Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes
| Autor: | Eisuke Kobayashi, Makoto Endo, Aiko Maejima, Yoichi Naito, Yasunori Megumi, Shunji Takahashi, Akira Kawai, Naofumi Asano |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Leiomyosarcoma Male 0301 basic medicine Oncology Cancer Research medicine.medical_specialty Adolescent Soft Tissue Neoplasms Liposarcoma Young Adult 03 medical and health sciences chemistry.chemical_compound soft tissue sarcoma (STS) 0302 clinical medicine Internal medicine medicine Humans Radiology Nuclear Medicine and imaging Eribulin Furans Adverse effect health care economics and organizations Aged Aged 80 and over Dose-Response Relationship Drug business.industry Soft tissue sarcoma Sarcoma General Medicine Ketones Middle Aged medicine.disease Interim analysis Clinical trial Treatment Outcome 030104 developmental biology chemistry 030220 oncology & carcinogenesis Original Article Female business post-marketing product surveillance |
| Zdroj: | Japanese Journal of Clinical Oncology |
| ISSN: | 1465-3621 |
| Popis: | Interim analysis from the first large-scale post-marketing surveillance study of eribulin treatment for soft tissue sarcomas (STSs) showed antitumor activity in both common and rare subtypes of STS (NCT03058406). 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) |
| Databáze: | OpenAIRE |
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