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

被引:19
作者
Waxman, Ian M. [1 ]
Militano, Olga [2 ]
Baldinger, Leah [1 ]
Roman, Elizabeth [1 ]
Qualter, Erin [1 ]
Morris, Erin [1 ]
Garvin, James [1 ]
Bradley, Mary Brigid [1 ]
Bhatia, Monica [1 ]
Satwani, Prakash [1 ]
George, Diane [1 ]
Del Toro, Gustavo [3 ]
Hawks, Ria [1 ]
Wolownik, Karen [1 ]
Foley, Sandra [1 ]
Cheung, Ying-Kuen [4 ]
Schwartz, Joseph [5 ]
van de Ven, Carmella [1 ]
Baxter-Lowe, Lee Ann [6 ]
Cairo, Mitchell S. [1 ,5 ,7 ]
机构
[1] Columbia Univ, Dept Pediat, New York, NY 10027 USA
[2] Holmes Reg Med Ctr, Dept Pharm, Melbourne, FL USA
[3] Mt Sinai Med Ctr, New York, NY 10029 USA
[4] Columbia Univ, Dept Biostat, New York, NY 10027 USA
[5] Columbia Univ, Dept Pathol, New York, NY 10027 USA
[6] Univ Calif San Francisco, Dept Surg, San Francisco, CA 94143 USA
[7] Columbia Univ, Dept Med, New York, NY 10027 USA
关键词
allogeneic stem cell transplant; growth factors; granulocyte-macrophage colony-stimulating factor; granulocyte-colony stimulating factor; neupogen; sequential administration; COLONY-STIMULATING FACTOR; BONE-MARROW-TRANSPLANTATION; VERSUS-HOST-DISEASE; HEMATOPOIETIC GROWTH-FACTORS; GRANULOCYTE-MACROPHAGE; G-CSF; GM-CSF; MYCOPHENOLATE-MOFETIL; PROGENITOR CELLS; CONTROLLED-TRIAL;
D O I
10.1111/j.1399-3046.2008.01000.x
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
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 mu g/m(2) IV QD) began on day of stem cell infusion. GM-CSF was switched to G-CSF (10 mu g/kg IV QD) when WBC >= 300/mm(3) x 2 days. G-CSF continued until ANC >= 2500/mm(3) x 2 days, then tapered to maintain ANC >= 1000/mm(3). Median time to myeloid engraftment (ANC >= 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 (TM) 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.
引用
收藏
页码:464 / 474
页数:11
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