title: Economic evaluation of recombinant human granulocyte colony-stimulating factor in very high-risk childhood acute lymphoblastic leukemia.
abstract: OBJECTIVE
  In a previous randomized study, the authors reported that granulocyte colony-stimulating factor (G-CSF) increased the chemotherapy dose-intensity delivered during the consolidation therapy of high-risk childhood acute lymphoblastic leukemia (ALL). The aim of the current study was to perform an economic evaluation in the same cohort.
  
  
  METHODS
  In this open-label multicenter randomized trial, prophylactic G-CSF was administered after consolidation therapy courses. Economic data were retrospectively quantified for each patient: hospital stays, drugs, and blood products.
  
  
  RESULTS
  Sixty-seven children were enrolled in the very high-risk branch of the FRALLE 93 protocol. Chemotherapy dose-intensity was significantly increased (105 +/- 5% in the G-CSF group vs. 91 +/- 4% in the non-G-CSF group, P < 0.001). The mean total costs per child were not statistically different: 32,309 dollars in the G-CSF group versus 31,569 dollars in the non-G-CSF group. Further analysis per child and per course (R3 or COPADM) demonstrated that the mean cost of hospitalization and the mean cost of intravenous antibiotics were significantly decreased in the G-CSF group after R3 courses (3,857 dollars vs. 4,993.80 dollars, P < 0.001; 171.40 dollars vs. 306.20 dollars, P = 0.029, respectively), but the cost of platelet transfusion was significantly increased (P = 0.03). Conversely, post-COPADM costs were similar. Finally, mean costs per course in the two randomized groups were not significantly different: 5,848.80 dollars versus 6,181 dollars and 7,388.10 dollars versus 6,475.70 dollars for R3 and COPADM, respectively. The 3-year probability of event-free survival between the two groups was not different.
  
  
  CONCLUSIONS
  G-CSF can increase chemotherapy dose-intensity in very high-risk ALL without raising costs, but event-free survival was not improved. The cost benefit of prophylactic treatment by G-CSF relies on the chemotherapeutic regimen given prior to G-CSF administration.
authors.affiliation: Department of Pharmacy, Research Unit INSERM No. 379, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Delorme
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Badin
authors.forename: Anne-Gaelle G
authors.initials: AG
authors.lastname: Le Corroller
authors.forename: Anne Aurtignon
authors.initials: AA
authors.lastname: Auvrignon
authors.forename: Marie-Françoise
authors.initials: MF
authors.lastname: Auclerc
authors.forename: Virginie
authors.initials: V
authors.lastname: Gandemer
authors.forename: Pierre
authors.initials: P
authors.lastname: Bordigoni
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Lamagnere
authors.forename: François
authors.initials: F
authors.lastname: Demeocq
authors.forename: Yves
authors.initials: Y
authors.lastname: Perel
authors.forename: Christian
authors.initials: C
authors.lastname: Berthou
authors.forename: François
authors.initials: F
authors.lastname: Bauduer
authors.forename: Brigitte
authors.initials: B
authors.lastname: Pautard
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Vannier
authors.forename: Diane
authors.initials: D
authors.lastname: Braguer
authors.forename: Thierry
authors.initials: T
authors.lastname: Leblanc
authors.forename: Guy
authors.initials: G
authors.lastname: Leverger
authors.forename: André
authors.initials: A
authors.lastname: Baruchel
authors.forename: Gérard
authors.initials: G
authors.lastname: Michel
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics* / Q000627:therapeutic use; D002648:Child; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D018572:Disease-Free Survival; D017850:Economics, Pharmaceutical; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000191:economics* / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009503:Neutropenia / Q000191:economics* / Q000517:prevention & control; D010166:Palliative Care / Q000191:economics; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000191:economics* / Q000401:mortality / Q000628:therapy; D011994:Recombinant Proteins; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor