Abstract 1269
Background
Eribulin mesylate (ERI) has received approval in Japan for the treatment of soft-tissue sarcomas (STSs). However, efficacy and safety data for ERI treatment of rare STS subtypes other than liposarcoma and leiomyosarcoma (L-type sarcomas) are limited.
Methods
This nationwide, multicenter, prospective, observational study is being conducted in patients with all types of STS (L-type and non-L-type) who have received ERI in a clinical setting for up to 2 years. Japanese patients (n = 255) with advanced or metastatic STS and receiving ERI treatment were monitored for treatment status, adverse events, tumor status by imaging, and clinical outcomes 3 and 12 months after treatment initiation. Patient outcomes will be followed up for 2 years. Here, we report interim analysis results on the efficacy and safety of ERI in 255 patients.
Results
Of the 255 enrolled patients, there were 120 males and the mean age ± standard deviation was 59.4 ± 13.6 years. Interim analysis included 1-year (n = 255), and 2-year (n = 239) data. ERI was the first-line treatment in 18 patients (7.1%) and second-line treatment in 81 patients (31.8%). The six major STS subtypes were: leiomyosarcoma (n = 73), liposarcoma (n = 70; of which 41 cases were dedifferentiated), undifferentiated pleomorphic sarcoma (n = 19), angiosarcoma (n = 14), synovial sarcoma (n = 13), and rhabdomyosarcoma (n = 12). Objective response rate (complete response [CR] + partial response [PR]) was 8.1%. Respective objective response rates for each of the six subtypes were 7.0%, 4.6%, 11.1%, 15.4%, 23.1%, and 18.2%; respective disease control rates (CR + PR + stable disease) were 49.3%, 50.8%, 22.2%, 30.8%, 46.2%, and 18.2%. Median overall survival (OS) (95% CI) was 328 days (259, 400) and was 386 (259, 585), 635 (271, –), 246 (121, 497), 386 (104, 516), 356 (136, –), and 136.5 (25, 296) days for each of the six subtypes, respectively. Adverse events occurred in 219 patients (85.9%). Grade 3/4 adverse drug reactions included neutropenia in 138 patients (54.1%) and leukopenia in 122 patients (47.8%).
Conclusions
These interim results suggest that ERI may be an option for patients with various types of STS, including non-L-type sarcomas.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Eisai Co., Ltd.
Funding
Eisai Co., Ltd.
Disclosure
S. Takahashi: Advisory / Consultancy: Eisai Co., Ltd. Y. Megumi: Full / Part-time employment: Eisai Co., Ltd. Y. Sakata: Full / Part-time employment: Eisai Co., Ltd. H. Ikezawa: Full / Part-time employment: Eisai Co., Ltd. T. Matsuoka: Full / Part-time employment: Eisai Co., Ltd. A. Kawai: Advisory / Consultancy: Eisai Co., Ltd.
Resources from the same session
3020 - Circulating tumor DNA (ctDNA) analysis depicts mechanisms of resistance and tumor response to BRAF inhibitors in BRAF-mutant non-small cell lung cancer (NSCLC)
Presenter: Sandra Ortiz - Cuaran
Session: Poster Display session 1
Resources:
Abstract
1271 - A large scale prospective concordance study of oncogene driver detection between plasma- and tissue-based NGS analysis in advanced non-small cell lung cancer (NSCLC).
Presenter: Ryo Itotani
Session: Poster Display session 1
Resources:
Abstract
1132 - Biomarker status as a mediator of age-related overall survival (OS) in advanced non-small cell lung cancer (aNSCLC)
Presenter: Aaron Cohen
Session: Poster Display session 1
Resources:
Abstract
1502 - An exploratory analysis of on-treatment ctDNA measurement as a potential surrogate for overall survival for atezolizumab benefit in the OAK Study
Presenter: David Gandara
Session: Poster Display session 1
Resources:
Abstract
3912 - Disease monitoring of EGFR mutation-positive NSCLC patients via circulating tumor DNA
Presenter: Wei Fang Hsu
Session: Poster Display session 1
Resources:
Abstract
3856 - Incidence of T790M in NSCLC patients progressed to gefitinib, erlotinib, and afatinib: a study on circulating tumor DNA
Presenter: Romano Danesi
Session: Poster Display session 1
Resources:
Abstract
1330 - Folate receptor-positive circulating tumor cells as a predictive biomarker for the efficacy of first-line pemetrexed-based therapy in patients with non-squamous non-small cell lung cancer
Presenter: Xiaoxia Chen
Session: Poster Display session 1
Resources:
Abstract
3512 - Carcinoembryonic Antigen of Cerebrospinal Fluid Predict Prognosis of Leptomeningeal Metastasis from Non-Small Cell Lung Cancer
Presenter: Junjie Zhen
Session: Poster Display session 1
Resources:
Abstract
3852 - Liquid biopsy in clinical pratice of Non-Small-Cell-Lung Cancer (NSCLC): a multi-institutional experience
Presenter: Giovanna De Maglio
Session: Poster Display session 1
Resources:
Abstract
1205 - A Phase III Study Comparing SB8, a Proposed Bevacizumab Biosimilar, and Reference Bevacizumab in Patients with Metastatic or Recurrent Non-squamous NSCLC
Presenter: Martin Reck
Session: Poster Display session 1
Resources:
Abstract