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Pleyer, L; Stauder, R; Burgstaller, S; Schreder, M; Tinchon, C; Pfeilstocker, M; Steinkirchner, S; Melchardt, T; Mitrovic, M; Girschikofsky, M; Lang, A; Krippl, P; Sliwa, T; Egle, A; Linkesch, W; Voskova, D; Angermann, H; Greil, R.
Azacitidine in patients with WHO-defined AML - results of 155 patients from the Austrian Azacitidine Registry of the AGMT-Study Group.
J Hematol Oncol. 2013; 6(4):32-32
Doi: 10.1186/1756-8722-6-32
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- Co-Autor*innen der Med Uni Graz
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Linkesch Werner
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- Abstract:
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The Austrian Azacitidine Registry is a multi-center database (ClinicalTrials.gov: NCT01595295). The nature and intent of the registry was to gain a comprehensive view of the use, safety and efficacy of the drug in a broad range of AML-patients treated in real-life scenarios.
The sole inclusion criteria were the diagnosis of WHO-AML and treatment with at least one dose of azacitidine. No formal exclusion criteria existed. A total of 155 AML-patients who were mostly unfit/ineligible for intensive chemotherapy, or had progressed despite conventional treatment, were included. True ITT-analyses and exploratory analyses regarding the potential prognostic value of baseline-variables/performance-/comorbidity-/risk-scores on overall survival (OS), were performed.
In this cohort of 155 pretreated (60%), and/or comorbid (87%), elderly (45% ≥75 years) AML-patients, azacitidine was well tolerated and efficacious, with an overall response rate (CR, mCR, PR, HI) of 45% in the total cohort (ITT) and 65% in patients evaluable according to IWG-criteria, respectively. Pre-treatment with conventional chemotherapy (P = .113), age ≤/>80 years (P = .853), number of comorbidities (P = .476), and bone marrow (BM) blast count (P = .663) did not influence OS. In multivariate analysis hematologic improvement alone (without the requirement of concomitant bone marrow blast reduction), although currently not regarded as a standard form of response assessment in AML, was sufficient to confer OS benefit (18.9 vs. 6.0 months; P = .0015). Further deepening of response after first response was associated with improved OS (24.7 vs. 13.7 months; P < .001).
In this large cohort of AML-patients treated with azacitidine, age >80 years, number of comorbidities and/or BM-blasts >30% did not adversely impact OS.
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Adult -
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Aged -
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Aged, 80 and over -
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Antimetabolites, Antineoplastic - therapeutic use
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Antimetabolites, Antineoplastic -
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Azacitidine - adverse effects
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Cohort Studies -
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Female -
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Humans -
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Leukemia, Myeloid, Acute - drug therapy
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Male -
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Middle Aged -
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Prognosis -
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Registries -
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Treatment Outcome -
- Find related publications in this database (Keywords)
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Austrian azacitidine registry
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Azacitidine
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AML
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Overall survival
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Prognostic factors
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Bone marrow blasts