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    Phase 1 dose-finding and pharmacokinetic study of eribulin-liposomal formulation in patients with solid tumours.

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    Authors
    Evans, T
    Dean, Emma J
    Molife, L
    Lopez, J
    Ranson, M
    El-Khouly, F
    Zubairi, I
    Savulsky, C
    Reyderman, L
    Jia, Y
    Sweeting, L
    Greystoke, A
    Barriuso, Jorge
    Kristeleit, R
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    Affiliation
    Beatson West of Scotland Cancer Centre, Glasgow, UK
    Issue Date
    2019
    
    Metadata
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    Abstract
    BACKGROUND: This phase 1 study examined the safety, tolerability, pharmacokinetics and preliminary efficacy of eribulin-liposomal formulation (eribulin-LF) in patients with advanced solid tumours. METHODS: Eligible patients with ECOG PS 0-1 were treated with eribulin-LF either on day 1 every 21 days (Schedule 1), or on days 1 and 15 every 28 days (Schedule 2). Doses ranged from 1.0 to 3.5?mg/m2, with dose escalation in a 3?+?3 design. The dose-expansion phase evaluated eribulin-LF in select tumour types. PRIMARY OBJECTIVES: maximum tolerated dose (MTD) and the recommended dose/schedule of eribulin-LF. RESULTS: Totally, 58 patients were enroled (median age?=?62 years). The MTD was 1.4?mg/m2 (Schedule 1) or 1.5?mg/m2 (Schedule 2), the latter dose selected for the dose-expansion phase. Dose-limiting toxicity (DLTs) in Schedule 1: hypophosphatemia and increased transaminase levels. DLTs in Schedule 2: stomatitis, increased alanine aminotransferase, neutropenia and febrile neutropenia. The pharmacokinetic profile of eribulin-LF showed a similar half-life to that of eribulin (~30?h), but with a 5-fold greater maximum serum concentration and a 40-fold greater area-under-the-curve. Eribulin-LF demonstrated clinical activity with approximately 10% of patients in both schedules achieving partial responses. CONCLUSIONS: Eribulin-LF was well tolerated with a favourable pharmacokinetic profile. Preliminary evidence of clinical activity in solid tumours was observed.
    Citation
    Evans TRJ, Dean E, Molife LR, Lopez J, Ranson M, El-Khouly F, et al. Phase 1 dose-finding and pharmacokinetic study of eribulin-liposomal formulation in patients with solid tumours. Br J Cancer. 2019 Jan 25.
    Journal
    British Journal of Cancer
    URI
    http://hdl.handle.net/10541/621564
    DOI
    10.1038/s41416-019-0377-x
    PubMed ID
    30679780
    Additional Links
    https://dx.doi.org/10.1038/s41416-019-0377-x
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1038/s41416-019-0377-x
    Scopus Count
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