Decitabine for the treatment of acute myeloid leukemia (AML): Memorial Sloan-Kettering Cancer Center experience.

Abstract

6593 Background: Decitabine is a cytosine nucleoside analog that is FDA-approved for previously untreated and treated patients with myelodysplastic syndromes. Recent studies have also demonstrated clinical activity of decitabine in AML as it has been investigated for remission induction (Cashen et al J Clin Oncol, 2010; Blum et al PNAS, 2010), salvage therapy and bridging to hematopoietic cell transplantation (HCT). We conducted a retrospective analysis of the efficacy of decitabine in patients with AML treated at Memorial Sloan-Kettering Cancer Center (MSKCC). Methods: Using the pharmacy database, patients who received decitabine for AML between June 2006 and August 2010 at MSKCC were identified. Patients had to be at least 18 years of age treated for AML with single-agent decitabine at 20 mg/m2 daily for 5 days to be included. The primary endpoint was the rate of complete remission (CR). Secondary endpoints include time to response and median overall survival. Results: Sixty patients with a mean age 61.9 (range 28-80) were treated at MSKCC between the specified time period. Thirteen (22%) patients received decitabine as initial remission induction therapy. Of the 47 (78%) patients that received decitabine as salvage therapy, 14 were post HCT. The average number of prior salvage chemotherapy regimens was 2.5. Decitabine was successfully used as bridge therapy to HCT in 3 patients. The overall response rate was 13% as 7 (12%) patients achieved a CR and 1 patient achieved PR. The mean number of cycles to achieve maximal response was 3.25 cycles. Three of 13 (23%) patients that received decitabine as initial remission induction therapy achieved a CR. Only 4 (8.5%) patients receiving decitabine as salvage therapy achieved a CR. Conclusions: Our results support earlier reports of the promising role of decitabine in the treatment of patients with newly diagnosed AML who are not candidates for intensive chemotherapy. However, the use of decitabine as a salvage regimen needs to be re-evaluated as our results demonstrated a rather poor response rate. Future studies are warranted to better understand the clinical benefit of decitabine in AML, particularly the efficacy of the 10-day regimen and bridge therapy to HCT.