Randomized study of continuous high-dose lenalidomide, sequential azacitidine and lenalidomide or azacitidine in persons =65 years with newly-diagnosed acute myeloid leukemia. Haematologica Medeiros, B. C., McCaul, K. n., Kambhampati, S. n., Pollyea, D. A., Kumar, R. n., Silverman, L. R., Kew, A. n., Saini, L. n., Beach, C. L., Vij, R. n., Wang, X. n., Zhong, J. n., Gale, R. P. 2017

Abstract

Therapy of acute myeloid leukemia in older persons is associated with poor outcomes because of intolerance to intensive therapy, resistant disease and co-morbidities. This multi-center, randomized, open-label, phase-2 trial compared safety and efficacy of three therapeutic strategies in persons =65 years with newly-diagnosed acute myeloid leukemia: (1) continuous high-dose lenalidomide (N=15); (2) sequential azacitidine and lenalidomide (N=39); and (3) azacitidine (N=34) only. The efficacy endpoint was 1-year survival. Median age was 76 years (range, 66-87 years). Thirteen subjects (15%) had prior myelodysplastic syndrome and 41 (47%), adverse cytogenetics. One-year survival was 21% (95% confidence interval, 0, 43%) with high-dose lenalidomide, 44% (28, 60%) with sequential azacitidine and lenalidomide, and 52% (35, 70%) with azacitidine only. Lenalidomide at a continuous high-dose schedule was poorly-tolerated resulting in a high rate of early-therapy discontinuations. Hazard of death in the 1(st) 4 months was greatest in subjects receiving continuous high-dose lenalidomide; hazards of death thereafter were similar. These data do not favor use of continuous high-dose lenalidomide or sequential lenalidomide and azacitidine over the conventional dose and schedule of azacitidine only in persons aged =65 years with newly-diagnosed acute myeloid leukemia. The study is registered at ClinicalTrials.gov (NCT01358734).

View details for PubMedID 29097499