Evidence map›Paper›PMID 28027945›Full record

ArticleThe Journal of molecular diagnostics : JMD2017

Next-Generation Assessment of Human Epidermal Growth Factor Receptor 2 (ERBB2) Amplification Status: Clinical Validation in the Context of a Hybrid Capture-Based, Comprehensive Solid Tumor Genomic Profiling Assay.

Dara S Ross, Ahmet Zehir, Donavan T Cheng, Ryma Benayed, Khedoudja Nafa, Jaclyn F Hechtman, Yelena Y Janjigian, Britta Weigelt, Pedram Razavi, David M Hyman and 4 more

Erratum issuedAbstract read
In one paragraph

Article in The Journal of molecular diagnostics : JMD, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 79 papers.

0numbers the graph read from it
0cells of the map it votes in
79citing 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

79 citing papers in PubMed.

  1. Trial
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  6. HER2-low and HER2-ultra-low salivary gland carcinomas: an exploratory study.Virchows Archiv : an international journal of pathology · 2026
    Article
  7. Article
  8. Identifying the genomic landscape of EGFR-mutant lung cancers with central nervous system metastases.Annals of oncology : official journal of the European Society for Medical Oncology · 2025
    Article
  9. Article
  10. Review
  11. Article
  12. Article
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  17. Review
  18. Clinical and Genomic Characterization ofJCO global oncology · 2024
    Article
  19. Review
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Dara S RossDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: rossd@mskcc.org.
Ahmet ZehirDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Donavan T ChengDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Ryma BenayedDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Khedoudja NafaDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Jaclyn F HechtmanDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Yelena Y JanjigianDivision of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Britta WeigeltDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Pedram RazaviDivision of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
David M HymanDivision of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
José BaselgaDivision of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Michael F BergerDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Marc LadanyiDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Maria E ArcilaDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Establishing ERBB2 [human epidermal growth factor receptor 2 (HER2)] amplification status in breast and gastric carcinomas is essential to treatment selection. Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) constitute the current standard for assessment. With further advancements in genomic medicine, new clinically relevant biomarkers are rapidly emerging and options for targeted therapy are increasing in patients with advanced disease, driving the need for comprehensive molecular profiling. Next-generation sequencing (NGS) is an attractive approach for up-front comprehensive assessment, including ERBB2 status, but the concordance with traditional methods of HER2 assessment is not well established. The Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets (MSK-IMPACT) assay, a hybrid capture-based NGS assay interrogating the coding regions of 410 cancer-related genes, was performed on manually macrodissected unstained sections from formalin-fixed, paraffin-embedded breast (n = 213) and gastroesophageal (n = 39) tumors submitted for clinical mutation profiling. ERBB2 status was assessed using a custom bioinformatics pipeline, and NGS results were compared to IHC and FISH. NGS ERBB2 amplification calls had an overall concordance of 98.4% (248/252) with the combined IHC/FISH results in this validation set. Discrepancies occurred in the context of low tumor content and HER2 heterogeneity. ERBB2 amplification status can be reliably determined by hybridization capture-based NGS methods, allowing efficient concurrent testing for other potentially actionable genomic alterations, particularly in limited material.

Indexed as

Gene AmplificationBiomarkers, TumorComputational BiologyDNA Copy Number VariationsErb-b2 Receptor Tyrosine KinasesGenetic TestingHumansImmunohistochemistryNeoplasmsReference StandardsReproducibility of ResultsSensitivity and SpecificityBiomarkers, TumorErb-b2 Receptor Tyrosine Kinases

Identifiers

PMID28027945
PMCPMC5397722

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.