MORPHOLOGY AND PATHOLOGY OF RADIATION-INDUCED ESOPHAGITIS - DOUBLE-BLIND-STUDY OF NAPROXEN VS PLACEBO FOR PREVENTION OF RADIATION-INJURY

Radiation-induced esophagitis can cause substantial morbidity. Experim ents in lab animals have shown that pretreatment with indomethacin pro tects the esophagus from radiation damage. We conducted a prospective, double-blind, randomized trial of naproxen vs placebo in patients und ergoing thoracic radiation therapy for lung cancer. Twenty-eight patie nts were enrolled, of which 26 completed the study. Sixteen patients w ere given a short course of radiation (30 Gy/10 fractions/2 weeks), an d 10 patients were given a longer course and a larger dose (40-50 Gy/2 5 fractions/5 weeks). Half of the irradiated patients were treated wit h naproxen, 375 mg, taken orally twice a day, and half were given an i dentical placebo. All patients were given ranitidine 300 mg, taken ora lly once a day Study drugs were taken throughout the course of radiati on. Endoscopy with esophageal biopsies and brushings was performed bef ore and on the last day of treatment. Patients kept a daily diary for symptom scoring. Symptoms such as chest pain, dysphagia, odynophagia, and/or heartburn were reported in 15 patients from both subgroups, res ulting in diet restriction to liquids only in eight patients and requi ring temporary discontinuation of radiation therapy in one of them App roximately half the patients in each subgroup developed esophagitis, u sually mild and usually limited to the proximal esophagus. Seventy of symptoms was not proportional to the severity of esophagitis. Candidia sis was documented in eight patients, but only four had symptoms that were severe in one. We conclude that acute radiation injury to the eso phagus is observed in approximately half the patients receiving radiat ion therapy and can result in substantial morbidity. Treatment with a prostaglandin inhibitor, naproxen, was not protective. Esophagitis may be complicated by esophageal candidiasis, but its contribution to the patient's morbidity is unclear.