Comparison Between 5-Azacytidine Treatment and Allogeneic Stem-Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability (VidazaAllo Study)
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Comparison Between 5-Azacytidine Treatment and Allogeneic Stem-Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability (VidazaAllo Study). / Kröger, Nicolaus; Sockel, Katja; Wolschke, Christine; Bethge, Wolfgang; Schlenk, Richard F; Wolf, Dominik; Stadler, Michael; Kobbe, Guido; Wulf, Gerald; Bug, Gesine; Schäfer-Eckart, Kerstin; Scheid, Christof; Nolte, Florian; Krönke, Jan; Stelljes, Matthias; Beelen, Dietrich; Heinzelmann, Marion; Haase, Detlef; Buchner, Hannes; Bleckert, Gabriele; Giagounidis, Aristoteles; Platzbecker, Uwe.
In: J CLIN ONCOL, Vol. 39, No. 30, 20.10.2021, p. 3318-3327.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Comparison Between 5-Azacytidine Treatment and Allogeneic Stem-Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability (VidazaAllo Study)
AU - Kröger, Nicolaus
AU - Sockel, Katja
AU - Wolschke, Christine
AU - Bethge, Wolfgang
AU - Schlenk, Richard F
AU - Wolf, Dominik
AU - Stadler, Michael
AU - Kobbe, Guido
AU - Wulf, Gerald
AU - Bug, Gesine
AU - Schäfer-Eckart, Kerstin
AU - Scheid, Christof
AU - Nolte, Florian
AU - Krönke, Jan
AU - Stelljes, Matthias
AU - Beelen, Dietrich
AU - Heinzelmann, Marion
AU - Haase, Detlef
AU - Buchner, Hannes
AU - Bleckert, Gabriele
AU - Giagounidis, Aristoteles
AU - Platzbecker, Uwe
PY - 2021/10/20
Y1 - 2021/10/20
N2 - 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.
AB - 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.
U2 - 10.1200/JCO.20.02724
DO - 10.1200/JCO.20.02724
M3 - SCORING: Journal article
C2 - 34283629
VL - 39
SP - 3318
EP - 3327
JO - J CLIN ONCOL
JF - J CLIN ONCOL
SN - 0732-183X
IS - 30
ER -
