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
4125 - DUBLIN-3, a Stage IIIb/IV NSCLC Phase (Ph)3 Trial Comparing the Plinabulin (P)/Docetaxel(D) Combination with D Alone
Presenter: Ramon Mohanlal
Session: Poster Display session 1
Resources:
Abstract
3345 - Escalation plans and DNACPR discussions in the unwell oncology patient
Presenter: Raghad Elghadi
Session: Poster Display session 1
Resources:
Abstract
4165 - The Relation between the Symptom Burden of Hospitalized Patients with Incurable Cancer and the Quality-of-Life of Their Family Caregivers
Presenter: Eman Tawfik
Session: Poster Display session 1
Resources:
Abstract
1784 - Clinical predictors for analgesic response to radiotherapy in patients with painful bone metastases
Presenter: Ragnhild Habberstad
Session: Poster Display session 1
Resources:
Abstract
5323 - 30-Day Mortality in Palliative Radiotherapy
Presenter: Shing Fung Lee
Session: Poster Display session 1
Resources:
Abstract
3942 - The relationship between Naldemedine administration and the maximum dose of oral opioids
Presenter: Shinya Kajiura
Session: Poster Display session 1
Resources:
Abstract
3698 - Exposure to low energy amplitude modulated radiofrequency electromagnetic fields (EMF) is associated with rapid improvement in quality of life (QoL) status in patients with advanced hepatocellular carcinoma (HCC), using various analyses of EORTC-C30.
Presenter: Elizabeth Santana
Session: Poster Display session 1
Resources:
Abstract
3885 - Olanzapine Combined with 5-HT3 RA Plus Dexamethasone for Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting in High and Moderate Emetogenic Chemotherapy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Presenter: Jian-Guo Zhou
Session: Poster Display session 1
Resources:
Abstract
5700 - Early Palliative care in advanced cancer, is it really effective?
Presenter: Raquel Gómez Bravo
Session: Poster Display session 1
Resources:
Abstract
5924 - Deprescribing Potentially Inappropriate Medication in Cancer Patients
Presenter: Simon Reuter
Session: Poster Display session 1
Resources:
Abstract