Cancer Research and Treatment

Original Articles

Long-Term Prognostic Value and Analytical Parameters of the Next-Generation Sequencing-Based Multigene Assay in Hormone Receptor-Positive, HER2-Negative Breast Cancer: Hyunji Kim, Jiwon Koh, Hyunwoo Lee, Gyungyub Gong, Sujin Oh, Jiyoung Lee, Ho Eun Chang, Yunhee Choi, Eunhye Kang, Jai Min Ryu, Dong Seung Shin, Sae Byul Lee, Hee Jin Lee, Hong-Kyu Kim, Hee-Chul Shin, Wonshik Han, Han-Byoel Lee, Kyoung Un Park; Received July 7, 2025 Accepted August 29, 2025 Published online September 1, 2025; DOI: https://doi.org/10.4143/crt.2025.701 [Accepted]

Abstract PDF: Purpose
In hormone receptor (HR)-positive, HER2-negative early breast cancer, gene expression testing facilitates treatment decisions. A next-generation sequencing (NGS)-based assay was developed to address test decentralization and underrepresentation of younger/premenopausal patients. We aimed to validate the long-term prognostic value of the NGS-based assay and analyze its quality control (QC) parameters.
Materials and Methods
We analyzed samples from 265 patients with breast cancer with at least 10 years of follow-up. We evaluated the long-term prognostic ability of the NGS-based assay according to the risk groups for distant recurrence, as determined by the Decision Index (DI), and the performance of the QC parameters used for the experimental process.
Results
Among 265 participants, 60.4% were ≤50 years old, and 39 (14.7%) experienced distant recurrence within 10 years. In the DI-stratified low- and high-risk groups (n=186; 70.2% and n=79; 29.8%), 10-year distant metastasis-free survival rates were 96.1% (95% CI 92.1-98.1) and 79.3% (95% CI 68.4-86.8), respectively. In patients aged ≤50 years, the high-risk group had a hazard ratio of 5.89 (95% CI 2.84-12.20). Analyses including 106 samples that failed the stringent QC criteria showed inferior prognostic value, wherein DV200 and cDNA concentrations were the most crucial parameters.
Conclusion
We validated the prognostic ability of an NGS-based assay to stratify HR-positive/HER2-negative breast cancers and predict the risk of distant recurrence, and confirmed the requirement for stringent QC criteria to ensure its prognostic ability.

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Breast cancer

Prognostic Value of the Evolution of HER2-Low Expression after Neoadjuvant Chemotherapy: Youzhao Ma, Mingda Zhu, Jingyang Zhang, Minhao Lv, Xiuchun Chen, Zhenzhen Liu; Cancer Res Treat. 2023;55(4):1210-1221. Published online April 4, 2023; DOI: https://doi.org/10.4143/crt.2022.1633

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Purpose
Patients with human epidermal growth factor receptor 2 (HER2)–low advanced breast cancer can benefit from trastuzumab deruxtecan. Given the unclear prognostic characteristics of HER2-low breast cancer, we investigated the prognostic characteristics of HER2-low expression from primary tumor to residual disease after neoadjuvant chemotherapy (NACT).
Materials and Methods
The data of HER2-negative patients receiving NACT at our center were collected. Pathological complete response (pCR) rate were compared between HER2-0 and HER2-low patients. The evolution of HER2 expression from primary tumor to residual disease and its impact on disease-free survival (DFS) were examined.
Results
Of the 690 patients, 494 patients had HER2-low status, of which 72.3% were hormone receptor (HR)–positive (p < 0.001). The pCR rates of HER2-low and HER2-0 patients (14.2% vs. 23.0%) showed no difference in multivariate analysis regardless of HR status. No association was observed between DFS and HER2 status. Of the 564 non-pCR patients, 57 (10.1%) changed to HER2-positive, and 64 of the 150 patients (42.7%) with HER2-0 tumors changed to HER2-low. HER2-low (p=0.004) and HR-positive (p=0.010) tumors before NACT were prone to HER2 gain. HER2 gain patients had a better DFS compared with HER2-negative maintained patients (87.9% vs. 79.5%, p=0.048), and the DFS of targeted therapy group was better than that of no targeted therapy group (92.4% vs. 66.7%, p=0.016).
Conclusion
Although HER2-low did not affect the pCR rate and DFS, significant evolution of HER2-low expression after NACT creates opportunities for targeted therapy including trastuzumab.

Citations

Citations to this article as recorded by

Preoperative Differentiation of HER2‐Zero and HER2‐Low from HER2‐Positive Invasive Ductal Breast Cancers Using BI‐RADS MRI Features and Machine Learning Modeling
Jiejie Zhou, Yang Zhang, Haiwei Miao, Ga Young Yoon, Jinhao Wang, Yezhi Lin, Hailing Wang, Yan‐Lin Liu, Jeon‐Hor Chen, Zhifang Pan, Min‐Ying Su, Meihao Wang
Journal of Magnetic Resonance Imaging.2025; 61(2): 928. CrossRef
Combining ultrasound and immunohistochemistry to differentiate HER-2-low from HER-2-null breast cancer: A diagnostic value analysis
Lu Li, Meng Zhang, Chen Qian, Hao Wu, Kexin Zhang, Wenying Wu
Journal of Radiation Research and Applied Sciences.2025; 18(4): 101918. CrossRef
HER2-low status as a dynamic biomarker in breast cancer: molecular and clinical correlations
A. I. Stukan, S. V. Vtorushin, A. P. Bogdan, T. Yu. Semiglazova, V. V. Kudrina, V. N. Bodnya, V. A. Porkhanov, A. A. Dovlatbekyan, M. A. Chagiev, A. A. Naniz
Siberian journal of oncology.2025; 24(4): 29. CrossRef
Prognostic significance of HER2-low and HER2-zero status before and after neoadjuvant chemotherapy in patients with HER2-negative breast cancer
Youzhao Ma, Jingyang Zhang, Lina Wang, Dechuang Jiao, Xiuchun Chen, Zhenzhen Liu
Therapeutic Advances in Medical Oncology.2025;[Epub] CrossRef
The Modified Neo-Bioscore System for Staging Breast Cancer Treated with Neoadjuvant Therapy Based on Prognostic Significance of HER2-Low Expression
Yingying Zhao, Xinru Chen, Yaohui Wang, Xueqing Zhang, Jingsong Lu, Wenjin Yin
Journal of Clinical Medicine.2024; 13(7): 1850. CrossRef
Comparison of the Pathological Complete Response Rate and Survival Between HER2-Low and HER2-Zero Breast Cancer in Neoadjuvant Chemotherapy Setting: A Systematic Review and Meta-Analysis
Mei Liu, Qin Xiang, Fengsheng Dai, Yixiao Yuan, Zhongjun Wu, Tingxiu Xiang
Clinical Breast Cancer.2024; 24(7): 575. CrossRef
Neoadjuvant chemotherapy efficacy and prognosis in HER2-low and HER2-zero breast cancer patients by HR status: a retrospective study in China
Shaorong Zhao, Yuyun Wang, Angxiao Zhou, Xu Liu, Yi Zhang, Jin Zhang
PeerJ.2024; 12: e17492. CrossRef
Alteration of HER2 Status During Breast Cancer Progression: A Clinicopathological Analysis Focusing on HER2-Low Status
Kyungah Bai, Ji Won Woo, Hyun Jung Kwon, Yul Ri Chung, Koung Jin Suh, Se Hyun Kim, Jee Hyun Kim, So Yeon Park
Laboratory Investigation.2024; 104(8): 102092. CrossRef
HER2-Low Breast Cancer: Now and in the Future
Sora Kang, Sung-Bae Kim
Cancer Research and Treatment.2024; 56(3): 700. CrossRef
Stable or at least once HER2-low status during neoadjuvant chemotherapy confers survival benefit in patients with breast cancer
Yingying Zhao, Xinru Chen, Yaohui Wang, Xueqing Zhang, Yumei Ye, Shuguang Xu, Liheng Zhou, Yanping Lin, Jingsong Lu, Wenjin Yin
Annals of Medicine.2024;[Epub] CrossRef
The prognostic impact of Her2 status in early triple negative breast cancer: a Turkish Oncology Group (TOG) study
Neslihan Özyurt, Ali Alkan, Burcu Gülbağcı, Mustafa Seyyar, Esra Aşık, Mustafa Şahbazlar, Mehmet Türker, Oğuzcan Kınıkoğlu, Tahir Yerlikaya, Gülhan Dinç, Ali Aytaç, Ziya Kalkan, Senar Ebinç, İlkay Gültürk, Merve Keskinkılıç, Zehra Sucuoğlu İşleyen, Dilek
Scientific Reports.2024;[Epub] CrossRef
Prognostic implications of HER2 changes after neoadjuvant chemotherapy in patients with HER2-zero and HER2-low breast cancer
Sora Kang, So Heun Lee, Hee Jin Lee, Hyehyun Jeong, Jae Ho Jeong, Jeong Eun Kim, Jin-Hee Ahn, Kyung Hae Jung, Gyungyub Gong, Hak Hee Kim, Saebyeol Lee, Jongwon Lee, Sung-Bae Kim
European Journal of Cancer.2023; : 112956. CrossRef

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Paranasal Sinus Invasion in Nasopharyngeal Carcinoma after Intensity-Modulated Radiotherapy: Caineng Cao, Feng Jiang, Qifeng Jin, Ting Jin, Shuang Huang, Qiaoying Hu, Yuanyuan Chen, Yongfeng Piao, Yonghong Hua, Xinglai Feng, Xiaozhong Chen; Cancer Res Treat. 2019;51(1):73-79. Published online February 26, 2018; DOI: https://doi.org/10.4143/crt.2017.607

Abstract PDF PubReader ePub

Purpose
The aim of this study is to evaluate the prognostic significance of paranasal sinus invasion for nasopharyngeal carcinoma (NPC) and its suitable position in the T classification.
Materials and Methods
The magnetic resonance imaging (MRI) scans of 695 patients with previously untreated, biopsy-proven, non-metastatic NPC that was treated with intensity-modulated radiotherapy (IMRT) were reviewed retrospectively.
Results
The incidence of paranasal sinus invasion was 39.4% (274 of 695 patients). Multivariate analysis showed that paranasal sinus invasion was an independent negative prognostic factor for local failure-free survival (LFFS) (p < 0.05). According to the eighth American Joint Committee on Cancer (AJCC) staging system, 275 patients were classified as T3 classification. Of these, 78 patients (28.4%) developed paranasal sinus invasion (T3b) and 197 (71.6%) didn’t (T3a). The estimated 5-year LFFS and overall survival (OS) rates for the patients with T3b and T3a classification were 88.6% versus 95.0% (p=0.047), and 84.5% versus 93.3% (p=0.183), respectively. The estimated 5-year LFFS and OS rates for the patientswith T4 classificationwere 89.5% and 83.2%,whichwere similarwith the outcomes of patients with T3b classification.
Conclusion
MRI-determined paranasal sinus invasion is an independent prognostic factor of NPC treated by IMRT. Paranasal sinus invasion is recommended to classify as T4 classification in the 8th AJCC staging system for NPC.

Citations

Citations to this article as recorded by

Clinical Study of Early-Nasal Intervention Among Individuals With Nasopharyngeal Cancer to Prevent Radiation-Induced Sinusitis
Tianbin Ouyang, Hou Shi, Yaowen Wang, Jianliang Zhou
Ear, Nose & Throat Journal.2025;[Epub] CrossRef
Use of 18F‐FDG PET/MRI as an Initial Staging Procedure for Nasopharyngeal Carcinoma
Caineng Cao, Yuting Fang, Bocheng Yu, Yuanfan Xu, Mengyun Qiang, Changjuan Tao, Shuang Huang, Xiaozhong Chen
Journal of Magnetic Resonance Imaging.2024; 59(3): 922. CrossRef
Extent of paranasal sinus involvement and its prognostic value in nasopharyngeal carcinoma: Proposed modification in the current UICC/AJCC staging system
Xiao-Yi Wang, Si-Yu Zhu, Wei-Jie WU, Hao-Jiang Li, Jiao Li, Xiao-Feng Lin, Li Li, Li-Zhi Liu
Radiotherapy and Oncology.2021; 160: 221. CrossRef
Prognostic Factors for Overall Survival in Nasopharyngeal Cancer and Implication for TNM Staging by UICC: A Systematic Review of the Literature
Chi Leung Chiang, Qiaojuan Guo, Wai Tong Ng, Shaojun Lin, Tiffany Sze Wai Ma, Zhiyuan Xu, Youping Xiao, Jishi Li, Tianzhu Lu, Horace Cheuk Wai Choi, Wenqi Chen, Eric Sze Chun Chau, Peter Ho Yin Luk, Shao Hui Huang, Brian O’Sullivan, Jianji Pan, Anne Wing
Frontiers in Oncology.2021;[Epub] CrossRef
Locoregional Extension Patterns of Nasopharyngeal Carcinoma Detected by FDG PET/MR
Caineng Cao, Yuanfan Xu, Shuang Huang, Feng Jiang, Ting Jin, Qifeng Jin, Yonghong Hua, Qiaoying Hu, Xiaozhong Chen
Frontiers in Oncology.2021;[Epub] CrossRef
Impact of Paranasal Sinus Invasion on Oncologic and Dosimetric Outcomes in Nasopharyngeal Carcinoma Following Intensity-Modulated Radiation Therapy—Implications for Risk Stratification and Planning Optimization
Xin Zhou, Xiayun He, Fen Xue, Xiaomin Ou, Chaosu Hu
Frontiers in Oncology.2020;[Epub] CrossRef
Prognostic Value and Staging Classification of Lymph Nodal Necrosis in Nasopharyngeal Carcinoma after Intensity-Modulated Radiotherapy
Yanru Feng, Caineng Cao, Qiaoying Hu, Xiaozhong Chen
Cancer Research and Treatment.2019; 51(3): 1222. CrossRef
Paranasal sinus invasion suggested T4 classification of patients of nasopharyngeal carcinoma: A two‐center retrospective investigation
Liqing Wu, Shuiqing Zhuo, Weike Zeng, Shaobo Liang, Shunxin Wang, Chunyan Cui, Jian Zhou, Guangyin Ruan, Shuoyu Xu, Lifei Wang, Ling Huang, Lizhi Liu, Haojiang Li
Head & Neck.2019; 41(12): 4088. CrossRef

10,644 View
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