Burke CA, et al. – The efficacy and safety of celecoxib were compared with placebo in the prevention and treatment of colorectal polyposis in children with familial adenomatous polyposis (FAP). Outcomes confirmed that celecoxib was a well–tolerated and was associated with a lower rate of colorectal polyposis and a longer time to disease progression compared with placebo.

Methods

• In this trial, patients aged 10–17 years with FAP were randomized to celecoxib (16 mg/kg/day) or placebo for up to 5 years.
• Patients underwent annual assessments, including colonoscopies, to detect the time from randomization to the earliest occurrence of ≥20 polyps (>2 mm in size) or colorectal malignancy.
• The study was terminated early due to low rate of observed endpoints combined with a lower than expected enrollment rate.
• Descriptive results are provided.

Results

• Out of 106 randomized patients, 55 were treated with celecoxib (mean age 12.6 years; 52.7% female) and 51 were given placebo (mean age 12.2 years; 54.9% female).
• Disease progression (≥20 polyps, >2 mm in size) was observed in seven (12.7%) and 13 (25.5%) patients, respectively.
• The median time to disease progression was 2.1 years in the celecoxib group and 1.1 years for placebo.
• No patient developed colorectal cancer.
• In both groups, the rate of adverse events (AEs) was similar (75.5% and 72.9%, respectively).
• In the celecoxib group, 3 patients experienced serious AEs (none in the placebo group).