The Efficacy of Celecoxib during Chemoradiation in Locally Advanced Head and Neck Carcinoma; A Phase 2 Randomized Placebo-Controlled Clinical Trial

Background: Cyclo-oxygenase-2 (COX-2), an enzyme induced in pathological states, mediates the production of prostaglandins. Celecoxib as a selective COX-2 inhibitor may affect the outcome of treatments in several cancer types. Objectives: We conducted a randomized controlled double-blind clinical trial to evaluate the toxicity and efficacy of celecoxib administered concurrently with chemoradiation in locally advanced head and neck carcinomas. Methods: Patients with locally advanced head and neck carcinoma referred for definitive chemoradiation were eligible to enter the study. Celecoxib (100mg, qid, oral) or placebo was administered all over the chemoradiation period. Results: Totally, 122 patients were enrolled. Patients in the celecoxib group had a longer median time to onset of grade 2 mucositis (56 days vs. 28 days, P < 0.001) and a lower rate of grade 3 mucositis (1.6% vs. 21.3%, P = 0.001). The 4-year progression-free survival was significantly higher in the celecoxib group (P = 0.0013). Conclusions: This study revealed that utilizing celecoxib may lead to better tumor local control and delayed and reduced mucosal side effects of chemoradiation.