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.

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.
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.
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.
In severe mucositis, GM-CSF is more effective than conventional treatment.
AuthorsGiuseppe Masucci, Peter Broman, Charles Kelly, Sten Lindahl, Lena Malmberg, Johan Reizenstein, Martin Alenius, Rolf Lewensohn
JournalMedical oncology (Northwood, London, England) (Med Oncol) Vol. 22 Issue 3 Pg. 247-56 ( 2005) ISSN: 1357-0560 [Print] United States
PMID16110136 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Recombinant Proteins
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Adult
  • Aged
  • Female
  • Granulocyte-Macrophage Colony-Stimulating Factor (administration & dosage, pharmacology, therapeutic use)
  • Humans
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Mouth Neoplasms (radiotherapy)
  • Mucositis (drug therapy, etiology)
  • Oropharyngeal Neoplasms (radiotherapy)
  • Radiation Injuries (drug therapy, etiology)
  • Recombinant Proteins
  • Treatment Outcome

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