Non-inferiority trial shows hypomethylating agents offer comparable survival to venetoclax in elderly AML, indicating reduced toxicity.
Hypomethylating agents (HMA) alone or in combination with venetoclax (VEN) are a mainstay for disease control in elderly acute myeloid leukemia (AML). We evaluated the non-inferiority of HMA monotherapy compared to HMA/VEN combination in 227 AML patients aged ≥ 75 years receiving HMA or HMA/VEN combination. No difference in overall survival (OS) was observed between the two groups, with HMA monotherapy demonstrating statistical non-inferiority. HMA-treated patients with favorable performance status had longer OS. The HMA/VEN group experienced higher mortality and worse QoL. HMA monotherapy offers comparable survival outcomes to HMA/VEN with reduced toxicity in elderly AML patients.
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Tarantini et al. (2026) studied this question.
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