Evidence map›Paper›PMID 31195996›Full record

Trial reportBMC cancer2019

Health-related quality of life in patients receiving first-line eribulin mesylate with or without trastuzumab for locally recurrent or metastatic breast cancer.

Lee Schwartzberg, Kristi McIntyre, Sharon Wilks, Shannon Puhalla, Joyce O'Shaughnessy, Erhan Berrak, Yaohua He, Linda Vahdat

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.3field-weighted citation impact, top 38% of its field
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.

NCT01268150 phase2completednot on this map

A Phase 2, Multicenter, Single-Arm Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer

TypeinterventionalSponsorEisai Inc.Ran2011 to 2013Enrolled56ConditionsLocally Recurrent, Metastatic Breast Cancer ( HER2 Negative)ArmsEribulin mesylate
NCT01269346 phase2completednot on this map

A Phase 2, Multicenter, Single-Arm Study of Eribulin Mesylate With Trastuzumab as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Positive Breast Cancer

TypeinterventionalSponsorEisai Inc.Ran2010 to 2016Enrolled52ConditionsBreast CancerArmsEribulin Mesylate
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
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

8 authors at 5 institutions in 1 country.

Lee SchwartzbergWest Cancer Center, 7945 Wolf River Blvd, Germantown, TN 38138, TN, 38120, USA. lschwartzberg@westclinic.com.ORCID http://orcid.org/0000-0002-7433-3428
Kristi McIntyreTexas Oncology-Dallas Presbyterian Hospital, US Oncology, Dallas, TX, USA.
Sharon WilksUS Oncology-Cancer Care Centers of South Texas, San Antonio, TX, USA.
Shannon PuhallaUniversity of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Joyce O'ShaughnessyBaylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX, USA.
Erhan BerrakEisai Inc. (former employees), Woodcliff Lake, NJ, USA.
Yaohua HeEisai Inc. (former employees), Woodcliff Lake, NJ, USA.
Linda VahdatWeill Cornell Medical College, New York, NY, USA.
Eisai (United States) · USTexas Oncology · USCornell University · USUniversity of Pittsburgh Medical Center · USWest Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEribulin mesylate is a nontaxane microtubule dynamics inhibitor approved for second-line (European Union) or third-line (United States) treatment of metastatic breast cancer. Two phase 2 single trials, evaluating first-line eribulin as monotherapy (Study 206; NCT01268150) or in combination with trastuzumab (Study 208; NCT01269346) in locally recurrent or metastatic breast cancer, demonstrated objective response rates of 28.6 and 71.2%, respectively. Median progression-free survival was 6.8 and 11.6 months, respectively. Tolerability profiles were similar to those from previous studies. This secondary analysis was conducted to assess health-related quality of life (HRQoL) in both phase 2 trials.

methodsPatients received eribulin mesylate 1.4 mg/m

resultsOf the 108 patients (56 in Study 206 and 52 in Study 208) treated, 57 and 87%, respectively, completed 6 cycles. Completion rates for both questionnaires were 94 and 98%, respectively, at cycle 6. Most patients had stable/improved HRQoL scores with some exceptions; for example, more patients experienced a worsening in cognitive functioning and systemic therapy side effects than experienced improvement. Mean QLQ-C30 symptom scores correlated with corresponding adverse event rates for nausea/vomiting, dyspnea, appetite loss, constipation, and diarrhea in Study 206 and for fatigue, nausea/vomiting, pain, dyspnea, insomnia, constipation, and diarrhea in Study 208.

conclusionsFirst-line eribulin ± trastuzumab therapy did not lead to deterioration of overall HRQoL in most patients, with more than 60% of patients having stable/improved global health status/quality-of-life scores. Eribulin has been demonstrated to be comparable with other chemotherapy agents with an acceptable safety profile. Therefore, further evaluation is warranted to determine whether eribulin ± trastuzumab therapy may be a potential option for first-line treatment in some patients with metastatic breast cancer who were recently treated in the neoadjuvant setting.

trial registrationNCT01268150 (December 29, 2010), NCT01269346 (January 4, 2011).

Indexed as

Quality of LifeAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDrug-Related Side Effects and Adverse ReactionsFemaleFuransHumansKetonesMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPolyether PolyketidesSurveys and QuestionnaireseribulinFuransKetonesPolyether PolyketidesTrastuzumabEribulinFirst-line therapyHealth-related quality of lifeMetastatic breast cancerTrastuzumab

Identifiers

PMID31195996
PMCPMC6567408
OpenAlexW2950869769

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.