Granulocyte macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: A prospective randomized study

Purpose: To compare subcutaneously given molgramostim (GM-CSF) and sucralfa te mouth washings to sucralfate mouth washings in prevention of radiation-i nduced mucositis, Methods and Materials: Forty head and neck cancer patients were randomly as signed to use either GM-CSF and sucralfate (n = 20) or sucralfate alone (II = 20) during radiotherapy. Sucralfate was used as 1.0 g mouth washing 6 ti mes daily after the first 10 Gy of radiotherapy, and 150-300 mu g GM-CSF wa s given subcutaneously, The grade of radiation mucositis and blood cell cou nts were monitored weekly. Salivary lactoferrin was measured as a surrogate marker for oral mucositis. Results: We found no significant difference between the molgramostim and th e control groups in the oral mucositis grade, oral pain, use of analgesic d rugs, weight loss, or survival, The median maximum neutrophil counts (media n, 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 conc entrations were higher in patients who received GM-CSF, The most common tox icities in the GM-CSF plus sucralfate group were skin reactions at the GM-C SF injection site (65%), fever (30%), bone pain (25%), and nausea (15%), wh ereas the toxicity of sucralfate given alone was minimal. Conclusion: We found no evidence indicating that subcutaneously given GM-CS F reduces the severity of radiation-induced mucositis, (C) 2000 Elsevier Sc ience Inc.