Granulocyte macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: a prospective randomized study.
OBJECTIVE
To compare subcutaneously given molgramostim (GM-CSF) and sucralfate mouth washings to sucralfate mouth washings in prevention of radiation-induced mucositis.


METHODS
Forty head and neck cancer patients were randomly assigned to use either GM-CSF and sucralfate (n = 20) or sucralfate alone (n = 20) during radiotherapy. Sucralfate was used as 1.0 g mouth washing 6 times daily after the first 10 Gy of radiotherapy, and 150-300 microg GM-CSF was given subcutaneously. The grade of radiation mucositis and blood cell counts were monitored weekly. Salivary lactoferrin was measured as a surrogate marker for oral mucositis.


RESULTS
We found no significant difference between the molgramostim and the control groups in the oral mucositis grade, oral pain, use of analgesic drugs, weight loss, or survival. The median maximum neutrophil counts (median, 9.2 x 10(9)/L vs. 5.9 x 10(9)/L, p = 0.0005), eosinophil counts (median, 1.3 x 10(9)/L vs. 0.2 x 10(9)/L, p = 0.0004), and salivary lactoferrin concentrations were higher in patients who received GM-CSF. The most common toxicities in the GM-CSF plus sucralfate group were skin reactions at the GM-CSF injection site (65%), fever (30%), bone pain (25%), and nausea (15%), whereas the toxicity of sucralfate given alone was minimal.


CONCLUSIONS
We found no evidence indicating that subcutaneously given GM-CSF reduces the severity of radiation-induced mucositis.
Makkonen
T A
TA
Department of Oral Surgery, Institute of Dentistry, University of Turku, Finland.
Minn
H
H
Jekunen
A
A
Vilja
P
P
Tuominen
J
J
Joensuu
H
H
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000627:therapeutic use; D015415:Biomarkers / Q000032:analysis; D019583:Dose Fractionation, Radiation; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007279:Injections, Subcutaneous; D007781:Lactoferrin / Q000032:analysis; D007970:Leukopenia / Q000209:etiology; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D018579:Patient Selection; D011446:Prospective Studies; D011832:Radiation Injuries / Q000097:blood / Q000150:complications / Q000517:prevention & control*; D011837:Radiation-Protective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D012463:Saliva / Q000737:chemistry; D013280:Stomatitis / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D013392:Sucralfate / Q000008:administration & dosage / Q000627:therapeutic use*
D000897:Anti-Ulcer Agents; D000935:Antifungal Agents; D015415:Biomarkers; D011837:Radiation-Protective Agents; D013392:Sucralfate; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D007781:Lactoferrin