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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

Lookup NU author(s): Dr Charles Kelly


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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 >= 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.

Publication metadata

Author(s): Masucci G, Broman P, Kelly C, Lindahl S, Malmberg L, Reizenstein J, Alenius M, Lewensohn R

Publication type: Article

Publication status: Published

Journal: Medical Oncology

Year: 2005

Volume: 22

Issue: 3

Pages: 247-256

ISSN (print): 1357-0560

ISSN (electronic): 1559-131X

Publisher: Humana Press, Inc.


DOI: 10.1385/MO:22:3:247


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