Hanley K Z, Siddiqui M T, Lawson D, Cohen C, Nassar A
Department of Pathology and Laboratory Medicine, Emory University Hospital, Atlanta, Georgia, USA.
Diagn Cytopathol. 2009 Apr;37(4):251-7. doi: 10.1002/dc.20989.
Accurate assessment of estrogen receptor (ER), progesterone receptor (PR), and Her2 status of breast carcinomas is critical for predicting response to systemic therapies. Recently, developed rabbit monoclonal antibodies (RMab) are reported to have higher sensitivity than murine monoclonal antibodies (Mab). This study compares RMabs against FDA-approved Mab (FMab) in breast carcinoma cell block sections using visual and image quantification. Cell blocks from 52 breast cancers were studied. Immunohistochemistry using RMab (ER, PR, and Her2) was compared with FMabs (ER, PR, Dako) and HercepTest (HerFDA). Fluorescent in situ hybridization (FISH) was used as a reference standard for Her2. Slides were later scanned and reanalyzed with an automated cellular imaging system (ACIS III, Dako). Frequency of ER (38.5% vs. 36.5% for visual; 55.8% vs. 57.7% for image) and PR (28.8% vs. 36.5% for visual; 50% vs. 51.9% for image), and concordance (overall agreement is 71.2% and 75% for visual and image ER; and 84.6% and 59.6% for visual and image PR) were similar for both FMab and RMab, respectively. Overall agreement (53.8% vs. 77.1% for visual and image detection, respectively, using HerFDA and RMab) is poor to moderate for Her2. Visual Her2 (RMab) has the highest concordance (94.1%), and visual HerFDA has the lowest concordance (35.3%) with FISH. ER and PR analysis (FMab vs. RMab) are almost comparable using both detection methods with good overall agreement. For Her2 overexpression, RMab proved to be superior to HerFDA and showed excellent agreement with FISH results with both quantitative detection methods.
准确评估乳腺癌的雌激素受体（ER）、孕激素受体（PR）和人表皮生长因子受体2（Her2）状态对于预测全身治疗的反应至关重要。最近，据报道新开发的兔单克隆抗体（RMab）比鼠单克隆抗体（Mab）具有更高的敏感性。本研究在乳腺癌细胞块切片中使用视觉和图像定量方法比较了RMab与美国食品药品监督管理局（FDA）批准的Mab（FMab）。对52例乳腺癌的细胞块进行了研究。将使用RMab（ER、PR和Her2）的免疫组织化学与FMab（ER、PR，达科公司）和HercepTest（HerFDA）进行比较。荧光原位杂交（FISH）用作Her2的参考标准。随后使用自动细胞成像系统（ACIS III，达科公司）对玻片进行扫描和重新分析。FMab和RMab的ER频率（视觉观察分别为38.5%对36.5%；图像分析分别为55.8%对57.7%）和PR频率（视觉观察分别为28.8%对36.5%；图像分析分别为50%对51.9%）以及一致性（视觉和图像ER的总体一致性分别为71.2%和75%；视觉和图像PR的总体一致性分别为84.6%和59.6%）相似。对于Her2，总体一致性较差至中等（使用HerFDA和RMab进行视觉和图像检测时分别为53.8%和77.1%）。视觉观察的Her2（RMab）与FISH的一致性最高（94.1%），而视觉观察的HerFDA与FISH的一致性最低（35.3%）。使用两种检测方法时，ER和PR分析（FMab与RMab）几乎具有可比性，总体一致性良好。对于Her2过表达，RMab被证明优于HerFDA，并且在两种定量检测方法中与FISH结果均显示出极好的一致性。
