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Peripheral-Blood Stem Cells versus Bone Marrow from Unrelated Donors N Engl J Med 2012;367:1487-96. R3 Sunhee park/Prof. Kyung-sam cho
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BACKGROUND Allogeneic hematopoietic stem-cell transplantation Unrelated donors : generic diversity results obtained with transplants from HLA-identical siblings may not be applicable BMFilgrastim-stimulated peripheral blood Source : Transplantation between HLA-identical sibling -better engraftment & survival, relapse rate↓ -higher risk of acute/chronic GVHD Aim To determine the effects of graft source for unrelated-donor transplants A randomized trial comparing outcomes of peripheral-blood stem-cell and bone marrow transplantations.
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METHODS Open-label, phase 3, multicenter, randomized trial Blood and Marrow Transplant Clinical Trials Network 2004.03.31~2009.09.09 550 donor- recipient pairs Randomization 1:1 Randomization 1:1 f/u for 3yrs Transplantation DNA typing Transplantation DNA typing BMSC donor PBSC donor GCSF PBSC donor GCSF Recipient Conditioning GVHD prophylaxis Recipient Conditioning GVHD prophylaxis
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Inclusion criteria -<66 yrs -Acute leukemia, myelodysplasia, chronic myeloid or myelomonocytic leukemia, or myelofibrosis transplantation Exclusion criteria -donor-specific anti-HLA ab, prior allogeneic or autologous transplantation, HIV infection, pregnancy or breast feeding, cardiac insufficiency or coronary artery dz, active infection -Cr, TB, AST/ALT ≥ 2x Primary end point : 2-year survival rate Secondary end point : Post-transplantation incidences of neutrophil & platelet engraftment, graft failure, acute & chronic GVHD, relapse, infection, adverse events Primary end point : 2-year survival rate Secondary end point : Post-transplantation incidences of neutrophil & platelet engraftment, graft failure, acute & chronic GVHD, relapse, infection, adverse events
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RESULTS
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2-year overall survival rate 51% 46% Fig 1. Survival after Randomization in the Intention-to-Treat Analysis.
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Fig 2. Outcomes after Transplantation, According to Study Group. No significant difference
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5 days 7 days
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CONCLUSIONS This trial did not detect significant survival differences between peripheral-blood stem-cell and bone marrow transplantation from unrelated donors. Secondary end points indicated that peripheral-blood stem cells may reduce the risk of graft failure, whereas bone marrow may reduce the risk of chronic GVHD.
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