According to results from a clinical trial published in Lancet Haematology, 5-day and 10-day decitabine schedules may have similar efficacy and safety in older patients with acute myeloid leukemia.
The single center, open label, randomized phase 2 trial (ClinicalTrials.gov Identifier: NCT01786343) was conducted at the University of Texas MD Anderson Cancer Center in Houston. Eligible patients with newly diagnosed acute myeloid leukemia were younger than 60 years of age and deemed unsuitable for intensive chemotherapy with an anthracycline plus cytarabine or 60 years or older and deemed unsuitable for intensive chemotherapy.
For induction therapy, patients received 20 mg/m² decitabine intravenously for 5 or 10 consecutive days every 4 to 8 weeks for up to 3 cycles. Patients who responded to the therapy continued to receive decitabine on a 5-day schedule as consolidation therapy for up to 24 cycles. The primary endpoint was a composite of complete remission, complete remission with incomplete platelet recovery, and complete remission with incomplete hematologic recovery.
The study enrolled 71 patients and was conducted from February 28, 2013, to April 12, 2018. After randomization, 28 and 43 patients received decitabine for 5 and 10 days, respectively. The 2 treatment groups showed no significant difference in the proportion of patients that achieved the composite primary endpoint (5-day, 12/28 [43%]; 10-day, 17/43 [40%]; P =.78). Overall survival at 1 year was 25% for both groups.
Neutropenic fever (5 day, 25%; 10 day, 33%) and infection (5 day, 18%; 10 day, 37%) were the most common grade 3 and 4 adverse events. One patient (4%) died from sepsis in the 5-day group, and 6 patients (14%) died from infections in the 10-day group. No deaths were determined to be related to the treatments.
1. Short NJ, Kantarjian HM, Loghavi S, et al. Treatment with a 5-day versus a 10-day schedule of decitabine in older patients with newly diagnosed acute myeloid leukaemia: a randomised phase 2 trial [published online December 10, 2018]. Lancet Haematol. doi: 10.1016/S2352-3026(18)30182-0