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
681 - Significance of the red blood cell distribution width in resected pathological stage I non-small cell lung cancer
Presenter: Gouji Toyokawa
Session: Poster Display session 1
Resources:
Abstract
3336 - Survival outcome of non-small cell lung cancer (NSCLC) patients: Comparing results between the database of the Comprehensive Cancer Center Zürich (CCCZ) and the Epidemiological Cancer Registry Zurich and Zug (KKR)
Presenter: Rolf A. Stahel
Session: Poster Display session 1
Resources:
Abstract
2204 - NORA trial (GECP 15/02): Updated results of the Spanish Lung Cancer Group (SLCG) phase II trial of concurrent chemo-radiotherapy (CT-RT) with cisplatin (P) plus metronomic oral vinorelbine (mOV) for unresectable locally advanced non-small cell lung cancer (LA-NSCLC)
Presenter: María Guirado
Session: Poster Display session 1
Resources:
Abstract
1446 - A nomogram to predict outcomes of lung cancer patients after pneumonectomy based on 47 indicators set by principle component analysis
Presenter: Bo Cheng
Session: Poster Display session 1
Resources:
Abstract
1788 - Prognostic and predictive value of 18F-PET/CT on the response to treatment in locally advanced non-small cell lung cancer (NSCLC)
Presenter: Cristina Alfaro Autor
Session: Poster Display session 1
Resources:
Abstract
2299 - Comparison of three different chemotherapy regimens for concomitant chemoradiotherapy in locally advanced non small cell lung cancer
Presenter: Abdurrahman Işıkdoğan
Session: Poster Display session 1
Resources:
Abstract
4211 - Predicting the first failure pattern in patients with inoperable local advanced non-small cell lung cancer (LA-NSCLC) receiving definitive chemoradiotherapy: Establishment and internal validation of a nomogram based on the clinicopathological factors
Presenter: Xueru Zhu
Session: Poster Display session 1
Resources:
Abstract
1550 - Prognostic impact of neutrophil-to-lymphocyte ratio (NLR) pre and post chemoradiotherapy (CRT) in stage III non-small cell lung cancer (NSCLC)
Presenter: Vicente Palomar Abril
Session: Poster Display session 1
Resources:
Abstract
2345 - Meta-analysis evaluating neutropenia incidence with EGFR inhibitors and chemotherapy in patients with NSCLC
Presenter: Bernardo Rapoport
Session: Poster Display session 1
Resources:
Abstract
3747 - Effector CD4+ T-cell induction by thoracic radiotherapy for patients with NSCLC
Presenter: Yu Miura
Session: Poster Display session 1
Resources:
Abstract