采用 Oncotype DX 检测法的定量 RT-PCR 对 HER2 低侵袭性乳腺癌的分子特征分析。
Molecular Characterization of HER2-Low Invasive Breast Carcinoma by Quantitative RT-PCR Using Oncotype DX Assay.
机构信息
Department of Medical Oncology, Yale School of Medicine, Yale Cancer Center, New Haven, CT, USA.
Exact Sciences Corporation, Redwood City, CA, USA.
出版信息
Oncologist. 2023 Oct 3;28(10):e973-e976. doi: 10.1093/oncolo/oyad249.
BACKGROUND
HER2 immunohistochemistry (IHC) reproducibility is suboptimal for HER-low cases (IHC 1+ or 2+).
METHODS
The Yale cohort included 214 stages I-II estrogen receptor positive breast cancers with IHC scores 0, 1+, and 2+ and routine Oncotype DX Recurrence Score (RS) results. The Exact Sciences (ES) cohort included 9 57 624 patients who had an Oncotype DX RS assay that assigns HER2-negative, equivocal, or positive status based on HER2 mRNA levels.
RESULTS
HER2 mRNA levels varied across IHC categories but with increasing medians of 9.10 (n = 89), 9.20 (n = 71), and 9.45 (n = 54) in IHC 0, 1+, and 2+, respectively. 22.4% of HER2-low (1+/2+) cancer had RS > 25. Over 98% of HER-low cancers were HER2-negative by Oncotype DX assignment.
CONCLUSIONS
Cancers with higher mRNA levels exist within IHC 0 and low categories, most of the HER2-low patients by IHC have low RS indicating no benefit from current adjuvant chemotherapies.
背景
HER2 免疫组织化学（IHC）在 HER-低表达病例（IHC 1+或 2+）中的重复性不理想。
方法
耶鲁队列包括 214 例 I 期至 II 期雌激素受体阳性乳腺癌患者，IHC 评分 0、1+和 2+，以及常规的 Oncotype DX 复发评分（RS）结果。Exact Sciences（ES）队列包括 957624 例患者，他们接受了 Oncotype DX RS 检测，该检测根据 HER2 mRNA 水平将 HER2-阴性、不确定或阳性状态进行赋值。
结果
HER2 mRNA 水平在 IHC 类别之间存在差异，但随着 IHC 0、1+和 2+的中位数分别为 9.10（n=89）、9.20（n=71）和 9.45（n=54）而逐渐升高。22.4%的 HER-低（1+/2+）癌症患者的 RS>25。超过 98%的 HER-低表达的癌症通过 Oncotype DX 检测为 HER2 阴性。
结论
在 IHC 0 和低分类中存在更高 mRNA 水平的癌症，大多数 IHC 为 HER-低表达的患者的 RS 较低，表明目前的辅助化疗没有获益。
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