Patients aged 65 years or older with newly diagnosed acute myeloid leukemia experienced improved complete response rates when given a treatment regimen of decitabine rather than supportive care or cytarabine.
Currently, available treatment options for older patients with AML — particularly those with poor performance status — are limited. Prior studies have shown that decitabine may have clinical activity in this patient group.
Therefore, in this study, researchers enrolled 485 patients aged 65 years or older with newly diagnosed AML and poor-risk or intermediate-risk cytogenetics. The patients were randomly assigned to treatment with either decitabine (n=242) or a patient choice — with physician guidance — of either supportive care (n=28) or cytarabine (n=215).
The primary OS analysis occurred with a 2009 cutoff date. At that time, 396 deaths had occurred. Data showed a nonsignificant trend toward an increased OS in patients who were assigned to decitabine compared with those who had treatment choice (7.7 months vs. 5.0 months). In addition, patients assigned to decitabine had a higher complete response rate plus pathological complete response compared with patients in the treatment choice group (17.8% vs. 7.8%; P=.001).
When the researchers evaluated mature OS data again in 2010, the OS difference between the two treatment arms had reached statistical significance, with an improved HR of 0.82 (P=.04).
Patients assigned to decitabine received a median of four cycles of therapy, while patients assigned to cytarabine received a median of two cycles. Still, the rate of adverse events between the two arms was similar, with the most commonly occurring events being thrombocytopenia (27%) and neutropenia (24%).
Although the study was limited somewhat by its open-label design, the results are significant “because older patients with AML have limited treatment options, and the toxicity of standard therapies limits treatment,” the researchers wrote
- Kantarjian HM. J Clin Oncol. 2012;doi:10.1200/JCO.2011.38.9429.