Reduced-intensity conditioning (RIC) resulted in similar outcomes to standard-dose myeloablative conditioning (MAC) among patients with myelodysplastic syndrome (MDS) undergoing allogeneic stem-cell transplantation (alloSCT), according to a study published in the Journal of Clinical Oncology.1
Retrospective studies suggested that RIC results in a reduced risk of non-relapse mortality, but increases the risk of relapse, compared with MAC. The aim of this study was to eliminate selection bias by comparing RIC and MAC in a prospective setting.
This multicenter, open-label, phase 3 trial randomly assigned 129 patients with MDS or secondary acute myeloid leukemia to receive MAC or RIC followed by alloSCT.
At baseline, the median age was 50.5 and 36.5% of patients had received prior induction chemotherapy. Most characteristics were similar between arms, except 30% of patients in the RIC arm had greater than 5% blasts vs 18% in the MAC arm.
Engraftment was similar between arms, and the cumulative incidence of grade 2 to 4 acute graft-versus-host disease was 32.3% and 37.5% in the RIC and MAC arms, respectively, which increased to 61.6% and 64.7%, respectively, at 24 months.
Patients who received MAC demonstrated a higher cumulative incidence of 1-year non-relapse mortality, with a rate of 25% (95% CI, 15%-36%) compared with 15% (95% CI, 6%-24%) in the RIC arm.
The 2-year relapse-free survival was similar with RIC (62%; 95% CI, 50%-74%) compared with MAC (58%; 95% CI, 46%-71%; P = .58).
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Overall survival was also similar, with 2-year rates of 76% (95% CI, 66%-87%) compared with 63% (95% CI, 51%-75%) in the RIC and MAC arms, respectively (P = .08).
The results of this study suggest, according to the authors, that RIC may be an alternative to MAC, particularly for patients of low cytogenetic risk.
- Kröger N, Iacobelli S, Franke GN, et al. Dose-reduced versus standard conditioning followed by allogeneic stem-cell transplantation for patients with myelodysplastic syndrome: a prospective randomized phase III study fo the EBMT (RICMAC Trial). J Clin Oncol. 2017 May 2. doi:10.1200/JCO.2016.70.7349 [Epub ahead of print]