PDF(Pubmed)
Abstract：
Background: Recently, the classification of HER2 status evolves from binary to ternary, and HER2-low expression may exhibit prognostic significance. We aimed to investigate whether HER2-low tumor is distinct from HER2-zero or HER2-positive tumors, and then to develop a modified staging system (mNeo-Bioscore) that incorporates HER2-low status into Neo-Bioscore. Patients and Methods: This cohort study was conducted using data from the prospective database on breast cancer patients between January 2014 and February 2019. Results: Among 259 patients enrolled in the study, the HER2-low tumor exhibited significantly lower histological grade, pathological staging and Ki-67 level than the other two groups. HER2-low patients and HER2-positive patients receiving concurrent HER2-directed therapy may have similar LRFS (p = 0.531) and OS (p = 0.853), while HER2-zero peers may have significantly worse LRFS (p = 0.006) and OS (p = 0.017). In particular, a similar trend was also found in the patients without pathological complete response after surgery. Incorporation of HER2-low status made improvement in fit: 5-year OS rate estimates ranged from 33.33% to 100% for mNeo-Bioscore vs 61.36% to 100% for Neo-Bioscore. Conclusions: This study demonstrated that HER2-low tumor may exhibit prognostic significance. The innovative mNeo-Bioscore, based on a new classification of HER2 status, may serve as a prognostic staging system superior to Neo-Bioscore.
摘要：
背景：最近，HER2状态的分类从二元发展到三元，HER2低表达可能具有预后意义。我们的目的是研究低HER2肿瘤是否不同于HER2零或HER2阳性肿瘤。然后开发一种改良的分期系统（mNeo-Bioscore），将低HER2状态纳入Neo-Bioscore。患者和方法：这项队列研究使用2014年1月至2019年2月乳腺癌患者前瞻性数据库的数据进行。结果：在参与研究的259例患者中，低HER2肿瘤表现出显著较低的组织学分级，病理分期和Ki-67水平优于其他两组。低HER2患者和同时接受HER2导向治疗的HER2阳性患者可能具有相似的LRFS(p=0.531)和OS(p=0.853)。而HER2-零同行的LRFS（p=0.006）和OS（p=0.017）可能明显更差。特别是,在手术后无病理完全缓解的患者中也发现了类似的趋势。HER2低状态的掺入使拟合度有所改善：mNeo-Bioscore的5年OS率估计值为33.33％至100％，而Neo-Bioscore的5年OS率估计值为61.36％至100％。结论：这项研究表明低HER2肿瘤可能具有预后意义。创新的mNeo-Bioscore，基于HER2状态的新分类，可能作为优于Neo-Bioscore的预后分期系统。
