Tuesday, 19. July 2022

Safety profile of blood cancer drug confirmed

Azacitidine is commonly used to treat a subset of blood cancers in patients unfit for chemotherapy. Doctors from all over Austria have recorded the occurrence of adverse events with this agent in a real-world setting. A team from the University Hospital of Krems and the Karl Landsteiner University participated in this study.

Azacitidine is a standard treatment for a subset of blood cancersMyelodysplastic syndromes, acute myeloid leukaemia and chronic myelomonocytic leukaemia are blood cancers characterised by a decrease in healthy blood cells and the proliferation of immature blood cells in the bone marrow. If intensive chemotherapy is contraindicated, hypomethylating agents, such as azacytidine, are used alone or in combination.

Austria-wide database records adverse effects of drugsThe Austrian Working Group on Medical Tumour Therapy (AGMT) collects data in a nationwide registry of hypomethylating agents in patients with myelodysplastic syndromes, acute myeloid leukaemia or chronic myelomonocytic leukaemia. PD Dr. Sonia Vallet, senior physician at the Clinical Department of Internal Medicine II of the University Hospital Krems and part of the scientific working group Molecular Oncology/Hematology, is a member of the AGMT and has contributed to this registry study. Sonia Vallet is supported in her research by Karl Landsteiner Private University within the framework of the Research Impulses.

Confirmed: Azacitidine safe also in the "real world” settingThe majority of side effects of azacitidine recorded in 1406 patients and 13,780 treatment cycles were not serious. Fatigue, pain, and reactions at the injection site are common side effects already reported in clinical studies. Severe to life-threatening events were observed in 16 patients.  In summary, the safety profile of azacitidine was confirmed in a real-world setting. The work highlights the enormous importance of real-world data from large multicentre registries for monitoring and exploring therapeutic strategies.

Originalpublication:Leisch M, Pfeilstöcker M, Stauder R, Heibl S, Sill H, Girschikofsky M, et al. 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):2459 [pii].