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<mods:namePart>Sanz Solas, Antonio</mods:namePart>
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<mods:namePart>Saiz Rodríguez, Miriam</mods:namePart>
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<mods:namePart>Solana-Altabella, Antonio</mods:namePart>
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<mods:namePart>Montesinos, Pau</mods:namePart>
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<mods:namePart>Labrador Gómez, Jorge</mods:namePart>
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<mods:identifier type="doi">10.1007/s00277-025-06543-3</mods:identifier>
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<mods:abstract>This meta-analysis, comprising 24 studies, evaluated the efficacy of venetoclax (VEN) in combination with hypomethylat-ing agents (HMAs), including azacitidine (AZA) and decitabine (DEC), in untreated patients with acute myeloid leukemia (AML), comparing outcomes from clinical trials and real-world practice. No significant difference in composite complete response (CRc) rates was observed between clinical trials (52%, 95% CI: 39–65%) and real-world studies (67%, 95% CI: 47–87%). However, overall survival (OS) was significantly longer in clinical trials (13.98 months, 95% CI: 11.89–16.07) compared to real-world cohorts (9.35 months, 95% CI: 8.46–10.23; p &lt; 0.005). In real-world studies, the VEN + HMA combination was associated with a significantly higher CRc rate (67%, 95% CI: 48–85%) compared to HMA monotherapy (17%, 95% CI: 13–21%; p &lt; 0.005), although no significant difference in OS was observed between these groups (9.35 vs. 9.38 months; p = 0.964). These findings highlight the need to optimize the implementation of VEN + HMA regimens in clinical practice, as real-world outcomes remain inferior to those reported in clinical trials.</mods:abstract>
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<mods:title>Comparative efficacy of venetoclax and hypomethylating agents in acute myeloid leukemia treatment: a meta-analysis of clinical trials and Real-World outcomes</mods:title>
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