Evidence map›Paper›PMID 31753013›Full record

Observational studyBMC pharmacology & toxicology2019

Real-world efficacy and safety of eribulin in advanced and pretreated HER2-negative breast cancer in a Spanish comprehensive cancer center.

Milana Bergamino Sirvén, Adela Fernández-Ortega, Agostina Stradella, Idoia Morilla, Catalina Falo, Silvia Vázquez, Roser Castany, Rafael Villanueva, Sabela Recalde, Valentí Navarro Pérez and 2 more

Abstract readObservational Study
In one paragraph

Observational study in BMC pharmacology & toxicology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Eribulin and Confusion: A Previously Unknown Drug Side-Effect.European journal of case reports in internal medicine · 2020
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Milana Bergamino SirvénDepartment of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain.
Adela Fernández-OrtegaDepartment of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain.
Agostina StradellaDepartment of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain.
Idoia MorillaDepartment of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain.
Catalina FaloDepartment of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain.
Silvia VázquezDepartment of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain.
Roser CastanyDepartment of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain.
Rafael VillanuevaDepartment of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain.
Sabela RecaldeDepartment of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain.
Valentí Navarro PérezResearch Unit, Institut Català d'Oncologia-(ICO) L'Hospitalet, Barcelona, Spain.
Miguel Gil-GilDepartment of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain.
Sonia PernasDepartment of Medical Oncology-Breast Cancer Unit, Insitut Catala d'Oncologia (ICO)-H.U.Bellvitge- IDIBELL, Avinguda Gran Via 199-203, 08908-L'Hospitalet de Llobregat, Barcelona, Spain. spernas@iconcologia.net.ORCID 0000-0002-1485-5080

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEribulin 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.

methodsAn 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.

resultsNinety-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.

conclusionIn 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.

Indexed as

AgedAntineoplastic AgentsBreast NeoplasmsCancer Care FacilitiesErb-b2 Receptor Tyrosine KinasesFemaleFuransHumansKetonesPolyether PolyketidesSpainSurvival AnalysisTreatment OutcomeAntineoplastic AgentsERBB2 protein, humanErb-b2 Receptor Tyrosine KinaseseribulinFuransKetonesPolyether PolyketidesBrain metastasesBreast cancerElderly patientsEribulinObesityProgression patternReal-world data

Identifiers

PMID31753013
PMCPMC6868802

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.