Sequential administration of sargramostim and filgrastim in pediatric allogeneic stem cell transplantation recipients undergoing myeloablative conditioning†

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Abstract

Waxman IM, Militano O, Baldinger L, Roman E, Qualter E, Morris E, Garvin J, Bradley MB, Bhatia M, Satwani P, George D, Del Toro G, Hawks R, Wolownik K, Foley S, Cheung YK, Schwartz J, van de Ven C, Baxter-Lowe LA, Cairo MS. Sequential administration of sargramostim and filgrastim in pediatric allogeneic stem cell transplantation recipients undergoing myeloablative conditioning. Pediatr Transplantation 2009:13:464–474. © 2008 John Wiley & Sons A/S

Abstract:

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 μg/m2 IV QD) began on day of stem cell infusion. GM-CSF was switched to G-CSF (10 μg/kg IV QD) when WBC ≥ 300/mm3 × 2 days. G-CSF continued until ANC ≥ 2500/mm3 × 2 days, then tapered to maintain ANC ≥ 1000/mm3. Median time to myeloid engraftment (ANC ≥ 500/mm3 × 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.

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