Comparison Between 5-Azacytidine Treatment and Allogeneic Stem-Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability (VidazaAllo Study)

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% 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.

Citation: JCO 39(30):3318-3327

Date Published: 20th Oct 2021

Registered Mode: by DOI

Authors: Nicolaus Kröger, Katja Sockel, Christine Wolschke, Wolfgang Bethge, Richard F. Schlenk, Dominik Wolf, Michael Stadler, Guido Kobbe, Gerald Wulf, Gesine Bug, Kerstin Schäfer-Eckart, Christof Scheid, Florian Nolte, Jan Krönke, Matthias Stelljes, Dietrich Beelen, Marion Heinzelmann, Detlef Haase, Hannes Buchner, Gabriele Bleckert, Aristoteles Giagounidis, Uwe Platzbecker

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Citation
Kröger, N., Sockel, K., Wolschke, C., Bethge, W., Schlenk, R. F., Wolf, D., Stadler, M., Kobbe, G., Wulf, G., Bug, G., Schäfer-Eckart, K., Scheid, C., Nolte, F., Krönke, J., Stelljes, M., Beelen, D., Heinzelmann, M., Haase, D., Buchner, H., … Platzbecker, U. (2021). Comparison Between 5-Azacytidine Treatment and Allogeneic Stem-Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability (VidazaAllo Study). In Journal of Clinical Oncology (Vol. 39, Issue 30, pp. 3318–3327). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.20.02724
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Created: 31st Oct 2024 at 15:40

Last updated: 31st Oct 2024 at 15:40

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