Mutation Clearance After Induction Links to Longer Remission in Intermediate-Risk AML
A phase II multicenter trial at Washington University School of Medicine enrolled 100 intermediate-risk acute myeloid leukemia patients aged 18 to 60 who achieved complete remission or complete remission with incomplete count recovery after induction therapy. Whole-exome sequencing identified somatic mutations at diagnosis, with a median of approximately 30 leukemia-associated mutations per patient. Researchers measured variant allele frequencies in remission marrow samples using a threshold below 2.5 percent to define clearance. The 33 patients who cleared all mutations and then received high-dose cytarabine consolidation had a median relapse-free survival of 33.1 months. A historical cohort of 239 intermediate-risk patients treated with similar high-dose cytarabine regimens in first complete remission had a median relapse-free survival of 11.7 months. The difference did not meet the prespecified threshold for statistical significance of 0.01, adjusted for an unplanned interim assessment. Patients with persistent mutations, defined as variant allele frequency at or above 2.5 percent, were recommended to undergo allogeneic hematopoietic cell transplantation.
The association between mutation clearance and longer relapse-free survival in intermediate-risk AML patients sets the stage for a randomized trial to test whether mutation tracking can guide consolidation therapy decisions in first complete remission.
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