@article{Bruno C. Medeiros_Kelly McCaul_Suman Kambhampati_Daniel A. Pollyea_Rajat Kumar_Lewis R. Silverman_Andrea Kew_Lalit Saini_CL Beach_Ravi Vij_Xiwei Wang_Jim Zhong_Robert Peter Gale_2017, place={Pavia, Italy}, title={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}, volume={103}, url={https://haematologica.org/article/view/8308}, DOI={10.3324/haematol.2017.172353}, abstractNote={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 II trial compared safety and efficacy of three therapeutic strategies in patients 65 years or over with newly-diagnosed acute myeloid leukemia: 1) continuous high-dose lenalidomide (n=15); 2) sequential azacitidine and lenalidomide (n=39); and 3) azacitidine only (n=34). The efficacy end point was 1-year survival. Median age was 76 years (range 66–87 years). Thirteen subjects (15%) had prior myelodysplastic syndrome and 41 (47%) had adverse cytogenetics. One-year survival was 21% [95% confidence interval (CI): 0, 43%] with high-dose lenalidomide, 44% (95%CI: 28, 60%) with sequential azacitidine and lenalidomide, and 52% (95%CI: 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 first four 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 azacitidine and lenalidomide over the conventional dose and schedule of azacitidine only in patients aged 65 years or over with newly-diagnosed acute myeloid leukemia. (<em><a href="http://clinicaltrials.gov">clinicaltrials.gov</a> identifier: 01358734</em&gt;).}, number={1}, journal={Haematologica}, author={Bruno C. Medeiros and Kelly McCaul and Suman Kambhampati and Daniel A. Pollyea and Rajat Kumar and Lewis R. Silverman and Andrea Kew and Lalit Saini and CL Beach and Ravi Vij and Xiwei Wang and Jim Zhong and Robert Peter Gale}, year={2017}, month={Dec.}, pages={101-106} }