ArticleBMC cancer2013
Assessment of HER2 status in breast cancer: overall positivity rate and accuracy by fluorescence in situ hybridization and immunohistochemistry in a single institution over 12 years: a quality control study.
Article in BMC cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers.
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.
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.
Who cites it
56 citing papers in PubMed, 105 citations in OpenAlex.
- Effects of HER Family-targeting Tyrosine Kinase Inhibitors on Antibody-dependent Cell-mediated Cytotoxicity in HER2-expressing Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021Trial
- Trial
- Integrated triplex LFIA platform for decentralized molecular subtyping of breast cancer.RSC advances · 2026Article
- Validation and Prospective Testing of a High-Sensitivity, Quantitative Analytic Assay for HER2 on Histopathology Slides.Laboratory investigation; a journal of technical methods and pathology · 2025Article
- Review
- Hormone and HER2-receptor status in breast cancer: determination using sonographically guided core needle biopsy and correlation with excision specimen-a German single institution diagnostic accuracy study.Archives of gynecology and obstetrics · 2025Article
- [Asia Oceania journal of nuclear medicine & biology · 2025Article
- Antibody-Drug Conjugates and Their Potential in the Treatment of Patients with Biliary Tract Cancer.Cancers · 2024Review
- Comprehensive genomic profiling and therapeutic implications for Taiwanese patients with treatment-naïve breast cancer.Cancer medicine · 2024Article
- ERBB2-amplified lobular breast carcinoma exhibits concomitant CDK12 co-amplification associated with poor prognostic features.The journal of pathology. Clinical research · 2024Article
- Molecular pathology in breast disease: diagnostic, prognostic, and therapeutic tools.Virchows Archiv : an international journal of pathology · 2024Review
- Discordance of HER2 Expression and/or Amplification on Repeat Testing.Molecular cancer therapeutics · 2023Article
- Dissecting sources of variability in patient response to targeted therapy: anti-HER2 therapies as a case study.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2023Article
- Comparisons of clinical characteristics, prognosis, epidemiological factors, and genetic susceptibility between HER2-low and HER2-zero breast cancer among Chinese females.Cancer medicine · 2023Article
- Multiplex imaging of breast cancer lymph node metastases identifies prognostic single-cell populations independent of clinical classifiers.Cell reports. Medicine · 2023Article
- Determining HER2 Status by Artificial Intelligence: An Investigation of Primary, Metastatic, and HER2 Low Breast Tumors.Diagnostics (Basel, Switzerland) · 2023Article
- Multi-institutional Assessment of Pathologist Scoring HER2 Immunohistochemistry.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2023Article
- HER2 amplification by next-generation sequencing to identify HER2-positive invasive breast cancer with negative HER2 immunohistochemistry.Cancer cell international · 2022Article
- Histologic analysis according to HER2 gene status in HER2 2 + invasive breast cancer: a study of 280 cases comparing ASCO/CAP 2013 and 2018 guideline recommendations.Virchows Archiv : an international journal of pathology · 2022Article
- Liquid Biopsy-based Precision Therapy in Patients with Advanced Solid Tumors: A Real-world Experience from a Community-based Oncology Practice.The oncologist · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe gold standard of HER2 status assessment in breast cancer is still debated. Immunohistochemistry (IHC) and in-situ technology as fluorescent-labeled methodology (FISH) can be influenced by pre-analytical factors, assay-conditions and interpretation of test results. We retrospectively conducted this quality control study and analyzed HER2 test results in breast cancer within the routine diagnostic service in a single institution over a period of 12 years. We addressed the question how stable and concordant IHC and FISH methods are and whether HER2 positivity rate has changed over this period.
methodsData of 7714 consecutive HER2-FISH-assays in a period of 12 years (2001-2012) on breast cancer biopsies and excision specimens were retrospectively analyzed. From 2001 to 2004, FISH tests were performed from all cases with IHC score 3+ and 2+ (and in some tumors with IHC score 1+ and 0). From 2005-2010, HER2 status was only determined by FISH. From 2011-2012, all breast carcinomas were analyzed by both IHC and FISH. Scoring and cut-off-definition were done according to time-current ASCO-CAP and FDA-guidelines.
resultsBetween 2001-2004, IHC score 3+ was diagnosed in 22% of cases, 69% of these 3+ cases were amplified by FISH. 6% of IHC score 0/1+ cases were amplified by FISH. There was a mean amplification rate of 15.8% (range 13 -19%) using FISH only HER2-assays (2005-2010). Starting 2008, a slight drop in the amplification rate from 17% to 14% was noticed due to the modified ASCO-criteria in 2007. From 2011-2012, 12% of cases were 3+ by IHC, 84% of them were amplified by FISH. Less than 1% of IHC score 0/1+ cases were amplified by FISH. Concordance between FISH and IHC increased from 83% to 97%.
conclusionsOur quality control study demonstrates that HER2 positivity rate remained stable by FISH-technology but showed a significant variation by IHC over the analyzed 12 years. Improvement in concordance rate was due to standardization of pre-analytical factors, scoring and interpretation.
Indexed as
Identifiers
What OpenQuestion holds
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.