Fluorescent In Situ Hybridization As a Primary Test for HER2 Status in Breast Cancer: Controversies

2010 ◽  
Vol 28 (5) ◽  
pp. e83-e84 ◽  
Author(s):  
Vincenzo Arena ◽  
Ilaria Pennacchia ◽  
Giovanni Monego ◽  
Arnaldo Carbone ◽  
Arnaldo Capelli
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Fluorescent In Situ Hybridization ◽  
Her2 Status ◽  
Primary Test

Comparison of HER2 Status by Fluorescence in Situ Hybridization and Immunohistochemistry to Predict Benefit From Dose Escalation of Adjuvant Doxorubicin-Based Therapy in Node-Positive Breast Cancer Patients

2005 ◽  
Vol 23 (19) ◽  
pp. 4287-4297 ◽  
Author(s):  
Lynn G. Dressler ◽  
Donald A. Berry ◽  
Gloria Broadwater ◽  
David Cowan ◽  
Kelly Cox ◽  
...  
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Fluorescence In Situ Hybridization ◽  
Cancer Patients ◽  
Her2 Status ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Node Positive ◽  
Positive Breast Cancer

Purpose HER2 is a clinically important tumor marker in breast cancer; however, there is controversy regarding which method reliably measures HER2 status. We compared three HER2 laboratory methods: immunohistochemistry (IHC), fluorescence in situ hybridization (FISH) and polymerase chain reaction (PCR), to predict disease-free survival (DFS) and overall survival (OS) after adjuvant doxorubicin-based therapy in node-positive breast cancer patients. Methods This is a Cancer and Leukemia Group B (CALGB) study, using 524 tumor blocks collected from breast cancer patients registered to clinical trial CALGB 8541. IHC employed CB11 and AO-11-854 monoclonal antibodies; FISH used PathVysion HER2 DNA Probe kit; PCR utilized differential PCR (D-PCR) methodology. Results Cases HER2 positive by IHC, FISH and D-PCR were 24%, 17%, and 18%, respectively. FISH and IHC were clearly related (κ = 64.8%). All three methods demonstrated a similar relationship for DFS and OS. By any method, for patients with HER2-negative tumors, there was little or no effect of dose of adjuvant doxorubicin-based therapy. For patients with HER2-positive tumors, all three methods predicted a benefit from dose-intense (high-dose) compared with low- or moderate-dose adjuvant doxorubicin-based therapy. Conclusion FISH is a reliable method to predict clinical outcome following adjuvant doxorubicin-based therapy for stage II breast cancer patients. There is a moderate level of concordance among the three methods (IHC, FISH, PCR). None of the methods is clearly superior. Although IHC-positive/FISH-positive tumors yielded the greatest interaction with dose of therapy in predicting outcome, no combination of assays tested was statistically superior.

Differential prognostic value of positive HER2 status determined by immunohistochemistry or fluorescence in situ hybridization in breast cancer

2020 ◽  
Vol 183 (2) ◽  
pp. 311-319 ◽  
Author(s):  
Albina Stocker ◽  
Andreas Trojan ◽  
Constanze Elfgen ◽  
Marie-Louis Hilbers ◽  
Linda Moskovszky ◽  
...  
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Fluorescence In Situ Hybridization ◽  
Prognostic Value ◽  
Her2 Status

HER2 status testing by immunohistochemical and fFluorescence in situ hybridization in China

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e22233-e22233
Author(s):  
W. Tao ◽  
J. Zefei ◽  
Z. Xuan ◽  
L. Xiaobing ◽  
Z. Shaohua ◽  
...  
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Her2 Status ◽  
Central Laboratory ◽  
Her2 Gene ◽  
Her2 Positive ◽  
Clinical Prognosis ◽  
Her2 Testing ◽  
Regional Laboratory

e22233 Background: HER2 gene overexpression is associated with aggressive breast cancer and poor clinical prognosis. Humanized anti-HER2 monoclonal antibody trastuzumab, which is targeted HER2 protein has showed to improve overall survival in patients with HER2-positive breast cancer in both the metastatic and adjuvant settings. There are some differences in HER2 positive rate among difference reports in China. This study tested HER2 status by immunohistochemistry(IHC) and fluorescence in situ hybridization (FISH) and compared HER2 testing at central and regional laboratories in China. Methods: Assessment of HER2 status was performed by FISH using the HercepTeast kit at central laboratory and by IHC using commercial available anti-HER2 probe in formalin-fixed and paraffin-embedded tissue section of 280 breast cancer samples. IHC HER2 testing was performed on 149 samples in the central laboratory. IHC HER2 testing was performed on 80 samples at both central laboratory and regional laboratory. Results: 280 samples were tested 373 times testing by IHC and FISH. The results were showed in table 1 . 80 samples was tested by IHC at central and regional laboratory and testing results of 36.4% samples were accordant (K=0.038). 94.1% IHC3+ at central laboratory were HER2 FISH positive and 83.3% IHC 3+ at regional laboratory were HER2 FISH positive. 86.7% IHC 2+ at central laboratory were HER2 FISH positive and 62.7% IHC 2+ at regional laboratory were HER2 FISH positive. 17 samples were observed HER2 FISH positive in the 27 IHC 0/1+ tested at regional laboratoty. So good correlation was obsearved between FISH HER2 status and IHC results from central laboratory but not from regional laboratory. Conclusions: This study emphasized the important of accurate HER2 testing. HER2 FISH test should be performed for the IHC 2+ samples. Even HER2 FISH test maybe performed for IHC 0/1 sample according to clinical characteristics in China in order to make the patients have targeted therapy chance. [Table: see text] No significant financial relationships to disclose.

scholarly journals ID3014 Evaluation of HER2 status in breast cancer: Current status and future directions

2017 ◽  
Vol 4 (S) ◽  
pp. 26
Author(s):  
Mohd Nazil Salleh
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Target Therapy ◽  
Molecular Signature ◽  
Current Status ◽  
Her2 Status ◽  
Her2 Gene ◽  
Clinical Prognosis ◽  
Advantages And Disadvantages

Human epidermal growth factor 2, (HER2) expression is observed in approximately 20% of invasive breast cancers and is associated with poor clinical prognosis. Accurate evaluation of HER2 gene amplification status is critical for optimizing breast cancer outcomes. Evaluation of HER2 status defines the eligibility for trastuzumab therapy and significantly improves the clinical outcome in a subset of patients who test positive for HER2. Last ten years the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) was developed guidelines for HER2 testing to reduce inaccuracy. However, current ASCO/CAP criteria may restrict access to HER2-target therapy for some patient groups who would derive a clear clinical benefit. In the present study, we presented preliminary data by comparing the dual-color-dual hapten-brightfield in situ hybridization (DDISH) and fluorescence in situ hybridization (FISH) from formalin-fixed paraffin embedded (FFPE) of in invasive breast cancer. A third generation, fully automated, DDISH can detect both markers on a single slide using two double stranded probes labeled with two haptens. In this report, we would like to present the clinical results, the advantages and disadvantages, as well to utilize DDISH as a tumour molecular signature application for alternative method and to improve in clinical diagnosis outcomes, recurrence prediction and individualized treatment strategies.

scholarly journals HER2 Testing in Invasive Breast Cancer: A Comparison Between Immunohistochemistry and Fluorescence In Situ Hybridization Assays

2020 ◽  
Vol 8 (3) ◽  
pp. 139-146
Author(s):  
Maryam Moradi Chaleshtori ◽  
◽  
Zohreh Hojati ◽  
Ali Jazaeri ◽  
Hossein Teimori ◽  
...  
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Fluorescence In Situ Hybridization ◽  
Gene Amplification ◽  
Invasive Breast Cancer ◽  
Concordance Rate ◽  
Her2 Status ◽  
Her2 Gene ◽  
Relative Copy Number

Background: HER2 status testing in breast cancer is crucial for the detection of eligible patients for trastuzumab therapy. In this study, the relative copy number of HER2 gene, in patients with breast cancer, was determined by fluorescence in situ hybridization (FISH) and the results were compared with those of immunohistochemistry (IHC) to obtain the concordance rate between these two methods. Material and Methods: HER2 status of 31 invasive breast cancer samples was compared using IHC and FISH techniques. The ratio of HER2/CEP17 was used to determine the amplification of the HER2 gene. If the ratio of HER2/CEP17 is greater than 2.2, HER2 gene amplification has occurred in the cancer cells. Then, a comparative analysis is performed to estimate the concordance rate between FISH and IHC results. Results: The gene amplification of HER2 was observed in 26% of cases by FISH. The IHC and FISH results showed 100%, 36.36%, and 85.71% concordance rates for cases with IHC scores of 3+, 2+, and 0/+1, respectively. The overall concordance between the two methods was 80%. Based on statistical analysis, HER2 status showed a considerable correlation with tumor grade (P= 0.02). No correlation was observed between HER2 gene status and the size and type of tumor, characteristics of lymph node, and patients’ age. Conclusion: The data suggested that IHC results are reliable for HER2 status testing in cases with IHC scores 0/+1 and 3+. However, in patients with an IHC score of +2, it is necessary to perform a complimentary test to evaluate HER2 status to avoid haphazard treatment with trastuzumab in negative cases and identifying positive cases for suitable treatment.

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