Paik Soonmyung, Kwon Youngmee, Lee Moo Hyun, Kim Ji Ye, Lee Da Kyung, Cho Won Jeong, Lee Eun Young, Lee Eun Sook
Institute for Personalized Cancer Therapy, Yonsei University College of Medicine, Seoul, South Korea.
Department of Pathology, National Cancer Center, Goyang, South Korea.
NPJ Breast Cancer. 2021 Feb 12;7(1):13. doi: 10.1038/s41523-021-00221-z.
Although Ki67 labeling index is a potential predictive marker for chemotherapy benefit, its clinical utility has been limited by the lack of a standard scoring method resulting in poor interobserver reproducibility. Especially, there is no consensus on the use of average versus hotspot score for reporting. In order to determine the best method for Ki67 scoring and validate manual scoring method proposed by the International Ki67 Working Group (IKWG), we systematically compared average versus hotspot score in 240 cases with a public domain image analysis program QuPath. We used OncotypeDx Recurrence Score (RS) as a benchmark to compare the potential clinical utility of each scoring methods. Both average and hotspot scores showed statistically significant but only modest correlation with OncotypeDx RS. Only hotspot score could meaningfully distinguish RS low-risk versus high-risk patients. However, hotspot score was less reproducible limiting its clinical utility. In summary, our data demonstrate that utility of the Ki67 labeling index is influenced by the choice of scoring method.
尽管Ki67标记指数是化疗获益的一个潜在预测标志物，但其临床应用因缺乏标准评分方法而受到限制，导致观察者间的可重复性较差。特别是，在报告时使用平均值还是热点评分尚无共识。为了确定Ki67评分的最佳方法并验证国际Ki67工作组（IKWG）提出的手动评分方法，我们使用公共领域图像分析程序QuPath系统地比较了240例病例的平均值与热点评分。我们使用OncotypeDx复发评分（RS）作为基准来比较每种评分方法的潜在临床应用价值。平均值和热点评分均显示出统计学上的显著相关性，但与OncotypeDx RS的相关性仅为中等。只有热点评分能够有意义地区分RS低风险和高风险患者。然而，热点评分的可重复性较差，限制了其临床应用。总之，我们的数据表明，Ki67标记指数的应用受到评分方法选择的影响。
