Bochra Sedaki, Alexandre Iat, Sami Benachour, Michael Loschi, Karine Risso, Ghada Abichou, Corinne Ferrero-Vacher, Neila De Pooter, Joy Mouanes-Abelin, Berengere Dadone-Montaudie, Thomas Cluzeau
{"title":"Real World Experience of Azacitidine + Venetoclax in AML rigorously following management guidelines from clinical trial.","authors":"Bochra Sedaki, Alexandre Iat, Sami Benachour, Michael Loschi, Karine Risso, Ghada Abichou, Corinne Ferrero-Vacher, Neila De Pooter, Joy Mouanes-Abelin, Berengere Dadone-Montaudie, Thomas Cluzeau","doi":"10.1159/000548334","DOIUrl":null,"url":null,"abstract":"<p><p>Azacitidine + venetoclax is a new standard of care for acute myeloid leukemia not eligible for intensive chemotherapy. This combination is associated with hematological toxicities and some drug interactions. Real-world studies have shown a decrease in results and outcomes when compared to VIALE-A study. We report here our single center experience using AZA + VEN rigorously following management guidelines from the VIALE-A study, applied to a real-life population. Forty-two AML patients were analyzed. CR/CRi/MLFS rate was 73,8 % after 1 cycle with 51% CR/CRi and 80,9% after 2 cycles. Median overall survival was 18 months [95% CI, 10.3-25.7]. Our retrospective study showed that rigorous use of AZA + VEN in real-world setting was associated with results close to clinical trial observations. We showed the need to rigorously follow AZA+VEN dosage but also toxicity guidelines and practice recommendations edited in the clinical trial even in real-world.</p>","PeriodicalId":6981,"journal":{"name":"Acta Haematologica","volume":" ","pages":"1-13"},"PeriodicalIF":1.1000,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta Haematologica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000548334","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Azacitidine + venetoclax is a new standard of care for acute myeloid leukemia not eligible for intensive chemotherapy. This combination is associated with hematological toxicities and some drug interactions. Real-world studies have shown a decrease in results and outcomes when compared to VIALE-A study. We report here our single center experience using AZA + VEN rigorously following management guidelines from the VIALE-A study, applied to a real-life population. Forty-two AML patients were analyzed. CR/CRi/MLFS rate was 73,8 % after 1 cycle with 51% CR/CRi and 80,9% after 2 cycles. Median overall survival was 18 months [95% CI, 10.3-25.7]. Our retrospective study showed that rigorous use of AZA + VEN in real-world setting was associated with results close to clinical trial observations. We showed the need to rigorously follow AZA+VEN dosage but also toxicity guidelines and practice recommendations edited in the clinical trial even in real-world.
期刊介绍:
''Acta Haematologica'' is a well-established and internationally recognized clinically-oriented journal featuring balanced, wide-ranging coverage of current hematology research. A wealth of information on such problems as anemia, leukemia, lymphoma, multiple myeloma, hereditary disorders, blood coagulation, growth factors, hematopoiesis and differentiation is contained in first-rate basic and clinical papers some of which are accompanied by editorial comments by eminent experts. These are supplemented by short state-of-the-art communications, reviews and correspondence as well as occasional special issues devoted to ‘hot topics’ in hematology. These will keep the practicing hematologist well informed of the new developments in the field.