Cost effectiveness of day 5 G-CSF (Lenograstim) administration after PBSC transplantation: results of a SFGM-TC randomised trial.
This randomised trial was designed to compare two groups treated with different G-CSF administration schedules with a third group receiving no G-CSF, after autologous peripheral blood stem cell transplantation (APBSCT). Children and adults with haematological malignancies or solid tumours were randomly assigned to receive either 150 microg/m2/day of Lenograstim starting on day 1 (G1) or on day 5 (G5) post APBSCT, or no Lenograstim (G0). Randomisation was stratified according to the conditioning regimen (Busulfan vs TBI vs no Busulfan and no TBI) and the graft CD 34+ cell count. A total of 240 patients were randomised; 239 were evaluable. All three patient groups were comparable. Median duration of neutropenia was 9 days (4-40), and 10 days (5-15) in the G1 and G5 groups, respectively, significantly shorter than in the G0 group, 13 days (7-36) (P < 0.0001). No difference was observed in the duration of thrombocytopenia, transfusion support and extra-haematological complications. The duration of post transplant hospitalisation was significantly shorter in adults who received G-CSF. Clinical and cost arguments favour the initiation of G-CSF on day 5 in adults. The same policy could be applied in children given that clinical management is easier and costs are similar.
Valteau-Couanet
D
D
Paediatrics Department, Institut Gustave Roussy, Villejuif, France. valteau@igr.fr
Faucher
C
C
Aupérin
A
A
Michon
J
J
Milpied
N
N
Boiron
J M
JM
Bourhis
J H
JH
Gisselbrecht
C
C
Vernant
J P
JP
Pinna
A
A
Bendahmane
B
B
Delabarre
F
F
Benhamou
E
E
D000293:Adolescent; D000328:Adult; D000368:Aged; D001803:Blood Transfusion; D002066:Busulfan / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D004334:Drug Administration Schedule; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000191:economics*; D019337:Hematologic Neoplasms / Q000150:complications / Q000628:therapy; D006801:Humans; D007223:Infant; D007902:Length of Stay; D000078224:Lenograstim; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000628:therapy; D009503:Neutropenia; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects / Q000191:economics* / Q000379:methods; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000191:economics; D013921:Thrombocytopenia; D019172:Transplantation Conditioning / Q000379:methods; D014182:Transplantation, Autologous
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim; D002066:Busulfan