ArticleInvestigational new drugs2013
A phase I, open-label, single-arm study for QT assessment of eribulin mesylate in patients with advanced solid tumors.
Article in Investigational new drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 19 citations in OpenAlex.
- Cardiotoxicity of Agents Used in Patients With Breast Cancer.JCO oncology practice · 2024Review
- Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes.Japanese journal of clinical oncology · 2019Observational
- A phase 1 study of eribulin mesylate (E7389), a novel microtubule-targeting chemotherapeutic agent, in children with refractory or recurrent solid tumors: A Children's Oncology Group Phase 1 Consortium study (ADVL1314).Pediatric blood & cancer · 2018Article
- Anticancer drugs-related QTc prolongation, torsade de pointes and sudden death: current evidence and future research perspectives.Oncotarget · 2018Review
- Eribulin in Cancer Treatment.Marine drugs · 2015Review
- Cancer chemotherapy and cardiac arrhythmias: a review.Drug safety · 2015Review
- Eribulin in the Management of Advanced Breast Cancer: Implications of Current Research Findings.Breast cancer : basic and clinical research · 2015Review
- Population pharmacokinetic-pharmacodynamic analysis for eribulin mesilate-associated neutropenia.British journal of clinical pharmacology · 2013Article
Corrections and comments
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Authors and funding
13 authors at 8 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSeveral cancer therapies can prolong cardiac repolarization. This study assessed the potential of eribulin to affect cardiac repolarization in patients with advanced solid tumors.
methodsIn this Phase I, open-label, single-arm study, patients received eribulin mesylate (1.4 mg/m(2); Days 1 and 8 of a 21-day cycle). The primary objective was to assess the effect of eribulin on the QTcF pre- and post-infusion; QTcF and QTcNi were compared for ability to remove heart-rate dependence of the QT interval. Relationship between concentration of eribulin and ΔQTc was explored using linear mixed-effects analysis. Secondary objectives explored pharmacokinetics, safety, and tolerability.
resultsTwenty-six patients were enrolled. QTcNi was more effective than QTcF in correcting for heart-rate dependency of the QT interval. On Day 1, mean ΔQTcNi were ~0 at all timepoints. An apparent time-dependent increase in ΔQTc was observed: on Day 8, changes from baseline were larger and more variable, without clear relation to plasma levels of eribulin. Day 8 predose ΔQTcNi was 5 ms, post-infusion mean values ranged from 2 to 9 ms (largest mean ΔQTcNi at 6 h). No new or unexpected toxicities were reported.
conclusionEribulin demonstrated an acceptable safety profile and a minor prolongation of QTc not expected to be of clinical concern in oncology patients.
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