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Novel combination yields early response in pediatric AML
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The addition of liposomal daunorubicin to fludarabine, cytarabine and granulocyte colony–stimulating factor was associated with encouraging treatment responses but no improvements in survival in a cohort of children with acute myeloid leukemia.
Optimal reinduction therapy remains unclear in pediatric relapsed AML, and daunorubicin citrate liposome injection (DaunoXome, Galen) may be an attractive option, according to researchers.
The patient population included 394 participants aged younger than 21 years with relapsed or primary refractory non–French-American-British type M3 AML.
Patients were randomly assigned to fludarabine, cytarabine and G-CSF (FLAG) or to FLAG plus liposomal daunorubicin during the first reinduction course.
Status of the bone marrow sample at day 28 — shortly before the second chemotherapy course — served as the primary outcome measure. Median follow-up for the intention-to-treat analysis was 4 years.
A 64% complete remission rate was reported, along with a 38% 4-year probability of survival.
Bone marrow samples at day 28 were available for 359 patients. Eighty percent of patients in the FLAG/liposomal daunorubicin group had good samples (defined as ≤20% leukemic blasts) vs. 70% of patients in the FLAG group (P=.04).
Researchers reported a 69% complete remission rate in the study drug arm and a 59% complete remission rate in the FLAG arm (P=.07). Similar OS rates were reported in both groups.
Among patients with core-binding factor AML, treatment with the study combination yielded a probability of survival of 82% in the study group and 58% in the FLAG group (P=.04).
Similarly low rates of grade 3 or 4 toxicities were reported in both groups.
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