Comparison between 5-azacytidine treatment and allogeneic stem-cell transplantation in elderly patients with advanced MDS according to donor availability (VidazaAllo Study)

PURPOSE - - In contrast to 5-azacytidine (5-aza), allogeneic stem-cell transplantation (HSCT) represents a curative treatment strategy for patients with myelodysplastic syndromes (MDS), but therapy-related mortality (TRM) limits its broader use in elderly patients with MDS. The present prospective...

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Main Authors: Kröger, Nicolaus (Author) , Sockel, Katja (Author) , Wolschke, Christine (Author) , Bethge, Wolfgang (Author) , Schlenk, Richard Friedrich (Author) , Wolf, Dominik (Author) , Stadler, Michael (Author) , Kobbe, Guido (Author) , Wulf, Gerald (Author) , Bug, Gesine (Author) , Schäfer-Eckart, Kerstin (Author) , Scheid, Christof (Author) , Nolte, Florian (Author) , Krönke, Jan (Author) , Stelljes, Matthias (Author) , Beelen, Dietrich (Author) , Heinzelmann, Marion (Author) , Haase, Detlef (Author) , Buchner, Hannes (Author) , Bleckert, Gabriele (Author) , Giagounidis, Aristoteles (Author) , Platzbecker, Uwe (Author)
Format: Article (Journal)
Language:English
Published: July 20, 2021
In: Journal of clinical oncology
Year: 2021, Volume: 39, Issue: 30, Pages: 3318-3327
ISSN:1527-7755
DOI:10.1200/JCO.20.02724
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.20.02724
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.20.02724
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Author Notes:Nicolaus Kröger, MD; Katja Sockel, MD; Christine Wolschke, MD; Wolfgang Bethge, MD; Richard F. Schlenk, MD, Dominik Wolf, MD; Michael Stadler, MD; Guido Kobbe, MD; Gerald Wulf, MD; Gesine Bug, MD; Kerstin Schäfer-Eckart, MD; Christof Scheid, MD; Florian Nolte, MD; Jan Krönke, MD; Matthias Stelljes, MD; Dietrich Beelen, MD; Marion Heinzelmann; Detlef Haase, MD; Hannes Buchner, PhD; Gabriele Bleckert, PhD; Aristoteles Giagounidis, MD; Uwe Platzbecker, MD; on behalf of the German MDS Study Group and the German Cooperative Transplant Study Group
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Summary:PURPOSE - - In contrast to 5-azacytidine (5-aza), allogeneic stem-cell transplantation (HSCT) represents a curative treatment strategy for patients with myelodysplastic syndromes (MDS), but therapy-related mortality (TRM) limits its broader use in elderly patients with MDS. The present prospective multicenter study compared HSCT following 5-aza pretreatment with continuous 5-aza treatment in patients with higher-risk MDS age 55-70 years. - - METHODS - - One hundred ninety patients with a median age of 63 years were enrolled. Patients received 4-6 cycles of 5-aza followed by HLA-compatible HSCT after reduced-intensity conditioning or by continuous 5-aza if no donor was identified. - - RESULTS - - Twenty-eight patients did not fulfill inclusion criteria (n = 20), died (n = 2) withdrew informed consent (n = 5), or were excluded for an unknown reason (n = 1). 5-aza induction started in 162 patients, but only 108 (67%) were eligible for subsequent allocation to HSCT (n = 81) or continuation of 5-aza (n = 27) because of disease progression (n = 26), death (n = 12), or other reasons (n = 16). Seven percent died during 5-aza before treatment allocation. The cumulative incidence of TRM after HSCT at 1 year was 19%. The event-free survival and overall survival after 5-aza pretreatment and treatment allocation at 3 years were 34% (95% CI, 22 to 47) and 50% (95% CI, 39 to 61) after allograft and 0% and 32% (95% CI, 14 to 52) after continuous 5-aza treatment (P < .0001 and P = .12), respectively. Fourteen patients progressing after continuous 5-aza received a salvage allograft from an alternative donor, and 43% were alive at last follow-up. - - CONCLUSION - - In older patients with MDS, reduced-intensity conditioning HSCT resulted in a significantly improved event-free survival in comparison with continuous 5-aza therapy. Bridging with 5-aza to HSCT before is associated with a considerable rate of dropouts because of progression, mortality, and adverse events.
Item Description:Gesehen am 25.03.2022
Physical Description:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.20.02724