Azacitidine-Venetoclax or Induction Chemotherapy for Acute Myeloid Leukemia.
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Fathi Amir T, Perl Alexander E, Fell Geoffrey G, Jonas Brian A, Ragon Brittany K, Mims Alice S, Borate Uma, Mannis Gabriel N, Quillen Karen, Stahl Maximilian, Aubrey Brandon J, Koller Paul, Artz Andrew S, Al Malki Monzr M, Stein Anthony S, Marcucci Guido, Peters Mary Linton B, Graubert Timothy A, Westervelt Peter, Amrein Philip C, Hock Hanno R, Brunner Andrew M, Hobbs Gabriela, Narayan Rupa, Lee Michelle H, Miller Peter G, Watson Alyssa L, Hao Richard, Marola Abigail C, Lombardi-Story Jennifer, Dhaver Shilton, Grunwald Michael R, Chen Yi-Bin, Weinstock Matthew J, Matthews Andrew H, McGovern Ian, Wood Brent L, Hourigan Christopher S, Neuberg Donna S, El-Jawahri Areej, Aldoss Ibrahim
Аннотация
METHODS: In this multicenter, phase 2 trial, we randomly assigned, in a 1:1 ratio, previously untreated adults with AML who were eligible for induction chemotherapy to receive either azacitidine plus venetoclax or induction chemotherapy. Patients with core binding factor fusions, mutations in the gene encoding FMS-like tyrosine kinase 3 (FLT3), or mutations in the gene encoding nucleophosmin-1 (NPM1; unless the patient was ≥60 years of age) were excluded. The primary end point was event-free survival.
RESULTS: A total of 172 patients underwent randomization, with 86 patients assigned to each group. The median age of the patients was 64 years. A total of 72% of the patients had adverse-risk disease according to the European LeukemiaNet 2022 classification. At a median follow-up of 21.9 months, the median event-free survival was 14.5 months (95% confidence interval [CI], 10.4 to 24.4) in the azacitidine-venetoclax group, as compared with 6.2 months (95% CI, 4.1 to 10.1) in the induction chemotherapy group, corresponding to a hazard ratio for event or death of 0.57 (95% CI, 0.39 to 0.84; P = 0.002 by the stratified log-rank test). Infection of grade 3 or higher occurred in 28% of the patients (95% CI, 19 to 39) receiving azacitidine-venetoclax and in 41% of those (95% CI, 30 to 52) receiving induction chemotherapy; hemorrhage of grade 3 or higher occurred in 2% (95% CI, 0.3 to 8) and 12% (95% CI, 6 to 20), respectively.
CONCLUSIONS: In this phase 2, randomized trial, azacitidine-venetoclax therapy led to significantly longer event-free survival than induction chemotherapy among induction-eligible patients with AML. (Funded by AbbVie and others; PARADIGM ClinicalTrials.gov number, NCT04801797.).