Transplantation of PBSC rather than bone marrow shortens the duration of pancytopenia following allogeneic transplant, and may reduce transplant-related mortality. We have previously shown that transplantation of 5 × 106 CD34+ cells/kg results in a 95% likelihood of neutrophil (ANC 500/nl) and platelet ( 20,000/Hl) recovery by Day +15. However, after mobilization with G-CSF alone (10 ng/kg/day), one-third of normal donors failed to achieve this target with one apheresis. We carried out a trial in which 77 normal donors received G-CSF (10 Jlg/kg/day) along with GM-CSF (5ng/kg/day) for 4 days, followed by 20Lapheresis on Day 5. The first apheresis products were compared with those collected from 97 donors who received the same dose and schedule of G-CSF without GM-CSF. All patients had hématologie malignancies and received a TBI-based preparative regimen with cyclosporine (CsA) and methylprednisolone (MP), or CsA alone as GVHD prophylaxis. Median follow-up for 74 surviving patients is 593 days (92-1975). Product data below are means. Clinical outcomes are 2 year actuarial probabilities. G+GM-CSF (n=77) G-CSF (n=97) p-value CD34+ cells × 106 9.0 6.8 .008 CD34+ cells/kg × 106 11.1 8.8 .04 CD3+/kg × 108 1.8 3.3 .0001 Grade II-IV AGVHD CsA + MP 0.43 0.33 .5 CsA alone 0.71 0.62 .4 Chronic GVHD 0.96 0.93 .5 Relapse Risk 0.42 0.41 .5 PFS 0.39 0.42 .5 For a hypothetical patient weighing over 70 kg, 69 of 77 (90%) G+GM-CSF mobilized collections exceeded the target of 5 x 10' CD34 cells/kg compared with 69 of 97 (71%) G-CSF mobilized collections (p=.003). Conclusion: mobilization with both G+GM-CSF resulted in a 25% increase in hematopoietic progenitors collected with one apheresis, increased the likelihood of collecting 5 x 100 CD34+ cells/kg with one apheresis by about 20%, reduced the CD34+ cell content of apheresis products by about 50%, did not effect PFS, risk of relapse or GVHD.
|Issue number||11 PART I|
|State||Published - Dec 1 2000|