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• W4361954206 abstract "<div>AbstractPurpose:<p>We report the dose-escalation part of a phase I study of liposomal eribulin (E7389-LF) in Japanese patients with advanced solid tumors and no alternative standard therapy.</p>Patients and Methods:<p>Patients ≥20 years old were enrolled. E7389-LF doses of 1.0 to 1.5 mg/m² once every two weeks (Q2W) or 1.0 to 2.5 mg/m² once every three weeks (Q3W) were planned. The primary objective was to determine the MTD by evaluating dose-limiting toxicities (DLT). Secondary objectives included safety/tolerability assessments, objective response rate (ORR), and progression-free survival; serum biomarker assessment was an exploratory objective.</p>Results:<p>Twenty-one patients were enrolled and treated; 12 in the Q3W group (1.0 mg/m², <i>n</i> = 3; 1.5 mg/m², <i>n</i> = 3; 2.0 mg/m², <i>n</i> = 6) and 9 in the Q2W group (1.0 mg/m², <i>n</i>=3; 1.5 mg/m², <i>n</i> = 6). The Q3W and Q2W MTDs were 2.0 mg/m² and 1.5 mg/m², respectively. One patient receiving 2.0 mg/m² Q3W had a DLT of grade 3 febrile neutropenia. The most common grade 3 treatment-emergent adverse events were neutropenia (66.7% in Q3W and Q2W) and leukopenia (Q3W, 58.3%; Q2W, 33.3%). One patient in the Q3W group (2.0 mg/m²) and 3 in the Q2W group (1.0 mg/m², <i>n</i> = 1; 1.5 mg/m², <i>n</i> = 2) achieved a partial response [overall ORR, 19.0%; 95% confidence interval (CI), 5.4–41.9]. Endothelial [TEK receptor tyrosine kinase (TEK), intercellular adhesion molecule 1 (ICAM1), vascular endothelial growth factor receptor 3 (VEGFR3), platelet/endothelial cell adhesion molecule 1 (PECAM1)], vasculature (collagen IV), and immune-related [interferon gamma (IFNγ), C-X-C motif chemokine ligand 11 (CXCL11), C-X-C motif chemokine ligand 10 (CXCL10)] biomarker levels were increased.</p>Conclusions:<p>E7389-LF was well tolerated at 2.0 mg/m² Q3W and 1.5 mg/m² Q2W. Considering the toxicity profile of both regimens, the recommended dose was 2.0 mg/m² Q3W. Expansion cohorts are ongoing.</p></div>" @default.
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• W4361954206 date "2023-03-31" @default.
• W4361954206 modified "2023-09-26" @default.
• W4361954206 title "Data from Dose Escalation Data from the Phase 1 Study of the Liposomal Formulation of Eribulin (E7389-LF) in Japanese Patients with Advanced Solid Tumors" @default.
• W4361954206 doi "https://doi.org/10.1158/1078-0432.c.6532530.v1" @default.
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