Article (Scientific journals)
Decitabine versus best supportive care in older patients with refractory anemia with excess blasts in transformation (RAEBt) - results of a subgroup analysis of the randomized phase III study 06011 of the EORTC Leukemia Cooperative Group and German MDS Study Group (GMDSSG)
BECKER, Heiko; SUCIU, Stefan; RUTER, Björn Hans et al.
2015In Annals of Hematology, 94, p. 2003-2013
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Keywords :
RAEBt; MDS; AML; Leukemia; Allogeneic transplantation; Epigenetic therapy
Abstract :
[en] In the European Organisation for Research and Treatment of Cancer (EORTC)/GMDSSG phase III trial06011, we compared decitabine (15 mg/m² every 8 h for 3 days) with best supportive care (BSC) in patients >/= 60 years with myelodysplastic syndromes (MDS) by French-Amercian-British (FAB) criteria. Here, we reinvestigate trial 06011 for the activity and efficacy specifically in patients with refractory anemia with excess blasts in transformation (RAEBt). Response rates in the decitabine arm (N=40) were as follow: complete or partial remission, 15 %; hematologic improvement, 15 %; resistant disease, 30 %. RAEBt patients in the decitabine arm had longer progression-free survival (PFS; hazard ratio (HR) 0.30, 95 % confidence interval (CI) 0.18-0.51; median, 6.2 vs 2.8 months) and overall survival (OS; HR 0.68, 95 % CI 0.42-1.11; median, 8.0 vs 6.0 months) than in the BSC arm (N=35). Censoring at allogeneic hematopoietic stem cell transplantation, the OS difference between the treatment groups increased, particularly among patients.
Disciplines :
Hematology
Author, co-author :
BECKER, Heiko
SUCIU, Stefan
RUTER, Björn Hans
PLATZBECKER, Uwe
GIAGOUNIDIS, Aristoteles
SELLESLAG, Dominik
LABAR, Boris
GERMING, Ulrich
SALIH, Helmut R.
MUUS, Petra
PFLUGER, Karl-Heinz
HAGEMEIJER, Anne
SCHAEFER, Hans-Eckart
FIACCADORI, Valeria
BARON, Frédéric  ;  Centre Hospitalier Universitaire de Liège - CHU > Hématologie clinique
GANSER, Arnold
AUL, Carlo
DE WITTE, Theo
WIJERMANS, Pierre W.
LUBBERT, Michael
More authors (10 more) Less
Language :
English
Title :
Decitabine versus best supportive care in older patients with refractory anemia with excess blasts in transformation (RAEBt) - results of a subgroup analysis of the randomized phase III study 06011 of the EORTC Leukemia Cooperative Group and German MDS Study Group (GMDSSG)
Publication date :
2015
Journal title :
Annals of Hematology
ISSN :
0939-5555
eISSN :
1432-0584
Publisher :
Springer Verlag, Berlin, Germany
Volume :
94
Pages :
2003-2013
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 12 November 2015

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