Kroeger, Nicolaus, Iacobelli, Simona, Franke, Georg-Nikolaus, Platzbecker, Uwe, Uddin, Ruzena, Huebel, Kai, Scheid, Christof, Weber, Thomas, Robin, Marie ORCID: 0000-0003-1388-9876, Stelljes, Matthias, Afanasyev, Boris, Heim, Dominik, Deliliers, Giorgio Lambertenghi, Onida, Francesco ORCID: 0000-0002-2991-3474, Dreger, Peter, Pini, Massimo, Guidi, Stefano, Volin, Liisa ORCID: 0000-0002-9731-8335, Guenther, Andreas, Bethge, Wolfgang, Poire, Xavier, Kobbe, Guido, van Os, Marleen, Brand, Ronald and de Witte, Theo (2017). Dose-Reduced Versus Standard Conditioning Followed by Allogeneic Stem-Cell Transplantation for Patients With Myelodysplastic Syndrome: A Prospective Randomized Phase III Study of the EBMT (RICMAC Trial). J. Clin. Oncol., 35 (19). S. 2157 - 2167. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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Abstract

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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Kroeger, NicolausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Iacobelli, SimonaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Franke, Georg-NikolausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Platzbecker, UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Uddin, RuzenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huebel, KaiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scheid, ChristofUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weber, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Robin, MarieUNSPECIFIEDorcid.org/0000-0003-1388-9876UNSPECIFIED
Stelljes, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Afanasyev, BorisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heim, DominikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Deliliers, Giorgio LambertenghiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Onida, FrancescoUNSPECIFIEDorcid.org/0000-0002-2991-3474UNSPECIFIED
Dreger, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pini, MassimoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Guidi, StefanoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Volin, LiisaUNSPECIFIEDorcid.org/0000-0002-9731-8335UNSPECIFIED
Guenther, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bethge, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Poire, XavierUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kobbe, GuidoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Os, MarleenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brand, RonaldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Witte, TheoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-226688
DOI: 10.1200/JCO.2016.70.7349
Journal or Publication Title: J. Clin. Oncol.
Volume: 35
Number: 19
Page Range: S. 2157 - 2167
Date: 2017
Publisher: AMER SOC CLINICAL ONCOLOGY
Place of Publication: ALEXANDRIA
ISSN: 1527-7755
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ACUTE MYELOID-LEUKEMIA; IDENTICAL SIBLING DONORS; 1ST COMPLETE REMISSION; OPEN-LABEL; INTENSITY; REGIMENS; MDS; AML; MARROW; GRAFTMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/22668

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