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
6079 - Invasive fungal diseases in patients with Hodgkin’s lymphoma before and after allogeneic hematopoietic stem cell transplantation
Presenter: Marina Popova
Session: Poster Display session 1
Resources:
Abstract
5995 - Invasive fungal diseases caused by rare pathogens in patients after hematopoietic stem cell transplantation (HSCT) & chemotherapy
Presenter: Yuliya Rogacheva
Session: Poster Display session 1
Resources:
Abstract
2961 - Safety and pharmacokinetics of novel CXCR4 antagonist YF-H-2015005 in the mobilization of hematopoietic stem cells in patients with non-Hodgkin's lymphoma
Presenter: Weiping Liu
Session: Poster Display session 1
Resources:
Abstract
5771 - Chemotherapy associated Hyponatremia in Hematological Malignancies: A retrospective study of 189 patients treated in a single medical center
Presenter: Vadim Lesan
Session: Poster Display session 1
Resources:
Abstract
1165 - Risk factors for Bacteremia-Associated Mortality of Aeromona sobria in Hematologic Malignancies
Presenter: Gabriel De la Cruz-Kú
Session: Poster Display session 1
Resources:
Abstract
5287 - Use of droplet digital polymerase chain reaction for detecting minimal residual disease: a prospective, multi-institutional study
Presenter: Hyunkyung Park
Session: Poster Display session 1
Resources:
Abstract
1886 - RUBIH2 — Use of NGS in haematological malignancies: from real world data to national recommendations, an innovative program to evaluate the impact of healthcare technology on patient care
Presenter: Severine Coquerelle
Session: Poster Display session 1
Resources:
Abstract
1940 - Outcomes of chronic myeloid leukemia with T315I mutation in the absence of targeted therapy or hematopoietic stem cell transplantation
Presenter: Nageswara Palukuri
Session: Poster Display session 1
Resources:
Abstract
1946 - Is bone marrow examination indispensible in chronic myeloid Leukemia at diagnosis ?
Presenter: Nageswara Palukuri
Session: Poster Display session 1
Resources:
Abstract
1904 - Incidence of Imatinib Resistance in Chronic Myeloid Leukemia (CML) Patients: Experience from Resource Poor Centre of Eastern India
Presenter: Debmalya Bhattacharyya
Session: Poster Display session 1
Resources:
Abstract