Cytarabine Plus Amonafide L-Malate Shows Similar Efficacy in Leukemia to Daunorubicin
Treatment with amonafide L-malate in combination with cytarabine did not improve response rate in secondary AML.
According to a new study published online in the Journal of Clinical Oncology, researchers have found that induction treatment with amonafide L-malate in combination with cytarabine did not improve the complete response rate compared with daunorubicin plus cytarabine in patients with secondary acute myeloid leukemia (AML).
Secondary AML occurs when a patient is diagnosed with AML after a prior myelodysplastic syndrome or after antineoplastic therapy.
Secondary AML is often associated with adverse karyotypic abnormalities and overexpression of proteins that mediate drug resistance, making it respond poorly to current therapies.
Therefore, researchers sought to determine in a phase III clinical trial whether induction therapy with amonafide L-malate and cytarabine would yield a superior complete remission rate compared with standard therapy with daunorubicin and cytarabine in patients with secondary AML.
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Researchers enrolled 433 patients and randomly assigned them 1:1 to receive cytarabine 200mg/m2 continuous IV infusion once daily on days 1 to 7 in combination with either amonafide L-malate 600mg/m2 IV over 4 hours daily on days 1 to 5 or daunorubicin 45mg/m2 IV over 30 minutes once daily on days 1 to 3.
Results showed that the complete remission rate was 46% in the amonafide L-malate arm and 45% in the daunorubicin arm.
The 30-day mortality rates were 19% and 13% in the amonafide L-malate arm and daunorubicin arm, respectively, while the 60-day mortality rates were 28% and 21%, respectively.