WS10-3 - Irsogladine Maleate Prevents Oral Mucositis Associated with Radiotherapy in Patients with Head and Neck Cancer

Abstract

ABSTRACT Background Oral mucositis is a frequent and serious adverse event associated with radiotherapy. Although a number of compounds have been tested for prophylaxis of oral mucositis, few are satisfactory now. Several studies have shown that irsogladine, a gastric mucosal protective drug which facilitates gap-junctional intercellular communications, is effective for oral mucositis. Therefore we investigated the effect of irsogladine on radiotherapy-induced oral mucositis. Methods A prospective randomized study of 43 patients (10 females, 33 males) with advanced head and neck cancer was conducted from November 2010 to December 2011. Group A (n = 21) received irsogladine 4 mg during radiotherapy and Group B (n = 22) received radiotherapy without irsogladine. Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN), Revised Oral Assessment Guide (ROAG) and Common Terminology Criteria for Adverse Events (CTCAE) scores were analyzed by the Mann Whitney U-test. Results A significant decline in health and quality of life was observed in both groups as measured by the OMWQ-HN. However, the score for group A was significantly greater than that for group B at 50 Gy of radiotherapy (P = 0.03). Moreover, a significant increase in ROAG score was observed in both groups. Nevertheless, the ROAG score for group A was significantly lower than that for group B after 20 Gy of radiotherapy. There was no difference in safety score between the two groups as measured by CTCAE ver. 4. Conclusion Irsogladine appears to be useful for the prevention of oral mucositis associated with radiotherapy in patients with head and neck cancer.