title: Effect of recombinant human granulocyte colony stimulating factor (R-metHuG-CSF) as an adjunct to large-field radiotherapy: a phase I study.
abstract: OBJECTIVE
  To test the feasibility of recombinant human granulocyte colony stimulating factor application during large-field radiotherapy.
  
  
  METHODS
  Fifteen patients with clinically and histologically proven malignancy who received large-field radiotherapy entered this study. Administration of recombinant granulocyte colony stimulating factor (G-CSF) at a dose of 300 microgram subcutaneously was started on Friday and was continued on Saturday and Sunday after the first radiotherapy treatment, which began on the Monday before. In this way four courses of G-CSF were applied every Friday, Saturday, and Sunday during the radiotherapy period. Absolute neutrophil cell (ANC) and blood counts were monitored twice a week and compared to a second group of 15 patients who received large-field radiotherapy without G-CSF. Before and at the end of every cycle of G-CSF, ANC, blood counts, and biochemistry were measured. We compared the myelotoxicity of the patients treated with G-CSF with 15 patients without G-CSF treated at the same period with large-field radiotherapy, in match pair technique.
  
  
  RESULTS
  G-CSF increased the ANC throughout the period of irradiation, and the treatment time needed for competing radiotherapy was shorter in the group who received G-CSF. Fourteen of 15 patients who received G-CSF treatment completed large-field radiotherapy without pause. Only 1 of 15 patients not receiving G-CSF was able to receive radiation treatment on schedule. Patients receiving G-CSF completed treatment with the mantle-field technique in 24 days and those with the abdominal bath technique in 26.5 days. Conversely, patients treated without G-CSF completed treatment with the mantle-field technique in 30.5 days and those with the abdominal bath technique in 36 days. The most frequent side effect was musculoskeletal pain.
  
  
  CONCLUSIONS
  The prophylactic application of G-CSF during large-field radiotherapy before the onset of neutropenia was feasible in this schedule. Whether or not this shortening of treatment duration will translate into an improvement in efficacy is not clear.
authors.affiliation: Department of Radiation Medicine, Offenbach a.M., Germany.
authors.forename: C
authors.initials: C
authors.lastname: Kolotas
authors.forename: N
authors.initials: N
authors.lastname: Zamboglou
authors.forename: T
authors.initials: T
authors.lastname: Schnabel
authors.forename: H
authors.initials: H
authors.lastname: Bojar
authors.forename: A
authors.initials: A
authors.lastname: Wintzer
authors.forename: H G
authors.initials: HG
authors.lastname: Vogt
authors.forename: G
authors.initials: G
authors.lastname: Schmitt
mesh_terms: D000328:Adult; D001853:Bone Marrow / Q000187:drug effects / Q000528:radiation effects; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000532:radiotherapy*; D009504:Neutrophils / Q000187:drug effects / Q000528:radiation effects; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor