A stratified randomized double-blind phase II trial of celecoxib for treating patients with cervical intraepithelial neoplasia: The potential predictive value of VEGF serum levels: An NRG Oncology/Gynecologic Oncology Group study.

摘要: Abstract Purpose To examine the effect of celecoxib on cervical intraepithelial neoplasia 3 (CIN 3). This is a NRG Oncology/Gynecologic Oncology Group study with translational biomarkers. Patients and methods CIN were randomized to 400mg once daily (67 patients) or placebo (63 for 14–18weeks. The primary outcome measure was histologic regression. A test equal probabilities success between two therapies conducted, using Fisher's Exact Test at alpha=10% 90% power when treatment arm boosted probability by 30%. Translational analysis included tissue HPV genotyping, COX-2 expression in biopsies, serum VEGF levels. Results In analysis, regression not significantly higher group (40%) than (34.1%). However, exploratory analyses suggest patients high levels exhibited greater (47.3%) (14.3%). Regression rates similar low VEGF. increased over time group, but remained same group. biopsies declined from pre-treatment end celecoxib; it did change placebo. Conclusions Celecoxib 14–18weeks decrease severity compared except, possibly, subjects baseline Therefore, might identify who may benefit other therapies, personalizing future chemoprevention trials 3.