1269 - One-year follow-up results of eribulin for soft-tissue sarcoma including rare subtypes in a real-world observational study in Japan

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.