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Updated: May 29, 2026
Establishment of a Primary Culture of Patient-derived Soft Tissue Sarcoma
Published on: April 11, 2018
Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological
Patrick Schöffski1, Isabelle Laure Ray-Coquard, Angela Cioffi
1University Hospitals Leuven, Catholic University Leuven, Department of General Medical Oncology, Leuven Cancer Institute, Leuven, Belgium. patrick.schoffski@uzleuven.be
Background:
Eribulin inhibits microtubule dynamics via a mechanism distinct from that of other tubulin-targeting drugs, inducing cell-cycle arrest and tumour regression in preclinical models. We assessed the activity and safety of eribulin in four strata of patients with different types of soft-tissue sarcoma.
Methods:
In this non-randomised multicentre phase 2 study, patients were included if they had progressive or high-grade soft-tissue sarcoma and had received no more than one previous combination chemotherapy or up to two single drugs for advanced disease. They were stratified by the type of soft-tissue sarcoma they had. Eribulin was given intravenously at a concentration of 1·4 mg/m(2) over 2-5 min at days 1 and 8 every 3 weeks to primarily assess progression-free survival at 12 weeks (RECIST 1.0), which we evaluated in all patients who started treatment. Safety analyses were done in all patients who started treatment. This trial is registered at ClinicalTrials.gov, number NCT00413192.
Findings:
Of 128 patients included, 37 had adipocytic sarcoma, 40 had leiomyosarcoma, 19 had synovial sarcoma, and 32 had other sarcomas. 12 (31·6%) of 38 patients with leiomyosarcoma evaluable for the primary endpoint, 15 (46·9%) of 32 patients with adipocytic sarcoma, four (21·1%) of 19 with synovial sarcoma, and five (19·2%) of 26 in other sarcomas were progression-free at 12 weeks. The most common grade 3-4 adverse events were neutropenia (66 [52%] of 127 patients evaluable for safety), leucopenia (44 [35%]), anaemia (nine [7%]), fatigue (nine [7%]), febrile neutropenia (eight [6%]), abnormal alanine aminotransferase concentrations (six [5%]), mucositis (four [3%]), and sensory neuropathy (four [3%]).
Interpretation:
Eribulin deserves further study in this setting, based on progression-free survival at 12 weeks in leiomyosarcoma and adipocytic sarcoma.
Funding:
Eisai Limited, Hatfield, UK.
Insights
Eribulin showed promising progression-free survival in patients with adipocytic and leiomyosarcoma soft-tissue sarcomas. Further investigation is warranted for this patient population, considering the observed safety profile.
Area of Science:
- Oncology
- Pharmacology
- Medical Research
Background:
- Eribulin is a microtubule-targeting agent with a unique mechanism of action, demonstrating preclinical efficacy in tumor regression.
- Soft-tissue sarcomas (STS) represent a diverse group of malignancies with varying treatment responses.
Purpose of the Study:
- To evaluate the efficacy and safety of eribulin in patients with advanced soft-tissue sarcoma, stratified by sarcoma subtype.
- To assess progression-free survival at 12 weeks as the primary endpoint.
Main Methods:
- A non-randomized, multicenter, phase 2 study was conducted.
- Patients with progressive or high-grade STS received eribulin (1.4 mg/m²) intravenously on days 1 and 8 every 3 weeks.
- Patients were stratified into four groups based on STS subtype: adipocytic, leiomyosarcoma, synovial, and other sarcomas.
Main Results:
- Progression-free survival at 12 weeks was observed in 46.9% of adipocytic sarcoma patients and 31.6% of leiomyosarcoma patients.
- Common grade 3-4 adverse events included neutropenia (52%), leucopenia (35%), and fatigue (7%).
- Specific response rates varied across the different STS subtypes.
Conclusions:
- Eribulin demonstrates potential activity in specific soft-tissue sarcoma subtypes, particularly adipocytic and leiomyosarcoma.
- The observed 12-week progression-free survival supports further investigation of eribulin in these STS settings.
- Safety monitoring is crucial due to the incidence of hematologic toxicities.
