Therapeutic efficacy by recombinant human granulocyte/monocyte-colony stimulating factor on mucositis occurring in patients with oral and oropharynx tumors treated with curative radiotherapy: a multicenter open randomized phase III study.
BACKGROUND
Previous studies suggested granulocyte-macrophage-colony stimulating factor (GM-CSF) might be beneficial for radiotherapy-induced mucositis. This trial examined the efficacy of GM-CSF in reducing mucositis of the oral cavity and/or oropharynx compared with conventional treatment.


METHODS
Mucositis, documented by a five-grade scale, was defined in patients with tumors of the head-neck. Centers were allowed to use their own preferred fractionation regimen. Randomization to treatment was decided before radiotherapy. Treatment with GM-CSF 4 microg/kg/d subcutaneous, started when patients displayed a mucositis score > or = 1.5.


RESULTS
Ninety-two patients entered the study according to intention-to-treat principle. Twenty did not reach a mucositis index of 1.5. Sixty-one patients were included in the statistical analysis. Forty-five percent of the patients randomized to receive GM-CSF had a significant reduction of the mucositis more than one grade compared to 9% of the conventional treated.


CONCLUSIONS
In severe mucositis, GM-CSF is more effective than conventional treatment.
Masucci
Giuseppe
G
Department of Oncology, Radiumhemmet, Karolinska University Hospital, Stockholm, Sweden. giumas@mbox.ki.se
Broman
Peter
P
Kelly
Charles
C
Lindahl
Sten
S
Malmberg
Lena
L
Reizenstein
Johan
J
Alenius
Martin
M
Lewensohn
Rolf
R
D000328:Adult; D000368:Aged; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000532:radiotherapy; D052016:Mucositis / Q000188:drug therapy* / Q000209:etiology; D009959:Oropharyngeal Neoplasms / Q000532:radiotherapy; D011832:Radiation Injuries / Q000188:drug therapy* / Q000209:etiology; D011994:Recombinant Proteins; D016896:Treatment Outcome
D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor