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
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
|---|---|
| Enthalten in: |
Cancers - 14(2022), 10 vom: 17. Mai |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Leisch, Michael [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Acute myeloid leukemia |
|---|
| Anmerkungen: |
Date Revised 16.07.2022 published: Electronic Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.3390/cancers14102459 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM341483435 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM341483435 | ||
| 003 | DE-627 | ||
| 005 | 20231226011900.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.3390/cancers14102459 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1138.xml |
| 035 | |a (DE-627)NLM341483435 | ||
| 035 | |a (NLM)35626063 | ||
| 035 | |a (PII)2459 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Leisch, Michael |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 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 |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 16.07.2022 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a acute myeloid leukemia | |
| 650 | 4 | |a adverse events | |
| 650 | 4 | |a azacitidine | |
| 650 | 4 | |a chronic myelomonocytic leukemia | |
| 650 | 4 | |a myelodysplastic syndromes | |
| 650 | 4 | |a prospective cohort study | |
| 650 | 4 | |a real-world evidence | |
| 650 | 4 | |a toxicity | |
| 650 | 4 | |a treatment | |
| 700 | 1 | |a Pfeilstöcker, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Stauder, Reinhard |e verfasserin |4 aut | |
| 700 | 1 | |a Heibl, Sonja |e verfasserin |4 aut | |
| 700 | 1 | |a Sill, Heinz |e verfasserin |4 aut | |
| 700 | 1 | |a Girschikofsky, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Stampfl-Mattersberger, Margarete |e verfasserin |4 aut | |
| 700 | 1 | |a Tinchon, Christoph |e verfasserin |4 aut | |
| 700 | 1 | |a Hartmann, Bernd |e verfasserin |4 aut | |
| 700 | 1 | |a Petzer, Andreas |e verfasserin |4 aut | |
| 700 | 1 | |a Schreder, Martin |e verfasserin |4 aut | |
| 700 | 1 | |a Kiesl, David |e verfasserin |4 aut | |
| 700 | 1 | |a Vallet, Sonia |e verfasserin |4 aut | |
| 700 | 1 | |a Egle, Alexander |e verfasserin |4 aut | |
| 700 | 1 | |a Melchardt, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Piringer, Gudrun |e verfasserin |4 aut | |
| 700 | 1 | |a Zebisch, Armin |e verfasserin |4 aut | |
| 700 | 1 | |a Machherndl-Spandl, Sigrid |e verfasserin |4 aut | |
| 700 | 1 | |a Wolf, Dominik |e verfasserin |4 aut | |
| 700 | 1 | |a Keil, Felix |e verfasserin |4 aut | |
| 700 | 1 | |a Drost, Manuel |e verfasserin |4 aut | |
| 700 | 1 | |a Greil, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Pleyer, Lisa |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Cancers |d 2009 |g 14(2022), 10 vom: 17. Mai |w (DE-627)NLM198667213 |x 2072-6694 |7 nnns |
| 773 | 1 | 8 | |g volume:14 |g year:2022 |g number:10 |g day:17 |g month:05 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.3390/cancers14102459 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 14 |j 2022 |e 10 |b 17 |c 05 | ||