Estrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancer
Estrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancer
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DOI：
10.1200/jco.1999.17.5.1474
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发表时间：
1999-05-01
影响因子：
45.3
通讯作者：
Allred, DC
中科院分区：
文献类型：
--
作者：
Harvey, JM;Clark, GM;Allred, DC
目的：免疫组化（IHC）是一种较新的检测乳腺癌雌激素受体（ER）状态的方法，它可以克服传统的配体结合法（LBA）的许多缺点。预测临床结果-特别是对辅助内分泌治疗的反应-在大量的长期临床随访的患者中。采用抗体6 F11和标准方法，在福尔马林固定石蜡包埋的组织切片上通过IHC评估了1，982例原发性乳腺癌的ER状态。根据代表阳性染色肿瘤细胞估计比例和强度的量表对载玻片进行评分（范围，0至8），将结果与在相同肿瘤中通过LBA获得的ER值和临床结果进行比较。IHC评分大于2根据所有可能评分和无病生存期（DFS）的单变量临界点分析，使用ER（对应于少至1%至10%的弱阳性细胞）定义ER阳性接受任何辅助内分泌治疗的患者。使用该定义，71%的所有肿瘤通过IHC确定为ER阳性，与LBA的一致性水平为86%。在单独接受辅助内分泌治疗的患者的多变量分析中，通过IHC确定的ER状态在预测DFS改善方面优于通过LBA确定的ER状态。（风险比/P分别为0.474/0.0008和0.707/0.3214），在预测总生存期时等同（分别为0.379/.0001和0.381/.0003）。在评估原发性乳腺癌的ER状态方面，IHC比LBA更上级，因为它更容易、更安全、更便宜，并且在预测对辅助内分泌治疗的反应方面具有等同或更好的能力。J Clin Oncol 17：1474-1481. (C)1999年，美国临床肿瘤学会。
Purpose: Immunohistochemistry (IHC) is a newer technique for assessing the estrogen receptor (ER) status of breast cancers, with the potential to overcome many of the shortcomings associated with the traditional ligand-binding assay (LBA), The purpose of this study was to evaluate the ability of ER status determination by IHC, compared with LBA, to predict clinical outcome-especially response to adjuvant endocrine therapy-in a large number of patients with long-term clinical follow-up.Patients and Methods: ER status was evaluated in 1,982 primary breast cancers by IHC on formalin-fixed paraffin-embedded tissue sections, using antibody 6F11 and standard methodology, Slides were scored on a scale representing the estimated proportion and intensity of positive-staining tumor cells (range, 0 to 8), Results were compared with ER values obtained by the LBA in the same tumors and to clinical outcome.Results: An IHC score of greater than 2 (corresponding to as few as 1% to 10% weakly positive cells) was used to define ER positivity on the basis of a univariate cut-point analysis of all possible scores and disease-free survival (DFS) in patients receiving any adjuvant endocrine therapy. Using this definition, 71% of all tumors were determined to be ER-positive by IHC, and the level of agreement with the LBA was 86%, In multivariate analyses of patients receiving adjuvant endocrine therapy alone, ER status determined by IHC was better than that determined by the LBA at predicting improved DFS (hazard ratios/P = 0.474/.0008 and 0.707/.3214, respectively) and equivalent at predicting overall survival (0.379/.0001 and 0.381/.0003, respectively).Conclusion: IHC is superior to the LBA for assessing ER status in primary breast cancer because it is easier, safer, and less expensive, and has an equivalent or better ability to predict response to adjuvant endocrine therapy. J Clin Oncol 17:1474-1481. (C) 1999 by American Society of Clinical Oncology.