A randomized double-blind phase II evaluation of the cyclooxygenase-2 protein inhibitor celecoxib in treating severe dysplasia of the cervix

Abstract

5106 Background: We evaluated the efficacy of daily Celecoxib in the regression of moderate and severe cervical dysplasia, when compared to placebo. Methods: All women, over the age of 18, with the histologic diagnosis of CIN II or III were entered onto the IRB approved study. Women who were pregnant, breast feeding, had a medical history of stomach bleeding, history of allergic reaction after taking NSAIDs, severe kidney or liver problems, positive dysplasia on ECC, cervical cytology diagnosis of, AGUS, CIS, AIS, invasive carcinoma, or severe clinical immunosuppression, were excluded. Women were randomized to receive either Celecoxib 200mg twice a day or placebo. Both examining physician and patients were blinded to treatment option. Follow-up colposcopy with cervical cytology was obtained at 2 months intervals for six months. Results: From November 2002 until October 2003 a total of 25 patients were enrolled in this Randomized Phase II study. 5 patients self terminated the study early but were included in the final statistical analysis. All of the Celecoxib patients tested positive by HC II for high risk HPV while only 85% of placebo patients were positive for high risk HPV. 92%, of the Celecoxib group had CIN II while, 15%, of the placebo group had CIN III. There was no statistical difference in the distribution of any of the clinical variables between the Celecoxib and placebo groups to include entry histology and cytology. 56% of patients enrolled had an overall response in the trial. The mean time to response was 69 days. 84% of patients who received Celecoxib had a clinical response. This was significantly higher than the 31%, of the placebo patients that had a clinical response, p< 0.025. 1 patient, 8%, of the Celecoxib group had progression of disease while three, 23%, of the placebo group had progression of disease at a mean time of 65 days. Conclusions: We have demonstrated that Celecoxib has significant activity in the treatment of high-grade cervical dysplasia. Those patients taking Celecoxib were 75% more likely to have a decrease in the severity of cervical dysplasia on therapy. Further trials with larger numbers are needed to assess duration of response. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer