31. Evaluation of pain and difficulty swallowing associated with oral mucositis during radiation for head and neck cancers

Background: Oral mucositis (OM) assessment scales vary on how objective findings are incorporated into the scoring system and, if and how subjective symptoms are integrated into the system. A randomized trial assessing the efficacy of iseganan in reducing the severity of OM was conducted using the visually objective NCICTC mucositis scale (NCMS) to measure the study's primary endpoint. We sought to determine whether patient reported assessments of the severity of their pain and difficulty swallowing correlated with objective measures of OM using the NCMS. Methods: 504 patients receiving radiation (XRT) to the oral cavity and/or oropharynx were randomized to receive iseganan, placebo or standard of care alone for treatment of OM. Twice weekly over the course of XRT, clinicians scored the severity of the patients' OM and dysphagia using the NCMS and patients reported the severity of their mouth pain and difficulty swallowing using an 11point numeric scale. Results: Over 95% of the scheduled assessments were obtained. Subjective pain scores were highly related to objective measures of OM and dysphagia; patient reported peak mouth pain and peak difficulty swallowing correlated with clinician assessed peak OM and peak dysphagia. The need for analgesics increased with increased peak mouth pain. Correlation between objective and subjective scores were seen with all 3 study arms as well as when patients were analyzed by subgroups: definitive versus postoperative XRT and concurrent chemoradiation versus XRT alone. Conclusion(s): Despite measuring the severity of OM by the objective visual appearance of mucosal damage only with a 5-point scale, the NCMS correlated well with patient reported severity of pain and difficulty swallowing. These results support the use of the NCMS as a clinically relevant and responsive endpoint for assessing the severity of OM secondary to XRT and its clinical sequelae in large multi-institutional clinical trials.