CenterDOI: 10.1038/ajg.2009.758
read more full text source
expertly curated content related to this topic
-
Female Fertility after Colorectal Surgery for Familial Adenomatous Polyposis (FAP)Poster Presentation Background & ...
-
Ostomy cleaning and wearhttps://www.youtube.com/watch?v=ZQ3PEnI7...
-
Surveillance of Duodenal Polyposis in Familial Adenomatous Polyposis: Should the Spigelman Score Be Modified?BACKGROUND: Duodenal polyposis is a mani...
-
@fapmomProud of my 2 inspiring kids that were d...
-
Strategy for Surgery in Familial Adenomatous Polyposis Patients with Invasive Colorectal CancerPURPOSE : Total proctocolectomy with ile...
-
Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?Total proctocolectomy with ileal pouch a...