Reduced-Intensity vs Standard Conditioning Followed by ASCT in Myelodysplastic Syndrome
In the phase III RICMAC trial, use of a dose-reduced vs a standard myeloablative conditioning regimen prior to allogeneic stem cell transplantation (ASCT) did not appear to reduce 2-year relapse-free or overall survival in patients with myelodysplastic syndrome. These findings were reported by Kröger et al in the Journal of Clinical Oncology.
Study Details
In the open-label trial, 129 patients from 18 sites in 7 countries were randomized between May 2004 and December 2012 to receive reduced-intensity conditioning with lower-dose busulfan/fludarabine (n = 65, 4 with secondary acute myeloid leukemia) vs myeloablative conditioning with full-dose busulfan/cyclophosphamide (n = 64, 8 with acute myeloid leukemia) prior to ASCT.
Engraftment, Relapse, and Survival
Graft failure occurred in three patients in the reduced-intensity conditioning group and four patients in the myeloablative conditioning group. The cumulative incidence of acute graft-vs-host disease grades II to IV was 32.3% after reduced-intensity conditioning and 37.5% after myeloablative conditioning (P = .35). The cumulative incidence of chronic graft-vs-host disease was 61.6% after reduced-intensity conditioning and 64.7% after myeloablative conditioning (P = .76).
The 1-year cumulative incidence of nonrelapse mortality was 17% vs 25% (P = .29). The 2-year cumulative incidence of relapse was 17% vs 15% (P = .6). Two-year relapse-free survival was 62% vs 58% (P = .58), and 2-year overall survival was 76% vs 63% (P = .08).
The investigators concluded: “This prospective, randomized trial of the European Society of Blood and Marrow Transplantation provides evidence that [reduced-intensity conditioning] resulted in at least a 2-year relapse-free survival and overall survival similar to [myeloablative conditioning] in patients with [myelodysplastic syndrome] or secondary acute myeloid leukemia.”
The study was supported by a grant from Pierre Fabre.
Nicolaus Kröger, MD, of the University Medical Center Hamburg-Eppendorf, is the corresponding author of the Journal of Clinical Oncology article.
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