유방암 환자에서 인간표피성장인자수용체 2의 발현 평가 방법인 면역조직화학염색법과 은제자리부합법의 일치율과 중등도 양성의 비율
Concordance and Proportion of Equivocal Results of Silver-Enhanced In Situ Hybridization and Immunohistochemical Technique for the Determination of HER2 Amplification in Breast Cancer Patients
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Purpose: Information on the status of human epidermal growth factor receptor 2 (HER2) is important for treatment planning in breast cancer; therefore, equivocal results of HER2 overexpression obtained using immunohistochemical staining (IHC) require additional evaluation regarding HER2 amplification, which can be obtained by other techniques such as fluorescence in situ hybridization (FISH) assay. The silver-enhanced in situ hybridization (SISH) technique is known to be comparable with FISH and can be performed under a bright field microscope. In this study, the authors evaluated the concordance between the results obtained by IHC and SISH used for determining HER2 status. Methods: Paraffin-embedded tissues from 511 breast cancer patients were prepared and the medical records of the patients were reviewed. HER2 amplification status was evaluated by SISH assay by determining the HER2/chromosome 17 ratio or HER2 copy number status. The slides were blindly reviewed without IHC information. Results: Among the collected tissues, invasive ductal carcinoma was detected in 440 patients (86.1%) and 27 (5.3%) showed ductal carcinoma in situ. The concordance rate between the results obtained by IHC and SISH was 90.6% (κ=0.723). Two cases of negative IHC results had equivocal SISH results. Conclusion: SISH was found to be a useful method for evaluating HER2 status in case of an equivocal result of IHC.
Abstract
Purpose: Information on the status of human epidermal growth factor receptor 2 (HER2) is important for treatment planning in breast cancer; therefore, equivocal results of HER2 overexpression obtained using immunohistochemical staining (IHC) require additional evaluation regarding HER2 amplification, which can be obtained by other techniques such as fluorescence in situ hybridization (FISH) assay. The silver-enhanced in situ hybridization (SISH) technique is known to be comparable with FISH and can be performed under a bright field microscope. In this study, the authors evaluated the concordance between the results obtained by IHC and SISH used for determining HER2 status. Methods: Paraffin-embedded tissues from 511 breast cancer patients were prepared and the medical records of the patients were reviewed. HER2 amplification status was evaluated by SISH assay by determining the HER2/chromosome 17 ratio or HER2 copy number status. The slides were blindly reviewed without IHC information. Results: Among the collected tissues, invasive ductal carcinoma was detected in 440 patients (86.1%) and 27 (5.3%) showed ductal carcinoma in situ. The concordance rate between the results obtained by IHC and SISH was 90.6% (κ=0.723). Two cases of negative IHC results had equivocal SISH results. Conclusion: SISH was found to be a useful method for evaluating HER2 status in case of an equivocal result of IHC.
참고문헌 (25)
- Beenken SW, "Molecular biomarkers for breast cancer prognosis : coexpression of c-erbB-2 and p53", Ann Surg, 233, pp.630~638 (2001)
- Yamashita H, "Coexistence of HER2 over-expression and p53 protein accumulation is a strong prognostic molecular marker in breast cancer", Breast Cancer Res, 6, pp.R24~R30 (2004)
- Ross JS, "HER-2", neu (c-erb-B2) gene and protein in breast cancer, 1999, pp.112(1 Suppl 1), S53~S67
- Rhodes A, "Evaluation of HER-2", neu immunohistochemical assay sensitivity and scoring on formalin-fixed and paraffin-processed cell lines and breast tumors : a comparative study involving results from laboratories in 21 countries, 2002, pp.118, 408~417
- Lewis F, "Testing for HER2 in breast cancer", Histopathology, 45, pp.207~217 (2004)
- Dietel M, "Comparison of automated silver enhanced in situ hybridization(SISH)and fluorescence ISH(FISH)for the validation of HER2 gene status in breast carcinoma according to the guidelines of the American Society of Clinical Oncology and the College of American Pathologists", Virchows Arch, 451, pp.19~25 (2007)
- Shousha S, "Evaluation of automated silver-enhanced in situ hybridization(SISH)for detection of HER2 gene amplification in breast carcinoma excision and core biopsy specimens", Histopathology, 54, pp.248~253 (2009)
- Wolff AC, "American Society of Clinical Oncology", College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer, 2007, pp.25, 118~145
- Landis JR, "The measurement of observer agreement for categorical data", Biometrics, 33, pp.159~174 (1977)
- Lakhani SR, "WHO Classification of Tumours of the Breast", pp.8~38 (2012), International Agency for Research on Cancer
- Park K, "Topoisomerase II-alpha(topoII)and HER2 amplification in breast cancers and response to preoperative doxorubicin chemotherapy", Eur J Cancer, 39, pp.631~634 (2003)
- Dowsett M, "Overexpression of HER-2 as a resistance mechanism to hormonal therapy for breast cancer", Endocr Relat Cancer, 8, pp.191~195 (2001)
- Shak S, "Overview of the trastuzumab (Herceptin) anti-HER2 monoclonal antibody clinical program in HER2-overexpressing metastatic breast cancer. Herceptin Multinational Investigator Study Group", Semin Oncol, 26(4 Suppl 12), pp.71~77 (1999)
- Press MF, "Sensitivity of HER-2", neu antibodies in archival tissue samples : potential source of error in immunohistochemical studies of oncogene expression, 1994, pp.54, 2771~2777
- Papadopoulos S, "Comparison of HER2 detection methods between central and regional laboratories in Greece", Clin Breast Cancer, 7, pp.784~790 (2007)
- Paik S, "Real-world performance of HER2 testing : National Surgical Adjuvant Breast and Bowel Project experience", J Natl Cancer Inst, 94, pp.852~854 (2002)
- Park K, "A single institute’s experience of standardization for the HER2 status by fluorescence in situ hybridization and immunohistochemistry on a primary breast cancer tissue microarray", J Korean Breast Cancer Soc, 7, pp.27~31 (2004)
- Mass RD, "Evaluation of clinical outcomes according to HER2 detection by fluorescence in situ hybridization in women with metastatic breast cancer treated with trastuzumab", Clin Breast Cancer, 6, pp.240~246 (2005)
- Cobleigh MA, "Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease", J Clin Oncol, 17, pp.2639~2648 (1999)
- Tvrdík D, "Comparison of the IHC, FISH, SISH and qPCR methods for the molecular diagnosis of breast cancer", Mol Med Rep, 6, pp.439~443 (2012)
- Jacquemier J, "SISH", CISH or qPCR as alternative techniques to FISH for determination of HER2 amplification status on breast tumors core needle biopsies : a multicenter experience based on 840 cases, 2013, pp.13, 351~
- 배영경, "HER2 Status by Standardized Immunohistochemistry and Silver-Enhanced In Situ Hybridization in Korean Breast Cancer", Journal of Breast Cancer, 15(4), pp.381~387 (2012), 한국유방암학회[DOI]
- Meijer SL, "HER2 gene amplification in patients with breast cancer with equivocal IHC results", J Clin Pathol, 64, pp.1069~1072 (2011)
- Dowsett M, "Disease-free survival according to degree of HER2 amplification for patients treated with adjuvant chemotherapy with or without 1 year of trastuzumab : the HERA Trial", J Clin Oncol, 27, pp.2962~2969 (2009)
- Schalper KA, "A retrospective population-based comparison of HER2 immunohistochemistry and fluorescence in situ hybridization in breast carcinomas : impact of 2007 American Society of Clinical Oncology", College of American Pathologists criteria, 2014, pp.138, 213~219
