Evidence map›Paper›PMID 28877230›Full record

ArticlePloS one2017

Decision impact and feasibility of different ASCO-recommended biomarkers in early breast cancer: Prospective comparison of molecular marker EndoPredict and protein marker uPA/PAI-1.

Johannes Ettl, Evelyn Klein, Alexander Hapfelmeier, Kirsten Grosse Lackmann, Stefan Paepke, Christoph Petry, Katja Specht, Laura Wolff, Heinz Höfler, Marion Kiechle

Registry-linked trialOpen access · goldAbstract readComparative Study
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03503799 (Prospective Assessment of Disease Progression in Primary Breast Cancer Patients Undergoing EndoPredict® Gene Expression Testing - a Care Research Study), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.0field-weighted citation impact, top 28% 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.

NCT03503799 active not recruitingnot on this mapstarted 2018, after this paper: background citation

Prospective Assessment of Disease Progression in Primary Breast Cancer Patients Undergoing EndoPredict® Gene Expression Testing - a Care Research Study

Typeobservational_patient_registrySponsorNorth Eastern German Society of Gynaecological OncologyRan2018 to 2032Enrolled1,191ConditionsPrimary Invasive Breast Cancer, Estrogen Receptor Positive Tumor, Human Epidermal Growth Factor Receptor 2 Negative TumorArmsObservation
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 17 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

10 authors at 2 institutions in 1 country.

Johannes EttlKlinik und Poliklinik für Frauenheilkunde, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.ORCID http://orcid.org/0000-0003-4754-8447
Evelyn KleinKlinik und Poliklinik für Frauenheilkunde, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Alexander HapfelmeierInstitute of Medical Statistics and Epidemiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Kirsten Grosse LackmannKlinik und Poliklinik für Frauenheilkunde, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Stefan PaepkeKlinik und Poliklinik für Frauenheilkunde, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Christoph PetrySividon Diagnostics GmbH, Cologne, Germany.
Katja SpechtInstitute of Pathology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Laura WolffKlinik und Poliklinik für Frauenheilkunde, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Heinz HöflerInstitute of Pathology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Marion KiechleKlinik und Poliklinik für Frauenheilkunde, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
TUM Klinikum · DECS Diagnostics · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdjuvant therapy decisions in early breast cancer are based on accurate risk assessment. Urokinase plasminogen activator (uPA) and plaminogen activator inhibitor-1 (PAI-1) have been the first biomarkers in hormone receptor (HR) positive breast cancer to reach highest level of evidence. The EndoPredict test (EPclin) combines gene expression information with nodal status and tumor size. The aim of this prospective study was to compare uPA/PAI-1 and EPclin as prognostic biomarkers with regard to feasibility, risk stratification and impact on adjuvant therapy recommendation. MATERIALS AND

method395 patients with HR positive, HER2 negative, intermediate risk breast cancer were enrolled. Relations and concordance of histologic grading as well as EPclin and uPA/PAI-1 values were assessed by Spearman's rank correlation coefficient and Cohen's Kappa. To compare decision impact of EPclin and uPA/PAI-1 three independent case discussions were held: One with known uPA/PAI-1 and EPclin results, one blinded to EPclin alone and another one blinded to both EPclin and uPA/PAI-1.

resultsEPclin could be determined in all 395 (100%), uPA/PAI-1 in 190 (48%) of the tumor samples. EPclin allocated 250 patients (63%) to the low-risk group and 145 patients (37%) to the high-risk group, whereas uPA/PAI-1 allocated 88 patients (46%) to the low-risk group and 102 patients (54%) to the high-risk group. In 59% of cases, both tests showed concordant results. EPclin resulted more frequently in a change of therapy recommendation than the uPA/PAI-1 test (46% vs 24%). Recommendation of adjuvant chemotherapy (CTX) was abandoned twice as often by EPclin (45%) compared to uPA/PAI-1 (22%).

conclusionIn this first prospective comparison of EPclin and uPA/PAI-1 we found, that EPclin is superior to uPA/PAI-1 with respect to feasibility and decision impact. This leads to substantial avoidance of adjuvant CTX in endocrine-sensitive, HER2-negative breast cancer. Data collection for patients´ clinical outcome is ongoing.

Indexed as

AdultAgedAged, 80 and overBiomarkersBreast NeoplasmsChemotherapy, AdjuvantFeasibility StudiesFemaleHumansMiddle AgedPlasminogen Activator Inhibitor 1Practice Guidelines as TopicPrognosisProspective StudiesRisk AssessmentUrokinase-Type Plasminogen ActivatorBiomarkersPlasminogen Activator Inhibitor 1SERPINE1 protein, humanUrokinase-Type Plasminogen Activator

Identifiers

PMID28877230
PMCPMC5587293
OpenAlexW2752594080

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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.