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  • Trastuzumab emtansine plus non-pegylated liposomal doxorubicin in HER2-positive metastatic breast cancer (Thelma) [Elektronski vir] : a single-arm, multicenter, phase Ib trial
    López-Miranda, Elena ...
    The paper assesses the dose-limiting toxicities and the maximum tolerated dose (MTD) of trastuzumab emtansine (T-DM1) combined with non-pegylated liposomal doxorubicin (NPLD) in HER2-positive (HER2+) ... metastatic breast cancer (MBC). This single-arm, open-label, phase Ib trial (NCT02562378) enrolled anthracycline-naïve HER2+ MBC patients who had progressed on trastuzumab and taxanes. Patients received a maximum of 6 cycles of NPLD intravenously (IV) at various dose levels (45, 50, and 60 mg/m2) in the %3 plus 3% dose-escalation part. During expansion, they received 60 mg/m2 of NPLD every 3 weeks (Q3W) plus standard doses of T-DM1. The MTD was T-DM1 3.6 mg/kg plus NPLD 60 mg/m2 administered IV Q3W. No clinically relevant worsening of cardiac function was observed. Among all evaluable patients, the overall response rate was 40.0% (95%CI, 16.3%67.7) with a median duration of response of 6.9 months (95%CI, 4.8%9.1). Clinical benefit rate was 66.7% (95%CI, 38.4%88.2) and median progression-free survival was 7.2 months (95%CI, 4.5%9.6). No significant influence of NPLD on T-DM1 pharmacokinetics was observed. The addition of NPLD to T-DM1 is feasible but does not seem to improve the antitumor e%cacy of T-DM1 in HER2+ MBC patients.
    Vir: Cancers [Elektronski vir]. - ISSN 2072-6694 (Vol. 12, no. 12, 2020, str. 3509-1-3509-14)
    Vrsta gradiva - e-članek
    Leto - 2020
    Jezik - angleški
    COBISS.SI-ID - 39863811

    Povezava(-e):

    https://www.mdpi.com/2072-6694/12/12/3509
    DOI

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