A randomized double-blind placebo-controlled phase II trial of the cyclooxygenase-2 inhibitor Celecoxib in the treatment of cervical dysplasia.

OBJECTIVES

The objective of the study was to evaluate the efficacy of daily Celecoxib in the regression of moderate and severe cervical dysplasia, when compared to placebo.

MATERIALS AND METHODS

Women, over the age of 18, with the histologic diagnosis of moderate or severe cervical dysplasia were enrolled in this IRB approved study. Women were randomized to receive either Celecoxib 200 mg 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-month intervals for 6 months, with cytologic and histologic specimens.

RESULTS

From June 2002 until October 2003, a total of 25 patients were enrolled in this randomized phase II study. There was no statistical difference in screening entry criteria, clinical histologic and cytologic variables between the two groups. 60% of patients enrolled had an overall response in the trial. The mean time to response was 72 days. 75% 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<0.03. 33% of patients in the Celecoxib group had complete pathologic response to therapy, which was higher than the placebo group 15%.

CONCLUSION

We have observed that Celecoxib could have activity in the treatment of high-grade cervical dysplasia. As a result, medical treatment of cervical dysplasia with Celecoxib could offer a minimally invasive treatment with minor morbidity and time constraints. Further trials with larger numbers are needed to confirm these results.