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Antitubulin Agents
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
In March 2010 Eisai announced that it had submitted simultaneous regulatory applications for approval of eribulin mesylate for the treatment of locally advanced or metastatic breast cancer to agencies in Japan, the US, and the European Union. The New Drug Application (NDA) in the US was granted priority review status by the FDA in May 2010. Eribulin is now used in the treatment of treatment of locally advanced or metastatic breast cancer when the disease has progressed after treatment with at least one chemotherapy regimen.
Breast Cancer
Published in Pat Price, Karol Sikora, Treatment of Cancer, 2020
Amy Case, Gwenllian Edwards, Catherine Pembroke
Eribulin, a non-taxane microtubule dynamics inhibitor, is now an option for patients who have progressed after at least two previous lines of chemotherapy, which include an anthracycline or a taxane, and capecitabine. It was studied within the EMBRACE trial (n = 762), comparing its impact on OS with treatment of the physician’s choice. A significant and clinically meaningful improvement in OS, 13.1 versus 10.6 months, was shown, which challenged the notion that an improved OS with additional lines of therapy is an unrealistic expectation in patients with heavily pre-treated disease.181
Systematic review of Real-World effectiveness of eribulin for locally advanced or metastatic breast cancer
Published in Current Medical Research and Opinion, 2020
Isabelle Chabot, Qi Zhao, Yun Su
A systematic review and pooled analysis of 13 retrospective series of eribulin in MBC was conducted in 2016, looking mainly at response rate and clinical benefit rate17. Numerous observational studies evaluating the effectiveness of eribulin within its US and EU marketing authorization utilization i.e. in study populations similar to those of EMBRACE and Study 301 have been published since then. No recent systematic review has been conducted to summarize this information in a meaningful way, considering the most relevant endpoints of OS and PFS to treatment decision-making17. The utilization and resulting effectiveness of eribulin in the second and later lines of sequential single-agent chemotherapy in the clinical practice setting is needed to further understand and inform to physicians when making treatment decisions.
The relative effectiveness of eribulin for advanced breast cancer treatment: a study of the southeast Netherlands advanced breast cancer registry
Published in Acta Oncologica, 2020
X. G. L. V. Pouwels, S. M. E. Geurts, B. L. T. Ramaekers, F. Erdkamp, B. E. P. J. Vriens, K. N. A. Aaldering, A. J. van de Wouw, M. W. Dercksen, T. J. Smilde, N. A. J. B. Peters, J. M. van Riel, M. J. Pepels, J. Heijnen-Mommers, M. A. Joore, V. C. G. Tjan-Heijnen, M. de Boer
The current study confirms the predictable and manageable toxicity profile of eribulin. Febrile neutropenia leading to dose reduction (which is according to the manufacturers guideline) or delay occurred in 2% of our patients, and occurred in 5% of patients in the EMBRACE trial [2]. As in EMBRACE, leucopenia or neutropenia was the most frequent toxicity (leading to dose delay or reduction), but the incidence of leucopenia or neutropenia (13%) resulting in dose delay or reduction was lower in the current study than in the eribulin group of EMBRACE (grade 3–4 leucopenia = 14%, grade 3–4 neutropenia = 45%). Incidences of other toxicities (e.g. neuropathy, febrile neutropenia, and fatigue) were comparable to previous observational analyses of eribulin [6,8,9]. Hospitalizations due to toxicity occurred in 31% of patients in this study, partly combined with tumor related symptoms, which can be explained by the extensively pretreated, late stage of advanced disease in our patients.
The place of trabectedin in the treatment of soft tissue sarcoma: an umbrella review of the level one evidence
Published in Expert Opinion on Orphan Drugs, 2019
Pavlina Andreeva-Gateva, Shenol Chakar
Liposarcomas are also sensitive to eribulin, another relatively new drug. Eribulin inhibits microtubules via a mechanism different from that of other drugs acting through inhibition of microtubules. In addition to a cytotoxic effect, eribulin stimulates vascular remodeling [50] and makes the epithelization of mesenchyme reversible [51]. A phase 3 clinical study, comparing eribulin and dacarbazine in patients with advanced leiomyosarcoma and liposarcoma. One has found a prolongation of overall survival in eribulin patients (13.5 vs. 11.5 months, p = 0.0169), those with liposarcoma having the most significant benefit (median survival rate 15.6 vs. 8.4) [52]. The median progression-free survival rate in the two groups was similar – 2.6 months. The positive effect on overall survival compared to the lack of progression-free survival is explained by the biological effects of the drug on the microvasculature and microenvironment that could potentiate the effects of subsequent treatment. Eribulin has been authorized for use by the FDA in 2010, in Canada – since 2011, by the EMA – 2011 for breast cancer treatment, and since 2016 – for liposarcomas, eribulin is approved for use for advanced liposarcoma in the United States and leiomyosarcoma and liposarcoma in other countries. Well-differentiated liposarcomas and pleomorphic liposarcomas, in particular, are believed to show a higher sensitivity to eribulin than to trabectedin, although there is no direct comparison performed [53]. The pivotal phase-3 trial comparing trabectedin with dacarbazine was not powered to find differences in these specific subtypes.