Decitabine versus best supportive care in older patients with refractory anemia with excess blasts in transformation (RAEBt) - results of ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2015-09-24

AUTHORS

Heiko Becker, Stefan Suciu, Björn Hans Rüter, Uwe Platzbecker, Aristoteles Giagounidis, Dominik Selleslag, Boris Labar, Ulrich Germing, Helmut R. Salih, Petra Muus, Karl-Heinz Pflüger, Anne Hagemeijer, Hans-Eckart Schaefer, Valeria Fiaccadori, Frédéric Baron, Arnold Ganser, Carlo Aul, Theo de Witte, Pierre W. Wijermans, Michael Lübbert

ABSTRACT

In the European Organisation for Research and Treatment of Cancer (EORTC)/GMDSSG phase III trial 06011, 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-American-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 follows: 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 aged 60–74 years (HR 0.48, 95 % CI 0.26–0.89). After regrouping the study cohort according to World Health Organization (WHO) criteria, patients with acute myeloid leukemia (AML) (i.e., ≥20 % blasts) in the decitabine arm (N = 27) also had longer PFS than in the BSC arm (N = 23) (HR 0.46, 95 % CI 0.26–0.83; median, 6.2 vs 2.8 months). In conclusion, 3-day decitabine displays clinical activity and efficacy in MDS and/or AML with 5–30 % blood or 20–30 % marrow blasts. More... »

PAGES

2003-2013

Journal

TITLE

Annals of Hematology

ISSUE

12

VOLUME

94

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00277-015-2489-6

DOI

http://dx.doi.org/10.1007/s00277-015-2489-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1046103336

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26400023


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