Management guide for treatment with venetoclax and azacitidine in patients with acute myeloid leukemia ineligible for intensive chemotherapy

Acute myeloid leukemia (AML) is a disease with poor prognosis, characterized by significant clinical and biological heterogeneity.Although the genetic diversity of AML has been recognized for over 30 years, recent advancements in gene sequencing have uncovered its complex molecular landscape, identifying clinical mechanisms and recurrently implicated genes driving its pathogenesis.This enhanced understanding has facilitated the development of risk-adapted therapies, which, combined with improvements in supportive care and hematopoietic stem cell transplantation (SCT), have increased the cure rates to approximately 50% in younger patients.However, this progress has not been mirrored in older patients or those with comorbidities, who are ineligible for intensive chemotherapy or SCT.In recent years, the VIALE clinical trials, which evaluate the combination of venetoclax with low-dose cytarabine or azacitidine, have demonstrated promising outcomes.Notably, the VIALE-A phase III trial demonstrated that combined venetoclax with azacitidine significantly improved overall survival, with a median of 14.7 months compared to 9.6 months observed with azacitidine as single agent.These findings have changed the therapeutic approach for these patients, leading the CETLAM (Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias) group to develop a consensus guideline for their management.