Study Compares Induction Chemotherapy in Newly Diagnosed AML

By Patrick Daly - Last Updated: April 26, 2024

Two induction chemotherapy regimens, both with one or two doses of gemtuzumab ozogamicin, had differing performance in younger patients with newly diagnosed acute myeloid leukemia (AML) with unknown adverse risk cytogenetics, according to a trial published in the Journal of Clinical Oncology.

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Overall, fludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin (FLAG-IDA) with gemtuzumab ozogamicin reduced relapse without improving overall survival (OS).

“However, exploratory analyses show that patients with NPM1 and FLT3 mutations had substantial improvements in OS,” reported Nigel Russel, MD, of Guy’s and St Thomas’ NHS Foundation Trust in London, United Kingdom, the study’s lead author. “By contrast, in patients with core-binding factor AML, outcomes were excellent with [daunorubicin and cytarabine (DA) plus gemtuzumab ozogamicin] with no FLAG-IDA benefit.”

After two courses of either FLAG-IDA or DA alongside gemtuzumab ozogamicin in the study, there were no differences in rates of complete remission (CR) plus CR with incomplete hematologic recovery at 93.0% and 91.0% or in 60-day mortality at 4.3% and 4.6%, respectively.

Compared with DA, FLAG-IDA reduced the risk of relapse (24% vs 41%; P<.001) and increased three-year event-free survival (57% vs 45%; P<.001). In the 30% of patients with an NPM1 mutation, three-year overall survival was 82% with the FLAG-IDA regimen versus 64% with DA (P=.005). Achieving NPM1 measurable residual disease (MRD) clearance in peripheral blood after cycle two was also improved with FLAG-IDA at 88% versus 77%.

Patients with an FLT3 mutation had increased three-year OS in the FLAG-IDA group compared with the DA group at 64% and 54% (P=.047), respectively, and there were fewer transplants conducted in the FLAG-IDA group (P=.02)

Finally, there were no differences in outcomes based on number of gemtuzumab ozogamicin doses, though the authors noted NPM1 MRD clearance was higher with two doses in patients receiving DA.

 

Reference

Russell NH, Wilhelm-Benartzi C, Othman J, et al. Fludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin with gemtuzumab ozogamicin improves event-free survival in younger patients with newly diagnosed AML and overall survival in patients with NPM1 and FLT3 mutations. J Clin Oncol. 2024;42(10):1158-1168. doi:10.1200/JCO.23.00943

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