title: Human granulocyte colony-stimulating factor in children with high-risk acute lymphoblastic leukemia: a Children's Cancer Group Study.
abstract: OBJECTIVE
  To investigate the effect of granulocyte colony-stimulating factor (G-CSF) on hematopoietic toxicities, supportive care requirements, time to complete intensive therapy, and event-free survival (EFS) and overall survival (OS) in children with high-risk acute lymphoblastic leukemia (HR-ALL).
  
  
  METHODS
  A total of 287 children with HR-ALL were randomly assigned to intensive chemotherapy regimens (New York I [NY I] or NY II) as part of the Children's Cancer Group (CCG)-1901 protocol. The induction phases consisted of five drugs (vincristine, prednisone, l-asparaginase, daunorubicin, and cyclophosphamide). Initial consolidation comprised six-agent chemotherapy combined with 18 Gy of total-brain irradiation. Patients were randomly assigned to receive G-CSF (5 microg/kg/day) during either induction or initial consolidation. A crossover study analysis was done on the 259 patients who completed both phases of therapy.
  
  
  RESULTS
  The mean time to neutrophil recovery (>/= 0.5 x 109/L) was reduced with G-CSF (16.7 v 19.1 days, P =.0003); however, patients who received G-CSF did not have significantly reduced episodes of febrile neutropenia (149 v 164, P =.41), positive blood cultures (57 v 61, P =.66), or serious infections (75 v 79, P =.62). Hospitalization (14.0 v 13.9 days, P =.87) and induction therapy completion times (NY I, 30.3 v 31.3 days, P =.11; NY II, 33.4 v 32.3 days, P =.40) were not significantly altered. There were no differences in 6-year EFS (P =.24) or OS (P =.54) between patients receiving or not receiving G-CSF on CCG-1901, NY I and NY II.
  
  
  CONCLUSIONS
  Children with high-risk ALL do not appear to benefit from prophylactic G-CSF.
authors.affiliation: Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA. steinhep@mskcc.org
authors.forename: John A
authors.initials: JA
authors.lastname: Heath
authors.forename: Peter G
authors.initials: PG
authors.lastname: Steinherz
authors.forename: Arnold
authors.initials: A
authors.lastname: Altman
authors.forename: Harland
authors.initials: H
authors.lastname: Sather
authors.forename: Suresh
authors.initials: S
authors.lastname: Jhanwar
authors.forename: Steven
authors.initials: S
authors.lastname: Halpern
authors.forename: Richard
authors.initials: R
authors.lastname: Pieters
authors.forename: Narayan
authors.initials: N
authors.lastname: Shah
authors.forename: Laurel
authors.initials: L
authors.lastname: Steinherz
authors.forename: Raymond
authors.initials: R
authors.lastname: Tannous
authors.forename: William
authors.initials: W
authors.lastname: Terry
authors.forename: Michael E
authors.initials: ME
authors.lastname: Trigg
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D001215:Asparaginase / Q000008:administration & dosage / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003630:Daunorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D008297:Male; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D009504:Neutrophils / Q000187:drug effects*; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy*; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D012074:Remission Induction; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D014750:Vincristine; D003520:Cyclophosphamide; D001215:Asparaginase; D011241:Prednisone; D003630:Daunorubicin