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Abstract：
OBJECTIVE: One-half of hormone receptor-positive (HR +) breast cancer (BC) patients have low expression of HER2 (HER2-low) and may benefit from trastuzumab deruxtecan (TDXd). This study aimed to identify parameters associated with HER2-low levels in primary and metastatic tumors. We specifically sought to determine whether OncotypeDX and HER2 mRNA levels could identify patients who would otherwise be considered HER2-negative by immunohistochemistry (IHC).
METHODS: This retrospective analysis of all consecutive HR + patients who underwent OncotypeDX from January 2004 to December 2020 was conducted in a single medical center (n = 1429). We divided HER2-negative cases into HER2-low (IHC = 1 + or 2 + and non-amplified fluorescent situ hybridization) and HER2-0 (IHC = 0). HER2 RT-PCR was evaluated from the OncotypeDX results.
RESULTS: HER2-low cases exhibited significantly higher HER2 RT-PCR scores (p = 2.1e-9), elevated estrogen receptor (ER) levels (p = 0.0114), and larger tumor sizes compared to HER2-0 cases (> 2 cm; 36.6% vs. 22.1%, respectively, p < 0.00001). Primary tumors > 2 cm were more likely to be HER2-low (OR = 2.07, 95% CI: 1.6317 to 2.6475, p < 0.0001). Metastatic BCs expressed higher HER2 IHC scores compared with primary BCs (Wilcoxon signed-rank, p = 0.046). HER2 IHC scores were higher for low-risk vs. medium-risk OncotypeDX (p = 0.0067). No other clinical or pathological parameters were associated with the increase in HER2 levels in the metastatic samples.
CONCLUSIONS: It might be beneficial to use clinical data from the primary tumor, including the HER2 RT-PCR score, to determine a HER2-low status.
METHODS: This retrospective analysis of all consecutive HR + patients who underwent OncotypeDX from January 2004 to December 2020 was conducted in a single medical center (n = 1429). We divided HER2-negative cases into HER2-low (IHC = 1 + or 2 + and non-amplified fluorescent situ hybridization) and HER2-0 (IHC = 0). HER2 RT-PCR was evaluated from the OncotypeDX results.
RESULTS: HER2-low cases exhibited significantly higher HER2 RT-PCR scores (p = 2.1e-9), elevated estrogen receptor (ER) levels (p = 0.0114), and larger tumor sizes compared to HER2-0 cases (> 2 cm; 36.6% vs. 22.1%, respectively, p < 0.00001). Primary tumors > 2 cm were more likely to be HER2-low (OR = 2.07, 95% CI: 1.6317 to 2.6475, p < 0.0001). Metastatic BCs expressed higher HER2 IHC scores compared with primary BCs (Wilcoxon signed-rank, p = 0.046). HER2 IHC scores were higher for low-risk vs. medium-risk OncotypeDX (p = 0.0067). No other clinical or pathological parameters were associated with the increase in HER2 levels in the metastatic samples.
CONCLUSIONS: It might be beneficial to use clinical data from the primary tumor, including the HER2 RT-PCR score, to determine a HER2-low status.
摘要：
目的：一半的激素受体阳性（HR+）乳腺癌（BC）患者HER2低表达（HER2低），可能受益于曲妥珠单抗deruxtecan（TDXd）。这项研究旨在确定与原发性和转移性肿瘤中HER2低水平相关的参数。我们特别试图确定OncotypeDX和HER2mRNA水平是否可以鉴定通过免疫组织化学（IHC）被认为是HER2阴性的患者。
方法：这项对2004年1月至2020年12月接受OncotypeDX的所有连续HR+患者的回顾性分析是在一个医疗中心进行的（n=1429）。我们将HER2阴性病例分为低HER2(IHC=1+或2+和非扩增荧光原位杂交)和HER2-0(IHC=0)。从OncotypeDX结果评估HER2RT-PCR。
结果：HER2低的病例表现出明显更高的HER2RT-PCR评分（p=2.1e-9），雌激素受体（ER）水平升高（p=0.0114），与HER2-0病例相比，肿瘤大小更大（>2cm；36.6%vs.22.1%,分别,p<0.00001)。>2cm的原发肿瘤更可能是HER2低（OR=2.07，95％CI：1.6317至2.6475，p<0.0001）。与原发性BCs相比，转移性BCs表达更高的HER2IHC评分（Wilcoxonsigned-rank，p=0.046)。低风险与低风险的HER2IHC评分较高中等风险OncotypeDX（p=0.0067）。没有其他临床或病理参数与转移样品中HER2水平的增加相关。
结论：使用原发肿瘤的临床数据可能是有益的，包括HER2RT-PCR评分,以确定HER2低状态。
方法：这项对2004年1月至2020年12月接受OncotypeDX的所有连续HR+患者的回顾性分析是在一个医疗中心进行的（n=1429）。我们将HER2阴性病例分为低HER2(IHC=1+或2+和非扩增荧光原位杂交)和HER2-0(IHC=0)。从OncotypeDX结果评估HER2RT-PCR。
结果：HER2低的病例表现出明显更高的HER2RT-PCR评分（p=2.1e-9），雌激素受体（ER）水平升高（p=0.0114），与HER2-0病例相比，肿瘤大小更大（>2cm；36.6%vs.22.1%,分别,p<0.00001)。>2cm的原发肿瘤更可能是HER2低（OR=2.07，95％CI：1.6317至2.6475，p<0.0001）。与原发性BCs相比，转移性BCs表达更高的HER2IHC评分（Wilcoxonsigned-rank，p=0.046)。低风险与低风险的HER2IHC评分较高中等风险OncotypeDX（p=0.0067）。没有其他临床或病理参数与转移样品中HER2水平的增加相关。
结论：使用原发肿瘤的临床数据可能是有益的，包括HER2RT-PCR评分,以确定HER2低状态。
