New data presented on ASCO on the use of Eribulin in advanced liposarcoma
New data presented at American Society of Clinical Oncology (ASCO) highlighted the efficacy of a novel therapeutic agent in two very different types of cancer. Eribulin (Halaven®, Eisai), a synthetic analogue of an antiproliferative substance originally isolated from the marine sponge Halichondrin okadai, inhibits the formation of microtubules, thus disrupting mitosis. It received approval by the European Medicines Agency (EMA) in 2014 for women with locally advanced or metastatic breast cancer (MBC) who have progressed after at least one chemotherapeutic regimen for advanced disease. Approval was based two pivotal Phase III studies: EMBRACE and Study 301. In the EMBRACE trial, eribulin increased overall survival (OS) by 2.7 months compared with treatment of the physician’s choice.1 Study 301 established a trend towards overall survival with eribulin versus capecitabine but this was not statistically significant.2
In April 2016, eribulin also received EMA approval for patients with unresectable liposarcoma, a type of soft tissue sarcoma that occurs in fat cells, following prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease. Approval was based on data from a phase III study (study 309), in which eribulin increased OS by 7.2 months compared with a commonly used chemotherapy, dacarbazine.3 This was the first and, to date, only randomised controlled trial of a single agent systemic therapy to demonstrate an OS advantage in people previously treated for advanced soft tissue sarcomas. Recently, the European Commission approved a variation to the terms of the Marketing Authorisation of eribulin for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy for advanced or metastatic disease. According to Patrick Schöffski Head of the Department of General Medical Oncology, University Hospitals Leuven, Belgium, this decision marks an important milestone for people in Europe with advanced liposarcomas. ‘There are currently limited treatment options available, but now we are able to offer them a treatment with a proven overall survival benefit.’ Professor Schöffski said. ‘Eribulin was the first-ever single agent therapy to show such a survival benefit, which makes the news all the more important for patients and clinicians across Europe.’
Professor Schöffski discussed data from a subset analysis of study 309, which investigated differences in health-related quality of life between eribulin and dacarbazine for patients with disease progression. Quality of life scores at baseline were equivalent for both arms. Patients on dacarbazine had significantly lower global health status compared to those on eribulin (56.1 versus 62.1; p=0.0083) and physical function (63.9 versus 73.3; p=0. 0022) as well as worse nausea/vomiting (p=0.0009) and appetite loss (p=0.001). According to Professor Schöffski, while there is a significant benefit in OS and progression free survival for eribulin compared with dacarbazine, it is equally important that these patients have an improved quality of life. ‘It is crucial to balance the improved survival with manageable side effects of treatment as seen in this study,’ he said.
1. Cortes J, O'Shaughnessy J, Loesch D, et al., Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study, Lancet, 2011;377:914-23.
2. Kaufman P, Awada A, Twelves C et al. A Phase III, open-label, randomised, multicenter study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes, Presented at 2012 CTRC-AACR San Antonio Breast Cancer Symposium
3. Schoffski P, Chawla S, Maki RG, et al., Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial, Lancet, 2016;387:1629-37.