McAleese, J.J., Bishop, K.M., A’Hern, R., & Henk, J.M. (2006). Randomized phase II study of GM-CSF to reduce mucositis caused by accelerated radiotherapy of laryngeal cancer. British Journal of Radiology, 79(943), 608–613.
GM-CSF 2 mcg/kg (-1) (150 mcg) daily for 14 days starting on day 14 of a 21-day course of RT.
Note: Placebo injections were not given; observer was blinded to treatment.
The study was comprised of 29 patients (GM-CSF = 14).
Power analysis was completed, but not met (n = 17 in each group).
Patients with proven T1 N0 or T2 N0 glottic carcinoma were being treated with radiotherapy using a 16 fraction 3-week regimen.
Required to have a WHO performance status of grade 0 or higher, no renal or hepatic issues, serious infections requiring antibiotics, or likely need for corticosteroids.
Prospective, randomized, observer blind phase II trial
Significant difference in the incidence of mucositis p < 0.05, mean time of healing improved but not significant p = 0.25.
No differences in dysphagia, odynophagia, analgesic use, candida infection, of laryngeal edema.