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 und ergoing therapy for advanced head and neck neoplasms leads to a significant rise in toxic side-effects. Oral mucositis remains one of the most distres sing factors leading to pain, impairment of oral nutrition, local and syste mic infection and often cessation of the oncological treatment. The local a nd systemic administration of recombinant growth factors has revealed a pot ential benefit in the treatment of oral mucositis. Clinical data concerning the topical use of granulocyte-macrophage colony-stimulating-factor (GM-CS F) in the prevention and therapy of mucositis in patients undergoing radioc hemotherapy for advanced cancer of the head and neck are presented in this paper. A prospective, randomised, open parallel-grouped, single centre stud y at a university hospital was performed. 35 patients with stage III and IV carcinomas of the head and neck were included. Statistical analysis concer ning the degree of oral mucositis, the perception of pain, the incidence of secondary infections and the change in haematological parameters revealed no superiority of GMCSF in comparison to conventional mouthwash between the two groups of patients. As a result, and faced with the tremendous costs o f the regular use of a recombinant cytokine, we ended the clinical trial af ter 35 patients. The topical administration of GMCSF to treat oral mucositi s as a result of radiochemotherapy in patients suffering from head and neck cancer cannot be recommended. (C) 2001 Elsevier Science Ltd. All rights re served.