The cyclooxygenase-2 inhibitor rofecoxib (Vioxx®) in the treatment of cervical dysplasia grade II–III: A phase II trial

ObjectiveTo determine whether the cyclooxygenase (COX)-2 inhibitor rofecoxib increases the regression rates of cervical intraepithelial neoplasia (CIN) grade II and III.Study designA prospective, randomized, placebo-controlled, double-blind study with rofecoxib 25 mg daily for six months as active treatment for patients with CIN II and III was started in May 2005 and was halted after rofecoxib withdrawal in October 2005.ResultsA total of 16 patients with CIN II (n = 9) and CIN III (n = 7) were included in our study. Eight and eight patients received rofecoxib and placebo, respectively. Regression rates in the rofecoxib and placebo arm were statistically not significant (25% versus 12.5%) after a mean of 87 (46.3) days of treatment. No severe side effects were noted during the therapy; no dropouts were recorded.ConclusionA conservative treatment of CIN II and III is feasible. Inhibitors of COX, especially COX-2, were seen as candidates for cancer chemoprevention. Our study was halted after rofecoxib was withdrawn. The results obtained should be added to those already published for planning future studies on medical therapies for high grade CIN.