Evidence map›Paper›PMID 25488926›Full record

GuidelineJournal of clinical pathology2015

Updated UK Recommendations for HER2 assessment in breast cancer.

Emad A Rakha, Sarah E Pinder, John M S Bartlett, Merdol Ibrahim, Jane Starczynski, Pauline J Carder, Elena Provenzano, Andrew Hanby, Sally Hales, Andrew H S Lee and 2 more

Registry-linked trialAbstract readPractice Guideline
In one paragraph

Guideline in Journal of clinical pathology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05493683 (A Single Arm, Open Label, Multiple Center, Prospective Study of Disitamab Vedotin Combined With Tislelizumab in HER2 Positive Advanced Colorectal Cancer Failed at Least Two Lines of Systemic Treatment.), which is not on this map. Cited by 112 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
112citing papers in PubMed, 4 pooled it
–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.

NCT05493683 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

A Single Arm, Open Label, Multiple Center, Prospective Study of Disitamab Vedotin Combined With Tislelizumab in HER2 Positive Advanced Colorectal Cancer Failed at Least Two Lines of Systemic Treatment.

TypeinterventionalSponsorThe First Affiliated Hospital with Nanjing Medical UniversityRan2022 to 2025Enrolled29ConditionsColorectal NeoplasmsArmsDisitamab vedotin, Tislelizumab
3 · Its place in the literature

Who cites it

112 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Unmet support and information needs of relatives of patients with advanced or metastatic breast cancer: results of the BRE-BY-MED study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review

52 more citing papers are in PubMed but not listed here.

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.

Emad A RakhaDepartment of Pathology, University of Nottingham and Nottingham University Hospitals NHS Trust, Nottingham, UK.
Sarah E PinderDivision of Cancer Studies, Department of Research Oncology, King's College London, London, UK.
John M S BartlettDepartment of Transformative Pathology, Ontario Institute of Cancer Research, Toronto, Canada.
Merdol IbrahimDepartment of Histopathology, UK NEQAS for Immunocytochemistry, University College London, London, UK.
Jane StarczynskiDepartment of Cellular Pathology, Birmingham Heartlands Hospital, Birmingham, UK.
Pauline J CarderDepartment of Histopathology, Bradford Royal Infirmary, Bradford, UK.
Elena ProvenzanoDepartment of Histopathology, Addenbrookes Hospital, Cambridge, UK.
Andrew HanbyDepartment of Histopathology, Academic Unit of Pathology, St James's University Hospital, Leeds, UK.
Sally HalesDepartment of Histopathology, Countess of Chester Hospital, Chester, UK.
Andrew H S LeeDepartment of Pathology, University of Nottingham and Nottingham University Hospitals NHS Trust, Nottingham, UK.
Ian O EllisDepartment of Pathology, University of Nottingham and Nottingham University Hospitals NHS Trust, Nottingham, UK.
National Coordinating Committee for Breast Pathology

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Human epidermal growth factor receptor 2 (HER2) overexpression is present in approximately 15% of early invasive breast cancers, and is an important predictive and prognostic marker. The substantial benefits achieved with anti-HER2 targeted therapies in patients with HER2-positive breast cancer have emphasised the need for accurate assessment of HER2 status. Current data indicate that HER2 test accuracy improved following previous publication of guidelines and the implementation of an external quality assessment scheme with a decline in false-positive and false-negative rates. This paper provides an update of the guidelines for HER2 testing in the UK. The aim is to further improve the analytical validity and clinical utility of HER2 testing by providing guidelines of test performance parameters, and recommendations on the postanalytical interpretation of test results. HER2 status should be determined in all newly diagnosed and recurrent breast cancers. Testing involves immunohistochemistry with >10% complete strong membrane staining defining a positive status. In situ hybridisation, either fluorescent or bright field chromogenic, is used either upfront or in immunohistochemistry borderline cases to detect the presence of HER2 gene amplification. Situations where repeat HER2 testing is advised are outlined and the impact of genetic heterogeneity is discussed. Strict quality control and external quality assurance of validated assays are essential. Testing laboratories should perform ongoing competency assessment and proficiency tests and ensure the reliability and accuracy of the assay. Pathologists, oncologists and surgeons involved in test interpretation and clinical use should adhere to published guidelines and maintain accurate performance and consistent interpretation of test results.

Indexed as

Antineoplastic AgentsBenchmarkingBiomarkers, TumorBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleGene Expression Regulation, NeoplasticHumansImmunohistochemistryIn Situ HybridizationIn Situ Hybridization, FluorescenceMolecular Targeted TherapyPatient SelectionPrecision MedicinePredictive Value of TestsQuality ControlAntineoplastic AgentsBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesBREASTBREAST CANCERBREAST PATHOLOGY

Identifiers

PMID25488926
PMCPMC4316916

What OpenQuestion holds

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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.