Low-dose hypomethylating agent decitabine in combination with aclacinomycin and cytarabine achieves a better outcome than standard FLAG chemotherapy in refractory/relapsed acute myeloid leukemia patients with poor-risk cytogenetics and mutations

BACKGROUND: Relapsed and refractory acute myeloid leukemia (RR-AML) still poses major treatment concerns. Current treatments include high doses of cytarabine or fludarabine in combination with cytarabine and G-CSF (FLAG), but provide mixed results. Low-dose decitabine, a hypomethylating drug, in combination with aclarubicin and cytarabine (DAC) has shown safety and efficacy in the treatment of AML; however, clinical data are limited for the treatment of RR-AML. METHODS: In this study, we retrospectively compared the response and safety of DAC vs FLAG for RR-AML patients. RESULTS: For the 35 patients with RR-AML enrolled in this study, the overall response rates reached 100% and 55.6% in the DAC group and FLAG group, respectively (P=0.002). Complete response rates after DAC and FLAG treatment were 64.7% and 33.3%, respectively (P=0.002). Median overall survival (95% CI) of the DAC treatment group was significantly higher than for the FLAG group (median not achieved vs 16.8 months, P=0.021). CONCLUSION: DAC treatment was also more effective in those patients with poor prognosis, suggesting that DAC resulted in a better outcome for RR-AML treatment. In conclusion, in our study, DAC therapy provided more safety and effectiveness and lower toxicity in the treatment of RR-AML compared to FLAG therapy.