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Granulocyte macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: a prospective randomized study.
Int J Radiat Oncol Biol Phys. 2000 Feb 01; 46(3):525-34.IJ

Abstract

PURPOSE

To compare subcutaneously given molgramostim (GM-CSF) and sucralfate mouth washings to sucralfate mouth washings in prevention of radiation-induced mucositis.

METHODS AND MATERIALS

Forty head and neck cancer patients were randomly assigned to use either GM-CSF and sucralfate (n = 20) or sucralfate alone (n = 20) during radiotherapy. Sucralfate was used as 1.0 g mouth washing 6 times daily after the first 10 Gy of radiotherapy, and 150-300 microg GM-CSF was given subcutaneously. The grade of radiation mucositis and blood cell counts were monitored weekly. Salivary lactoferrin was measured as a surrogate marker for oral mucositis.

RESULTS

We found no significant difference between the molgramostim and the control groups in the oral mucositis grade, oral pain, use of analgesic drugs, weight loss, or survival. The median maximum neutrophil counts (median, 9.2 x 10(9)/L vs. 5.9 x 10(9)/L, p = 0.0005), eosinophil counts (median, 1.3 x 10(9)/L vs. 0.2 x 10(9)/L, p = 0.0004), and salivary lactoferrin concentrations were higher in patients who received GM-CSF. The most common toxicities in the GM-CSF plus sucralfate group were skin reactions at the GM-CSF injection site (65%), fever (30%), bone pain (25%), and nausea (15%), whereas the toxicity of sucralfate given alone was minimal.

CONCLUSION

We found no evidence indicating that subcutaneously given GM-CSF reduces the severity of radiation-induced mucositis.

Authors+Show Affiliations

Department of Oral Surgery, Institute of Dentistry, University of Turku, Finland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

10701730

Citation

Makkonen, T A., et al. "Granulocyte Macrophage-colony Stimulating Factor (GM-CSF) and Sucralfate in Prevention of Radiation-induced Mucositis: a Prospective Randomized Study." International Journal of Radiation Oncology, Biology, Physics, vol. 46, no. 3, 2000, pp. 525-34.
Makkonen TA, Minn H, Jekunen A, et al. Granulocyte macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: a prospective randomized study. Int J Radiat Oncol Biol Phys. 2000;46(3):525-34.
Makkonen, T. A., Minn, H., Jekunen, A., Vilja, P., Tuominen, J., & Joensuu, H. (2000). Granulocyte macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: a prospective randomized study. International Journal of Radiation Oncology, Biology, Physics, 46(3), 525-34.
Makkonen TA, et al. Granulocyte Macrophage-colony Stimulating Factor (GM-CSF) and Sucralfate in Prevention of Radiation-induced Mucositis: a Prospective Randomized Study. Int J Radiat Oncol Biol Phys. 2000 Feb 1;46(3):525-34. PubMed PMID: 10701730.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Granulocyte macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: a prospective randomized study. AU - Makkonen,T A, AU - Minn,H, AU - Jekunen,A, AU - Vilja,P, AU - Tuominen,J, AU - Joensuu,H, PY - 2000/3/4/pubmed PY - 2000/3/18/medline PY - 2000/3/4/entrez SP - 525 EP - 34 JF - International journal of radiation oncology, biology, physics JO - Int. J. Radiat. Oncol. Biol. Phys. VL - 46 IS - 3 N2 - PURPOSE: To compare subcutaneously given molgramostim (GM-CSF) and sucralfate mouth washings to sucralfate mouth washings in prevention of radiation-induced mucositis. METHODS AND MATERIALS: Forty head and neck cancer patients were randomly assigned to use either GM-CSF and sucralfate (n = 20) or sucralfate alone (n = 20) during radiotherapy. Sucralfate was used as 1.0 g mouth washing 6 times daily after the first 10 Gy of radiotherapy, and 150-300 microg GM-CSF was given subcutaneously. The grade of radiation mucositis and blood cell counts were monitored weekly. Salivary lactoferrin was measured as a surrogate marker for oral mucositis. RESULTS: We found no significant difference between the molgramostim and the control groups in the oral mucositis grade, oral pain, use of analgesic drugs, weight loss, or survival. The median maximum neutrophil counts (median, 9.2 x 10(9)/L vs. 5.9 x 10(9)/L, p = 0.0005), eosinophil counts (median, 1.3 x 10(9)/L vs. 0.2 x 10(9)/L, p = 0.0004), and salivary lactoferrin concentrations were higher in patients who received GM-CSF. The most common toxicities in the GM-CSF plus sucralfate group were skin reactions at the GM-CSF injection site (65%), fever (30%), bone pain (25%), and nausea (15%), whereas the toxicity of sucralfate given alone was minimal. CONCLUSION: We found no evidence indicating that subcutaneously given GM-CSF reduces the severity of radiation-induced mucositis. SN - 0360-3016 UR - https://www.unboundmedicine.com/medline/citation/10701730/Granulocyte_macrophage_colony_stimulating_factor__GM_CSF__and_sucralfate_in_prevention_of_radiation_induced_mucositis:_a_prospective_randomized_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0360301699004526 DB - PRIME DP - Unbound Medicine ER -