Journal of clinical oncology, 2017, Vol.35 (19), p.2157-2164
Purpose To compare a reduced-intensity conditioning regimen (RIC) with a myeloablative conditioning regimen (MAC) before allogeneic transplantation in patients with myelodysplastic syndrome (MDS) within a randomized trial. Patients and Methods Within the European Society of Blood and Marrow Transplantation, we conducted a prospective, multicenter, open-label, randomized phase III trial that compared a busulfan-based RIC with MAC in patients with MDS or secondary acute myeloid leukemia. A total of 129 patients were enrolled from 18 centers. Patients were randomly assigned in a 1:1 ratio and were stratified according to donor, age, and blast count. Results Engraftment was comparable between both groups. The CI of acute graft-versus-host disease II to IV was 32.3% after RIC and 37.5% after MAC ( P = .35). The CI of chronic graft-versus-host disease was 61.6% after RIC and 64.7% after MAC ( P = .76). The CI of nonrelapse mortality after 1 year was 17% (95% CI, 8% to 26%) after RIC and 25% (95% CI, 15% to 36%) after MAC ( P = .29). The CI of relapse at 2 years was 17% (95% CI, 8% to 26%) after RIC and 15% (95% CI, 6% to 24%) after MAC ( P = .6), which resulted in a 2-year relapse-free survival and overall survival of 62% (95% CI, 50% to 74%) and 76% (95% CI, 66% to 87%), respectively, after RIC, and 58% (95% CI, 46% to 71%) and 63% (95% CI, 51% to 75%), respectively, after MAC ( P = .58 and P = .08, respectively). Conclusion This prospective, randomized trial of the European Society of Blood and Marrow Transplantation provides evidence that RIC resulted in at least a 2-year relapse-free survival and overall survival similar to MAC in patients with MDS or secondary acute myeloid leukemia.
Cyclophosphamide - administration & dosage ; Humans ; Middle Aged ; Male ; Vidarabine - analogs & derivatives ; Busulfan - administration & dosage ; Transplantation, Homologous ; Dose-Response Relationship, Drug ; Young Adult ; Myelodysplastic Syndromes - therapy ; Stem Cell Transplantation - methods ; Leukemia, Myeloid, Acute - drug therapy ; Adult ; Female ; Leukemia, Myeloid, Acute - surgery ; Transplantation Conditioning - adverse effects ; Vidarabine - administration & dosage ; Transplantation Conditioning - methods ; Graft vs Host Disease - etiology ; Myelodysplastic Syndromes - surgery ; Leukemia, Myeloid, Acute - therapy ; Myelodysplastic Syndromes - drug therapy ; Stem Cell Transplantation - adverse effects ; Index Medicus
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