Adverse Events in 1406 Patients Receiving 13,780 Cycles of Azacitidine within the Austrian Registry of Hypomethylating Agents-A Prospective Cohort Study of the AGMT Study-Group

Michael Leisch, Michael Pfeilstöcker, Reinhard Stauder, Sonja Heibl, Heinz Sill, Michael Girschikofsky, Margarete Stampfl-Mattersberger, Christoph Tinchon, Bernd Hartmann, Andreas Petzer, Martin Schreder, David Kiesl, Sonia Vallet, Alexander Egle, Thomas Melchardt, Gudrun Piringer, Armin Zebisch, Sigrid Machherndl-Spandl, Dominik Wolf, Felix KeilManuel Drost, Richard Greil, Lisa Pleyer

Research output: Journal article (peer-reviewed)Journal article

Abstract

Background: Azacitidine is the treatment backbone for patients with acute myeloid leukemia, myelodysplastic syndromes and chronic myelomonocytic leukemia who are considered unfit for intensive chemotherapy. Detailed reports on adverse events in a real-world setting are lacking. Aims: To analyze the frequency of adverse events in the Austrian Registry of Hypomethylating agents. To compare real-world data with that of published randomized clinical trials. Results: A total of 1406 patients uniformly treated with a total of 13,780 cycles of azacitidine were analyzed. Hematologic adverse events were the most common adverse events (grade 3-4 anemia 43.4%, grade 3-4 thrombopenia 36.8%, grade 3-4 neutropenia 36.1%). Grade 3-4 anemia was significantly more common in the Registry compared to published trials. Febrile neutropenia occurred in 33.4% of patients and was also more common in the Registry than in published reports. Other commonly reported adverse events included fatigue (33.4%), pain (29.2%), pyrexia (23.5%), and injection site reactions (23.2%). Treatment termination due to an adverse event was rare (5.1%). Conclusion: The safety profile of azacitidine in clinical trials is reproducible in a real-world setting. With the use of prophylactic and concomitant medications, adverse events can be mitigated and azacitidine can be safely administered to almost all patients with few treatment discontinuations.

Original languageEnglish
Article number2459
JournalCancers
Volume14
Issue number10
DOIs
Publication statusPublished - 1 May 2022

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