Economic evaluation of recombinant human granulocyte colony-stimulating factor in very high-risk childhood acute lymphoblastic leukemia.
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.
Delorme
Jean
J
Department of Pharmacy, Research Unit INSERM No. 379, France.
Badin
Stéphanie
S
Le Corroller
Anne-Gaelle G
AG
Auvrignon
Anne Aurtignon
AA
Auclerc
Marie-Françoise
MF
Gandemer
Virginie
V
Bordigoni
Pierre
P
Lamagnere
Jean-Pierre
JP
Demeocq
François
F
Perel
Yves
Y
Berthou
Christian
C
Bauduer
François
F
Pautard
Brigitte
B
Vannier
Jean-Pierre
JP
Braguer
Diane
D
Leblanc
Thierry
T
Leverger
Guy
G
Baruchel
André
A
Michel
Gérard
G
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
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor