Discordant Results Obtained for Different Methods of HER-2/Neu Testing in Breast Cancer – A Question of Standardization, Automation and Timing

Lüftner, Diana; Henschke, P.; Kafka, Ariane; Anagnostopoulos, I; Wiechen, Kai; Geppert, R.; Stein, Harald; Wernecke, Klaus‐D.; Possinger, K.

doi:10.1177/172460080401900101

Cited by 15 publications

(4 citation statements)

References 27 publications

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“…Patients with negative tumor HER-2 status at the time of biopsy may become HER-2-positive as they progress to metastatic disease (28 ). This could explain discrepancies between negative tissue testing and increased serum HER-2 concentrations in metastatic breast cancer (29 ). Moreover, reduced metalloprotease activity could lead to decreased s-HER-2 concentrations.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Quantitative Analytical Methods Real-Time PCR for HER-2 Gene Quantification and ELISA of Serum HER-2 Protein and Comparison with Fluorescence in Situ Hybridization and Immunohistochemistry for Determining HER-2 Status in Breast Cancer Patients

et al. 2005

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Background: HER-2 status is generally determined by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). Both methods are only semiquantitative, require a tumor sample, and can be difficult to reproduce. We compared these methods with 2 quantitative approaches, one measuring HER-2 gene copy number in tissue by real-time quantitative PCR (qPCR), and the other measuring shed HER-2 protein in serum by ELISA in patients with metastatic disease. Methods: We analyzed 52 cases of metastatic breast cancer for which both serum collected at the diagnosis of metastasis and stored primary breast tumor specimens were available. The within-and between-run imprecision of real-time qPCR and ELISA were evaluated according to Clinical and Laboratory Standards Institute (formerly known as NCCLS) recommendations. Concordance among the 4 methods was assessed by calculating the statistic and its 95% confidence interval (95% CI).

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Section: Discussionmentioning

confidence: 99%

Evaluation of the Quantitative Analytical Methods Real-Time PCR for HER-2 Gene Quantification and ELISA of Serum HER-2 Protein and Comparison with Fluorescence in Situ Hybridization and Immunohistochemistry for Determining HER-2 Status in Breast Cancer Patients

et al. 2005

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“…In another recent study where HER-2/neu tissue results were correlated with the serum HER-2/neu levels at the time of metastatic spread, the number of patients with stage IV breast cancer and elevated serum HER-2/neu level was much higher than HER-2/neu positivity in tissue. Therefore, authors recommend that patients with an elevated serum HER-2/neu level and no tissue overexpression should be considered for retesting of tissue or a new biopsy (195). ECD HER-2/neu specificity in the detection of relapse is reported as high as 100%, but sensitivity varies from 31% to 45% (152,190).…”

Section: Her-2/neumentioning

confidence: 99%

Biomolecular markers of breast cancer

Nicolini

Carpi²,

Tarro³

2006

Front Biosci

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Here, the structure, function, biological and pathological significance and clinical utility of the principal biomolecular markers of breast cancer is reviewed. Each marker was scored for clinical utility using a recently developed tumor marker utility grading system (TMUGS). Among the tissue markers, ERs and PRs are important prognostic/predictive factors and the only tissue markers routinely determined. ER cross-talks with other growth factors while co-regulatory factors enhance (co-activators) or decrease (co-repressors) its transcriptional activity. C-erbB-2 and Ki67/MIB-1 select for adjuvant chemotherapy a subgroup of lymph-node negative patients at a high risk of relapse. Monoclonal antibodies (trastuzumab, gefitinib, erlotinib and bevacizumab) targeting tissue markers and involved in tumor growth and metastasization (EGFR, C-erbB-2, VEGF) have been developed; they showed therapeutical single agent activity as well as potent synergy with chemotherapy agents in metastatic cancer. Among circulating markers, some are potentially useful in the early detection and monitoring of metastatic disease; nevertheless, none is routinely recommended. To suspect distant metastases, CEA-TPA-CA15.3 panel attained accuracy of about 90%. ECD HER2-neu, p53 and nucleophosmin antibodies seem suitable candidates for different associations. Preliminary observations suggest that an early detection with tumor markers and successive treatment of relapses significantly prolongs disease-free and overall survival in selected patients. In conclusion, biomolecular markers are improving understanding of biology and management of breast cancer.

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“…However, both are invasive, low-throughput methodologies. Furthermore, it has been reported that serum p185 her2/neu levels are a better indicator for stage IV breast cancer than immunohistochemistry scores (111). Accordingly, a sensitive serum p185 her2/neu test has been developed for screening patients for trastuzumab-based therapy and monitoring post-treatment p185 her2/neu levels (112).…”

Section: Early Detection Technologiesmentioning

confidence: 99%

ErbB receptors: from oncogenes to targeted cancer therapies

Zhang

Berezov²,

Wang³

et al. 2007

J. Clin. Invest.

510

363

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Understanding the genetic origin of cancer at the molecular level has facilitated the development of novel targeted therapies. Aberrant activation of the ErbB family of receptors is implicated in many human cancers and is already the target of several anticancer therapeutics. The use of mAbs specific for the extracellular domain of ErbB receptors was the first implementation of rational targeted therapy. The cytoplasmic tyrosine kinase domain is also a preferred target for small compounds that inhibit the kinase activity of these receptors. However, current therapy has not yet been optimized, allowing for opportunities for optimization of the next generation of targeted therapy, particularly with regards to inhibiting heteromeric ErbB family receptor complexes.

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Discordant Results Obtained for Different Methods of HER-2/Neu Testing in Breast Cancer – A Question of Standardization, Automation and Timing

Cited by 15 publications

References 27 publications

Evaluation of the Quantitative Analytical Methods Real-Time PCR for HER-2 Gene Quantification and ELISA of Serum HER-2 Protein and Comparison with Fluorescence in Situ Hybridization and Immunohistochemistry for Determining HER-2 Status in Breast Cancer Patients

Evaluation of the Quantitative Analytical Methods Real-Time PCR for HER-2 Gene Quantification and ELISA of Serum HER-2 Protein and Comparison with Fluorescence in Situ Hybridization and Immunohistochemistry for Determining HER-2 Status in Breast Cancer Patients

Biomolecular markers of breast cancer

ErbB receptors: from oncogenes to targeted cancer therapies

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