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J Clin Oncol. 2017 Oct 20;35(30):3433-3439. doi: 10.1200/JCO.2016.71.6605. Epub 2017 Aug 30.

Activity of Eribulin in Patients With Advanced Liposarcoma Demonstrated in a Subgroup Analysis From a Randomized Phase III Study of Eribulin Versus Dacarbazine.

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1
George D. Demetri, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; Patrick Schöffski, University Hospitals Leuven, Leuven, Belgium; Giovanni Grignani, Fondazione del Piemonte per l'Oncologia Istituto di Ricovero e Cura a Carattere Scientifico, Candiolo, Italy; Jean-Yves Blay, Université Claude Bernard and Centre Léon Bérard, Lyon, France; Robert G. Maki, Monter Cancer Center, Lake Success; and Cold Spring Harbor Laboratory, New Hyde Park, NY; Brian A. Van Tine, Barnes and Jewish Hospital, Washington University in St. Louis, St. Louis, MO; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec, Canada; Robin L. Jones, The Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom; David R. D'Adamo and Matthew Guo, Eisai, Woodcliff Lake, NJ; and Sant Chawla, Sarcoma Oncology Center, Santa Monica, CA.

Abstract

Purpose A phase III study comparing eribulin with dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma showed a significant improvement in overall survival (OS) for the eribulin arm, with a manageable toxicity profile. We now report the histology-specific subgroup analysis of the efficacy and safety of eribulin compared with dacarbazine in patients with LPS, an independently randomized stratified subgroup of this phase III trial. Methods Patients ≥ 18 years with advanced or metastatic dedifferentiated, myxoid/round cell, or pleomorphic LPS incurable by surgery or radiotherapy were included. Patients with Eastern Cooperative Oncology Group performance status ≤ 2 and two or more prior systemic treatment regimens, including one with anthracycline, were randomly assigned 1:1 to receive eribulin mesylate (1.4 mg/m2 intravenously on days 1 and 8) or dacarbazine (850, 1,000, or 1,200 mg/m2 intravenously on day 1) every 21 days. OS, progression-free survival (PFS), and safety were analyzed. Results In the LPS subgroup, OS was significantly improved: 15.6 versus 8.4 months (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P < .001) with eribulin versus dacarbazine, respectively. Longer OS with eribulin was observed in all LPS histologic subtypes and in all geographic regions evaluated. PFS was also improved with eribulin versus dacarbazine (2.9 v 1.7 months, respectively; hazard ratio, 0.52; 95% CI, 0.35 to 0.78; P = .0015). Adverse events were similar between arms. Conclusion In patients with previously treated LPS, eribulin was associated with significantly superior OS and PFS compared with dacarbazine. Eribulin represents an important treatment option for patients with LPS, a sarcoma subtype for which limited effective systemic treatments are available. Further studies are justified to explore the role of eribulin in earlier lines of therapy as well as in combination with other agents.

PMID:
28854066
DOI:
10.1200/JCO.2016.71.6605
[Indexed for MEDLINE]

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