ArticleOpen medicine (Warsaw, Poland)2026
Evaluation of treatment outcomes for AML patients ineligible for intensive chemotherapy before and after the implementation of VEN/AZA - a retrospective cohort study.
Article in Open medicine (Warsaw, Poland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objectives: Acute myeloid leukemia (AML) predominantly affects older patients, many of whom are ineligible for intensive chemotherapy. Although the VIALE-A trial demonstrated improved survival with azacitidine plus venetoclax, its strict eligibility criteria may limit generalizability to routine clinical practice. We therefore evaluated real-world outcomes at our institution. Methods: We conducted a retrospective single-centre cohort study of adult AML patients ineligible for intensive chemotherapy. Patients received azacitidine monotherapy (2014-2018) or azacitidine plus venetoclax (2019-2023). Overall survival (OS) and progression-free survival (PFS) were analyzed using Kaplan-Meier estimates and log-rank tests. VIALE-A eligibility was assessed retrospectively. Results: 21 patients met the inclusion criteria: 8 received azacitidine alone and 13 azacitidine plus venetoclax. Median age was 79 years. Patients receiving azacitidine plus venetoclax completed more treatment cycles (median 7 vs. 4). Median OS was 12.6 vs. 9.1 months with azacitidine alone (p=0.416). Median PFS was 10.0 vs. 8.1 months, respectively (p=0.707). Overall, only 66 % of patients fulfilled the VIALE-A eligibility criteria. Conclusions: Azacitidine plus venetoclax was associated with numerically longer OS and PFS, although differences were not statistically significant. Only two-thirds of patients would have met VIALE-A eligibility criteria, highlighting the challenges of translating trial outcomes into routine practice. Larger multicentre studies are warranted.
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