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. 2024 Mar;204(3):871-876.
doi: 10.1111/bjh.19220. Epub 2023 Nov 28.

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

Mhairi Copland  1 , Cono Ariti  2   3 , Ian F Thomas  2 , Laura Upton  2 , Mia Sydenham  2 , Priyanka Mehta  4 , Shahid Islam  5 , Lars Kjeldsen  6 , Alan K Burnett  1 , Robert K Hills  7 , Nigel Russell  8 , Mike Dennis  9 ; UK NCRI AML Study Group
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Free article

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

Mhairi Copland et al. Br J Haematol. 2024 Mar.
Free article

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 >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.

Keywords: acute myeloid leukaemia; clinical trial; elderly; lenalidomide; low-dose cytosine arabinoside.

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Conflict of interest statement

M.C. has received research funding from Cyclacel and Incyte, is/has been an advisory board member for Novartis, Incyte, Jazz Pharmaceuticals, Pfizer and Servier, and has received honoraria from Astellas, Novartis, Incyte, Pfizer and Jazz Pharmaceuticals. P.M. has received advisory fees and speaker honoraria from Jazz Pharmaceuticals, Pfizer, Astellas, Servier and Celgene. L.K. has received honoraria from Celgene.

References

REFERENCES

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