Cargando…
Real-world efficacy and safety of eribulin in advanced and pretreated HER2-negative breast cancer in a Spanish comprehensive cancer center
BACKGROUND: Eribulin improves survival in pre-treated HER2-negative advanced breast cancer (ABC). However, limited data exist on co-morbidities and central nervous system (CNS) efficacy. The purpose of this study was to review eribulin’s efficacy and safety in everyday clinical practice with special...
Autores principales: | , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6868802/ https://www.ncbi.nlm.nih.gov/pubmed/31753013 http://dx.doi.org/10.1186/s40360-019-0367-x |
_version_ | 1783472347018166272 |
---|---|
author | Sirvén, Milana Bergamino Fernández-Ortega, Adela Stradella, Agostina Morilla, Idoia Falo, Catalina Vázquez, Silvia Castany, Roser Villanueva, Rafael Recalde, Sabela Pérez, Valentí Navarro Gil-Gil, Miguel Pernas, Sonia |
author_facet | Sirvén, Milana Bergamino Fernández-Ortega, Adela Stradella, Agostina Morilla, Idoia Falo, Catalina Vázquez, Silvia Castany, Roser Villanueva, Rafael Recalde, Sabela Pérez, Valentí Navarro Gil-Gil, Miguel Pernas, Sonia |
author_sort | Sirvén, Milana Bergamino |
collection | PubMed |
description | BACKGROUND: Eribulin improves survival in pre-treated HER2-negative advanced breast cancer (ABC). However, limited data exist on co-morbidities and central nervous system (CNS) efficacy. The purpose of this study was to review eribulin’s efficacy and safety in everyday clinical practice with special focus on age, body mass index (BMI) and central nervous system (CNS) activity. METHODS: An observational study was conducted in a series of HER2-negative ABC patients treated from January’14-December’17 outside a clinical trial. Objective Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS), and association of clinical and pathological variables with outcome were evaluated. RESULTS: Ninety-five women were treated with at least one cycle of eribulin. Median age was 57 (33–83), and 18% were obese. Median number of prior chemotherapies for ABC was 3 (2–5) and 76% of patients had visceral metastases, including 21% with CNS involvement. Most tumors were estrogen receptor-positive (79%). ORR and stable disease (SD) at 6 months were 26.2 and 37.5%, respectively. Remarkably, relevant CNS efficacy was observed with eribulin: 20% of patients obtained partial response and 25% SD. Treatment was generally well tolerated and manageable, with 29% grade 3 and 10.9% grade 4 toxicities. Median PFS and OS were 4.1 months (CI95% 3.2–4.9) and 11.1 months (CI95% 9.5–14.7), respectively. Triple-negative disease, > 2organs involved and being younger than 70 years old were independent prognosis factors for worse OS in multivariate analysis. Most patients (75%) progressed in pre-existing metastases sites. CONCLUSION: In everyday clinical practice, eribulin’s efficacy seems similar to pivotal trials. CNS-efficacy was observed. TNBC, > 2 organs involved and being younger than 70 years old were independent prognosis factors for worse OS. Remarkably, less incidence of grade 4-toxicity compared to previous studies was found. |
format | Online Article Text |
id | pubmed-6868802 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-68688022019-12-12 Real-world efficacy and safety of eribulin in advanced and pretreated HER2-negative breast cancer in a Spanish comprehensive cancer center Sirvén, Milana Bergamino Fernández-Ortega, Adela Stradella, Agostina Morilla, Idoia Falo, Catalina Vázquez, Silvia Castany, Roser Villanueva, Rafael Recalde, Sabela Pérez, Valentí Navarro Gil-Gil, Miguel Pernas, Sonia BMC Pharmacol Toxicol Research Article BACKGROUND: Eribulin improves survival in pre-treated HER2-negative advanced breast cancer (ABC). However, limited data exist on co-morbidities and central nervous system (CNS) efficacy. The purpose of this study was to review eribulin’s efficacy and safety in everyday clinical practice with special focus on age, body mass index (BMI) and central nervous system (CNS) activity. METHODS: An observational study was conducted in a series of HER2-negative ABC patients treated from January’14-December’17 outside a clinical trial. Objective Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS), and association of clinical and pathological variables with outcome were evaluated. RESULTS: Ninety-five women were treated with at least one cycle of eribulin. Median age was 57 (33–83), and 18% were obese. Median number of prior chemotherapies for ABC was 3 (2–5) and 76% of patients had visceral metastases, including 21% with CNS involvement. Most tumors were estrogen receptor-positive (79%). ORR and stable disease (SD) at 6 months were 26.2 and 37.5%, respectively. Remarkably, relevant CNS efficacy was observed with eribulin: 20% of patients obtained partial response and 25% SD. Treatment was generally well tolerated and manageable, with 29% grade 3 and 10.9% grade 4 toxicities. Median PFS and OS were 4.1 months (CI95% 3.2–4.9) and 11.1 months (CI95% 9.5–14.7), respectively. Triple-negative disease, > 2organs involved and being younger than 70 years old were independent prognosis factors for worse OS in multivariate analysis. Most patients (75%) progressed in pre-existing metastases sites. CONCLUSION: In everyday clinical practice, eribulin’s efficacy seems similar to pivotal trials. CNS-efficacy was observed. TNBC, > 2 organs involved and being younger than 70 years old were independent prognosis factors for worse OS. Remarkably, less incidence of grade 4-toxicity compared to previous studies was found. BioMed Central 2019-11-21 /pmc/articles/PMC6868802/ /pubmed/31753013 http://dx.doi.org/10.1186/s40360-019-0367-x Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Sirvén, Milana Bergamino Fernández-Ortega, Adela Stradella, Agostina Morilla, Idoia Falo, Catalina Vázquez, Silvia Castany, Roser Villanueva, Rafael Recalde, Sabela Pérez, Valentí Navarro Gil-Gil, Miguel Pernas, Sonia Real-world efficacy and safety of eribulin in advanced and pretreated HER2-negative breast cancer in a Spanish comprehensive cancer center |
title | Real-world efficacy and safety of eribulin in advanced and pretreated HER2-negative breast cancer in a Spanish comprehensive cancer center |
title_full | Real-world efficacy and safety of eribulin in advanced and pretreated HER2-negative breast cancer in a Spanish comprehensive cancer center |
title_fullStr | Real-world efficacy and safety of eribulin in advanced and pretreated HER2-negative breast cancer in a Spanish comprehensive cancer center |
title_full_unstemmed | Real-world efficacy and safety of eribulin in advanced and pretreated HER2-negative breast cancer in a Spanish comprehensive cancer center |
title_short | Real-world efficacy and safety of eribulin in advanced and pretreated HER2-negative breast cancer in a Spanish comprehensive cancer center |
title_sort | real-world efficacy and safety of eribulin in advanced and pretreated her2-negative breast cancer in a spanish comprehensive cancer center |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6868802/ https://www.ncbi.nlm.nih.gov/pubmed/31753013 http://dx.doi.org/10.1186/s40360-019-0367-x |
work_keys_str_mv | AT sirvenmilanabergamino realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter AT fernandezortegaadela realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter AT stradellaagostina realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter AT morillaidoia realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter AT falocatalina realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter AT vazquezsilvia realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter AT castanyroser realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter AT villanuevarafael realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter AT recaldesabela realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter AT perezvalentinavarro realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter AT gilgilmiguel realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter AT pernassonia realworldefficacyandsafetyoferibulininadvancedandpretreatedher2negativebreastcancerinaspanishcomprehensivecancercenter |