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    A randomised evaluation of low-dose Ara-C plus pegylated recombinant arginase BCT-100 versus low dose Ara-C in older unfit patients with acute myeloid leukaemia: Results from the LI-1 trial

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    Authors
    Mussai, F.
    De Santo, C.
    Cheng, P.
    Thomas, I. F.
    Ariti, C.
    Upton, L.
    Scarpa, U.
    Stavrou, V.
    Sydenham, M.
    Burnett, A. K.
    Knapper, S. K.
    Mehta, P.
    McMullin, M. F.
    Copland, M.
    Russell, N. H.
    Dennis, Michael
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    Affiliation
    Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK
    Issue Date
    2022
    
    Metadata
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    Abstract
    The survival of acute myeloid leukaemia (AML) patients aged over 60 has been suboptimal historically, whether they are treated using hypomethylating agents, low-dose cytarabine (LDAC) or venetoclax-based regimens. Progress is being made, however, for subgroups with favourable molecular or cytogenetic findings. Arginine metabolism plays a key role in AML pathophysiology. We report the only randomised study of LDAC with recombinant arginase BCT-100 versus LDAC alone in older AML patients unsuitable for intensive therapy. Eighty-three patients were randomised to the study. An overall response rate was seen in 19.5% (all complete remission [CR]) and 15% (7.5% each in CR and CR without evidence of adequate count recovery [CRi]) of patients in the LDAC+BCT-100 and LDAC arms respectively (odds ratio 0.73, confidence interval 0.23-2.33; p = 0.592). No significant difference in overall or median survival between treatment arms was seen. The addition of BCT-100 to LDAC was well tolerated.
    Citation
    Mussai F, De Santo C, Cheng P, Thomas IF, Ariti C, Upton L, et al. A randomised evaluation of low-dose Ara-C plus pegylated recombinant arginase BCT-100 versus low dose Ara-C in older unfit patients with acute myeloid leukaemia: Results from the LI-1 trial. British journal of haematology. 2022 Nov 22. PubMed PMID: 36413792. Epub 2022/11/23. eng.
    Journal
    British Journal of Haematology
    URI
    http://hdl.handle.net/10541/625868
    DOI
    10.1111/bjh.18560
    PubMed ID
    36413792
    Additional Links
    https://dx.doi.org/10.1111/bjh.18560
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1111/bjh.18560
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