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Celecoxib prevented colorectal polyps in children with familial adenomatous polyposis
PHILADELPHIA — Celecoxib reduced event rate and delayed progression of adenomas in children with familial adenomatous polyposis, known as FAP, when compared with placebo, according to phase 3 study data presented at the ACG Annual Scientific Meeting.
“Because of the burden of the disease on both the parent and the child, and this inexorable progression from polyps to cancer in individuals with FAP unless the colon is removed, we devised a study to look at the effect of an anti-inflammatory medication, celecoxib — which has been shown to reduce colon polyps in adults — for its effectiveness in children with FAP so we could delay the time to surgery or even obviate the need for surgery if shown to be extremely effective,” Carol A. Burke, MD, division of gastroenterology and hepatology at the Cleveland Clinic, told Healio.com/Gastroenterology.
Carol A. Burke
Burke and colleagues performed a double-blind study at 18 centers in 13 countries from 2006 to 2013 in order to assess the safety and efficacy of celecoxib in preventing colorectal polyps in pediatric patients with FAP. The study included 106 patients aged 10 to 17 years with less than 20 polyps sized greater than 2 mm. The patients were randomly assigned to receive either 16 mg/kg celecoxib daily (n=55; mean age, 12.6 years) for 23 months or placebo (n=51; mean age 12.2 years) for 25.5 months, and underwent annual colonoscopy.
Thirteen percent of patients receiving celecoxib developed more than 20 polyps larger than 2 mm compared with 26% of the placebo group, and median time to progression for these patients was 2.1 and 1.1 years, respectively. Causality treatment emergent AEs (TEAEs) occurred in 76% of the celecoxib group compared with 73% of the placebo group; treatment-related TEAEs occurred in 34% vs. 31%, respectively, and colorectal malignancy occurred in no patients.
“What we found was that half of the children developed polyps in twice the period of time than the children that were in the placebo arm,” Burke said. “So, on the basis of our study, we showed that there was suggestion of obvious benefit in delaying disease progression in children with FAP.”
The study also proved that celecoxib seemed to be safe in these children, she added.
For more information:
Burke CA. Abstract 26. Presented at: ACG Annual Scientific Meeting, Oct. 20-22, 2014; Philadelphia, PA.
Disclosure: Burke, Phillips, Lynch, Berger, Li and Iorga report financial ties to Pfizer.