365PD The role of Cox-2inhibitor in combination with chemoradiotherapy in head and neck carcinoma to reduce mucositis and other side effects

Abstract

Background Chemotherapy and radiotherapy-induced oral mucositis represents a therapeutic challenge frequently encountered in cancer patients. This side effect causes significant morbidity and may delay or interruption of treatment plan, as well as reduce theraeutic index. Cyclo-oxygenase 2 (Cox2) is an inducible enzyme primarily expressd in inflamed tissue and tumor. Cox-2 inhibitors have shown promise as radio- and chemosensitizer and reduce radio induced toxicities. We conducted a phase III, randomised, double blind, clinical trial to evaluate the toxicity and efficacy of celecoxib, a selective Cox-2 inhibitor, administered concurrently with chemotherapy, and radiation for locally advanced head and neck. Here we report the first report about the role of Cox-2 inhibitor in acute toxicities. Methods Patients with stage III/IV (locally advance) carcinoma of oropharynx, oral cavity, hypopharynx, larynx or nasopharynx who were referred to the department of radiation oncology were eligible. The end points of this study were acute toxicity, response rate and local control. Patients were treated with chemotherapy and concurrent radiation 60-70GY. Celecoxib (100mg qid) was started on the first day of radiotherapy and was given for a total of 8 weeks. Acute toxicities were evaluated every week by WHO scale. Results 122 patients were recruited to this study (each group with 62 patients), 74 male and 48 female with median age of 55.7 years. We used analysis of variance of repeated measures; both groups had acute toxicity but the toxicity in group B was very significantly induced. Mucusitis in group A was significantly (p < 0.000) better than in group B. In group A dermatitis and weight were better than group B. wBC and Cr in both groups were not different. Conclusions It seems that the use of Cox-2 inhibitors may reduce toxicity, especially mucositis resulting from chemoradioation in head and neck cancer. Legal entity responsible for the study Dr Mojahed Funding Tehran University Medical School - Departman Radiation Oncology Disclosure All authors have declared no conflicts of interest.