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First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study
PURPOSE: Combining bevacizumab with paclitaxel significantly improves progression-free survival (PFS) versus paclitaxel alone in HER2-negative metastatic breast cancer (MBC). Eribulin is active and tolerable in pretreated MBC. To assess whether eribulin may offer a more tolerable yet effective combi...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7672314/ https://www.ncbi.nlm.nih.gov/pubmed/33188992 http://dx.doi.org/10.1016/j.breast.2020.09.011 |
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author | Hardy-Bessard, Anne-Claire Brocard, Fabien Clatot, Florian Lortholary, Alain You, Benoît Grenier, Julien Martin-Babau, Jérôme Lucas, Brigitte Meunier, Jérôme Ferrero, Jean-Marc Savoye, Aude-Marie Marti, Adina Despax, Raymond Moullet, Isabelle Emile, George |
author_facet | Hardy-Bessard, Anne-Claire Brocard, Fabien Clatot, Florian Lortholary, Alain You, Benoît Grenier, Julien Martin-Babau, Jérôme Lucas, Brigitte Meunier, Jérôme Ferrero, Jean-Marc Savoye, Aude-Marie Marti, Adina Despax, Raymond Moullet, Isabelle Emile, George |
author_sort | Hardy-Bessard, Anne-Claire |
collection | PubMed |
description | PURPOSE: Combining bevacizumab with paclitaxel significantly improves progression-free survival (PFS) versus paclitaxel alone in HER2-negative metastatic breast cancer (MBC). Eribulin is active and tolerable in pretreated MBC. To assess whether eribulin may offer a more tolerable yet effective combination partner for bevacizumab, we evaluated a bevacizumab/eribulin combination regimen as first-line therapy for MBC. METHODS: In this single-arm phase II study, patients with histologically confirmed HER2-negative MBC and no prior chemotherapy for MBC received eribulin 1.23 mg/m(2) on days 1 and 8 every 3 weeks for ≥6 cycles plus bevacizumab 15 mg/kg on day 1 every 3 weeks until disease progression. The primary endpoint was non-progression rate at 1 year. Secondary endpoints included objective response rate (ORR), PFS, and safety. RESULTS: The median age of the 61 treated female patients was 59 years, 16% had triple-negative MBC, 30% had ≥3 metastatic sites, and 71% had received prior (neo)adjuvant chemotherapy. Patients received a median of six eribulin and nine bevacizumab cycles. The non-progression rate at 1 year was 32% (95% confidence interval [CI]: 20–43%), ORR was 47% (95% CI: 34–60%), and median PFS was 8.3 months (95% CI: 7.0–9.6 months). The only grade ≥3 clinical adverse events in >5% of patients were hypertension (39%), neutropenia (26%), thrombosis (10%), and paresthesia/dysesthesia (7%). CONCLUSION: First-line eribulin/bevacizumab combination therapy showed interesting activity in MBC with an acceptable safety profile, including a particularly low incidence of high-grade neuropathy. |
format | Online Article Text |
id | pubmed-7672314 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-76723142020-11-24 First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study Hardy-Bessard, Anne-Claire Brocard, Fabien Clatot, Florian Lortholary, Alain You, Benoît Grenier, Julien Martin-Babau, Jérôme Lucas, Brigitte Meunier, Jérôme Ferrero, Jean-Marc Savoye, Aude-Marie Marti, Adina Despax, Raymond Moullet, Isabelle Emile, George Breast Original Article PURPOSE: Combining bevacizumab with paclitaxel significantly improves progression-free survival (PFS) versus paclitaxel alone in HER2-negative metastatic breast cancer (MBC). Eribulin is active and tolerable in pretreated MBC. To assess whether eribulin may offer a more tolerable yet effective combination partner for bevacizumab, we evaluated a bevacizumab/eribulin combination regimen as first-line therapy for MBC. METHODS: In this single-arm phase II study, patients with histologically confirmed HER2-negative MBC and no prior chemotherapy for MBC received eribulin 1.23 mg/m(2) on days 1 and 8 every 3 weeks for ≥6 cycles plus bevacizumab 15 mg/kg on day 1 every 3 weeks until disease progression. The primary endpoint was non-progression rate at 1 year. Secondary endpoints included objective response rate (ORR), PFS, and safety. RESULTS: The median age of the 61 treated female patients was 59 years, 16% had triple-negative MBC, 30% had ≥3 metastatic sites, and 71% had received prior (neo)adjuvant chemotherapy. Patients received a median of six eribulin and nine bevacizumab cycles. The non-progression rate at 1 year was 32% (95% confidence interval [CI]: 20–43%), ORR was 47% (95% CI: 34–60%), and median PFS was 8.3 months (95% CI: 7.0–9.6 months). The only grade ≥3 clinical adverse events in >5% of patients were hypertension (39%), neutropenia (26%), thrombosis (10%), and paresthesia/dysesthesia (7%). CONCLUSION: First-line eribulin/bevacizumab combination therapy showed interesting activity in MBC with an acceptable safety profile, including a particularly low incidence of high-grade neuropathy. Elsevier 2020-09-30 /pmc/articles/PMC7672314/ /pubmed/33188992 http://dx.doi.org/10.1016/j.breast.2020.09.011 Text en © 2020 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Original Article Hardy-Bessard, Anne-Claire Brocard, Fabien Clatot, Florian Lortholary, Alain You, Benoît Grenier, Julien Martin-Babau, Jérôme Lucas, Brigitte Meunier, Jérôme Ferrero, Jean-Marc Savoye, Aude-Marie Marti, Adina Despax, Raymond Moullet, Isabelle Emile, George First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study |
title | First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study |
title_full | First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study |
title_fullStr | First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study |
title_full_unstemmed | First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study |
title_short | First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study |
title_sort | first-line bevacizumab and eribulin combination therapy for her2-negative metastatic breast cancer: efficacy and safety in the gineco phase ii esmeralda study |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7672314/ https://www.ncbi.nlm.nih.gov/pubmed/33188992 http://dx.doi.org/10.1016/j.breast.2020.09.011 |
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