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    The impact of dose escalation and resistance modulation in older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome: the results of the LRF AML14 trial.

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    Authors
    Burnett, Alan K
    Milligan, Donald W
    Goldstone, Anthony H
    Prentice, Archibald G
    McMullin, Mary-Frances
    Dennis, Michael
    Sellwood, Elizabeth
    Pallis, Monica
    Russell, Nigel
    Hills, Robert K
    Wheatley, Keith
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    Affiliation
    Department of Haematology, School of Medicine, Cardiff University Heath Park, Cardiff, UK. BurnettAK@Cardiff.ac.uk
    Issue Date
    2009-05
    
    Metadata
    Show full item record
    Abstract
    The acute myeloid leukaemia (AML)14 trial addressed four therapeutic questions in patients predominantly aged over 60 years with AML and High Risk Myelodysplastic Syndrome: (i) Daunorubicin 50 mg/m(2) vs. 35 mg/m(2); (ii) Cytarabine 200 mg/m(2) vs. 400 mg/m(2) in two courses of DA induction; (iii) for part of the trial, patients allocated Daunorubicin 35 mg/m(2) were also randomized to receive, or not, the multidrug resistance modulator PSC-833 in a 1:1:1 randomization; and (iv) a total of three versus four courses of treatment. A total of 1273 patients were recruited. The response rate was 62% (complete remission 54%, complete remission without platelet/neutrophil recovery 8%); 5-year survival was 12%. No benefits were observed in either dose escalation randomization, or from a fourth course of treatment. There was a trend for inferior response in the PSC-833 arm due to deaths in induction. Multivariable analysis identified cytogenetics, presenting white blood count, age and secondary disease as the main predictors of outcome. Although patients with high Pgp expression and function had worse response and survival, this was not an independent prognostic factor, and was not modified by PSC-833. In conclusion, these four interventions have not improved outcomes in older patients. New agents need to be explored and novel trial designs are required to maximise prospects of achieving timely progress.
    Citation
    The impact of dose escalation and resistance modulation in older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome: the results of the LRF AML14 trial. 2009, 145 (3):318-32 Br. J. Haematol.
    Journal
    British Journal of Haematology
    URI
    http://hdl.handle.net/10541/69769
    DOI
    10.1111/j.1365-2141.2009.07604.x
    PubMed ID
    19291085
    Type
    Article
    Language
    en
    ISSN
    1365-2141
    ae974a485f413a2113503eed53cd6c53
    10.1111/j.1365-2141.2009.07604.x
    Scopus Count
    Collections
    All Christie Publications
    Haematology

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