title: Subcutaneous granulocyte-macrophage colony-stimulating factor in mucositis induced by an adjuvant 5-fluorouracil plus leucovorin regimen. A phase II study and review of the literature.
abstract: OBJECTIVE
  To test the activity of subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF) administration in patients with colorectal cancer treated with adjuvant 5-fluorouracil (5-FU) plus leucovorin (LV) and suffering from mucositis.
  
  
  METHODS
  Thirty-one patients treated with adjuvant 5-FU 370 mg/m(2) and LV 100 mg/m(2) for 5 days every 4 weeks and reporting grade >/=2 mucositis participated in the study. Subcutaneous GM-CSF 4 microg/kg/day from days 6 to 10 was administered without chemotherapy dose reductions in the cycle that followed the cycle during which mucositis was reported. The disappearance of mucositis or a decrease by >/=1 grade was recorded as a therapeutic success. Baseline toxicity was: grade 2 stomatitis in 12 patients and grade 3 in 9; grade 4, 3 and 2 diarrhoea in 1, 4 and 8 patients, respectively.
  
  
  RESULTS
  Seventy-seven GM-CSF cycles were administered. A success was achieved in 20 (64.5%) patients. The efficacy was assessable in 5 (16.1%) patients with grade 2 and in 8 (25.8%) with grade 3 stomatitis, respectively, as well as in 1 (3.2%) and 5 (16.1%) patients with grade 3 and 2 diarrhoea, respectively. Success (3.2%) was reported in 2 patients suffering from both grade 2 stomatitis and diarrhoea. In 7 (22.5%) patients there was no evidence of efficacy. In 4 (12.9%) patients the treatment was stopped after the first administration of GM-CSF due to a grade 2 allergic reaction.
  
  
  CONCLUSIONS
  The subcutaneous administration of GM-CSF relieved patients from symptoms of 5-FU/LV-induced mucositis with acceptable side effects permitting the maintenance of full-dose chemotherapy.
authors.affiliation: UO Oncologia Medica, Azienda Ospedaliera 'San G. Moscati', Avellino, Italy. arossi_it@yahoo.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Rossi
authors.forename: Gerardo
authors.initials: G
authors.lastname: Rosati
authors.forename: Diodoro
authors.initials: D
authors.lastname: Colarusso
authors.forename: Luigi
authors.initials: L
authors.lastname: Manzione
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D007279:Injections, Subcutaneous; D002955:Leucovorin / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009092:Mucous Membrane / Q000187:drug effects*; D018714:Radiotherapy, Adjuvant; D013280:Stomatitis / Q000139:chemically induced / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D002955:Leucovorin; D005472:Fluorouracil