Kroeger, Nicolaus, Sockel, Katja, Wolschke, Christine, Bethge, Wolfgang, Schlenk, Richard F., Wolf, Dominik, Stadler, Michael, Kobbe, Guido, Wulf, Gerald, Bug, Gesine ORCID: 0000-0003-2359-131X, Schaefer-Eckart, Kerstin, Scheid, Christof, Nolte, Florian, Kroenke, Jan, Stelljes, Matthias, Beelen, Dietrich, Heinzelmann, Marion, Haase, Detlef, Buchner, Hannes, Bleckert, Gabriele ORCID: 0000-0002-4341-9042, Giagounidis, Aristoteles and Platzbecker, Uwe (2021). Comparison Between 5-Azacytidine Treatment and Allogeneic Stem-Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability (VidazaAllo Study). J. Clin. Oncol., 39 (30). S. 3318 - 3329. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1527-7755

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Abstract

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% Cl, 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. (C) 2021 by American Society of Clinical Oncology

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Kroeger, NicolausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sockel, KatjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolschke, ChristineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bethge, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schlenk, Richard F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolf, DominikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stadler, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kobbe, GuidoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wulf, GeraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bug, GesineUNSPECIFIEDorcid.org/0000-0003-2359-131XUNSPECIFIED
Schaefer-Eckart, KerstinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scheid, ChristofUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nolte, FlorianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kroenke, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stelljes, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beelen, DietrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heinzelmann, MarionUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haase, DetlefUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Buchner, HannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bleckert, GabrieleUNSPECIFIEDorcid.org/0000-0002-4341-9042UNSPECIFIED
Giagounidis, AristotelesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Platzbecker, UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-606012
DOI: 10.1200/JCO.20.02724
Journal or Publication Title: J. Clin. Oncol.
Volume: 39
Number: 30
Page Range: S. 3318 - 3329
Date: 2021
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Place of Publication: PHILADELPHIA
ISSN: 1527-7755
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ACUTE MYELOID-LEUKEMIA; RISK MYELODYSPLASTIC SYNDROMES; MALIGNANCIES WORKING PARTY; SOCIETE FRANCAISE; SCORING SYSTEM; AZACITIDINE; CHEMOTHERAPY; SUBCOMMITTEE; EFFICACY; GREFFEMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60601

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