Randomized study of continuous high-dose lenalidomide, sequential azacitidine and lenalidomide, or azacitidine in persons 65 years and over with newly-diagnosed acute myeloid leukemia.

摘要: Therapy of acute myeloid leukemia in older persons is associated with poor outcomes because intolerance to intensive therapy, resistant disease and co-morbidities. This multi-center, randomized, open-label, phase II trial compared safety efficacy three therapeutic strategies patients 65 years or over newly-diagnosed leukemia: 1) continuous high-dose lenalidomide (n=15); 2) sequential azacitidine (n=39); 3) only (n=34). The end point was 1-year survival. Median age 76 (range 66–87 years). Thirteen subjects (15%) had prior myelodysplastic syndrome 41 (47%) adverse cytogenetics. One-year survival 21% [95% confidence interval (CI): 0, 43%] lenalidomide, 44% (95%CI: 28, 60%) 52% 35, 70%) only. Lenalidomide at a schedule poorly-tolerated resulting high rate early therapy discontinuations. Hazard death the first four months greatest receiving lenalidomide; hazards thereafter were similar. These data do not favor use conventional dose aged leukemia. (clinicaltrials.gov identifier: 01358734).