Daunorubicin 90 Mg/m2 and 60 Mg/m2 Demonstrates Comparable Efficacy, Safety Profiles, and Long-Term Outcomes in Chinese Patients with Newly Diagnosed Acute Myeloid Leukemia

Background: In the UK NCRI AML17 trial, daunorubicin at 90 mg/m² and 60 mg/m² during the induction phase of acute myeloid leukemia (AML) treatment showed similar efficacy, safety, and long-term prognosis. However, these findings have not been replicated in Chinese AML patients. To address this gap, we conducted a real-world retrospective study to evaluate whether there is a significant difference in the outcomes of daunorubicin at 90 mg/m² compared to 60 mg/m² in the induction therapy of Chinese patients with newly diagnosed acute myeloid leukemia, excluding those with the M3 subtype.

Methods: A retrospective analysis was conducted on a total of 102 Chinese patients newly diagnosed with AML, enrolled from two of the largest hospitals in Shenzhen, Guangdong Province, P.R. China. The study population comprised 52 patients who received daunorubicin at a dosage of 90 mg/m² (DA90 group) and 50 patients who received 60 mg/m² (DA60 group). Outcomes assessed included response rates, hematological and non-hematological adverse events, as well as progression-free survival (PFS), relapse-free survival (RFS), and overall survival (OS), with comparisons made between the two treatment groups.

Results: In our study, baseline characteristics such as gender, ELN2017 and ELN2022 risk stratifications, initial white blood cell (WBC) count, hemoglobin (Hb), platelet (PLT) count, and the proportion of bone marrow blast cells at initial diagnosis were essentially consistent between the two groups, with no statistically significant differences. However, there was a statistically significant difference in age, with an average of 38.62 years in the high-dose group and 43.2 years in the low-dose group (p = 0.046). The complete remission (CR) rates were 78.8% for the high-dose group and 76% for the low-dose group, with no statistically significant difference observed. The CR rates within the ELN2017 risk stratification categories were 97.1% for low-risk, 86.5% for intermediate-risk, and 48.1% for high-risk groups. Corresponding rates for ELN2022 risk stratification were 95%, 81.1%, and 50%, respectively. Hematological adverse events showed statistically significant differences in the duration of thrombocytopenia, PLT and RBC consumption, and neutropenia between the groups (P < 0.05). The DA90 group experienced faster recovery from bone marrow suppression, which may correlate with the younger average age of patients in this group. There was no statistically significant difference in the incidence of severe hemorrhage. Regarding non-hematological adverse events, the incidence of pneumonia and sepsis was comparable between the groups. With a median follow-up time of 39.2m (95%CI 24.6-53.7m), there were no statistically significant differences in PFS, RFS, and OS between DA60 and DA90 groups. Further analysis of PFS, RFS, and OS, with a cutoff at the date of allogeneic hematopoietic stem cell transplantation (allo-HSCT), did not reveal any statistically significant differences in long-term prognosis between the two groups either. Multivariate analysis identified ELN2022 risk stratification as the sole independent risk factor for PFS, while ELN2022 risk stratification and secondary AML were the two independent risk factors for OS. Daunorubicin dosage did not impact long-term prognosis, regardless of whether patients underwent allo-HSCT.

Conclusion: Consistent with the findings from the UK NCRI AML17 trial, our real-world data corroborate that daunorubicin administered at 90 mg/m² and 60 mg/m² during the induction phase demonstrates comparable efficacy, safety profiles, and long-term outcomes for Chinese patients newly diagnosed with AML.

No relevant conflicts of interest to declare.