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Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies
Data from two phase 3 studies of eribulin were pooled in analyses initially requested by the European Medicines Agency to assess whether specific patient subgroups, previously treated with an anthracycline and a taxane, benefited from eribulin. Study 305/EMBRACE included women after two-to-five line...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer US
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4243003/ https://www.ncbi.nlm.nih.gov/pubmed/25381136 http://dx.doi.org/10.1007/s10549-014-3144-y |
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author | Twelves, Chris Cortes, Javier Vahdat, Linda Olivo, Martin He, Yi Kaufman, Peter A. Awada, Ahmad |
author_facet | Twelves, Chris Cortes, Javier Vahdat, Linda Olivo, Martin He, Yi Kaufman, Peter A. Awada, Ahmad |
author_sort | Twelves, Chris |
collection | PubMed |
description | Data from two phase 3 studies of eribulin were pooled in analyses initially requested by the European Medicines Agency to assess whether specific patient subgroups, previously treated with an anthracycline and a taxane, benefited from eribulin. Study 305/EMBRACE included women after two-to-five lines of chemotherapy for advanced breast cancer who were randomized to eribulin mesylate (1.4 mg/m(2) on days 1 and 8 every 21 days) or treatment of physician’s choice. In Study 301, patients who had received up to two prior chemotherapy regimens for advanced disease were randomized to eribulin (as above) or capecitabine (1.25 g/m(2) b.i.d. on days 1–14 every 21 days). In the pooled population, overall survival (OS), progression-free survival and response rates were analysed in the intent-to-treat population and selected subgroups. Overall, 1,062 patients were randomized to eribulin and 802 patients to control. Median OS was 15.2 months with eribulin versus 12.8 months with control (hazard ratio [HR] 0.85; 95 % CI 0.77, 0.95; P = 0.003). In all subgroups assessed, OS data favoured eribulin; significant improvements occurred in some subgroups, notably in women with human epidermal growth factor receptor 2 (HER2)-negative disease (HR 0.82; P = 0.002), although the effect in those with HER2-negative but hormone-receptor-positive disease did not reach statistical significance; benefits were also seen, among others, in those with estrogen-receptor-negative and triple-negative disease. Eribulin improves OS in various patient subgroups with advanced/metastatic breast cancer who had previously received an anthracycline and a taxane. Women with HER2-negative disease are among those who may obtain benefit from eribulin. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s10549-014-3144-y) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4243003 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-42430032014-12-02 Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies Twelves, Chris Cortes, Javier Vahdat, Linda Olivo, Martin He, Yi Kaufman, Peter A. Awada, Ahmad Breast Cancer Res Treat Clinical Trial Data from two phase 3 studies of eribulin were pooled in analyses initially requested by the European Medicines Agency to assess whether specific patient subgroups, previously treated with an anthracycline and a taxane, benefited from eribulin. Study 305/EMBRACE included women after two-to-five lines of chemotherapy for advanced breast cancer who were randomized to eribulin mesylate (1.4 mg/m(2) on days 1 and 8 every 21 days) or treatment of physician’s choice. In Study 301, patients who had received up to two prior chemotherapy regimens for advanced disease were randomized to eribulin (as above) or capecitabine (1.25 g/m(2) b.i.d. on days 1–14 every 21 days). In the pooled population, overall survival (OS), progression-free survival and response rates were analysed in the intent-to-treat population and selected subgroups. Overall, 1,062 patients were randomized to eribulin and 802 patients to control. Median OS was 15.2 months with eribulin versus 12.8 months with control (hazard ratio [HR] 0.85; 95 % CI 0.77, 0.95; P = 0.003). In all subgroups assessed, OS data favoured eribulin; significant improvements occurred in some subgroups, notably in women with human epidermal growth factor receptor 2 (HER2)-negative disease (HR 0.82; P = 0.002), although the effect in those with HER2-negative but hormone-receptor-positive disease did not reach statistical significance; benefits were also seen, among others, in those with estrogen-receptor-negative and triple-negative disease. Eribulin improves OS in various patient subgroups with advanced/metastatic breast cancer who had previously received an anthracycline and a taxane. Women with HER2-negative disease are among those who may obtain benefit from eribulin. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s10549-014-3144-y) contains supplementary material, which is available to authorized users. Springer US 2014-11-08 2014 /pmc/articles/PMC4243003/ /pubmed/25381136 http://dx.doi.org/10.1007/s10549-014-3144-y Text en © The Author(s) 2014 https://creativecommons.org/licenses/by-nc/4.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. |
spellingShingle | Clinical Trial Twelves, Chris Cortes, Javier Vahdat, Linda Olivo, Martin He, Yi Kaufman, Peter A. Awada, Ahmad Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies |
title | Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies |
title_full | Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies |
title_fullStr | Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies |
title_full_unstemmed | Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies |
title_short | Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies |
title_sort | efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies |
topic | Clinical Trial |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4243003/ https://www.ncbi.nlm.nih.gov/pubmed/25381136 http://dx.doi.org/10.1007/s10549-014-3144-y |
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