A randomised evaluation of low‐dose cytosine arabinoside plus lenalidomide versus single‐agent low‐dose cytosine arabinoside in older patients with acute myeloid leukaemia: Results from the LI‐1 trial.

Summary: Improving outcomes for older patients with acute myeloid leukaemia remains an unmet need. As part of the LI‐1 trial, we evaluated lenalidomide (LEN) in combination with low‐dose cytosine arabinoside (LDAC) in patients aged >60 years unfit for intensive therapy and compared this to LDAC alone. Two hundred and two patients, randomised 1:1, were evaluable. Overall response rate (CR + CRi) was higher for LDAC + LEN versus LDAC (26% and 13.7% respectively p = 0.031). However, there was no difference in overall survival between the arms (14% and 11.5% at 2 years for LDAC + LEN and LDAC respectively). The addition of LEN was associated with increased toxicity and supportive care requirements. [ABSTRACT FROM AUTHOR]