Copland, Mhairi and Ariti, Cono and Thomas, Ian F. and Upton, Laura and Sydenham, Mia and Mehta, Priyanka and Islam, Shahid and Kjeldsen, Lars and Burnett, Alan K. and Hills, Robert K. and Russell, Nigel and Dennis, Mike (2024) 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. British Journal of Haematology, 204 (3). ISSN 0007-1048

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Abstract

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 &gt;60 years unfit for intensive therapy and compared this to LDAC alone. 202 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). Addition of LEN was associated with increased toxicity and supportive care requirements.

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