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 granulocyte/monocyte-colony Therapeutic efficacy by recombinant humanstimulating factor on mucositis occurring in patients with oral and oropharynx tumors treated with curative radiotherapy - A multicenter open randomized phase III study
Karolinska University Hospital.
Karlstad Central Hospital.
Newcastle General Hospital.
Karlstad Central Hospital.
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2005 (English)In: Medical Oncology, ISSN 1357-0560, E-ISSN 1559-131X, Vol. 22, no 3, 247-256 p.Article in journal (Refereed) Published
Abstract [en]

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 mu g/kg/d subcutaneous, started when patients displayed a mucositis score greater than= 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.

Place, publisher, year, edition, pages
Stockton , 2005. Vol. 22, no 3, 247-256 p.
Keyword [en]
GM-CSF; mucositis; radiotherapy; oral cancer; oropharynx cancer
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-59681DOI: 10.1385/MO:22:3:247ISI: 000231533600005PubMedID: 16110136OAI: diva2:353084
Available from: 2010-09-23 Created: 2010-09-23 Last updated: 2010-09-24

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