title: Granulocyte colony-stimulating factor after intensive consolidation chemotherapy in acute myeloid leukemia: results of a randomized trial of the Groupe Ouest-Est Leucémies Aigues Myeloblastiques.
abstract: OBJECTIVE
  Ten years after the first clinical studies, the clinical impact of myeloid growth factors in acute myeloid leukemia is still unclear. One of the objectives of the Groupe Ouest-Est Leucémies Aigues Myeloblastiques (GOELAM) 2 trial was to evaluate the benefit of granulocyte colony-stimulating factor (GCSF) given only after the two courses of intensive consolidation chemotherapy (ICC) used to maintain complete remission (CR).
  
  
  METHODS
  One hundred ninety-four patients who were in CR after induction treatment were randomly assigned to receive G-CSF (100 patients) or no G-CSF (94 patients) after two courses of ICC (ICC 1, high-dose cytarabine plus mitoxantrone; ICC 2, amsacrine plus etoposide). G-CSF (filgrastim) was administered from the day after chemotherapy until granulocyte recovery at a daily dose of 5 microg/kg.
  
  
  RESULTS
  In the G-CSF group, the median duration of neutropenia (< 0.5 x 10(9)/L) was dramatically reduced, both after ICC 1 (12 v 19 days, P <.001) and after ICC 2 (20 v 28 days, P <.001). The median duration of hospitalization was also significantly shorter in the G-CSF group (24 v 27 days after ICC 1, P <.001; 29 v 34 days after ICC 2, P <. 001). The median duration of intravenous antibiotics was significantly reduced after ICC 1 and ICC 2, and the median duration of antifungal therapy was significantly reduced after ICC 1. However, the incidence of microbiologically documented infections, the toxic death rate, the 2-year disease-free survival, and the 2-year overall survival were not affected by G-CSF administration. Moreover, the median interval between ICC1 and ICC2 was reduced by only 2 days, and the number of patients undergoing ICC2 was not increased in the G-CSF arm.
  
  
  CONCLUSIONS
  G-CSF should be administered routinely after ICC to reduce the duration of neutropenia and hospitalization. However, G-CSF did not seem to significantly increase the feasibility of this two-course program or modify overall outcome.
authors.affiliation: Departments of Hematology of University Hospital, Nantes, France. jlharousseau@sante.univ_nantes.fr
authors.forename: J L
authors.initials: JL
authors.lastname: Harousseau
authors.forename: B
authors.initials: B
authors.lastname: Witz
authors.forename: B
authors.initials: B
authors.lastname: Lioure
authors.forename: M
authors.initials: M
authors.lastname: Hunault-Berger
authors.forename: B
authors.initials: B
authors.lastname: Desablens
authors.forename: M
authors.initials: M
authors.lastname: Delain
authors.forename: F
authors.initials: F
authors.lastname: Guilhot
authors.forename: P Y
authors.initials: PY
authors.lastname: Le Prise
authors.forename: J F
authors.initials: JF
authors.lastname: Abgrall
authors.forename: E
authors.initials: E
authors.lastname: Deconinck
authors.forename: D
authors.initials: D
authors.lastname: Guyotat
authors.forename: J P
authors.initials: JP
authors.lastname: Vilque
authors.forename: P
authors.initials: P
authors.lastname: Casassus
authors.forename: O
authors.initials: O
authors.lastname: Tournilhac
authors.forename: B
authors.initials: B
authors.lastname: Audhuy
authors.forename: E
authors.initials: E
authors.lastname: Solary
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000677:Amsacrine / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006760:Hospitalization; D006801:Humans; D007902:Length of Stay; D007951:Leukemia, Myeloid / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009503:Neutropenia / Q000517:prevention & control; D011994:Recombinant Proteins; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D011994:Recombinant Proteins; D000677:Amsacrine; D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; D005047:Etoposide; D008942:Mitoxantrone; D000069585:Filgrastim