Azacitidine in Acute Myeloid Leukemia with >30% Bone Marrow Blasts and <15 G/L White Blood Cell Count: Results from the Austrian Azacitidine Registry of the AGMT Study Group Versus Randomized Controlled Phase III Clinical Trial Data

Background In the Phase III trial (AML-001; NCT01074047) that assessed azacitidine (AZA) vs conventional care regimens (CCR; intensive chemotherapy, low-dose cytarabine or best supportive care as preselected by the treating physician) in older patients (≥65 years) with newly diagnosed acute myeloid...

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Published in:Blood 2015-12, Vol.126 (23), p.2515-2515
Main Authors: Pleyer, Lisa, Burgstaller, Sonja, Stauder, Reinhard, Girschikofsky, Michael, Sill, Heinz, Schlick, Konstantin, Thaler, Josef, Halter, Britta, Machherndl-Spandl, Sigrid, Zebisch, Armin, Pichler, Angelika, Pfeilstöcker, Michael, Autzinger, Eva-Maria, Lang, Alois, Geissler, Klaus, Voskova, Daniela, Geissler, Dietmar, Sperr, Wolfgang R, Hojas, Sabine, Mandac Rogulj, Inga, Andel, Johannes, Greil, Richard
Format: Article
Language:English
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Summary:Background In the Phase III trial (AML-001; NCT01074047) that assessed azacitidine (AZA) vs conventional care regimens (CCR; intensive chemotherapy, low-dose cytarabine or best supportive care as preselected by the treating physician) in older patients (≥65 years) with newly diagnosed acute myeloid leukemia (AML) and >30% bone marrow (BM) blasts, AZA was associated with a clinically meaningful improvement in overall survival (OS) vs CCR.1Patient registry data, if performed with adequate quality control, can complement and be of additional value to data generated in clinical trials. The Austrian Azacitidine Registry (AAR; NCT01595295) was initiated to gain a comprehensive view of the use, safety and efficacy of AZA in patients with AML in a 'real world' clinical practice setting.2,3 No formal exclusion criteria existed, as the aim was to include all AML patients treated with AZA, irrespective of age, comorbidities, and/or previous lines of treatment.2,3 Aims and methods The aim of this analysis was to assess the efficacy and safety of 1st -line AZA in patients with AML who were included in the AAR and who fulfilled the BM blast percentage and white blood cell (WBC) count entry criteria of the AML-001 trial (BM blasts >30% and WBC
ISSN:0006-4971
1528-0020
DOI:10.1182/blood.V126.23.2515.2515