A meta-analysis on concordance between immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) to detect HER2 gene overexpression in breast cancer

Bahreini, Fatemeh; Soltanian, Ali Reza; Mehdipour, Parvin

doi:10.1007/s12282-014-0528-0

Cited by 62 publications

(49 citation statements)

References 84 publications

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“…In addition, quality assurance measures as described in the ASCO/CAP HER2 guidelines were probably not yet widely implemented in 2008 [11,12]. Nevertheless, the agreement between the IHC-and ISH-determined amplification status for the cases with concordant HER2 IHC results, was in line with previous publications [34].…”

Section: Discussionsupporting

confidence: 66%

Quality of pathology reporting is crucial for cancer care and registration: A baseline assessment for breast cancers diagnosed in Belgium in 2008

Schutter¹,

Damme²,

Colpaert

et al. 2015

The Breast

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Section: Discussionsupporting

confidence: 66%

Quality of pathology reporting is crucial for cancer care and registration: A baseline assessment for breast cancers diagnosed in Belgium in 2008

Schutter¹,

Damme²,

Colpaert

et al. 2015

The Breast

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“…[15] Therefore, the need for accurate detection of the Her2 alteration has now become even more important, because therapeutic decisions for patients with breast cancer are increasingly dependent on this information, [11,16] We evaluated results of IHC and FISH among 133 patients with HER2 positive (Table 1). There was a concordance rate between IHC 3+ and FISH, but was a discordance rate between IHC 2+ and FISH.…”

Section: Discussionmentioning

confidence: 99%

“…This results were statistically significant (P<00.1). A few of studies [11,[17][18][19] show a concordance rate between IHC 3+ and discordance rate between IHC 2+ with FISH. But, other studies [14,20] show a concordance rate between IHC 2+ and FISH.…”

Section: Discussionmentioning

confidence: 99%

“…[10] Protein over-expression detected by IHC or amplification of Her-2 gene analyzed by fluorescence in situ hybridization (FISH) are the two main methods used to detect Her-2 status in clinical practice. [9] IHC is a preferred method for screening and determining cases which need to be genetically evaluated, [11] and IHC using scoring tools such as the "Hercept scale" and, more recently, the ASCO/CAP scale, was the simplest way to identify positive cases likely to benefit from trastuzumab that is susceptible to interobserver variability and, as with any assay technique, required standardization and validation. [12] Thin tissue section FISH is the routinely used method for the detection of gene status in paraffin-embedded breast cancer samples.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of IHC, FISH, ER and PR in Breast Cancer in Western Iran

Payandeh¹,

Sadeghi²,

Sadeghi³

et al. 2014

AJCP

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To evaluate the concordance and discordance between IHC and FISH results for detection of Her2/neu protein, analyses of ER and PR, and also evaluation of the benefit of adjuvant trastuzumab in patients diagnosed with human epidermal growth factor receptor 2 (HER2) -positive invasive ductal carcinoma enrolled onto the Herceptin adjuvant. IHC analysis of ER, PR and HER2 was performed in 133 patients of breast cancer with invasive ductal carcinoma. 90(67.6%) cases were confirmed by FISH. Statistical analysis was performed with IBM SPSS version 19, Kaplan-Meier method and log-rank test. Age mean of patients was 46.39±10.81 years (range, 24-78 years). Concordance rates between IHC and FISH were 32.4% for IHC 2+ and 81.25% for IHC 3+ (P<0.001). There were 17 and 56 patients of IHC 2+ and 3+ with ER positive and also 23 and 59 patients of IHC 2+ and 3+ had PR positive.The 83 patients had age ≤50 years and 50 patients had >50 years. Of 133 the patients, 48(36.1%) patients were treated with trastuzumab and 85(63.9%) were treated without trastuzumab. The overall survival(OS) for patients treating with trastuzumab were mean of 37.8 months and the OS for patients treating without trastuzumab were mean of 20.8 months (P<0.05). The results are that trastuzumab therapy is effective and improves the survival of HER2-positive breast cancer patients and trastuzumab therapy is effective and tolerated for breast cancer with Her-2 positive. There is a statistically significant relationship between ER positive with PR positive and ER negative with PR negative that these results need to more studies with more patients in the world.

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“…Unfortunately, assessments of biomarker status struggle with intra-and interobserver variability, as well as discordance with the gene expression tests. 11,12 This is perhaps especially evident for Ki67 [13][14][15] as there is no consensus on what tumor region or number of cells to score 13,16,17 and what cutoff values for the proportion of positive cells (Ki67 index) distinguish highly from lowly proliferative tumors. In fact, even the consensus guidelines that do exist have been considered unreliable outside individual laboratories' own reference data.…”

mentioning

confidence: 99%

Digital image analysis outperforms manual biomarker assessment in breast cancer

Stålhammar

Martínez

Lippert³

et al. 2016

Modern Pathology

145

120

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In the spectrum of breast cancers, categorization according to the four gene expression-based subtypes 'Luminal A,' 'Luminal B,' 'HER2-enriched,' and 'Basal-like' is the method of choice for prognostic and predictive value. As gene expression assays are not yet universally available, routine immunohistochemical stains act as surrogate markers for these subtypes. Thus, congruence of surrogate markers and gene expression tests is of utmost importance. In this study, 3 cohorts of primary breast cancer specimens (total n = 436) with up to 28 years of survival data were scored for Ki67, ER, PR, and HER2 status manually and by digital image analysis (DIA). The results were then compared for sensitivity and specificity for the Luminal B subtype, concordance to PAM50 assays in subtype classification and prognostic power. The DIA system used was the Visiopharm Integrator System. DIA outperformed manual scoring in terms of sensitivity and specificity for the Luminal B subtype, widely considered the most challenging distinction in surrogate subclassification, and produced slightly better concordance and Cohen's κ agreement with PAM50 gene expression assays. Manual biomarker scores and DIA essentially matched each other for Cox regression hazard ratios for all-cause mortality. When the Nottingham combined histologic grade (Elston-Ellis) was used as a prognostic surrogate, stronger Spearman's rank-order correlations were produced by DIA. Prognostic value of Ki67 scores in terms of likelihood ratio χ 2 (LR χ 2 ) was higher for DIA that also added significantly more prognostic information to the manual scores (LR− Δχ 2 ). In conclusion, the system for DIA evaluated here was in most aspects a superior alternative to manual biomarker scoring. It also has the potential to reduce time consumption for pathologists, as many of the steps in the workflow are either automatic or feasible to manage without pathological expertise.

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A meta-analysis on concordance between immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) to detect HER2 gene overexpression in breast cancer

Abstract: The results of this study show that IHC score 0/1+ and 3+ cannot be completely considered as negative and positive breast cancer test, respectively. Therefore, we suggest a valid and complementary test, the same as FISH, to explore HER2 expression.

Cited by 62 publications

References 84 publications

Quality of pathology reporting is crucial for cancer care and registration: A baseline assessment for breast cancers diagnosed in Belgium in 2008

Quality of pathology reporting is crucial for cancer care and registration: A baseline assessment for breast cancers diagnosed in Belgium in 2008

Comparison of IHC, FISH, ER and PR in Breast Cancer in Western Iran

Digital image analysis outperforms manual biomarker assessment in breast cancer

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