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Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy

BACKGROUND: Based on data from two multicenter, phase III clinical trials (Studies 301 and 305), eribulin (a microtubule dynamics inhibitor) is indicated in the European Union (EU) for patients with locally advanced or metastatic breast cancer (MBC) after ≥1 prior chemotherapy for advanced disease,...

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Autores principales: Pivot, X., Marmé, F., Koenigsberg, R., Guo, M., Berrak, E., Wolfer, A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4959925/
https://www.ncbi.nlm.nih.gov/pubmed/27177860
http://dx.doi.org/10.1093/annonc/mdw203
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author Pivot, X.
Marmé, F.
Koenigsberg, R.
Guo, M.
Berrak, E.
Wolfer, A.
author_facet Pivot, X.
Marmé, F.
Koenigsberg, R.
Guo, M.
Berrak, E.
Wolfer, A.
author_sort Pivot, X.
collection PubMed
description BACKGROUND: Based on data from two multicenter, phase III clinical trials (Studies 301 and 305), eribulin (a microtubule dynamics inhibitor) is indicated in the European Union (EU) for patients with locally advanced or metastatic breast cancer (MBC) after ≥1 prior chemotherapy for advanced disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting. Data from Studies 305 and 301 were pooled to investigate the efficacy of eribulin in various subgroups of patients who matched the EU label, including those with human epidermal growth factor receptor 2 (HER2)-negative and triple-negative disease. PATIENTS AND METHODS: In Study 305 (NCT00388726), patients were randomized 2:1 to eribulin mesylate 1.4 mg/m(2) (equivalent to eribulin 1.23 mg/m(2) [expressed as free base]) intravenously on days 1 and 8 every 21 days] or treatment of physician's choice after 2–5 prior chemotherapies (≥2 for advanced disease), including an anthracycline and a taxane (in early/advanced setting). In Study 301 (NCT00337103), patients were randomized 1:1 to eribulin (as above) or capecitabine (1.25 g/m(2) orally twice daily on days 1–14 every 21 days) following ≤3 prior chemotherapies (≤2 for advanced disease), including an anthracycline and a taxane. Efficacy end points were investigated in the intent-to-treat population and subgroups, pooled as discussed above. RESULTS: Overall, 1644 patients were included (eribulin: 946; control: 698); baseline characteristics were well matched. Overall survival was significantly longer with eribulin versus control (P < 0.01), as were progression-free survival and clinical benefit rate (both P < 0.05). Significant survival benefits with eribulin versus control were observed in a wide range of patient subgroups, including HER2-negative or triple-negative disease (all P < 0.05). CONCLUSION: Our findings underline the survival benefit achieved by eribulin used according to EU label in the overall MBC population and in various subgroups of interest, including patients with HER2-negative and triple-negative disease.
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spelling pubmed-49599252016-07-29 Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy Pivot, X. Marmé, F. Koenigsberg, R. Guo, M. Berrak, E. Wolfer, A. Ann Oncol Original Articles BACKGROUND: Based on data from two multicenter, phase III clinical trials (Studies 301 and 305), eribulin (a microtubule dynamics inhibitor) is indicated in the European Union (EU) for patients with locally advanced or metastatic breast cancer (MBC) after ≥1 prior chemotherapy for advanced disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting. Data from Studies 305 and 301 were pooled to investigate the efficacy of eribulin in various subgroups of patients who matched the EU label, including those with human epidermal growth factor receptor 2 (HER2)-negative and triple-negative disease. PATIENTS AND METHODS: In Study 305 (NCT00388726), patients were randomized 2:1 to eribulin mesylate 1.4 mg/m(2) (equivalent to eribulin 1.23 mg/m(2) [expressed as free base]) intravenously on days 1 and 8 every 21 days] or treatment of physician's choice after 2–5 prior chemotherapies (≥2 for advanced disease), including an anthracycline and a taxane (in early/advanced setting). In Study 301 (NCT00337103), patients were randomized 1:1 to eribulin (as above) or capecitabine (1.25 g/m(2) orally twice daily on days 1–14 every 21 days) following ≤3 prior chemotherapies (≤2 for advanced disease), including an anthracycline and a taxane. Efficacy end points were investigated in the intent-to-treat population and subgroups, pooled as discussed above. RESULTS: Overall, 1644 patients were included (eribulin: 946; control: 698); baseline characteristics were well matched. Overall survival was significantly longer with eribulin versus control (P < 0.01), as were progression-free survival and clinical benefit rate (both P < 0.05). Significant survival benefits with eribulin versus control were observed in a wide range of patient subgroups, including HER2-negative or triple-negative disease (all P < 0.05). CONCLUSION: Our findings underline the survival benefit achieved by eribulin used according to EU label in the overall MBC population and in various subgroups of interest, including patients with HER2-negative and triple-negative disease. Oxford University Press 2016-08 2016-05-13 /pmc/articles/PMC4959925/ /pubmed/27177860 http://dx.doi.org/10.1093/annonc/mdw203 Text en © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. . http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Articles
Pivot, X.
Marmé, F.
Koenigsberg, R.
Guo, M.
Berrak, E.
Wolfer, A.
Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy
title Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy
title_full Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy
title_fullStr Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy
title_full_unstemmed Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy
title_short Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy
title_sort pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4959925/
https://www.ncbi.nlm.nih.gov/pubmed/27177860
http://dx.doi.org/10.1093/annonc/mdw203
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