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      Analysis of the molecular subtypes of preoperative core needle biopsy and surgical specimens in invasive breast cancer

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          Abstract

          Background

          Accurate molecular classification of breast core needle biopsy (CNB) tissue is important for determining neoadjuvant systemic therapies for invasive breast cancer. The researchers aimed to evaluate the concordance rate (CR) of molecular subtypes between CNBs and surgical specimens.

          Methods

          This study was conducted with invasive breast cancer patients who underwent surgery after CNB at Seoul St. Mary’s Hospital between December 2014 and December 2017. Estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), and Ki67 were analyzed using immunohistochemistry. ER and PR were evaluated by Allred score (0–8). HER2 was graded from 0 to +3, and all 2+ cases were reflex tested with silver in situ hybridization. The labeling index of Ki67 was counted by either manual scoring or digital image analysis. Molecular subtypes were classified using the above surrogate markers.

          Results

          In total, 629 patients were evaluated. The CRs of ER, PR, HER2, and Ki67 were 96.5% (kappa, 0.883; p<.001), 93.0% (kappa, 0.824; p<.001), 99.7% (kappa, 0.988; p<.001), and 78.7% (kappa, 0.577; p<.001), respectively. Digital image analysis of Ki67 in CNB showed better concordance with Ki67 in surgical specimens (CR, 82.3%; kappa, 0.639 for digital image analysis vs. CR, 76.2%; kappa, 0.534 for manual counting). The CRs of luminal A, luminal B, HER2, and triple negative types were 89.0%, 70.0%, 82.9%, and 77.2%, respectively.

          Conclusions

          CNB was reasonably accurate for determining ER, PR, HER2, Ki67, and molecular subtypes. Using digital image analysis for Ki67 in CNB produced more accurate molecular classifications.

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          Most cited references27

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          Ki67 Index, HER2 Status, and Prognosis of Patients With Luminal B Breast Cancer

          Maggie C. U. Cheang, Stephen Chia, David Voduc … (2009)
          Background Gene expression profiling of breast cancer has identified two biologically distinct estrogen receptor (ER)-positive subtypes of breast cancer: luminal A and luminal B. Luminal B tumors have higher proliferation and poorer prognosis than luminal A tumors. In this study, we developed a clinically practical immunohistochemistry assay to distinguish luminal B from luminal A tumors and investigated its ability to separate tumors according to breast cancer recurrence-free and disease-specific survival. Methods Tumors from a cohort of 357 patients with invasive breast carcinomas were subtyped by gene expression profile. Hormone receptor status, HER2 status, and the Ki67 index (percentage of Ki67-positive cancer nuclei) were determined immunohistochemically. Receiver operating characteristic curves were used to determine the Ki67 cut point to distinguish luminal B from luminal A tumors. The prognostic value of the immunohistochemical assignment for breast cancer recurrence-free and disease-specific survival was investigated with an independent tissue microarray series of 4046 breast cancers by use of Kaplan–Meier curves and multivariable Cox regression. Results Gene expression profiling classified 101 (28%) of the 357 tumors as luminal A and 69 (19%) as luminal B. The best Ki67 index cut point to distinguish luminal B from luminal A tumors was 13.25%. In an independent cohort of 4046 patients with breast cancer, 2847 had hormone receptor–positive tumors. When HER2 immunohistochemistry and the Ki67 index were used to subtype these 2847 tumors, we classified 1530 (59%, 95% confidence interval [CI] = 57% to 61%) as luminal A, 846 (33%, 95% CI = 31% to 34%) as luminal B, and 222 (9%, 95% CI = 7% to 10%) as luminal–HER2 positive. Luminal B and luminal–HER2-positive breast cancers were statistically significantly associated with poor breast cancer recurrence-free and disease-specific survival in all adjuvant systemic treatment categories. Of particular relevance are women who received tamoxifen as their sole adjuvant systemic therapy, among whom the 10-year breast cancer–specific survival was 79% (95% CI = 76% to 83%) for luminal A, 64% (95% CI = 59% to 70%) for luminal B, and 57% (95% CI = 47% to 69%) for luminal–HER2 subtypes. Conclusion Expression of ER, progesterone receptor, and HER2 proteins and the Ki67 index appear to distinguish luminal A from luminal B breast cancer subtypes.
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            Neoadjuvant therapy in the treatment of breast cancer.

            Mediget Teshome, Kelly Hunt (2014)
            Neoadjuvant systemic therapy in breast cancer treatment was initially utilized for inoperable disease. However, several randomized prospective studies have demonstrated comparable survival with adjuvant chemotherapy in early-stage, operable breast cancer while also decreasing tumor size facilitating breast conservation without significant increases in local recurrence. Response to therapy can predict outcome, with improved survival associated with pathologic complete response (pCR). Triple negative and HER2-positive subtypes show increased pCR rates. A multidisciplinary approach is necessary with neoadjuvant treatment. This can improve rates of breast conservation, provide insights into tumor biology and predict patient outcomes.
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              An overview of assessment of prognostic and predictive factors in breast cancer needle core biopsy specimens.

              David Ellis, E Rakha (2007)
              Needle core biopsy (NCB), as part of triple assessment for preoperative evaluation and diagnosis of breast cancer, is now considered as an established, highly accurate method for diagnosing breast cancer that has replaced either fine needle aspiration cytology or excisional biopsy as the initial diagnostic biopsy procedures in many institutions. In addition to its primary role in establishing an accurate histological diagnosis, NCB can potentially provide important additional pathological prognostic information which may be of direct clinical value in certain situations, such as patients being considered for preoperative (neoadjuvant) therapy. With this background in mind we briefly review the current role of NCB in breast cancer diagnosis and then concentrate this review on the usefulness and issues relating to use of this technique in providing accurate, reliable and clinically relevant preoperative prognostic and predictive information in patients with breast cancer.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Pathol Transl Med
                Journal ID (iso-abbrev): J Pathol Transl Med
                Journal ID (publisher-id): JPTM
                Title: Journal of Pathology and Translational Medicine
                Publisher: The Korean Society of Pathologists and the Korean Society for Cytopathology
                ISSN (Print): 2383-7837
                ISSN (Electronic): 2383-7845
                Publication date (Print): January 2020
                Publication date (Electronic): 13 November 2019
                Volume: 54
                Issue: 1
                Pages: 87-94
                Affiliations
                [1 ]Department of Hospital Pathology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
                [2 ]Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
                [3 ]Cancer Research Institute, The Catholic University of Korea, Seoul, Korea
                [4 ]Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
                [5 ]Department of Radiology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
                Author notes
                Corresponding Author: Ahwon Lee, MD, PhD, Department of Hospital Pathology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea Tel: +82-2-2258-1621, Fax: +82-2-2258-1627, E-mail: klee@ 123456catholic.ac.kr
                Author information
                http://orcid.org/0000-0003-2952-1662
                http://orcid.org/0000-0002-7967-0917
                http://orcid.org/0000-0002-2656-0650
                http://orcid.org/0000-0002-5790-353X
                http://orcid.org/0000-0003-4478-9720
                http://orcid.org/0000-0002-2523-9531
                Article
                Publisher ID: jptm-2019-10-14
                DOI: 10.4132/jptm.2019.10.14
                PMC ID: 6986971
                PubMed ID: 31718121
                SO-VID: d48dd960-5570-460c-bc31-ba1747331f0b
                Copyright © © 2020 The Korean Society of Pathologists/The Korean Society for Cytopathology
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 1 August 2019
                Date revision received : 25 September 2019
                Date accepted : 14 October 2019
                Categories
                Subject: Original Article

                Keywords: breast neoplasms,core needle biopsy,receptors, estrogen,receptors, progesterone,human epidermal growth factor receptor 2,immunohistochemistry
                Data availability:
                Keywords: breast neoplasms, core needle biopsy, receptors, estrogen, receptors, progesterone, human epidermal growth factor receptor 2, immunohistochemistry

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