EFFICACY AND SAFETY OF GRANULOCYTE MACROPHAGE-COLONY-STIMULATING FACTOR (GM-CSF) ON THE FREQUENCY AND SEVERITY OF RADIATION MUCOSITIS IN PATIENTS WITH HEAD AND NECK-CARCINOMA

Purpose: Based on the clinical evidence of mucosal protection by GM-CS F during cytotoxic chemotherapy, a pilot study was undertaken to deter mine the safety and mucosal reaction of patients receiving GM-CSF whil e undergoing definitive conventional fractionated radiotherapy in head and neck carcinoma. Methods and Materials: Patients were considered e ligible if buccal mucosa and oropharynx were included in the teleradia tion field. Ten adult patients with squamous cell carcinoma of head an d neck (buccal mucosa-8 and posterior 1/3 tongue-2) were entered into the trial. Radiation therapy was delivered with telecobalt machine at conventional 2 Gy fraction and 5 fractions/week. The radiation portals consisted of two parallel opposing lateral fields. GM-CSF was given s ubcutaneously at a dose of 1 mu g/kg body weight, daily, after 20 Gy u ntil the completion of radiation therapy. Patients were evaluated dail y for mucosal reaction, pain, and functional impairment. Results: The median radiation dose was 66 Gy. Eight patients received greater than or equal to 60 Gy. The tolerance to GM-CSF was good. All 10 patients c ompleted the planned daily dose of GM-CSF without interruption. Mucosa l toxicity was Grade I in four patients till the completion of radioth erapy (dose range 50-66 Gy). Six patients developed Grade II reaction, fibrinous mucosal lesions of maximum size 1.0-1.5 cm, during radiothe rapy. None developed Grade III mucositis. The maximum mucosal pain was Grade I during GM-CSF therapy. In two patients after starting GM-CSF the pain reduced in intensity. Functional impairment was mild to moder ate. All patients were able to maintain adequate oral intake during th e treatment period. Total regression of mucosal reaction occured withi n 8 days following completion of radiotherapy. Conclusions: GM-CSF adm inistration concurrently with conventional fractionated radiotherapy w as feasible without significant toxicity. The acute side effects of ra diotherapy namely mucositis, pain, and functional impairment were nil to minimal. The results are suggestive of mucosal protection by GM-CSF during radiotherapy and warrants further study in randomized double b lind trial. (C) 1997 Elsevier Science Inc.