University Library
  • Login
A gateway to Melbourne's research publications
Minerva Access is the University's Institutional Repository. It aims to collect, preserve, and showcase the intellectual output of staff and students of the University of Melbourne for a global audience.
View Item 
  • Minerva Access
  • Medicine, Dentistry & Health Sciences
  • Melbourne Medical School
  • Medicine and Radiology
  • Medicine and Radiology - Research Publications
  • View Item
  • Minerva Access
  • Medicine, Dentistry & Health Sciences
  • Melbourne Medical School
  • Medicine and Radiology
  • Medicine and Radiology - Research Publications
  • View Item
JavaScript is disabled for your browser. Some features of this site may not work without it.

    Nilotinib dose-optimization in newly diagnosed chronic myeloid leukaemia in chronic phase: final results from ENESTxtnd

    Thumbnail
    Download
    Published version (461.1Kb)

    Citations
    Scopus
    Web of Science
    Altmetric
    8
    7
    Author
    Hughes, TP; Munhoz, E; Salvino, MA; Ong, TC; Elhaddad, A; Shortt, J; Quach, H; Pavlovsky, C; Louw, VJ; Shih, L-Y; ...
    Date
    2017-10-01
    Source Title
    British Journal of Haematology
    Publisher
    WILEY
    University of Melbourne Author/s
    Shortt, Jake; Quach, Hang
    Affiliation
    Medicine and Radiology
    Sir Peter MacCallum Department of Oncology
    Metadata
    Show full item record
    Document Type
    Journal Article
    Citations
    Hughes, T. P., Munhoz, E., Salvino, M. A., Ong, T. C., Elhaddad, A., Shortt, J., Quach, H., Pavlovsky, C., Louw, V. J., Shih, L. -Y., Turkina, A. G., Meillon, L., Jin, Y., Acharya, S., Dalal, D. & Lipton, J. H. (2017). Nilotinib dose-optimization in newly diagnosed chronic myeloid leukaemia in chronic phase: final results from ENESTxtnd. BRITISH JOURNAL OF HAEMATOLOGY, 179 (2), pp.219-228. https://doi.org/10.1111/bjh.14829.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/254714
    DOI
    10.1111/bjh.14829
    Abstract
    The Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Extending Molecular Responses (ENESTxtnd) study was conducted to evaluate the kinetics of molecular response to nilotinib in patients with newly diagnosed chronic myeloid leukaemia in chronic phase and the impact of novel dose-optimization strategies on patient outcomes. The ENESTxtnd protocol allowed nilotinib dose escalation (from 300 to 400 mg twice daily) in the case of suboptimal response or treatment failure as well as dose re-escalation for patients with nilotinib dose reductions due to adverse events. Among 421 patients enrolled in ENESTxtnd, 70·8% (95% confidence interval, 66·2-75·1%) achieved major molecular response (BCR-ABL1 ≤ 0·1% on the International Scale) by 12 months (primary endpoint). By 24 months, 81·0% of patients achieved major molecular response, including 63·6% (56 of 88) of those with dose escalations for lack of efficacy and 74·3% (55 of 74) of those with dose reductions due to adverse events (including 43 of 54 patients with successful re-escalation). The safety profile of nilotinib was consistent with prior studies. The most common non-haematological adverse events were headache, rash, and nausea; cardiovascular events were reported in 4·5% of patients (grade 3/4, 3·1%). The study was registered at clinicaltrials.gov (NCT01254188).

    Export Reference in RIS Format     

    Endnote

    • Click on "Export Reference in RIS Format" and choose "open with... Endnote".

    Refworks

    • Click on "Export Reference in RIS Format". Login to Refworks, go to References => Import References


    Collections
    • Minerva Elements Records [53102]
    • Sir Peter MacCallum Department of Oncology - Research Publications [1023]
    • Medicine and Radiology - Research Publications [3320]
    Minerva AccessDepositing Your Work (for University of Melbourne Staff and Students)NewsFAQs

    BrowseCommunities & CollectionsBy Issue DateAuthorsTitlesSubjectsThis CollectionBy Issue DateAuthorsTitlesSubjects
    My AccountLoginRegister
    StatisticsMost Popular ItemsStatistics by CountryMost Popular Authors