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      Comparison of clinicopathological characteristics and response to neoadjuvant chemotherapy between HER2-low and HER2-zero breast cancer

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          Abstract

          Novel anti-HER2 antibody-drug conjugates trastuzumab deruxtecan (DS-8201a) showed its effect in previously-treated HER2-low metastatic breast cancer, suggesting a promising future in HER2-low breast cancer. We retrospectively reviewed the clinicopathological data of 325 patients with stage I–III HER2 negative breast cancer who received neoadjuvant chemotherapy in the First Affiliated Hospital of Sun Yat-sen University from January 2016 to June 2021. In general, 91 patients (28.0%) were HER2-zero, and 234 patients (72.0%) were HER2-low. The pathological complete response (pCR) rate of the entire cohort was 17.3%. The pCR rate was 16.7% in HER2-low group, and 18.9% in HER2-zero group, showing no significant difference. Patients with HER2-low tumors had significantly longer overall survival (OS) than patients with HER2-zero tumors. ER status was the affecting factor of OS in HER2-low patients in both univariate and multivariate analysis. In conclusion, evidence for HER2-low BC as a distinct entity is insufficient, and more efforts are needed to standardize the scoring of HER2-low breast cancer.

          Highlights

          • •

            HER2-low breast cancer has a higher proportion of positive hormone receptor status compared with HER-zero breast cancer.

          • •

            HER2-low and HER2-zero breast cancer had similar pathological response rate to neoadjuvant chemotherapy.

          • •

            HER2-low tumors had a significantly longer overall survival than HER2-zero tumors.

          • •

            Estrogen receptor and androgen receptor may play a role in HER2-low breast cancer.

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          Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update

          Antonio Wolff, M. Hammond, Kimberly H. Allison … (2018)
          Purpose To update key recommendations of the American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guideline. Methods Based on the signals approach, an Expert Panel reviewed published literature and research survey results on the observed frequency of less common in situ hybridization (ISH) patterns to update the recommendations. Recommendations Two recommendations addressed via correspondence in 2015 are included. First, immunohistochemistry (IHC) 2+ is defined as invasive breast cancer with weak to moderate complete membrane staining observed in > 10% of tumor cells. Second, if the initial HER2 test result in a core needle biopsy specimen of a primary breast cancer is negative, a new HER2 test may (not "must") be ordered on the excision specimen based on specific clinical criteria. The HER2 testing algorithm for breast cancer is updated to address the recommended work-up for less common clinical scenarios (approximately 5% of cases) observed when using a dual-probe ISH assay. These scenarios are described as ISH group 2 ( HER2/chromosome enumeration probe 17 [CEP17] ratio ≥ 2.0; average HER2 copy number < 4.0 signals per cell), ISH group 3 ( HER2/CEP17 ratio < 2.0; average HER2 copy number ≥ 6.0 signals per cell), and ISH group 4 ( HER2/CEP17 ratio < 2.0; average HER2 copy number ≥ 4.0 and < 6.0 signals per cell). The diagnostic approach includes more rigorous interpretation criteria for ISH and requires concomitant IHC review for dual-probe ISH groups 2 to 4 to arrive at the most accurate HER2 status designation (positive or negative) based on combined interpretation of the ISH and IHC assays. The Expert Panel recommends that laboratories using single-probe ISH assays include concomitant IHC review as part of the interpretation of all single-probe ISH assay results. Find additional information at www.asco.org/breast-cancer-guidelines .
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            Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene

            D Slamon, G G Clark, S C-S Wong … (1987)
            The HER-2/neu oncogene is a member of the erbB-like oncogene family, and is related to, but distinct from, the epidermal growth factor receptor. This gene has been shown to be amplified in human breast cancer cell lines. In the current study, alterations of the gene in 189 primary human breast cancers were investigated. HER-2/neu was found to be amplified from 2- to greater than 20-fold in 30% of the tumors. Correlation of gene amplification with several disease parameters was evaluated. Amplification of the HER-2/neu gene was a significant predictor of both overall survival and time to relapse in patients with breast cancer. It retained its significance even when adjustments were made for other known prognostic factors. Moreover, HER-2/neu amplification had greater prognostic value than most currently used prognostic factors, including hormonal-receptor status, in lymph node-positive disease. These data indicate that this gene may play a role in the biologic behavior and/or pathogenesis of human breast cancer.
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              Trastuzumab emtansine for HER2-positive advanced breast cancer.

              Sunil Verma, David Miles, Luca Gianni … (2012)
              Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate incorporating the human epidermal growth factor receptor 2 (HER2)-targeted antitumor properties of trastuzumab with the cytotoxic activity of the microtubule-inhibitory agent DM1. The antibody and the cytotoxic agent are conjugated by means of a stable linker. We randomly assigned patients with HER2-positive advanced breast cancer, who had previously been treated with trastuzumab and a taxane, to T-DM1 or lapatinib plus capecitabine. The primary end points were progression-free survival (as assessed by independent review), overall survival, and safety. Secondary end points included progression-free survival (investigator-assessed), the objective response rate, and the time to symptom progression. Two interim analyses of overall survival were conducted. Among 991 randomly assigned patients, median progression-free survival as assessed by independent review was 9.6 months with T-DM1 versus 6.4 months with lapatinib plus capecitabine (hazard ratio for progression or death from any cause, 0.65; 95% confidence interval [CI], 0.55 to 0.77; P<0.001), and median overall survival at the second interim analysis crossed the stopping boundary for efficacy (30.9 months vs. 25.1 months; hazard ratio for death from any cause, 0.68; 95% CI, 0.55 to 0.85; P<0.001). The objective response rate was higher with T-DM1 (43.6%, vs. 30.8% with lapatinib plus capecitabine; P<0.001); results for all additional secondary end points favored T-DM1. Rates of grade 3 or 4 adverse events were higher with lapatinib plus capecitabine than with T-DM1 (57% vs. 41%). The incidences of thrombocytopenia and increased serum aminotransferase levels were higher with T-DM1, whereas the incidences of diarrhea, nausea, vomiting, and palmar-plantar erythrodysesthesia were higher with lapatinib plus capecitabine. T-DM1 significantly prolonged progression-free and overall survival with less toxicity than lapatinib plus capecitabine in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane. (Funded by F. Hoffmann-La Roche/Genentech; EMILIA ClinicalTrials.gov number, NCT00829166.).
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                Author and article information

                Contributors
                Shuling Zhou
                Ting Liu
                Xiaying Kuang
                Tiantian Zhen
                Huijuan Shi
                Ying Lin
                Nan Shao
                Journal
                Journal ID (nlm-ta): Breast
                Journal ID (iso-abbrev): Breast
                Title: The Breast : Official Journal of the European Society of Mastology
                Publisher: Elsevier
                ISSN (Print): 0960-9776
                ISSN (Electronic): 1532-3080
                Publication date PMC-release: 14 December 2022
                Publication date Collection: February 2023
                Publication date (Electronic): 14 December 2022
                Volume: 67
                Pages: 1-7
                Affiliations
                [a ]Department of Breast Surgery, The First Affiliated Hospital, Sun Yat-sen University, 58 Zhong Shan Er Lu, Guangzhou, 510080, China
                [b ]Laboratory of Surgery, The First Affiliated Hospital, Sun Yat-sen University, 58 Zhong Shan Er Lu, Guangzhou, 510080, China
                [c ]Department of Pathology, The First Affiliated Hospital, Sun Yat-sen University, 58 Zhong Shan Er Lu, Guangzhou, 510080, China
                Author notes
                [∗ ]Corresponding author. linying3@ 123456mail.sysu.edu.cn
                [∗∗ ]Corresponding author. shaon@ 123456mail.sysu.edu.cn
                [1]

                These authors contributed equally to this work.

                Article
                Publisher Item ID: S0960-9776(22)00198-9
                DOI: 10.1016/j.breast.2022.12.006
                PMC ID: 9792954
                PubMed ID: 36535072
                SO-VID: a5340121-2c19-458c-87b3-de1d926b549c
                Copyright © © 2022 The Authors
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 15 September 2022
                Date revision received : 11 December 2022
                Date accepted : 13 December 2022
                Categories
                Subject: Original Article

                ScienceOpen disciplines: Obstetrics & Gynecology
                Keywords: her2-low breast cancer,neoadjuvant chemotherapy,pathological complete response,survival
                Data availability:
                ScienceOpen disciplines: Obstetrics & Gynecology
                Keywords: her2-low breast cancer, neoadjuvant chemotherapy, pathological complete response, survival

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