Unknown

Dataset Information

0

Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes.


ABSTRACT: 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).

SUBMITTER: Kobayashi E 

PROVIDER: S-EPMC6886464 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

altmetric image

Publications

Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes.

Kobayashi Eisuke E   Naito Yoichi Y   Asano Naofumi N   Maejima Aiko A   Endo Makoto M   Takahashi Shunji S   Megumi Yasunori Y   Kawai Akira A  

Japanese journal of clinical oncology 20191001 10


<h4>Background</h4>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.<h4>Methods</h4>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 w  ...[more]

Similar Datasets

| S-EPMC9092704 | biostudies-literature
| S-EPMC6453888 | biostudies-literature
| S-EPMC8614600 | biostudies-literature
| S-EPMC5943671 | biostudies-literature
| S-EPMC3541987 | biostudies-literature
| S-EPMC5504216 | biostudies-other
| S-EPMC6394617 | biostudies-literature
| S-EPMC7497681 | biostudies-literature
| S-EPMC3825462 | biostudies-literature
| S-EPMC7430493 | biostudies-literature