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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
| Content Provider | MDPI |
|---|---|
| Author | Michael, Pfeilstöcker Leisch, Michael Stauder, Reinhard Heibl, Sonja Sill, Heinz Girschikofsky, Michael Stampfl-Mattersberger, Margarete Tinchon, Christoph Hartmann, Bernd Petzer, Andreas Schreder, Martin Kiesl, David Vallet, Sonia Egle, Alexander Melchardt, Thomas Piringer, Gudrun Zebisch, Armin Machherndl-Spandl, Sigrid Wolf, Dominik Keil, Felix Drost, Manuel Greil, Richard Pleyer, Lisa |
| Copyright Year | 2022 |
| Description | 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. |
| Starting Page | 2459 |
| e-ISSN | 20726694 |
| DOI | 10.3390/cancers14102459 |
| Journal | Cancers |
| Issue Number | 10 |
| Volume Number | 14 |
| Language | English |
| Publisher | MDPI |
| Publisher Date | 2022-05-17 |
| Access Restriction | Open |
| Subject Keyword | Cancers Oncology Azacitidine Treatment Acute Myeloid Leukemia Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia Adverse Events Toxicity Real-world Evidence Prospective Cohort Study |
| Content Type | Text |
| Resource Type | Article |
