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

Authors


  • Presented in part at American Society of Blood and Marrow Transplantation (ASBMT) 2006 Annual BMT Tandem meeting

Mitchell S. Cairo, Professor of Pediatrics, Medicine and Pathology, Chief, Division of Pediatric Blood and Marrow Transplantation, Morgan Stanley Children’s Hospital of NewYork-Presbyterian, Columbia University, 3959 Broadway, CHN 10-03, New York, NY 10032, USA
Tel.: +1 212 305 8316; Fax: +1 212 305 8428
E-mail: mc1310@columbia.edu

Abstract

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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