Abstract | BACKGROUND: 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:
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Authors | Giuseppe Masucci, Peter Broman, Charles Kelly, Sten Lindahl, Lena Malmberg, Johan Reizenstein, Martin Alenius, Rolf Lewensohn |
Journal | Medical oncology (Northwood, London, England)
(Med Oncol)
Vol. 22
Issue 3
Pg. 247-56
( 2005)
ISSN: 1357-0560 [Print] United States |
PMID | 16110136
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Recombinant Proteins
- Granulocyte-Macrophage Colony-Stimulating Factor
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Topics |
- 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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