5-Fluorouracil (5-FU) is the most effective and frequently used agent for gastrointestinal cancer, and that is well known for causing mucositis. Irsogladine maleate (IM), an anti-ulcer drug, reinforces gap junction and accelerated intercellular communication in the oral and gastric mucosa. The objective of the present study was to evaluate irsogladine maleate in the prophylaxis of fluorouracil-induced oral mucositis.Methods
We retrospectively analyzed 34 cancer patients undergoing fluorouracil and platinum chemotherapy as primary treatment between August 2011 and November 2011. The chemotherapy regimens consist of continuous infusion of 5-FU 700 mg/m2 on day 1–4 and cisplatin 70 mg/m2 on day 1 (FP), or continuous infusion of 5-FU 700 mg/m2 on day 1–5 and nedaplatin 130 mg/m2 on day 6 (FN), repeated every 4 weeks. Patients were randomly assigned to IM group (given 4 mg/day IM on day 1–14) or non-IM group. Oral mucositis were graded according to World Health Organization criteria.Results
The incidence of 5-FU associated oral mucositis (WHO grade 1 or above) in which four patients (23.5%) in IM group (1 patient with grade 2 and 2 patients with grade 1) and 13 patients (76.5%) in non-IM group (four patients with grade 2 and 7 patients with grade 1) were observed (x2 test: odds ratio, 5.96; 95% confidence interval, 1.33–26.66; P = 0.015). No patient with grade 3 or above oral mucositis was observed in both groups.Conclusion
Our study demonstrated that irsogladine maleate was effective for prophylaxis of fluorouracil-induced oral mucositis.