Abstract
Idarubicin 12mg/m2 has been recommended as a standard induction therapy for acute myeloid leukemia (AML). It is unknown whether a higher dose of idarubicin can improve the remission rate. This phase 2 prospective single-arm study enrolled 45 adults with newly diagnosed AML between September 2019 and May 2021 (NCT 04,069,208). Induction therapy included administration of idarubicin 14mg/m2 for 3days and cytarabine 100mg/m2 every 12h subcutaneously for 7days. The primary endpoint was the composite complete response rate (complete response (CR) plus complete response with incomplete blood count recovery (CRi)). The median age was 45years (range 14-60years). Forty (88.9%) patients had CR or CRi, including 39 patients with CR and 1 patient with CRi after one course of induction therapy. The median times to recovery of absolute neutrophil and platelet counts were 21days. Only 1 patient died of intracranial hemorrhage during induction therapy. After a median follow-up of 14months (range 3.5-24months), the estimated 18-month overall survival and disease-free survival (DFS) were 66.9% and 57.5%, respectively. In conclusion, idarubicin 14mg/m2plus cytarabine was a safe and efficient intensive regimen for younger and fit patients with newly diagnosed AML.
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