Evidence map›Paper›PMID 32133606›Full record

Trial reportBreast cancer (Tokyo, Japan)2020

High absolute lymphocyte counts are associated with longer overall survival in patients with metastatic breast cancer treated with eribulin-but not with treatment of physician's choice-in the EMBRACE study.

Yasuo Miyoshi, Yuta Yoshimura, Kenichi Saito, Kenzo Muramoto, Michiko Sugawara, Karenza Alexis, Kenichi Nomoto, Seigo Nakamura, Toshiaki Saeki, Junichiro Watanabe and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Breast cancer (Tokyo, Japan), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00388726 (The "EMBRACE" Trial), which is not on this map. Cited by 45 papers.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed
3.9field-weighted citation impact, top 5% 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.

NCT00388726 phase3completednot on this map

The "EMBRACE" Trial: Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389. A Phase III Open-Label, Randomized, Parallel, Two-arm, Multi-center Study of E7389 Versus "Treatment of Physician's Choice" in Patients With Locally Recurrent, Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

TypeinterventionalSponsorEisai Inc.Ran2006 to 2013Enrolled762ConditionsBreast CancerArmsE7389, Physician's Choice
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 77 citations in OpenAlex.

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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 at 8 institutions in 3 countries.

Yasuo MiyoshiDepartment of Surgery, Division of Breast and Endocrine Surgery, Hyogo College of Medicine, Mukogawa-cho 1-1, Nishinomiya, Hyogo, 663-8501, Japan. ymiyoshi@hyo-med.ac.jp.ORCID http://orcid.org/0000-0001-8535-4008
Yuta YoshimuraEisai Co., Ltd., Koishikawa, Bunkyo-ku, Tokyo, Japan.
Kenichi SaitoEisai Inc., Woodcliff Lake, NJ, USA.
Kenzo MuramotoEisai Co., Ltd., Koishikawa, Bunkyo-ku, Tokyo, Japan.
Michiko SugawaraEisai Co., Ltd., Koishikawa, Bunkyo-ku, Tokyo, Japan.
Karenza AlexisEisai Inc., Woodcliff Lake, NJ, USA.
Kenichi NomotoEisai Inc., Woodcliff Lake, NJ, USA.
Seigo NakamuraDivision of Breast Surgical Oncology, Department of Surgery, Showa University, Hatanodai, Shinagawa-ku, Tokyo, Japan.
Toshiaki SaekiDepartment of Breast Oncology, International Medical Center, Saitama Medical University, Yamane, Hidaka, Saitama, Japan.
Junichiro WatanabeDivision of Breast Oncology, Shizuoka Cancer Center, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.
Jose Manuel Perez-GarciaIOB Institute of Oncology, Quironsalud Group, Madrid, Barcelona, Spain.
Javier CortesIOB Institute of Oncology, Quironsalud Group, Madrid, Barcelona, Spain.
Eisai (Japan) · JPEisai (United States) · USHyogo Medical University · JPMedSIR (Spain) · ESSaitama Medical University · JPShizuoka Cancer Center · JPShowa University · JPVall d'Hebron Institut de Recerca · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEribulin, a nontaxane synthetic inhibitor of microtubule dynamics, is widely used to manage locally advanced or metastatic breast cancer (MBC). Eribulin has demonstrated immunomodulatory activity on the tumour microenvironment. Baseline neutrophil-to-lymphocyte ratio (NLR), a marker of immune status, may predict progression-free survival in eribulin treatment. This post hoc analysis assessed predictors for overall survival (OS).

methodsThe phase 3 open-label study (EMBRACE) of eribulin versus treatment of physician's choice (TPC) in patients with MBC provided source data. Baseline absolute lymphocyte counts (ALCs) and NLR were evaluable in 751 and 713 patients, respectively.

resultsEribulin prolonged OS versus TPC in patients with baseline ALC ≥ 1500/µl (hazard ratio [HR] 0.586; 95% confidence interval [CI] 0.437-0.784; P < 0.001). There was no significant difference by treatment for ALC < 1500/µl (HR 1.002; 95% CI 0.800-1.253; P = 0.989). Univariate and multivariate analyses were performed and identified baseline ALC as a potential predictor of OS in eribulin-treated patients. Interaction analysis of OS supported 1500/µl as a potentially differential cutoff value. NLR at a cutoff value of 3 was associated with prolonged OS (eribulin group). However, similar results were also observed in the TPC group, without apparent interaction effect, suggesting that NLR may be a general prognostic marker rather than a specific predictor of OS for eribulin. DISCUSSION: This hypothesis-generating study speculates that baseline ALC may be an independent predictor for longer OS in eribulin-treated MBC patients and could be clinically impactful because it can be evaluated without the need for additional invasive procedures.

trial registrationwww.ClinicalTrials.gov code: NCT00388726.

Indexed as

AgedAntineoplastic AgentsBreast NeoplasmsDrug Administration ScheduleFemaleFuransHumansInfusions, IntravenousKaplan-Meier EstimateKetonesLymphocyte CountLymphocytesMiddle AgedNeutrophilsPolyether PolyketidesPrognosisAntineoplastic AgentseribulinFuransKetonesPolyether PolyketidesAbsolute lymphocyte countEribulinMetastatic breast cancerOverall survivalTreatment of physician’s choice

Identifiers

PMID32133606
PMCPMC7297864
OpenAlexW3009691144

What OpenQuestion holds

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LicenceCC BY
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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.