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: | , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
July 20, 2021
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| 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 |
| 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 |
| 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. |
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| Item Description: | Gesehen am 25.03.2022 |
| Physical Description: | Online Resource |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO.20.02724 |