• Patrick Schöffski, Isabelle Laure Ray-Coquard, Angela Cioffi, Nguyen Bin Bui, Sebastian Bauer, Joerg Thomas Hartmann, Anders Krarup-Hansen, Viktor Grünwald, Raf Sciot, Herlinde Dumez, Jean-Yves Blay, Axel Le Cesne, Jantien Wanders, Carolyn Hayward, Sandrine Marreaud, Monia Ouali, Peter Hohenberger, and European Organisation for Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group (STBSG).
• University Hospitals Leuven, Catholic University Leuven, Department of General Medical Oncology, Leuven Cancer Institute, Leuven, Belgium. patrick.schoffski@uzleuven.be
• Lancet Oncol. 2011 Oct 1; 12 (11): 1045-52.

BackgroundEribulin inhibits microtubule dynamics via a mechanism distinct from that of other tubulin-targeting drugs, inducing cell-cycle arrest and tumour regression in preclinical models. We assessed the activity and safety of eribulin in four strata of patients with different types of soft-tissue sarcoma.MethodsIn this non-randomised multicentre phase 2 study, patients were included if they had progressive or high-grade soft-tissue sarcoma and had received no more than one previous combination chemotherapy or up to two single drugs for advanced disease. They were stratified by the type of soft-tissue sarcoma they had. Eribulin was given intravenously at a concentration of 1·4 mg/m(2) over 2-5 min at days 1 and 8 every 3 weeks to primarily assess progression-free survival at 12 weeks (RECIST 1.0), which we evaluated in all patients who started treatment. Safety analyses were done in all patients who started treatment. This trial is registered at ClinicalTrials.gov, number NCT00413192.FindingsOf 128 patients included, 37 had adipocytic sarcoma, 40 had leiomyosarcoma, 19 had synovial sarcoma, and 32 had other sarcomas. 12 (31·6%) of 38 patients with leiomyosarcoma evaluable for the primary endpoint, 15 (46·9%) of 32 patients with adipocytic sarcoma, four (21·1%) of 19 with synovial sarcoma, and five (19·2%) of 26 in other sarcomas were progression-free at 12 weeks. The most common grade 3-4 adverse events were neutropenia (66 [52%] of 127 patients evaluable for safety), leucopenia (44 [35%]), anaemia (nine [7%]), fatigue (nine [7%]), febrile neutropenia (eight [6%]), abnormal alanine aminotransferase concentrations (six [5%]), mucositis (four [3%]), and sensory neuropathy (four [3%]).InterpretationEribulin deserves further study in this setting, based on progression-free survival at 12 weeks in leiomyosarcoma and adipocytic sarcoma.FundingEisai Limited, Hatfield, UK.Copyright © 2011 Elsevier Ltd. All rights reserved.

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