scholarly journals Determination of the HER2 amplification status by in situ fluorescent hybridization and concordance with immunohistochemistry for breast cancer samples in Colombia

2013 ◽  
pp. 108-114
Author(s):  
Adriana Plata ◽  
María Mercedes Torres ◽  
Rocío López ◽  
Rafael E. Andrade
Keyword(s):  
Breast Cancer ◽  
False Negative ◽  
False Negative Rate ◽  
Her2 Status ◽  
Santa Fe ◽  
Her2 Amplification ◽  
The Status ◽  
Positive Results

Objectives: To determine the status of the HER2 amplification in Breast cancer performed in peripheral laboratories in Colombia by immunohistochemistry and its comparison with central laboratories and the FISH status. Methods: Four thousand one hundred and five cases referred for the determination of the HER2 status by FISH and/or IHQ to the Department of Pathology of the Fundacion Santa Fe were studied. The analysis included correlation between the IHQ HER2 score submitted by the peripheral laboratory (PL), the HER2 score emitted in the LC and the FISH studies performed in the central laboratory (CL). Results: two thousand five hundred and eight HER2 IHQ studies were performed in the (CL), using the Dako Herceptest. With the following results: 68.2 % negative (0-1+); 16.4% indeterminate (2+); 15.3% 3+ and 2.3 % not adequate. 1360/ 1719 cases studied by FISH came from the (PL), and 329 (19.1%) from the (Lc). Comparing the IHQ score emitted by the PL and the positive FISH status showed: 6/28 0+ were positive (21.4%); 7/31 1+ (22.5%); 397/1.240 2+ (32.8%) and 74/91 3+ (81.3%). In the CL the results were 1/9 0+ (11.1%); 3/18 1+ (16.7%); 154/292 2+ (53.0%); and 9/9 3+ (100%). Only 1/4 negative cases (0/1+) was in house. Conclusion: The false negative rate (22.0%), and false positive results (18.7%), of the HER2 status performed by IHQ in peripheral laboratories in Colombia is unacceptable high as well as the inadequacy of tissue indicating that pre-analytical factors have to be improved in Colombia in order to get optimal results

scholarly journals Comparison of Fluorescence In Situ Hybridization (FISH) and Dual-ISH (DISH) in the Determination of HER2 Status in Breast Cancer

2013 ◽  
Vol 139 (2) ◽  
pp. 144-150 ◽  
Author(s):  
Aaron S. Mansfield ◽  
William R. Sukov ◽  
Jeanette E. Eckel-Passow ◽  
Yuta Sakai ◽  
Frank J. Walsh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Fluorescence In Situ Hybridization ◽  
Her2 Status

scholarly journals Agreement between chromogenic in situ hybridisation (CISH) and FISH in the determination of HER2 status in breast cancer

2003 ◽  
Vol 88 (10) ◽  
pp. 1587-1591 ◽  
Author(s):  
L Arnould ◽  
Y Denoux ◽  
G MacGrogan ◽  
F Penault-Llorca ◽  
M Fiche ◽  
...  
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridisation ◽  
Her2 Status

scholarly journals Central retesting of breast cancer with HER2 immunohistochemistry score of 0 or 1+ using silver-enhanced in situ hybridisation: a multicentre, prospective study in Greece

2014 ◽  
Vol 5 (1) ◽  
pp. 20-28
Author(s):  
Savvas Papadopoulos ◽  
Petroula Arapantoni-Dadioti ◽  
Konstantinos Sfikas ◽  
Artemis Stylianidou ◽  
Helen Trichia ◽  
...  
Keyword(s):  
In Situ Hybridisation ◽  
False Negative ◽  
False Negative Rate ◽  
Growth Factor Receptor ◽  
Chromosome 17 ◽  
Her2 Status ◽  
Breast Cancers ◽  
Negative Results ◽  
Status Assessment

Abstract Newly diagnosed invasive breast cancers should be evaluated for Human Epidermal Growth Factor Receptor 2 (HER2) status by immunohistochemistry (IHC) and/or in situ hybridisation (ISH) to determine eligibility for trastuzumab or other HER2-targeted therapies. Previous reports of high discordance rates between IHC and ISH have raised concerns over the accuracy of HER2 testing, especially when IHC is conducted locally. This study aimed to determine the rate of false-negative IHC results at three pathology centres (one central, two local) in Greece by central retesting of 240 prospectively collected invasive breast cancers scored as IHC 0/1+ at initial testing. All samples were from female patients (median age 58.0 years). Initial IHC tests utilised either the CB11 (159/239; 66.5%) or 4B5 (80/239; 33.5%) antibodies and were scored as 0 in 105/240 cases (43.8%) and 1+ in 135/240 cases (56.3%). All samples were centrally retested by automated silver in situ hybridisation (SISH). Of 237 samples with SISH staining suitable for assessment, 223 (94.1%; 95% confidence interval 90.3–96.5%) were classed as SISH-negative (HER2:chromosome enumeration probe 17 (CEP17) <1.8). Eight tested SISH-positive (HER2:CEP17 >2.2), providing a false-negative rate of 3.4%. A further four samples (1.7%) exhibited equivocal amplification status (HER2:CEP17 1.8–2.2) and two (0.8%) showed polysomy of chromosome 17. The proportion of SISH-negative results did not significantly differ between the IHC 0 and 1+ subgroups (95.2% vs. 93.2%; p=0.505). In conclusion, the low observed rate of false-negative IHC results in this study supports the use of IHC for initial HER2 status assessment in local or central laboratories in Greece.

Reliability of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry in Breast Core Needle Biopsies

2010 ◽  
Vol 28 (20) ◽  
pp. 3264-3270 ◽  
Author(s):  
Annette Lebeau ◽  
Andreas Turzynski ◽  
Susanne Braun ◽  
Wera Behrhof ◽  
Barbara Fleige ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Drug Administration ◽  
False Positive ◽  
Food And Drug Administration ◽  
False Negative ◽  
Growth Factor Receptor ◽  
Her2 Status ◽  
Core Needle ◽  
Epidermal Growth ◽  
Positive Results

Purpose Core needle biopsies (CNBs) are widely used to determine human epidermal growth factor receptor 2 (HER2) status in breast cancer. Recent publications reported up to 20% false-positive results on CNBs if immunohistochemistry (IHC) is compared with fluorescent in situ hybridization (FISH). To clarify, if confirmation of IHC positivity by FISH is generally required, we analyzed the reliability of IHC positivity on CNBs versus surgical specimens in a multi-institutional study. Patients and Methods Five pathologic laboratories contributed to this study by performing IHC on 500 CNBs and the corresponding surgical specimens overall. If IHC revealed score 2+ or 3+, HER2 status was confirmed by FISH in a central laboratory. We compared evaluation according to US Food and Drug Administration–approved scoring criteria and recently published American Society of Clinical Oncology (ASCO)–College of American Pathologists (CAP) guidelines. Results CNBs scored 3+ revealed five false-positive results if scoring followed the US Food and Drug Administration criteria (five of 40; 12.5%) and two false-positives in terms of the ASCO-CAP criteria (two of 33; 6.1%). IHC was false negative in one CNB only. By contrast, IHC on surgical specimens revealed five false-negative results, but only one false-positive result (one of 35; 2.9%) if scored following US Food and Drug Administration–approved criteria. With the aid of the ASCO-CAP criteria, false-positive IHC results were obtained in only one of the five participating institutions. Conclusion IHC 3+ scores on CNBs proved to be reliable in four of the five participating institutions if scoring followed the ASCO-CAP criteria. Therefore, accurate determination of HER2 status in breast cancer is possible on CNB using the common strategy to screen all cases by IHC and retest only 2+ scores by FISH. Prerequisites are quality assurance and the application of the new ASCO-CAP criteria.

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