Local application of granulocyte-macrophage colony stimulating factor (GM-CSF) for the treatment of oral mucositis.

The combination of radiation and chemotherapy administered for patients undergoing therapy for advanced head and neck neoplasms leads to a significant rise in toxic side-effects. Oral mucositis remains one of the most distressing factors leading to pain, impairment of oral nutrition, local and systemic infection and often cessation of the oncological treatment. The local and systemic administration of recombinant growth factors has revealed a potential benefit in the treatment of oral mucositis. Clinical data concerning the topical use of granulocyte-macrophage colony-stimulating-factor (GM-CSF) in the prevention and therapy of mucositis in patients undergoing radiochemotherapy for advanced cancer of the head and neck are presented in this paper. A prospective, randomised, open parallel-grouped, single centre study at a university hospital was performed. 35 patients with stage III and IV carcinomas of the head and neck were included. Statistical analysis concerning the degree of oral mucositis, the perception of pain, the incidence of secondary infections and the change in haematological parameters revealed no superiority of GM-CSF in comparison to conventional mouthwash between the two groups of patients. As a result, and faced with the tremendous costs of the regular use of a recombinant cytokine, we ended the clinical trial after 35 patients. The topical administration of GM-CSF to treat oral mucositis as a result of radiochemotherapy in patients suffering from head and neck cancer cannot be recommended.

RCT Entities:   Population Interventions Outcomes