The lower intensity, prolonged-therapy approach of clofarabine plus low-dose cytarabine alternating with decitabine is well tolerated and highly effective in older patients with acute myeloid leukemia (AML), a recent study published online early in the journal Cancer has shown.
Because treatment of older patients with AML using standard intensive chemotherapy has been linked with poor outcomes, researchers sought to evaluate a regimen consisting of clofarabine and low-dose cytarabine alternating with decitabine in this population.
Researchers enrolled 118 patients with newly diagnosed AML. All patients received an induction with clofarabine 20mg/m2 IV on days 1-5 plus low-dose cytarabine 20mg SC twice daily on days 1-10.
Those who responded were then treated with a prolonged consolidation/maintenance regimens that alternated with cycles of decitabine.
Results showed an overall response rate of 68%. There was a 60% overall complete remission rate, a 71% complete remission rate for patients with a diploid karyotype, and a 50% complete remission rate for patients with an adverse karyotype.
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Researchers observed an overall survival of 11.1 months for all patients and 18.5 months for patients who achieved a complete remission with incomplete platelet recovery.
A multivariate analysis showed that a white blood cell count ≥ 10 × 109/L was associated with worse overall survival.
In regard to safety, the most common nonhematologic adverse events were elevated liver enzymes, nausea, and rash.