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Clinical Implications According to Diagnostic Methods of Human Epidermal Growth Factor Receptor 2 Positivity in Breast Cancer: A Retrospective Study

  • Kim, Bong Kyun (Department of Surgery, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Jeong, Joon (Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine) ;
  • Han, Wonshik (Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine) ;
  • Yoon, Tae-In (Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Seong, Min-Ki (Department of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences) ;
  • Jung, Jin Hyang (Department of Surgery, Kyungpook National University School of Medicine) ;
  • Jung, Sung Hoo (Department of Surgery, Chonbuk National University Medical School) ;
  • Lee, Jina (Department of Surgery, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Sun, Woo Young (Department of Surgery, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Korean Breast Cancer Society (Korean Breast Cancer Society)
  • 투고 : 2018.05.30
  • 심사 : 2018.08.28
  • 발행 : 2018.12.31

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.

키워드

참고문헌

  1. Ballinger TJ, Sanders ME, Abramson VG. Current HER2 testing recommendations and clinical relevance as a predictor of response to targeted therapy. Clin Breast Cancer 2015;15:171-80. https://doi.org/10.1016/j.clbc.2014.11.009
  2. Christgen M, van Luttikhuizen JL, Raap M, Braubach P, Schmidt L, Jonigk D, et al. Precise ERBB2 copy number assessment in breast cancer by means of molecular inversion probe array analysis. Oncotarget 2016;7:82733-40.
  3. Stocker A, Hilbers ML, Gauthier C, Grogg J, Kullak-Ublick GA, Seifert B, et al. HER2/CEP17 ratios and clinical outcome in HER2-positive early breast cancer undergoing trastuzumab-containing therapy. PLoS One 2016;11:e0159176. https://doi.org/10.1371/journal.pone.0159176
  4. Kim HA, Kim EK, Kim MS, Yu JH, Lee MR, Lee HK, et al. Association of human epidermal growth factor receptor 2 with radiotherapy resistance in patients with T1N0M0 breast cancer. J Breast Cancer 2013;16:266-73. https://doi.org/10.4048/jbc.2013.16.3.266
  5. Andrulis IL, Bull SB, Blackstein ME, Sutherland D, Mak C, Sidlofsky S, et al. neu/erbB-2 amplification identifies a poor-prognosis group of women with node-negative breast cancer. Toronto Breast Cancer Study Group. J Clin Oncol 1998;16:1340-9. https://doi.org/10.1200/JCO.1998.16.4.1340
  6. Lim TH, Lim AS, Thike AA, Tien SL, Tan PH. 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. Arch Pathol Lab Med 2016;140:140-7. https://doi.org/10.5858/arpa.2015-0108-OA
  7. Kurozumi S, Padilla M, Kurosumi M, Matsumoto H, Inoue K, Horiguchi J, et al. 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 2016;158:99-111. https://doi.org/10.1007/s10549-016-3856-2
  8. Engel RH, Kaklamani VG. HER2-positive breast cancer: current and future treatment strategies. Drugs 2007;67:1329-41. https://doi.org/10.2165/00003495-200767090-00006
  9. Perez EA, Romond EH, Suman VJ, Jeong JH, Davidson NE, Geyer CE Jr, et al. 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 N9831 and NSABP B-31. J Clin Oncol 2011;29:3366-73. https://doi.org/10.1200/JCO.2011.35.0868
  10. Park K, Han S, Kim JY, Kim HJ, Kwon JE, Gwak G. Silver-enhanced in situ hybridization as an alternative to fluorescence in situ hybridization for assaying HER2 amplification in clinical breast cancer. J Breast Cancer 2011;14:276-82. https://doi.org/10.4048/jbc.2011.14.4.276
  11. Wesola M, Jelen M. A comparison of IHC and FISH cytogenetic methods in the evaluation of HER2 status in breast cancer. Adv Clin Exp Med 2015;24:899-903. https://doi.org/10.17219/acem/27923
  12. Petroni S, Caldarola L, Scamarcio R, Giotta F, Latorre A, Mangia A, et al. FISH testing of HER2 immunohistochemistry 1+ invasive breast cancer with unfavorable characteristics. Oncol Lett 2016;12: 3115-22. https://doi.org/10.3892/ol.2016.5125
  13. Zabaglo L, Stoss O, Ruschoff J, Zielinski D, Salter J, Arfi M, et al. HER2 staining intensity in HER2-positive disease: relationship with FISH amplification and clinical outcome in the HERA trial of adjuvant trastuzumab. Ann Oncol 2013;24:2761-6. https://doi.org/10.1093/annonc/mdt275
  14. Kim Z, Min SY, Yoon CS, Jung KW, Ko BS, Kang E, et al. The basic facts of Korean breast cancer in 2012: results from a nationwide survey and breast cancer registry database. J Breast Cancer 2015;18: 103-11. https://doi.org/10.4048/jbc.2015.18.2.103
  15. Min SY, Kim Z, Hur MH, Yoon CS, Park EH, Jung KW, et al. The basic facts of Korean breast cancer in 2013: results of a nationwide survey and breast cancer registry database. J Breast Cancer 2016;19: 1-7. https://doi.org/10.4048/jbc.2016.19.1.1
  16. Choi MY, Lee SK, Lee JE, Park HS, Lim ST, Jung Y, et al. Characterization of Korean male breast cancer using an online nationwide breast-cancer database: matched-pair analysis of patients with female breast cancer. Medicine (Baltimore) 2016;95:e3299. https://doi.org/10.1097/MD.0000000000003299
  17. Chang JS, Choi JE, Park MH, Jung SH, Choi BO, Park HS, et al. 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) 2016;95:e3592. https://doi.org/10.1097/MD.0000000000003592
  18. Singhai R, Patil V, Patil A. Immunohistochemical (IHC) HER-2/neu and fluorescent-in situ hybridization (FISH) gene amplification of breast cancer in Indian women. Asian Pac J Cancer Prev 2011;12: 179-83.
  19. Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987;235:177-82. https://doi.org/10.1126/science.3798106
  20. Goud KI, Dayakar S, Vijayalaxmi K, Babu SJ, Reddy PV. Evaluation of HER-2/neu status in breast cancer specimens using immunohistochemistry (IHC) & fluorescence in-situ hybridization (FISH) assay. Indian J Med Res 2012;135:312-7.
  21. Pauletti G, Dandekar S, Rong H, Ramos L, Peng H, Seshadri R, et al. 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. J Clin Oncol 2000;18:3651-64. https://doi.org/10.1200/JCO.2000.18.21.3651
  22. Pehlivanoglu B, Serin G, Yeniay L, Zekioglu O, Gokmen E, Ozdemir N. 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 2017;31:36-40. https://doi.org/10.1016/j.anndiagpath.2017.06.005
  23. Mass RD, Press MF, Anderson S, Cobleigh MA, Vogel CL, Dybdal N, et al. 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 2005;6: 240-6. https://doi.org/10.3816/CBC.2005.n.026
  24. Toi M, Sperinde J, Huang W, Saji S, Winslow J, Jin X, et al. 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 2010;10:56. https://doi.org/10.1186/1471-2407-10-56
  25. Lipton A, Kostler WJ, Leitzel K, Ali SM, Sperinde J, Weidler J, et al. Quantitative HER2 protein levels predict outcome in fluorescence in situ hybridization-positive patients with metastatic breast cancer treated with trastuzumab. Cancer 2010;116:5168-78. https://doi.org/10.1002/cncr.25430
  26. Xu QQ, Pan B, Wang CJ, Zhou YD, Mao F, Lin Y, et al. 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 2016;7:63571-82.
  27. Chibon F, de Mascarel I, Sierankowski G, Brouste V, Bonnefoi H, Debled M, et al. Prediction of HER2 gene status in Her2 2+ invasive breast cancer: a study of 108 cases comparing ASCO/CAP and FDA recommendations. Mod Pathol 2009;22:403-9. https://doi.org/10.1038/modpathol.2008.195
  28. Ohnstad HO, Borgen E, Falk RS, Lien TG, Aaserud M, Sveli MA, et al. Prognostic value of PAM50 and risk of recurrence score in patients with early-stage breast cancer with long-term follow-up. Breast Cancer Res 2017;19:120. https://doi.org/10.1186/s13058-017-0911-9
  29. Jimenez RE, Wallis T, Tabasczka P, Visscher DW. Determination of Her-2/neu status in breast carcinoma: comparative analysis of immunohistochemistry and fluorescent in situ hybridization. Mod Pathol 2000;13:37-45. https://doi.org/10.1038/modpathol.3880007
  30. Mrhalova M, Kodet R, Kalinova M, Hilska I. 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 2003;199:453-61. https://doi.org/10.1078/0344-0338-00445