PDF(Pubmed)
Abstract：
OBJECTIVE: It remains unclear whether patients with HER2-negative, low-estrogen receptor (ER-low)-positive early breast cancer (BC) benefit from Oncotype DX® (ODX) testing.
METHODS: We conducted a retrospective review of cases referred for ODX testing over a seven-year period from a breast biomarker testing referral center (n = 854). For each case, we recorded the ODX Recurrence Score (RS) along with percentage of ER nuclear positivity and staining intensity on immunohistochemistry. Our criteria for ER-low was defined as ≤10% cells with nuclear positivity and/or weak intensity of staining. Slides from all ER-low cases were reviewed and the reported ODX ER gene scores were recorded. We randomly selected a comparator group of 56 patients with ER > 10% positivity and non-weak staining intensity (ER-high).
RESULTS: We identified 27 cases (3.2%) that met our criteria for ER-low. Of these, 92.6% had a high RS (>25), and 7.4% had a RS of 25. All cases with ≤10% ER nuclear positivity had a high RS. Most ER-low cases (85.2%) had ODX quantitative ER gene scores in the negative range, whereas all (100%) ER-high cases had positive ER gene scores.
CONCLUSIONS: ODX does not appear to add significant additional information to inform treatment decisions for most patients with ER-low BC. Incorporating weak ER staining intensity in addition to low percentage of nuclear positivity identifies about twice as many ER-low patients, although with reduced specificity for high RS. Our study supports the contention that most ER-low early BC should be regarded similarly to ER-negative BC.
METHODS: We conducted a retrospective review of cases referred for ODX testing over a seven-year period from a breast biomarker testing referral center (n = 854). For each case, we recorded the ODX Recurrence Score (RS) along with percentage of ER nuclear positivity and staining intensity on immunohistochemistry. Our criteria for ER-low was defined as ≤10% cells with nuclear positivity and/or weak intensity of staining. Slides from all ER-low cases were reviewed and the reported ODX ER gene scores were recorded. We randomly selected a comparator group of 56 patients with ER > 10% positivity and non-weak staining intensity (ER-high).
RESULTS: We identified 27 cases (3.2%) that met our criteria for ER-low. Of these, 92.6% had a high RS (>25), and 7.4% had a RS of 25. All cases with ≤10% ER nuclear positivity had a high RS. Most ER-low cases (85.2%) had ODX quantitative ER gene scores in the negative range, whereas all (100%) ER-high cases had positive ER gene scores.
CONCLUSIONS: ODX does not appear to add significant additional information to inform treatment decisions for most patients with ER-low BC. Incorporating weak ER staining intensity in addition to low percentage of nuclear positivity identifies about twice as many ER-low patients, although with reduced specificity for high RS. Our study supports the contention that most ER-low early BC should be regarded similarly to ER-negative BC.
摘要：
目的：尚不清楚HER2阴性患者低雌激素受体（ER低）阳性早期乳腺癌（BC）受益于OncotypeDX®（ODX）测试。
方法：我们对从乳腺生物标志物检测转诊中心转诊7年的ODX检测病例进行了回顾性回顾（n=854）。对于每种情况，我们记录了ODX复发评分(RS)以及ER核阳性百分比和免疫组化染色强度.我们的ER低标准定义为≤10％的细胞具有核阳性和/或弱染色强度。回顾了所有ER低病例的切片，并记录了报告的ODXER基因评分。我们随机选择了一个比较组的56名ER>10％阳性且染色强度非弱（ER高）的患者。
结果：我们确定了27例（3.2%）符合我们的低ER标准。其中,92.6%的RS较高(>25)，7.4%的RS为25。所有ER核阳性≤10%的病例均有较高的RS。大多数低ER病例(85.2%)的ODX定量ER基因评分在阴性范围,而所有（100％）ER高病例的ER基因评分均为阳性。
结论：ODX似乎没有增加显著的额外信息来告知大多数ER低BC患者的治疗决策。除了低百分比的核阳性外，结合弱ER染色强度可识别约两倍的ER低患者，尽管对高RS的特异性降低。我们的研究支持以下论点：大多数ER低的早期BC应与ER阴性BC相似。
方法：我们对从乳腺生物标志物检测转诊中心转诊7年的ODX检测病例进行了回顾性回顾（n=854）。对于每种情况，我们记录了ODX复发评分(RS)以及ER核阳性百分比和免疫组化染色强度.我们的ER低标准定义为≤10％的细胞具有核阳性和/或弱染色强度。回顾了所有ER低病例的切片，并记录了报告的ODXER基因评分。我们随机选择了一个比较组的56名ER>10％阳性且染色强度非弱（ER高）的患者。
结果：我们确定了27例（3.2%）符合我们的低ER标准。其中,92.6%的RS较高(>25)，7.4%的RS为25。所有ER核阳性≤10%的病例均有较高的RS。大多数低ER病例(85.2%)的ODX定量ER基因评分在阴性范围,而所有（100％）ER高病例的ER基因评分均为阳性。
结论：ODX似乎没有增加显著的额外信息来告知大多数ER低BC患者的治疗决策。除了低百分比的核阳性外，结合弱ER染色强度可识别约两倍的ER低患者，尽管对高RS的特异性降低。我们的研究支持以下论点：大多数ER低的早期BC应与ER阴性BC相似。
