Standard induction chemotherapy is noninferior to high-dose chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML), according to new research published in the Journal of Clinical Oncology (published online June 20, 2017; doi:10.1200.JCO.2017.72.8618).
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Idarubicin and daunorubicin have both been validated in clinical trials to offer survival benefits for young patients with newly diagnosed AML. However, the chemotherapy agents have not been compared for safety and efficacy to date.
Je-Hwan Lee, MD, college of medicine, University of Ulsan (Seoul, South Korea), and colleagues conducted a study to compare the effects of idarubicin versus daunorubicin in young patients with newly diagnosed AML. Researchers randomly assigned a total of 299 patients to receive either cytarabine plus idarubicin (12 mg/m2 per day for three days; n = 149) or cytarabine plus high-dose daunorubicin (90 mg/m2 per day for three days; n = 150). All patients received cytarabine dosing at 200 mg/m2 per day for seven days.
Researchers reported that complete remission was observed in 232 (77.6%) patients, with no significant difference in rate between the idarubicin and daunorubicin cohorts (80.5% vs 74.7%, respectively; P = .224).
After a median follow-up of 34.9 months, overall survival rates were similar between the two cohorts (51.1% vs 54.7%, P = .194). Additionally, relapse rates were also similar between the idarubicin and daunorubicin cohorts (cumulative incidence of relapse, 35.2% vs 25.1%; P = .772).
Toxicity profiles remained consistent between the two cohorts.
Researchers acknowledged that overall and event-free survival times of patients with FLT3 internal tandem duplication mutation were significantly different among the two cohorts, favoring high-dose daunorubicin (median overall survival, 15.5 months vs not reached; P = .030; event-free survival, 11.9 months vs not reached; P = .028).
Findings of the trial indicate that idarubicin and high-dose daunorubicin—both in combination with cytarabine—are noninferior to each other in complete response rates, relapse, survival, and toxicity. Further research is necessary to examine the association between FLT3 internal tandem duplication and poor survival outcomes, researchers concluded.—Zachary Bessette
