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

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.

journal_name

Br J Cancer

journal_title

British journal of cancer

authors

Evans TRJ,Dean E,Molife LR,Lopez J,Ranson M,El-Khouly F,Zubairi I,Savulsky C,Reyderman L,Jia Y,Sweeting L,Greystoke A,Barriuso J,Kristeleit R

doi

10.1038/s41416-019-0377-x

subject

Has Abstract

pub_date

2019-02-01 00:00:00

pages

379-386

issue

4

eissn

0007-0920

issn

1532-1827

pii

10.1038/s41416-019-0377-x

journal_volume

120

pub_type

杂志文章,多中心研究

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