基于14642例患者的回顾性队列研究，HER2低乳腺癌症患者的临床病理特征、预后和生存率
Clinicopathological Characteristics, Prognosis, and Survival of HER2-Low Breast Cancer Patients Based on a Retrospective Cohort Study of 14,642 Patients.
摘要(中文译文)
随着HER2抗体药物偶联物的出现，乳腺癌患者尤其是HER2低表达患者获得了新的治疗选择。HER2低表达乳腺癌的生物学特征目前尚不明确。本研究纳入了迄今最大的样本量，旨在探讨HER2低表达乳腺癌与HER2-0及HER2高表达乳腺癌在临床病理特征、病理完全缓解（pCR）及预后方面的差异。本研究纳入14642例女性乳腺癌患者以及来自TCGA的544例女性乳腺癌患者。采用逻辑回归模型确定pCR的预测因素，应用K-M曲线和log-rank检验确定OS和DFS。与HER2-0和HER2高表达患者相比，HER2低表达组中N1-2分期、I-II级、肿瘤大小≤20 mm、Ki-67指数≤14%及浸润性癌的患者比例更高。在HER2低表达亚组的HR+亚型中，病理类型、pN分期、Ki-67值和肿瘤大小的分布存在显著差异。在HER2低表达患者的三阴性乳腺癌亚型中，年龄、病理类型、组织学分级和Ki-67指数的分布存在显著差异。Ki-67指数和病理类型是影响腋窝淋巴结pCR的独立因素。HER2表达的变化主要由新辅助化疗后转为或转出HER2低表达的患者所驱动。三种HER2亚型之间的pCR率和生存率无显著差异。HER2低表达乳腺癌在临床病理特征方面不同于HER2-0和HER2高表达乳腺癌。HER2低表达乳腺癌在化疗过程中高度不稳定；因此，重新评估HER2表达可能为新辅助治疗后部分患者提供新的治疗策略。
Abstract
With the emergence of HER2 antibody-drug conjugates, new treatment options have been provided to patients with breast cancer, especially those with low HER2 expression. The biology of HER2-low breast cancer is not yet well understood. This study included the largest sample size thus far to explore the different clinicopathological characteristics, pathological complete responses (pCRs), and prognoses of HER2-low cancers compared with those of HER2-0 and HER2-high cancers. This study included 14,642 female breast cancer patients and 544 female patients with breast cancer from the TCGA. A logistic regression model was used to determine predictive factors for pCR. K-M curves and log-rank tests were applied to determine OS and DFS. Compared with HER2-0 and HER2-high patients, the HER2-low group had a greater proportion of members in the N1-2 group and with grade I-II disease, a tumor size ≤ 20 mm, a Ki-67 index ≤ 14%, and invasive cancer. Among the HR+ subtypes of the HER2-low subgroup, the distribution of pathological types, pN stages, Ki-67 values, and tumor sizes significantly differed. In the triple-negative breast cancer subtypes of HER2-low patients, the distributions of age, pathological type, histological grade, and Ki-67 index were significantly different. The Ki-67 index and pathological type were independent factors that affected the pCR of the axillary lymph nodes. HER2 expression was mostly driven by patients who switched to or from HER2-low expression after neoadjuvant chemotherapy. The pCR rate and survival did not differ markedly across the three HER2 subtypes. HER2-low breast cancer is distinct from HER2-0 and HER2-high breast cancer with respect to clinicopathological characteristics. HER2-low breast cancer is highly unstable during chemotherapy; therefore, reevaluating HER2 expression may provide new treatment strategies for some patients after neoadjuvant therapy.
如何引用
AMA
Wantong Sun, Xinyu Hou, Zihan Yang, Guozheng Li, Lei Zhang, Qin Wang, et al. Clinicopathological Characteristics, Prognosis, and Survival of HER2-Low Breast Cancer Patients Based on a Retrospective Cohort Study of 14,642 Patients.. Cancers. 2026; doi:10.3390/cancers18101637.
APA
Wantong Sun, Xinyu Hou, Zihan Yang, Guozheng Li, Lei Zhang, Qin Wang, et al (2026). Clinicopathological Characteristics, Prognosis, and Survival of HER2-Low Breast Cancer Patients Based on a Retrospective Cohort Study of 14,642 Patients.. Cancers. https://doi.org/10.3390/cancers18101637
GB/T 7714
Wantong Sun, Xinyu Hou, Zihan Yang, Guozheng Li, Lei Zhang, Qin Wang, et al. Clinicopathological Characteristics, Prognosis, and Survival of HER2-Low Breast Cancer Patients Based on a Retrospective Cohort Study of 14,642 Patients.[J]. Cancers, 2026 doi:10.3390/cancers18101637.
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