Int J Biol Markers. 2005 Jul-Sep;20(3):189-94.
The clinical interest in HER-2/neu is related to trastuzumab, a drug used to treat patients with invasive breast carcinoma overexpressing the HER-2/neu protein. It is very important to correctly identify those patients who may benefit from trastuzumab by accurate assessment of the HER-2/neu status. Of the various methods available, the Dako Herceptest for immunohistochemical assay is considered the most reliable to reach this goal. The aim of this study was to investigate within a group of Italian laboratories the reproducibility of the results of HER-2/neu assessment by means of the Dako scoring system on slides stained with the Herceptest kit. This study was also conceived as the continuation of one of our previous studies, which was similar in its aims but different in the classification criteria adopted. Our results show that, whereas the intra-observer reproducibility was generally satisfactory, the interobserver reproducibility was not. Moreover, our findings confirm that the two extreme classes (0 and 3+) are more easy to identify than the other two and that the Herceptest does not allow to discriminate optimally between scoring classes 2+ and 3+. These findings are relevant in clinical practice where the treatment choice is based on categories defined by this assay, suggesting the need of adopting educational programs and/or new reference materials to improve the assay performance.
对HER-2/neu的临床关注与曲妥珠单抗有关，该药物用于治疗HER-2/neu蛋白过表达的浸润性乳腺癌患者。通过准确评估HER-2/neu状态来正确识别那些可能从曲妥珠单抗治疗中获益的患者非常重要。在可用的各种方法中，Dako Herceptest免疫组织化学检测法被认为是实现这一目标最可靠的方法。本研究的目的是在一组意大利实验室中，通过Dako评分系统对用Herceptest试剂盒染色的玻片进行HER-2/neu评估，研究结果的可重复性。本研究也被视为我们之前一项研究的延续，该研究目的相似，但采用的分类标准不同。我们的结果表明，虽然观察者内的可重复性总体上令人满意，但观察者间的可重复性却不尽人意。此外，我们的研究结果证实，两个极端类别（0和3+）比其他两个类别更容易识别，并且Herceptest无法在2+和3+评分类别之间进行最佳区分。这些发现在临床实践中具有重要意义（在临床实践中，治疗选择基于该检测所定义的类别），这表明需要采用教育项目和/或新的参考材料来提高检测性能。
