Abstract | Objective: Methods: This open-label, multicenter, nonrandomized, Phase 2 study enrolled Japanese patients with measurable, advanced/metastatic soft tissue sarcoma of high/intermediate grade and ≥1 prior chemotherapy for advanced disease. Patients received eribulin mesilate 1.4 mg/m2 intravenously over 2–5 minutes on Days 1 and 8 of a 21-day cycle. The primary endpoint was progression-free rate at 12 weeks. Secondary endpoints included overall survival, progression-free survival and safety. Efficacy analyses were stratified by histology ( liposarcoma or leiomyosarcoma, and other subtypes). Results: Overall, 52 patients were enrolled and 51 patients were treated. Patients with liposarcoma/ leiomyosarcoma (n = 35) had similar characteristics to those with other subtypes (n = 16), except for a higher proportion of women (63% vs 38%, respectively) and patients with Eastern Cooperative Oncology Group performance status 0 (57% vs 44%). Progression-free rate at 12 weeks was 60% in liposarcoma/ leiomyosarcoma patients, 31% in other subtypes and 51% overall. Median progression-free survival was 5.5 months in liposarcoma/ leiomyosarcoma patients, 2.0 months in other subtypes and 4.1 months overall. Median overall survival was 17.0 months in liposarcoma/ leiomyosarcoma patients, 7.6 months in other subtypes and 13.2 months overall. The most common Grade 3–4 adverse events were neutropenia (86%), leukopenia (75%), lymphopenia (33%), anemia (14%) and febrile neutropenia (8%). Conclusion:
Eribulin showed clinical activity with a manageable safety profile in previously treated Japanese patients with advanced/metastatic soft tissue sarcoma.
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Authors | Akira Kawai, Nobuhito Araki, Yoichi Naito, Toshifumi Ozaki, Hideshi Sugiura, Yasuo Yazawa, Hideo Morioka, Akihiko Matsumine, Kenichi Saito, Shun Asami, Kazuo Isu |
Journal | Japanese journal of clinical oncology
(Jpn J Clin Oncol)
Vol. 47
Issue 2
Pg. 137-144
(02 01 2017)
ISSN: 1465-3621 [Electronic] England |
PMID | 28173193
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
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Chemical References |
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Topics |
- Adult
- Aged
- Disease-Free Survival
- Female
- Furans
(therapeutic use)
- Humans
- Ketones
(therapeutic use)
- Middle Aged
- Neoplasm Metastasis
- Sarcoma
(drug therapy, pathology)
- Treatment Outcome
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