Supplementary Material 1 from Phase II Study of Eribulin plus Pembrolizumab in Metastatic Soft-tissue Sarcomas: Clinical Outcomes and Biological Correlates (2024)

Phase 2 study of eribulin in patients with previously treated advanced or metastatic soft tissue sarcoma

Japanese journal of clinical oncology, 2017

Eribulin, a microtubule dynamics inhibitor, is approved for the treatment of patients with breast cancer and soft tissue sarcoma. We investigated the efficacy and safety of eribulin in Japanese patients with soft tissue sarcoma. This open-label, multicenter, nonrandomized, Phase 2 study enrolled Japanese patients with measurable, advanced/metastatic soft tissue sarcoma of high/intermediate grade and ≥1 prior chemotherapy for advanced disease. Patients received eribulin mesilate 1.4 mg/m2 intravenously over 2–5 minutes on Days 1 and 8 of a 21-day cycle. The primary endpoint was progression-free rate at 12 weeks. Secondary endpoints included overall survival, progression-free survival and safety. Efficacy analyses were stratified by histology (liposarcoma or leiomyosarcoma, and other subtypes). Overall, 52 patients were enrolled and 51 patients were treated. Patients with liposarcoma/leiomyosarcoma (n = 35) had similar characteristics to those with other subtypes (n = 16), except for ...

Eribulin-based treatment in patients affected by sarcomas: a case series

Future Oncology

Activity of Eribulin in Patients With Advanced Liposarcoma Demonstrated in a Subgroup Analysis From a Randomized Phase III Study of Eribulin Versus Dacarbazine

Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017

Purpose A phase III study comparing eribulin with dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma showed a significant improvement in overall survival (OS) for the eribulin arm, with a manageable toxicity profile. We now report the histology-specific subgroup analysis of the efficacy and safety of eribulin compared with dacarbazine in patients with LPS, an independently randomized stratified subgroup of this phase III trial. Methods Patients ≥ 18 years with advanced or metastatic dedifferentiated, myxoid/round cell, or pleomorphic LPS incurable by surgery or radiotherapy were included. Patients with Eastern Cooperative Oncology Group performance status ≤ 2 and two or more prior systemic treatment regimens, including one with anthracycline, were randomly assigned 1:1 to receive eribulin mesylate (1.4 mg/m(2) intravenously on days 1 and 8) or dacarbazine (850, 1,000, or 1,200 mg/m(2) intravenously on day 1) every 21 days. OS, progression-free survival (PFS), ...

Experience with eribulin in pretreated patients with advanced liposarcoma: a case series

Future Oncology, 2020

Systemic treatments for advanced soft tissue sarcoma are limited. Eribulin showed activity in metastatic soft tissue sarcoma, particularly liposarcomas. Data from six patients with advanced liposarcoma that received eribulin as third- or fourth-line therapy are presented herein. Eribulin treatment was well tolerated; no grade 3–4 toxicity or therapy delay was observed. Two patients had a partial response; four had a prolonged stable disease. The first case, with pre-existing chronic renal dysfunction, achieved a 6-month stable disease with dose-reduced eribulin. The second case became resectable after eribulin treatment, with a 6-month complete surgical remission. The third case obtained a 7-month stable disease with eribulin and stereotactic body radiotherapy. The last three cases were ≥65 years old, and two of them had objective response with eribulin.

Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological subtypes

The Lancet Oncology, 2011

Efficacy and safety of eribulin mesylate in advanced soft tissue sarcomas

Indian journal of medical and paediatric oncology : official journal of Indian Society of Medical & Paediatric Oncology

Despite recent advances in the field, treatment options for metastatic soft tissue sarcoma patients are limited. Eribulin, an antimitotic derived from the natural marine sponge product halichondrin B, is currently approved for the treatment of metastatic breast cancer. Following the promising activity of eribulin in sarcoma in a Phase II trial, the drug was recently compared to dacarbazine in pretreated advanced leiomyosarcoma (LMS) and liposarcoma (LPS) patients in a Phase III trial. Eribulin was associated with a significant 2-month improvement in median overall survival compared to dacarbazine (13.5 vs. 11.5 months, heart rate: 0.768) despite no documented significant difference in progression-free survival. In a subgroup analysis, the survival advantage associated with eribulin was evident in the LPS subgroup but not in the LMS subgroup. Following these encouraging results, the Food and Drug Administration has approved eribulin for the treatment of advanced LPS for patients who ...

Eribulin therapy for the treatment of patients with advanced soft tissue sarcoma

Future Oncology, 2018

Eribulin is a structurally simplified, synthetic macrocyclic ketone analog of halichondrin B, which is a natural, polyether macrolide derived from marine sponges. Eribulin exerts its cytotoxicity by its unique microtubule dynamics inhibitory action. Eribulin was approved in 2010 by the US FDA as a third-line therapy for metastatic breast cancer patients previously treated with an anthracycline and a taxane. In 2016, it was approved for treatment of metastatic liposarcoma for patients who have progressed with anthracycline treatment. In this article, we review the pharmacokinetics, mechanism of action of eribulin with focus on preclinical and clinical data in sarcoma and also the role of miRNAs in soft tissue sarcomas.

Advances in the treatment of soft tissue sarcoma: focus on eribulin

Cancer Management and Research, 2018

Efficacy of Eribulin Plus Gemcitabine Combination in L-Sarcomas

International Journal of Molecular Sciences

Although the overall survival of advanced soft-tissue sarcoma (STS) patients has increased in recent years, the median progression-free survival is lower than 5 months, meaning that there is an unmet need in this population. Among second-line treatments for advanced STS, eribulin is an anti-microtubule agent that has been approved for liposarcoma. Here, we tested the combination of eribulin with gemcitabine in preclinical models of L-sarcoma. The effect in cell viability was measured by MTS and clonogenic assay. Cell cycle profiling was studied by flow cytometry, while apoptosis was measured by flow cytometry and Western blotting. The activity of eribulin plus gemcitabine was evaluated in in vivo patient-derived xenograft (PDX) models. In L-sarcoma cell lines, eribulin plus gemcitabine showed to be synergistic, increasing the number of hypodiploid events (increased subG1 population) and the accumulation of DNA damage. In in vivo PDX models of L-sarcomas, eribulin combined with gemci...

A Single-Arm Phase Ib/II Study of Lenvatinib plus Eribulin in Advanced Liposarcoma and Leiomyosarcoma

Clinical Cancer Research, 2022