A pilot study of the effect of granulocyte-macrophage colony-stimulating factor on oral mucositis in head and neck cancer patients during X-radiation therapy: a preliminary report.

PURPOSE: To evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) in reduction of radiotherapy-induced oral mucositis. METHODS AND MATERIALS: Seventeen patients who were going to be irradiated with a total dose of 50-70 Gy for head and neck malignancies were included in the study. After the second week of radiotherapy, with the experience of oral pain, GM-CSF 400 microg was administered locally, once a day, until completion of radiotherapy. Patients were evaluated weekly for mucosal reaction and functional impairment.
RESULTS: Three patients with gross and functional mucositis grade I after the second week, completed the planned radiotherapy showing mucositis grade I. Eleven patients who experienced, after 2 weeks of radiotherapy, mucositis grade II and III, presented after the third week with gross mucositis grade I and II and functional impairment grade I. One of these 11 patients was then lost to follow-up and the remaining 10 completed their planned radiotherapy having an almost asymptomatic mucositis grade I. The 15th patient with gross mucositis grade III after the 2 weeks of radiotherapy, had a 2-day interruption because of painful mucositis and then continued and completed radiotherapy with gross and functional mucositis grade I. The 16th patient with mucositis grade III after the second week, did not show any improvement, and completed her planned radiotherapy with mucositis grade III which finally healed after the administration of acyclovir. The last, 17th patient discontinued radiotherapy at the third week because of mucositis grade IV and severe ulceration in apposition to an extensive gold prosthesis.
CONCLUSION: The local administration of GM-CSF significantly reduced and almost healed radiation-induced oral mucositis in 14 of 17 patients during the radiotherapy, which was completed within the preplanned time and without any significant patient weight loss or functional impairment.