Sequential administration of sargramostim and filgrastim in pediatric allogeneic stem cell transplantation recipients undergoing myeloablative conditioning.
G-CSF and GM-CSF both hasten myeloid engraftment post-MA-alloSCT; however, GM-CSF is earlier acting and less expensive. The objective was to evaluate efficacy/safety of sequential administration of GM-CSF followed by G-CSF in children post-MA-alloSCT. From January 2001 to June 2005, 31 children received 32 MA-alloSCT: mean age 6.65 yr; MRD BM or PBSC vs. related or unrelated UCB 11:21; malignant vs. non-malignant disorders 22:10. GM-CSF (250 microg/m(2) IV QD) began on day of stem cell infusion. GM-CSF was switched to G-CSF (10 microg/kg IV QD) when WBC >or= 300/mm(3) x 2 days. G-CSF continued until ANC >or= 2500/mm(3) x 2 days, then tapered to maintain ANC >or= 1000/mm(3). Median time to myeloid engraftment (ANC >or= 500/mm(3) x 3 days) was 17 days [13 days vs. 24 days, MRD BM/PBSC vs. UCB (p < 0.0001)], occurring at a median time of two days after switch to G-CSF. Clinically relevant adverse events were bone pain (n = 8) and large pleural effusion (n = 1). It was estimated that sequential GM-CSF/G-CSF was cost-effective compared with G-CSF alone [cost-savings of $1311/patient ($41,952/study), 2007 Red Book Average Wholesale Price]. In summary, it was demonstrated that sequential administration of GM-CSF/G-CSF post-MA-alloSCT was safe, cost-effective and resulted in prompt myeloid engraftment.
Waxman
Ian M
IM
Department of Pediatrics, Columbia University, New York, NY 10032, USA.
Militano
Olga
O
Baldinger
Leah
L
Roman
Elizabeth
E
Qualter
Erin
E
Morris
Erin
E
Garvin
James
J
Bradley
Mary Brigid
MB
Bhatia
Monica
M
Satwani
Prakash
P
George
Diane
D
Del Toro
Gustavo
G
Hawks
Ria
R
Wolownik
Karen
K
Foley
Sandra
S
Cheung
Ying-Kuen
YK
Schwartz
Joseph
J
van de Ven
Carmella
C
Baxter-Lowe
Lee Ann
LA
Cairo
Mitchell S
MS
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage*; D007223:Infant; D008297:Male; D011994:Recombinant Proteins; D033581:Stem Cell Transplantation; D019172:Transplantation Conditioning / Q000379:methods*; D014184:Transplantation, Homologous
D007155:Immunologic Factors; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C081222:sargramostim; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D000069585:Filgrastim