Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Leisch, M; Pfeilstöcker, M; Stauder, R; Heibl, S; Sill, H; Girschikofsky, M; Stampfl-Mattersberger, M; Tinchon, C; Hartmann, B; Petzer, A; Schreder, M; Kiesl, D; Vallet, S; Egle, A; Melchardt, T; Piringer, G; Zebisch, A; Machherndl-Spandl, S; Wolf, D; Keil, F; Drost, M; Greil, R; Pleyer, L.
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.
Cancers (Basel). 2022; 14(10):
Doi: 10.3390/cancers14102459
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- Co-Autor*innen der Med Uni Graz
- Sill Heinz
- Zebisch Armin
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- 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.
- Find related publications in this database (Keywords)
- azacitidine
- treatment
- acute myeloid leukemia
- myelodysplastic syndromes
- chronic myelomonocytic leukemia
- adverse events
- toxicity
- real-world evidence
- prospective cohort study