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Updated: Jan 21, 2026
Establishment of a Primary Culture of Patient-derived Soft Tissue Sarcoma
Published on: April 11, 2018
Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes
Eisuke Kobayashi1,2, Yoichi Naito3,4, Naofumi Asano5
1Department of Musculoskeletal Oncology and Rehabilitation, National Cancer Center Hospital, Tokyo, Japan.
Background:
Although eribulin is used to treat soft tissue sarcomas (STSs), treatment data for rare subtypes are limited. We conducted a post-marketing surveillance study to assess safety and efficacy of eribulin in STS patients stratified by subtype.
Methods:
Japanese patients (n = 256) with advanced or metastatic STS receiving eribulin treatment were monitored for treatment status, adverse events, diagnostic imaging, and clinical outcomes at 3 months and 1 year. Interim analysis was performed. Patients will be monitored up to 2 years.
Results:
Interim analysis included 3-month (n = 255), imaging (n = 226), and 1-year (n = 105) data. STS subtype distribution was normal. Median number of eribulin cycles was 3.0 (range: 1-17 cycles). Among patients with imaging data, best overall tumor response (12 weeks) was partial response, 7.5% (n = 17); stable disease, 34.5% (n = 78); and stable disease ≥11 weeks, 10.2% (n = 23). Overall response rate (ORR), disease control rate (DCR), and clinical benefit rate (CBR) for all patients were 7.5%, 42.0% and 17.7%, respectively. ORR, DCR, and CBR were 10.3%, 32.0% and 16.5%, respectively, for patients with STS subtypes other than liposarcoma and leiomyosarcoma and included responses from patients with rare STS subtypes. Adverse drug reactions (ADRs) occurred in 211 (82.7%) patients (42 [16.5%] patients had serious ADRs), and none led to death. ADRs leading to drug withdrawal and dose reduction occurred in 27 (10.6%) and 55 (21.6%) patients, respectively.
Conclusion:
Eribulin was generally well tolerated and showed antitumor activity against STSs, including rare subtypes that currently have few treatment options.
Clinical Trial Number:
NCT03058406 (ClinicalTrials.gov).
Insights
Eribulin demonstrated antitumor activity in soft tissue sarcoma (STS) patients, including rare subtypes. The drug was generally well tolerated, with manageable adverse events, offering a new option for patients with limited treatment choices.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Limited treatment data exists for rare soft tissue sarcoma (STS) subtypes.
- Eribulin is an established treatment for STSs, but its efficacy in diverse subtypes requires further investigation.
- Post-marketing surveillance is crucial for evaluating real-world safety and effectiveness.
Purpose of the Study:
- To assess the safety and efficacy of eribulin in Japanese patients with advanced or metastatic STS.
- To stratify treatment outcomes by STS subtype, with a focus on rare subtypes.
- To provide real-world data on eribulin's performance in a diverse STS patient population.
Main Methods:
- A post-marketing surveillance study involving 256 Japanese patients with advanced or metastatic STS treated with eribulin.
- Monitoring of treatment status, adverse events, imaging, and clinical outcomes at 3 months and 1 year.
- Interim analysis of collected data, with ongoing patient monitoring for up to 2 years.
Main Results:
- Interim analysis included data from 255 patients at 3 months and 105 at 1 year.
- Overall response rate (ORR), disease control rate (DCR), and clinical benefit rate (CBR) were 7.5%, 42.0%, and 17.7%, respectively.
- Adverse drug reactions (ADRs) occurred in 82.7% of patients; 16.5% experienced serious ADRs, with none leading to death. Drug withdrawal and dose reduction due to ADRs were reported in 10.6% and 21.6% of patients, respectively.
Conclusions:
- Eribulin demonstrated antitumor activity in soft tissue sarcomas (STSs), including rare subtypes.
- The drug was generally well tolerated in this patient population.
- Eribulin provides a valuable treatment option for patients with STSs, particularly those with limited therapeutic alternatives.
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