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dc.contributor.authorEvans, T
dc.contributor.authorDean, Emma J
dc.contributor.authorMolife, L
dc.contributor.authorLopez, J
dc.contributor.authorRanson, M
dc.contributor.authorEl-Khouly, F
dc.contributor.authorZubairi, I
dc.contributor.authorSavulsky, C
dc.contributor.authorReyderman, L
dc.contributor.authorJia, Y
dc.contributor.authorSweeting, L
dc.contributor.authorGreystoke, A
dc.contributor.authorBarriuso, Jorge
dc.contributor.authorKristeleit, R
dc.date.accessioned2019-03-04T12:32:43Z
dc.date.available2019-03-04T12:32:43Z
dc.date.issued2019en
dc.identifier.citationEvans 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.en
dc.identifier.pmid30679780en
dc.identifier.doi10.1038/s41416-019-0377-xen
dc.identifier.urihttp://hdl.handle.net/10541/621564
dc.description.abstractBACKGROUND: 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.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1038/s41416-019-0377-xen
dc.titlePhase 1 dose-finding and pharmacokinetic study of eribulin-liposomal formulation in patients with solid tumours.en
dc.typeArticleen
dc.contributor.departmentBeatson West of Scotland Cancer Centre, Glasgow, UKen
dc.identifier.journalBritish Journal of Canceren
dc.description.noteen]
refterms.dateFOA2020-04-22T12:34:26Z


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