Sulfasalazine decreases acute gastrointestinal complications due to pelvicradiotherapy

BACKGROUND: Radiation-induced gastrointestinal toxicity is a significant co ncern for patients who are treated with this modality for pelvic malignanci es. Eicosanoids and free radicals are thought to be among the reasons for t his effect. Sulfasalazine is an inhibitor of their synthesis in the mucosa. OBJECTIVE: To determine whether sulfasalazine can reduce the radiation-indu ced acute gastrointestinal complications. METHODS: In this prospective, double-blind study, 31 patients receiving pel vic radiotherapy were randomized to receive two sulfasalazine 500-mg tablet s twice daily or placebo, administered orally from the, first day of irradi ation. Patients were evaluated weekly, and gastrointestinal toxicities were graded according to the Late Effect of Normal Tissue - Subjective Objectiv e Management Analytic (LENT-SOMA) toxicity table during pelvic radiotherapy . On the last day of week 5, the subjects were graded endoscopically, and b iopsies taken from the rectum were classified histopathologically.; RESULTS: Groups did not differ in age, gender, tumor site, or irradiation p rocedure. During radiotherapy, grade 2 or higher gastrointestinal toxicity occurred in 20% (3/15) and 63% (10/16) of the sulfasalazine and placebo gro ups, respectively. This - difference was significant (p = 0.017). No statis tically significant differences were found in endoscopic and histopathologi c evaluations. CONCLUSIONS: Sulfasalazine is effective in decreasing clinically acute gast rointestinal toxicities. Long-term follow-up with the subjects will help to determine the net effect of sulfasalazine on the radiation-induced gastroi ntestinal injuries.