Azacitidine in patients with WHO-defined AML – Results of 155 patients from the Austrian Azacitidine Registry of the AGMT-Study Group

Journal of Hematology & Oncology

Richard Greil^1,12  Hubert Angermann⁷  Daniela Voskova^1,13  Werner Linkesch⁸  Alexander Egle^1,12  Thamer Sliwa⁹  Peter Krippl²  Alois Lang⁶  Michael Girschikofsky¹  Martina Mitrovic³  Thomas Melchardt^1,12  Susanne Steinkirchner^1,12  Michael Pfeilstocker⁴  Christoph Tinchon⁵  Martin Schreder^1,11  Sonja Burgstaller^1,10  Reinhard Stauder³  Lisa Pleyer^1,12 

[1] 1st Medical Department with Hematology, Stem cell transplantation, Hemostatsis and Medical Oncology, Elisabethinen Hospital, Fadingerstrasse 1, Linz, 4010, Austria;Department for Internal Medicine, LKH Fuerstenfeld, Krankenhausgasse 1, Fuerstenfeld, 8280, Austria;Internal Medicine V (Hematology and Oncology), Innsbruck Medical University, Anichstrasse 35, Innsbruck, 6020, Austria;IIIrd Medical Department, Hanusch Hospital, Heinrich-Collin-Strasse 30, Vienna, 1140, Austria;Department for Hematology and Oncology, LKH Leoben-Eisenerz, Radmeisterstrasse 7-9, Eisenerz, 8790, Austria;Internal Medicine, Hospital Feldkirch, Carinagasse 47, Feldkirch, 6800, Austria;UNIDATA GEODESIGN GmbH, Gaertnergasse 3, Vienna, 1030, Austria;Department of Hematology, Medical University, Auenbruggerplatz 1, Graz, 8036, Austria;5th Medical Department with Oncology und Palliative Medicine, Hietzing, Wolkersbergenstrasse 1, Vienna, 1130, Austria;Department for Internal Medicine IV, Hospital Wels-Grieskirchen, Grieskirchnerstrasse 42, Wels, 4600, Austria;1st Department of Internal Medicine, Center for Oncology and Hematology, Wilhelminenspital, Montleartstrasse 37, Vienna, 1160, Austria;3rd Medical Department with Hematology and Medical Oncology, Hemostaseology, Rheumatology and Infectious Diseases, Laboratory for Immunological and Molecular Cancer Research, Oncologic Center, Paracelsus Medical University Hospital Salzburg, Müllnerhauptstrasse 48, Salzburg, 5020, Austria;Internal Medicine 3, Center for Hematology and Medical Oncology, General Hospital-Linz GesmbH, Krankenhausstrasse 9, Linz, 4021, Austria

关键词: Bone marrow blasts;    Prognostic factors;    Overall survival;    AML;    Azacitidine;    Austrian azacitidine registry;   

Others  :  806381
DOI  :  10.1186/1756-8722-6-32

 received in 2013-02-11, accepted in 2013-03-22,  发布年份 2013

【 摘 要 】

Objective

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.

Patients and methods

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.

Results

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).

Conclusions

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.

【 授权许可】

   
2013 Pleyer et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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