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

Alexander Egle¹  Richard Greil¹  Thomas Melchardt¹  Lisa Pleyer¹  Michael Leisch¹  Manuel Drost²  Sonja Heibl³  Bernd Hartmann³  Sigrid Machherndl-Spandl³  Reinhard Stauder³  David Kiesl³  Martin Schreder³  Sonia Vallet³  Dominik Wolf³  Armin Zebisch³  Felix Keil³  Michael Girschikofsky³  Andreas Petzer³  Gudrun Piringer³  Heinz Sill³  Christoph Tinchon³  Michael Pfeilstöcker³  Margarete Stampfl-Mattersberger³ 

[1] 3rd Medical Department with Hematology, Medical Oncology, Rheumatology and Infectiology, Paracelsus Medical University, 5020 Salzburg, Austria;Assign Data Management and Biostatistics GmbH, 6020 Innsbruck, Austria;Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria;

关键词: azacitidine;    treatment;    acute myeloid leukemia;    myelodysplastic syndromes;    chronic myelomonocytic leukemia;    adverse events;   

DOI  :  10.3390/cancers14102459

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown