title: Efficacy and safety of granulocyte macrophage-colony stimulating factor (GM-CSF) on the frequency and severity of radiation mucositis in patients with head and neck carcinoma.
abstract: OBJECTIVE
  Based on the clinical evidence of mucosal protection by GM-CSF during cytotoxic chemotherapy, a pilot study was undertaken to determine the safety and mucosal reaction of patients receiving GM-CSF while undergoing definitive conventional fractionated radiotherapy in head and neck carcinoma.
  
  
  METHODS
  Patients were considered eligible if buccal mucosa and oropharynx were included in the teleradiation field. Ten adult patients with squamous cell carcinoma of head and neck (buccal mucosa--8 and posterior 1/3 tongue--2) were entered into the trial. Radiation therapy was delivered with telecobalt machine at conventional 2 Gy fraction and 5 fractions/week. The radiation portals consisted of two parallel opposing lateral fields. GM-CSF was given subcutaneously at a dose of 1 microg/kg body weight, daily, after 20 Gy until the completion of radiation therapy. Patients were evaluated daily for mucosal reaction, pain, and functional impairment.
  
  
  RESULTS
  The median radiation dose was 66 Gy. Eight patients received > or = 60 Gy. The tolerance to GM-CSF was good. All 10 patients completed the planned daily dose of GM-CSF without interruption. Mucosal toxicity was Grade I in four patients till the completion of radiotherapy (dose range 50-66 Gy). Six patients developed Grade II reaction, fibrinous mucosal lesions of maximum size 1.0-1.5 cm, during radiotherapy. None developed Grade III mucositis. The maximum mucosal pain was Grade I during GM-CSF therapy. In two patients after starting GM-CSF the pain reduced in intensity. Functional impairment was mild to moderate. All patients were able to maintain adequate oral intake during the treatment period. Total regression of mucosal reaction occured within 8 days following completion of radiotherapy.
  
  
  CONCLUSIONS
  GM-CSF administration concurrently with conventional fractionated radiotherapy was feasible without significant toxicity. The acute side effects of radiotherapy namely mucositis, pain, and functional impairment were nil to minimal. The results are suggestive of mucosal protection by GM-CSF during radiotherapy and warrants further study in randomized double blind trial.
authors.affiliation: Department of Radiotherapy, Kidwai Memorial Institute of Oncology, Bangalore, India.
authors.forename: V
authors.initials: V
authors.lastname: Kannan
authors.forename: P P
authors.initials: PP
authors.lastname: Bapsy
authors.forename: N
authors.initials: N
authors.lastname: Anantha
authors.forename: D C
authors.initials: DC
authors.lastname: Doval
authors.forename: H
authors.initials: H
authors.lastname: Vaithianathan
authors.forename: G
authors.initials: G
authors.lastname: Banumathy
authors.forename: K B
authors.initials: KB
authors.lastname: Reddy
authors.forename: S V
authors.initials: SV
authors.lastname: Kumaraswamy
authors.forename: A M
authors.initials: AM
authors.lastname: Shenoy
mesh_terms: D000328:Adult; D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy*; D005240:Feasibility Studies; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000528:radiation effects*; D010147:Pain Measurement; D010865:Pilot Projects; D011879:Radiotherapy Dosage; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control*
chemical_list: D016178:Granulocyte-Macrophage Colony-Stimulating Factor