Evidence map›Paper›PMID 40057925›Full record

ArticleClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2025

Reliability of core needle biopsy for HER2-low early-stage breast cancer.

C M Ciniselli, P Verderio, V Duroni, P Baili, S Pizzamiglio, F G de Braud, S Folli, C Depretto, G Scaperrotta, M C De Santis and 5 more

Abstract read
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In one paragraph

Article in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

15 authors.

C M Ciniselli *Bioinformatics and Biostatistics Unit, Department of Epidemiology and Data Science, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.
P VerderioBioinformatics and Biostatistics Unit, Department of Epidemiology and Data Science, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy. paolo.verderio@istitutotumori.mi.it.ORCID http://orcid.org/0000-0002-9231-1281
V DuroniBioinformatics and Biostatistics Unit, Department of Epidemiology and Data Science, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.
P BailiData Science Unit, Department of Epidemiology and Data Science, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.
S PizzamiglioBioinformatics and Biostatistics Unit, Department of Epidemiology and Data Science, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.
F G de BraudDepartment of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.
S FolliBreast Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.
C DeprettoBreast Imaging Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.
G ScaperrottaBreast Imaging Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.
M C De SantisBreast Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.
M G CarnevaleRadiation Oncology 1, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.
C De MarcoDepartment of Advanced Diagnostics, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.
A VingianiUniversity of Milan, Milan, Italy.
G PruneriUniversity of Milan, Milan, Italy.
S Di CosimoDepartment of Advanced Diagnostics, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milan, Italy.

Funding

Associazione Italiana per la Ricerca sul Cancro AIRC IG 20774European Commission CAN.HEAL - 101080009
6 · The paper itself

Abstract

backgroundThe reliability of core needle biopsy (CNB) for HER2-positive breast cancer is well established. However, data on HER2-low and the potential for inconsistencies with surgical samples are limited. MATERIALS AND

methodsConcordance between CNB and surgical samples was assessed using the unweighted Cohen kappa statistic (Kc) in a consecutive series of 776 treatment-naïve early-stage breast cancer patients. Logistic regression models were used to evaluate the association between concordance and clinico-pathological features.

resultsThe agreement for HER2-positive status between CNB and surgical specimens was high at 95%, with a Kc value of 0.86 indicating almost perfect agreement. However, 65 of 123 (53%) cases initially classified as HER2-0 were reclassified as HER2 1 + or 2 + /ISH-negative, and 89 of 374 (24%) cases initially classified as HER2 1 + /2 + were HER2-0 in surgical samples. This resulted in a Kc value of 0.22, indicating fair agreement in classifying HER2-0 versus HER2-low breast cancer. Tumor size was a significant factor influencing discordance, with tumors larger than 2 cm having double the risk of misclassification.

conclusionThese findings suggest that HER2 status should be retested, particularly for large tumors initially diagnosed as HER2-0, in light of new effective therapies for HER2-low breast cancer, such as antibody-drug conjugates.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesAdultAgedAged, 80 and overBiomarkers, TumorBiopsy, Large-Core NeedleFemaleHumansMiddle AgedNeoplasm StagingReproducibility of ResultsBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesConcordanceCore needle biopsyEarly-stage breast cancerHER2-lowImmunohistochemistrySurgical samples

Identifiers

PMID40057925
PMCPMC12259780

What OpenQuestion holds

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LicenceCC BY
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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.