Clinical Implications According to Diagnostic Methods of Human Epidermal Growth Factor Receptor 2 Positivity in Breast Cancer: A Retrospective Study
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Purpose: According to American Society of Clinical Oncology/College of American Pathologists guidelines, breast cancer is human epidermal growth factor receptor 2 (HER2) positive if there is HER2 protein overexpression at a 3+ level on immunohistochemistry (IHC 3+) or gene amplification (more than six copies per nucleus) on fluorescence in situ hybridization (FISH+). However, there have been few reports on whether outcomes differ based on diagnosis by these two techniques. In this study, we compared outcomes based on the two methods in patients with HER2-positive breast cancer. Methods: This study was a retrospective analysis of HER2-positive breast cancer in 18,304 patients, including 14,652 IHC 3+ patients and 3,652 FISH+ patients from the Korean Breast Cancer Society Registry. We compared breast cancer-specific survival and overall survival based on IHC 3+ and FISH+ status with or without trastuzumab. Results: Breast cancer-specific survival was significantly different between the IHC 3+ and FISH+ groups, with 5-year cumulative survival rates of 95.0% for IHC 3+ and 98.5% for FISH+ patients who did not receive trastuzumab (p=0.001) in Kaplan-Meier methods. However, there were no significant differences in breast cancer-specific survival and overall survival between IHC 3+ and FISH+ groups regardless of trastuzumab treatment in Cox proportional hazards models. Conclusion: The survival outcomes were not affected by the different two diagnostic methods of HER2-positive breast cancer. Further research to evaluate differences in prognosis and other characteristics according to the diagnostic methods of HER2 positivity is needed in the future.
Abstract
Purpose: According to American Society of Clinical Oncology/College of American Pathologists guidelines, breast cancer is human epidermal growth factor receptor 2 (HER2) positive if there is HER2 protein overexpression at a 3+ level on immunohistochemistry (IHC 3+) or gene amplification (more than six copies per nucleus) on fluorescence in situ hybridization (FISH+). However, there have been few reports on whether outcomes differ based on diagnosis by these two techniques. In this study, we compared outcomes based on the two methods in patients with HER2-positive breast cancer. Methods: This study was a retrospective analysis of HER2-positive breast cancer in 18,304 patients, including 14,652 IHC 3+ patients and 3,652 FISH+ patients from the Korean Breast Cancer Society Registry. We compared breast cancer-specific survival and overall survival based on IHC 3+ and FISH+ status with or without trastuzumab. Results: Breast cancer-specific survival was significantly different between the IHC 3+ and FISH+ groups, with 5-year cumulative survival rates of 95.0% for IHC 3+ and 98.5% for FISH+ patients who did not receive trastuzumab (p=0.001) in Kaplan-Meier methods. However, there were no significant differences in breast cancer-specific survival and overall survival between IHC 3+ and FISH+ groups regardless of trastuzumab treatment in Cox proportional hazards models. Conclusion: The survival outcomes were not affected by the different two diagnostic methods of HER2-positive breast cancer. Further research to evaluate differences in prognosis and other characteristics according to the diagnostic methods of HER2 positivity is needed in the future.
참고문헌 (30)
- Ballinger TJ, "Current HER2 testing recommendations and clinical relevance as a predictor of response to targeted therapy", Clin Breast Cancer, 15, pp.171~180 (2015)
- Christgen M, "Precise ERBB2 copy number assessment in breast cancer by means of molecular inversion probe array analysis", Oncotarget, 7, pp.82733~82740 (2016)
- Stocker A, "HER2", CEP17 ratios and clinical outcome in HER2-positive early breast cancer undergoing trastuzumab-containing therapy, 2016, pp.11, e0159176~
- 김현아, "Association of Human Epidermal Growth Factor Receptor 2 with Radiotherapy Resistance in Patients with T1N0M0 Breast Cancer", Journal of Breast Cancer, 16(3), pp.266~273 (2013), 한국유방암학회
- Andrulis IL, "neu", erbB-2 amplification identifies a poor-prognosis group of women with node-negative breast cancer. Toronto Breast Cancer Study Group, 1998, pp.16, 1340~1349
- Lim TH, "Implications of the updated 2013 American Society of Clinical Oncology", College of American Pathologists guideline recommendations on human epidermal growth factor receptor 2 gene testing using immunohistochemistry and fluorescence in situ hybridization for breast cancer, 2016, pp.140, 140~147
- Kurozumi S, "HER2 intratumoral heterogeneity analyses by concurrent HER2 gene and protein assessment for the prognosis of HER2 negative invasive breast cancer patients", Breast Cancer Res Treat, 158, pp.99~111 (2016)
- Engel RH, "HER2-positive breast cancer: current and future treatment strategies", Drugs, 67, pp.1329~1341 (2007)
- Perez EA, "Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831and NSABP B-31", J Clin Oncol, 29, pp.3366~3373 (2011)
- 박경미, "Silver-Enhanced In Situ Hybridization as an Alternative to Fluorescence In Situ Hybridization for Assaying HER2 Amplification in Clinical Breast Cancer", Journal of Breast Cancer, 14(4), pp.276~282 (2011), 한국유방암학회
- Wesoła M, "A comparison of IHC and FISH cytogenetic methods in the evaluation of HER2 status in breast cancer", Adv Clin Exp Med, 24, pp.899~903 (2015)
- Petroni S, "FISH testing of HER2 immunohistochemistry 1+ invasive breast cancer with unfavorable characteristics", Oncol Lett, 12, pp.3115~3122 (2016)
- Zabaglo L, "HER2 staining intensity in HER2-positive disease: relationship with FISH amplification and clinical outcome in the HERA trial of adjuvant trastuzumab", Ann Oncol, 24, pp.2761~2766 (2013)
- 김지선, "The Basic Facts of Korean Breast Cancer in 2012: Results from a Nationwide Survey and Breast Cancer Registry Database", Journal of Breast Cancer, 18(2), pp.103~111 (2015), 한국유방암학회
- 민선영, "The Basic Facts of Korean Breast Cancer in 2013: Results of a Nationwide Survey and Breast Cancer Registry Database", Journal of Breast Cancer, 19(1), pp.1~7 (2016), 한국유방암학회
- Choi MY, "Characterization of Korean male breast cancer using an online nationwide breast-cancer database: matched-pair analysis of patients with female breast cancer", Medicine (Baltimore), 95, pp.e3299~ (2016)
- Chang JS, "Trends in the application of postmastectomy radiotherapy for breast cancer with 1 to 3 positive axillary nodes and tumors ≤5 cm in the modern treatment era: a retrospective Korean Breast Cancer Society report", Medicine (Baltimore), 95, pp.e3592~ (2016)
- Singhai R, "Immunohistochemical (IHC) HER-2", neu and fluorescent-in situ hybridization (FISH) gene amplification of breast cancer in Indian women, 2011, pp.12, 179~183
- Slamon DJ, "Human breast cancer: correlation of relapse and survival with amplification of the HER-2", neu oncogene, 1987, pp.235, 177~182
- Goud KI, "Evaluation of HER-2", neu status in breast cancer specimens using immunohistochemistry (IHC) & fluorescence in-situ hybridization (FISH) assay, 2012, pp.135, 312~317
- Pauletti G, "Assessment of methods for tissue-based detection of the HER-2", neu alteration in human breast cancer: a direct comparison of fluorescence in situ hybridization and immunohistochemistry, 2000, pp.18, 3651~3664
- Pehlivanoglu B, "Comparison of HER2 status determination methods in HER2(2+) patients: manual fluorescent in situ hybridization (FISH) vs. dual silver enhanced in situ hybridization (SISH)", Ann Diagn Pathol, 31, pp.36~40 (2017)
- 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)
- Toi M, "Differential survival following trastuzumab treatment based on quantitative HER2 expression and HER2 homodimers in a clinic-based cohort of patients with metastatic breast cancer", BMC Cancer, 10, pp.56~ (2010)
- Lipton A, "Quantitative HER2 protein levels predict outcome in fluorescence in situ hybridization-positive patients with metastatic breast cancer treated with trastuzumab", Cancer, 116, pp.5168~5178 (2010)
- Xu QQ, "HER2 amplification level is not a prognostic factor for HER2-positive breast cancer with trastuzumab-based adjuvant treatment: a systematic review and meta-analysis", Oncotarget, 7, pp.63571~63582 (2016)
- Chibon F, "Prediction of HER2 gene status in Her2 2+ invasive breast cancer: a study of 108 cases comparing ASCO", CAP and FDA recommendations, 2009, pp.22, 403~409
- Ohnstad HO, "Prognostic value of PAM50 and risk of recurrence score in patients with early-stage breast cancer with long-term follow-up", Breast Cancer Res, 19, pp.120~ (2017)
- Jimenez RE, "Determination of Her-2", neu status in breast carcinoma: comparative analysis of immunohistochemistry and fluorescent in situ hybridization, 2000, pp.13, 37~45
- Mrhalová M, "Relative quantification of ERBB2 mRNA in invasive duct carcinoma of the breast: correlation with ERBB-2 protein expression and ERBB2 gene copy number", Pathol Res Pract, 199, pp.453~461 (2003)