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Clofarabine plus cytarabine shows promise in pediatric AML
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The combination of clofarabine and cytarabine appeared safe and effective in pediatric patients with recurrent acute myeloid leukemia and may also serve as a treatment before hematopoietic stem cell transplantation, according to study results.
The AAML0523 trial included 49 children in their first relapse who were refractory to induction therapy. Nine patients were included in the dose-finding phase, and the remaining 40 patients were included in the efficacy phase.
Patients in the dose-finding cohort received 40 mg/m2 daily doses of clofarabine (Clolar, Genzyme). This dose escalated to 52 mg/m2 daily for 5 days, which researchers established as the recommended dose. Doses of cytarabine were fixed at 1 g/m2 daily.
The overall response rate — which included complete remission or complete remission with partial platelet recovery — was 48%. Four additional patients achieved a complete remission without an absolute neutrophil count recovery.
Of the 23 patients who responded, 21 underwent HSCT.
The 3-year OS rate among responders was 46% compared with 16% among non-responders (P˂.001).
An additional flow cytometric analysis indicated patients with no minimal residual disease after the first treatment cycle were more likely to achieve 1-year OS (100% vs. 38%; P=.01).
The most common adverse events — all of which are typical with clofarabine — were infection, nausea/diarrhea/anorexia, fever/neutropenia, transaminitis, hyperglycemia and hypokalemia.
“The results of the current study demonstrated that the non-anthracycline–based combination of clofarabine and cytarabine has clinically significant activity in pediatric patients with refractory/recurrent AML,” the researchers concluded. “The durability of these responses and the relatively high 3-year OS rate of 46% indicate that this combination is an effective therapy as a bridge to HSCT in this patient population.”
Disclosure: One researcher reports consultant roles with and research funding from Amgen, Ariad, AstraZeneca, Bristol-Myers Squibb, EUSA Pharma, Genzyme, GlaxoSmithKline, Jazz Pharmaceuticals, MedImmune, Micromet, Novartis, Pfizer, Sanofi-Aventis, Seattle Genetics and Talon.
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