The comparison between effect of chemoradiation with weekly cisplatin with or without celecoxib in treatment of nasopharyngeal carcinoma: A phase III clinical trial

Introduction: Concurrent cisplatin-based chemoradiation is currently considered the treatment of choice for locoregional nasopharyngeal carcinoma. Celecoxib is a selective cyclooxygenase-۲ (COX-۲) inhibitor which can potentially enhance the effect of radiotherapy. The aim of this study was to determine the efficacy and safety of celecoxib in nasopharyngeal carcinoma. Materials and Methods: Patients with newly diagnosed locoregional nasopharyngeal carcinoma were included in this clinical trial study. The patients were assigned to receive ۷ weeks concurrent chemoradiation with weekly cisplatin and either celecoxib ۱۰۰ mg twice daily or placebo. After completion of chemoradiation, all patients received combined chemotherapy with cisplatin plus ۵-Fu every ۳ weeks for ۳ cycles. Clinical response rates and treatment-related toxicity were the primary and secondary end-point of the study. Results: Total of ۵۰ eligible patients with the median age of ۴۳ years were enrolled in the trial. Overall (complete and partial) clinical response rate was ۱۰۰% in both groups. Complete and partial clinical response rates were ۶۴% and ۳۶% in study group and ۴۴% and ۵۶% in control group respectively (P>۰.۲۵). There was no difference in terms of treatment-related toxicity rates between two groups. Conclusions: This clinical trial showed that addition of celecoxib ۱۰۰ mg twice daily to concurrent chemoradiation does not increase the response rates and treatment-related toxicities in patients with locoregional nasopharyngeal carcinoma.

کلیدواژه ها:

Celecoxib ، chemotherapy ، Nasopharyngeal carcinoma ، Radiotherapy ، Response rate