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Differentiating HER2-low and HER2-zero tumors with 21-gene multigene assay in 2,295 h+HER2-breast cancer: a retrospective analysis

Authors
 Yoonwon Kook  ;  Young-Jin Lee  ;  Chihhao Chu  ;  Ji Soo Jang  ;  Seung Ho Baek  ;  Soong June Bae  ;  Yoon Jin Cha  ;  Gyungyup Gong  ;  Joon Jeong  ;  Sae Byul Lee  ;  Sung Gwe Ahn 
Citation
 BREAST CANCER RESEARCH, Vol.26 : 154, 2024-11 
Journal Title
BREAST CANCER RESEARCH
ISSN
 1465-5411 
Issue Date
2024-11
MeSH
Adult ; Aged ; Biomarkers, Tumor* / genetics ; Breast Neoplasms* / drug therapy ; Breast Neoplasms* / genetics ; Breast Neoplasms* / mortality ; Breast Neoplasms* / pathology ; Female ; Gene Expression Profiling ; Humans ; Immunohistochemistry ; Middle Aged ; Prognosis ; Receptor, ErbB-2* / genetics ; Receptor, ErbB-2* / metabolism ; Retrospective Studies
Keywords
21-gene multigene assay ; Breast cancer ; HER2-low
Abstract
Background: HER2-positivity is an essential marker for therapeutic decisions, while HER2 expression is heterogenous. In recent years, there has been increasing recognition of a subgroup of breast cancer patients who have low levels of HER2 expression, also known as HER2-low because trastuzumab deruxtecan offers clinical benefit for patients with HER2-low metastatic breast cancer. Despite the growing interest in HER2-low breast cancer, there is limited research on how multigene assays can help differentiate between HER2-low and HER2-negative breast cancer. Among HR + HER2- breast cancer, we compared genomic characteristics between HER2-low and HER2-zero using the 21-gene assay.

Methods: A retrospective review of clinical records was performed in 2,295 patients who underwent Oncotype DX® test in two hospitals between 2013 and 2020. Patients were classified into two groups as the HER2-zero and HER2-low based on HER2 immunohistochemistry. In cases with HER2 2+, no amplification of HER2 gene was confirmed by silver in situ hybridization. High genomic risk was defined as cases with 21-gene recurrence score (RS) > 25. Multivariable binary logistic-regression analysis was performed.

Results: Of these, 944 (41.1%) patients were assigned to the HER2-zero group, while 1351 (58.9%) patients were assigned to the HER2-low group. The average Recurrence Score (RS) was found to be 17.802 in the HER2-zero breast cancer group and 18.503 in the HER2-low group, respectively (p-value < 0.005). When comparing the proportion of high RS between the two groups, the HER2-zero group had a high RS rate of 12.4% (117 out of 944), while the HER2-low group had a high RS rate of 17.0% (230 out of 1351) (p = 0.002). The HER2 score identified by qRT-PCR was 8.912 in the HER2-zero group and 9.337 in the HER2-low group (p < 0.005). In multivariable analysis, HER2-low status was found to be an independent factor for high RS, with an odds ratio of 1.517 (1.172-1.964), independent of ER, PR, and Ki67. Within the subgroup of patients with invasive ductal carcinoma, the high RS rates were 19% in the HER2-low group and 14% in the HER2-zero group. However, when considering all patients, there were no significant differences observed in recurrence-free survival and overall survival between the HER2-low and HER2-zero groups.

Conclusion: Within HR + HER2- breast cancer, HER2-low tumors are associated with high RS, especially for histologically invasive ductal carcinoma. A prognostic influence of HER2-low expression among HR + HER2- breast cancer remains as an area that requires further study.
Files in This Item:
T992024808.pdf Download
DOI
10.1186/s13058-024-01911-9
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Chu, Chihhao(곡지호)
Kook, Yoonwon(국윤원)
Bae, Soong June(배숭준) ORCID logo https://orcid.org/0000-0002-0012-9694
Baek, Seung Ho(백승호)
Ahn, Sung Gwe(안성귀) ORCID logo https://orcid.org/0000-0002-8778-9686
Jeong, Joon(정준) ORCID logo https://orcid.org/0000-0003-0397-0005
Cha, Yoon Jin(차윤진) ORCID logo https://orcid.org/0000-0002-5967-4064
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/201700
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