Children's International Polyposis (CHIP) study: a randomized, double-blind, placebo-controlled study of celecoxib in
Carol A Burke1, Robin Phillips2, Manuela F Berger3
1Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH, USA.
Insights
Celecoxib reduced colorectal polyposis in children with familial adenomatous polyposis (FAP), delaying disease progression compared to placebo. However, the study
Area of Science:
- Pediatric Gastroenterology
- Oncology
- Pharmacology
Background:
- Familial adenomatous polyposis (FAP) is a genetic disorder characterized by numerous colorectal polyps, increasing cancer risk.
- Current management strategies for FAP in pediatric patients require effective and safe interventions to prevent polyposis progression.
Purpose of the Study:
- To assess the efficacy and safety of celecoxib in preventing and treating colorectal polyposis in pediatric patients with FAP.
- To compare celecoxib's effects against a placebo in this specific patient population.
Main Methods:
- Phase III, double-blind, randomized, placebo-controlled, multicenter trial involving patients aged 10-17 years with FAP.
- Patients received either celecoxib (16 mg/kg/day) or placebo for up to 5 years, with annual colonoscopies.
- Primary endpoint: time to earliest occurrence of ≥20 polyps (>2 mm) or colorectal malignancy; study terminated early.
Main Results:
- Disease progression occurred in 12.7% of the celecoxib group versus 25.5% in the placebo group.
- Median time to disease progression was significantly longer with celecoxib (2.1 years) compared to placebo (1.1 years).
- Adverse event rates were similar; however, serious adverse events were reported in three celecoxib patients.
Conclusions:
- Celecoxib demonstrated a lower rate of colorectal polyposis and delayed disease progression in pediatric FAP patients compared to placebo.
- Celecoxib was well-tolerated, but the study's early termination limited assessment of long-term impact.
- Further research is needed to confirm long-term benefits and safety profiles.
Objective:
To evaluate the efficacy and safety of celecoxib versus placebo in the prevention and treatment of colorectal polyposis in children with familial adenomatous polyposis (FAP).
Methods:
In this Phase III, double-blind, randomized, placebo-controlled, multicenter 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:
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. The rate of adverse events (AEs) was similar in both groups (75.5% and 72.9%, respectively). Three patients in the celecoxib group (none in the placebo group) experienced serious AEs.
Conclusion:
In children with FAP, celecoxib was a well-tolerated treatment that was associated with a lower rate of colorectal polyposis and a longer time to disease progression compared with placebo. Due to the low rate of observed endpoints, the long-term impact of these results could not be ascertained.
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