Kitano Yuriko, Umemura Shinobu, Ohbayashi Hirokazu, Takenaga Masato, Osamura Robert Yoshiyuki
Research and Development Center, Nichirei Biosciences Inc., Higashimurayama, Tokyo, Japan.
Appl Immunohistochem Mol Morphol. 2007 Dec;15(4):389-93. doi: 10.1097/PAI.0b013e31802f411c.
It is critical to evaluate the overexpression of human epidermal growth factor receptor 2 (HER2) adequately in breast cancer cases. The aim of the present study is to assess the characteristics and usefulness of a novel monoclonal antibody, clone SV2-61gamma. The overexpression of HER2 was studied on paraffin sections of 50 breast cancers using a polyclonal antibody assay (HercepTest) and monoclonal antibodies (clones SV2-61gamma and CB11). Gene amplification of HER2 was determined by fluorescent in situ hybridization (FISH) using a HER2/CEP17DNA probe kit. Fifty tumors were scored as 0 (50.0%), 1+ (26.0%), 2+ (4.0%), or 3+ (20.0%) by immunohistochemistry using a monoclonal antibody, clone SV2-61gamma. The specificities of immunohistochemistry were 72.0% for the polyclonal antibody, 97.0% for SV2-61gamma, and 92.0% for CB11. The concordances with FISH were 78.0% for the polyclonal antibody, 98.0% for SV2-61gamma, and 94.0% for CB11. The positive predictive value of SV2-61gamma (92.0%) was higher than those of the polyclonal antibody (50.0%) and CB11 (79.0%). A monoclonal antibody clone SV2-61gamma showed very specific staining, with the best concordance with FISH, and it is useful for the evaluation of HER2 overexpression.
在乳腺癌病例中充分评估人表皮生长因子受体2（HER2）的过表达至关重要。本研究的目的是评估一种新型单克隆抗体克隆SV2 - 61γ的特性和实用性。使用多克隆抗体检测法（HercepTest）和单克隆抗体（克隆SV2 - 61γ和CB11）对50例乳腺癌的石蜡切片进行HER2过表达研究。使用HER2/CEP17 DNA探针试剂盒通过荧光原位杂交（FISH）确定HER2的基因扩增情况。使用单克隆抗体克隆SV2 - 61γ通过免疫组织化学对50个肿瘤进行评分，结果为0（50.0%）、1 +（26.0%）、2 +（4.0%）或3 +（20.0%）。免疫组织化学的特异性多克隆抗体为72.0%，SV2 - 61γ为97.0%，CB11为92.0%。与FISH的一致性多克隆抗体为78.0%，SV2 - 61γ为98.0%，CB11为94.0%。SV2 - 61γ的阳性预测值（92.0%）高于多克隆抗体（50.0%）和CB11（79.0%）。单克隆抗体克隆SV2 - 61γ显示出非常特异的染色，与FISH的一致性最佳，对评估HER2过表达很有用。
