Ryu, J.K., Swann, S., LeVeque, F., Scarantino, C.W., Johnson, D., Chen, A., et al. (2007). The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective phase III study by Radiation Therapy Oncology Group 9901. International Journal of Radiation Oncology, Biology, Physics, 67(3), 643–650.
Subcutaneous GM-CSF (250 mcg/m2) was started one week before radiation and stopped two weeks after completion. GM-CSF was given within two hours after each radiation fraction on Monday, Wednesday, and Friday. Doses were held on days that patients received chemotherapy.
Patients with head and neck cancer with radiation ports on 50% or more of oral cavity or oropharynx to 60-70 Gy.
GM-CSF: n = 63
Placebo: n = 58
October 2000-September 2002
No statistical differences in mucositis or QOL scores
Some participants discontinued study because of unspecified “toxicity”. Drug supply ended before all patients completed therapy.