HER2 overexpression and amplification as a potential therapeutic target in colorectal cancer: analysis of 3256 patients enrolled in the QUASAR , FOCUS and PICCOLO colorectal cancer trials
Open accessAbstract
HER2 overexpression/amplification is linked to trastuzumab response in breast/gastric cancers. One suggested anti‐ EGFR resistance mechanism in colorectal cancer ( CRC ) is aberrant MEK–AKT pathway activation through HER2 up‐regulation. We assessed HER2 ‐amplification/overexpression in stage II–III and IV CRC patients, assessing relationships to KRAS / BRAF and outcome. Pathological material was obtained from 1914 patients in the QUASAR stage II–III trial and 1342 patients in stage IV trials ( FOCUS and PICCOLO ). Tissue microarrays were created for HER2 immunohistochemistry. HER2 ‐amplification was assessed using FISH and copy number variation. KRAS / BRAF mutation status was assessed by pyrosequencing. Progression‐free survival ( PFS ) and overall survival ( OS ) data were obtained for FOCUS / PICCOLO and recurrence and mortality for QUASAR ; 29/1342 (2.2%) stage IV and 25/1914 (1.3%) stage II–III tumours showed HER2 protein overexpression. Of the HER2 ‐overexpressing cases, 27/28 (96.4%) stage IV tumours and 20/24 (83.3%) stage II–III tumours demonstrated HER2 amplification by FISH ; 41/47 (87.2%) also showed copy number gains. HER2 ‐overexpression was associated with KRAS / BRAF wild‐type ( WT ) status at all stages: in 5.2% WT versus 1.0% mutated tumours ( p < 0.0001) in stage IV and 2.1% versus 0.2% in stage II–III tumours ( p = 0.01), respectively. HER2 was not associated with OS or PFS . At stage II–III , there was no significant correlation between HER2 overexpression and 5FU / FA response. A higher proportion of HER2 ‐overexpressing cases experienced recurrence, but the difference was not significant. HER2 ‐amplification/overexpression is identifiable by immunohistochemistry, occurring infrequently in stage II–III CRC , rising in stage IV and further in KRAS / BRAF WT tumours. The value of HER2 ‐targeted therapy in patients with HER2 ‐amplified CRC must be tested in a clinical trial. © 2015 The Authors. Journal of Pathology published by John Wiley & Sons Ltd on behalf of Pathological Society of Great Britain and Ireland.
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HER2 overexpression/amplification occurs in 3-5% of patients with metastatic colorectal cancer, rising to 5-14% among those with RAS wild-type.
“HER2 overexpression/amplification occurs in 3–5% of patients with mCRC, rising to 5–14% among those with RAS WT [25].”
From RAS Mutations in Advanced Colorectal Cancer: Mechanisms, Clinical Implications, and Novel Therapeutic Approaches (2025) · cites this paper as [25]
The prognostic relevance of ERBB2 amplification itself in metastatic colorectal cancer remains controversial.
“the prognostic relevance of ERBB2 amplification itself in mCRC remains controversial.42 43 45”
From Current and emerging concepts for systemic treatment of metastatic colorectal cancer (2025) · cites this paper as [45]
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- Authors
- Richman, S. D., Southward, K., Chambers, P., Cross, D., Barrett, J., Hemmings, G., Taylor, M., Wood, H., Hutchins, G., Foster, J. M., Oumie, A., Spink, K. G., Brown, S. R., Jones, M., Kerr, D., Handley, K., Gray, R., Seymour, M., & Quirke, P.
- Affiliations
- University of Leeds (GB)
- St James's University Hospital (GB)
- Affymetrix UK Ltd High Wycombe UK
- University of Oxford (GB)
- Cancer Research UK Clinical Trials Unit (GB)
- Section of Oncology Leeds Institute of Cancer and Pathology, University of Leeds UK
- Corresponding author
- Richman, Susan D
- ORCID
- Venue
- The Journal of Pathology
- Publisher
- Wiley
- Published
- 2016-01-29
- Volume
- 238
- Issue
- 4
- Pages
- 562-570
- ISSN
- 0022-3417 (ISSN-L)
- 1096-9896
- PMC
- PMC4785607
- OpenAlex
- W2212171768
- Cited by
- 241
- References
- 35
- Citations by year
- 2026: 13 · 2025: 23 · 2024: 29 · 2023: 27 · 2022: 36 · 2021: 23 · 2020: 26 · 2019: 25 · 2018: 18 · 2017: 15 · 2016: 6
- FWCI
- 5.68
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Journal of Pathology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, cc-by)
- Funders
- Yorkshire Cancer Research
- Cancer Research UK (C37059/A11941)
- Amgen
- Technology Strategy Board (101032)
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Health Sciences › Medicine › Pathology and Forensic Medicine › Genetic factors in colorectal cancer
- Keywords
- HER2 overexpression, HER2 amplification, colorectal cancer, KRAS mutation, BRAF mutation, anti-EGFR resistance, trastuzumab, copy number gain, progression-free survival, overall survival, recurrence, HER2-targeted therapy, stage IV colorectal cancer
- MeSH terms
- Antineoplastic Combined Chemotherapy Protocols, Clinical Trials as Topic, Female, Humans, Immunohistochemistry, Male, Mutation, Neoplasm Recurrence, Local, Neoplasm Staging, Colorectal Neoplasms, Gene Expression Regulation, Neoplastic, Erb-b2 Receptor Tyrosine Kinases, DNA Copy Number Variations
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