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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.
Originalsprache | Englisch |
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Aufsatznummer | 2459 |
Fachzeitschrift | Cancers |
Jahrgang | 14 |
Ausgabenummer | 10 |
DOIs | |
Publikationsstatus | Veröffentlicht - 01 Mai 2022 |
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- 1 Abgeschlossen
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BONE: Biomarker-basierte therapeutische Praevention von Knochenmetastasen beim Mammakarzinom: Die pathophysiologische Rolle der endostalen Nische
Vallet, S. (PI)
01.08.2020 → 31.12.2023
Projekt: Forschungsimpulse › Forschungsfreiraum (RTO)