(ChemotherapyAdvisor) – One of the largest randomized phase 3 trials to date in patients ≥65 years of age with newly diagnosed acute myeloid leukemia (AML) has found that decitabine improved response rates compared with low-dose cytarabine or supportive care and had a possible survival advantage, according to results published in the Journal of Clinical Oncology online June 11.

The investigators randomly assigned 485 patients with poor prognostic factors to receive decitabine 20 mg/m2/day or supportive care or cytarabine 20 mg/m2/day, two of the most commonly selected treatments.

At the 2009 study cutoff with 396 deaths (81.6%), the primary analysis showed a nonsignificant increase in median overall survival (OS), the primary end point: 7.7 months in the decitabine arm vs 5.0 months in the control arm (P=0.108). The complete response (CR) rate plus CR rate without platelet recovery was 17.8% with decitabine vs 7.8% with controls (OR 2.5; P=0.001).

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An unplanned analysis of mature survival data collected up to the 2010 cutoff, which reflected 446 deaths (92%), showed the difference in OS in favor of decitabine became statistically significant (nominal P=0.037) in this difficult-to-treat population, they noted.

Adverse events (AEs) were similar for decitabine and cytarabine, although patients received a median of 4 cycles of decitabine versus 2 cycles of the control treatments. For decitabine, the most common AEs were thrombocytopenia (27%) and neutropenia (24%).