title: 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.
abstract: 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.
authors.affiliation: Department of Oncology, Radiumhemmet, Karolinska University Hospital, Stockholm, Sweden. giumas@mbox.ki.se
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Masucci
authors.forename: Peter
authors.initials: P
authors.lastname: Broman
authors.forename: Charles
authors.initials: C
authors.lastname: Kelly
authors.forename: Sten
authors.initials: S
authors.lastname: Lindahl
authors.forename: Lena
authors.initials: L
authors.lastname: Malmberg
authors.forename: Johan
authors.initials: J
authors.lastname: Reizenstein
authors.forename: Martin
authors.initials: M
authors.lastname: Alenius
authors.forename: Rolf
authors.initials: R
authors.lastname: Lewensohn
mesh_terms: 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
chemical_list: D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor