Department of Pathology, University of British Columbia, Vancouver, BC.
Appl Immunohistochem Mol Morphol. 2023 Aug 1;31(7):478-484. doi: 10.1097/PAI.0000000000001087. Epub 2022 Nov 29.
Ki-67 is a nuclear protein serendipitously discovered by monoclonal antibody selection in the early 1980s. While it has been applied for decades in the context of breast cancer as a putative prognostic and, more recently, predictive, biomarker, even after all this time there is incomplete agreement as to the validity of the immunohistochemical assays employed for Ki-67 assessment, given possible effects of the disparate methodologies employed and possible confounding preanalytical, analytical, and interpretive variables. In this brief review, the history of Ki-67 and the problems, particularly with the analytical and interpretive variables, are highlighted through a selective review of the published literature. The contributions of the International Ki-67 Breast Cancer Working Group are highlighted, and in particular, the recommendations made by this group are reviewed. The potential of Ki-67 as a biomarker for breast cancer has not yet been fully realized, but an understanding of the power as well as the limitations of the methods of Ki-67 assessment are important if this biomarker can realize its potential.
Ki-67 是一种核蛋白，于 20 世纪 80 年代初通过单克隆抗体选择偶然发现。尽管几十年来，Ki-67 一直被应用于乳腺癌的预后和最近的预测生物标志物，但由于所使用的免疫组织化学检测方法可能存在差异，以及可能存在混杂的分析前、分析和解释变量，其有效性仍存在不完全一致的情况。在这篇简要的综述中，通过对已发表文献的选择性回顾，突出了 Ki-67 的历史和问题，特别是分析和解释变量方面的问题。强调了国际 Ki-67 乳腺癌工作组的贡献，特别是该小组提出的建议。Ki-67 作为乳腺癌生物标志物的潜力尚未得到充分实现，但如果该生物标志物能够发挥其潜力，了解 Ki-67 评估方法的优势和局限性非常重要。
