The hypomethylating agents azacitidine (AZA) and decitabine (DEC) have been backbone therapies for older or unfit patients with newly diagnosed acute myeloid leukemia (AML) as single agents and, more recently, in combination with venetoclax.1-5 Despite being widely used for >15 years, AZA and DEC have not been directly compared in a large randomized trial. Here, we sought to indirectly compare the clinical outcomes with DEC or AZA in this patient population in the context of a large prospective trial.
The ASTRAL-1 trial (registered at www.clinicaltrials.gov as #NCT02348489) was among the largest randomized phase 3 trials ever conducted for unfit or older patients with newly diagnosed AML.