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评估Ki-67指数作为原发性乳腺癌预后因素的最佳临界值:一项回顾性研究。

Evaluation of an Optimal Cut-Off Point for the Ki-67 Index as a Prognostic Factor in Primary Breast Cancer: A Retrospective Study.

作者信息

Tashima Rumiko, Nishimura Reiki, Osako Tomofumi, Nishiyama Yasuyuki, Okumura Yasuhiro, Nakano Masahiro, Fujisue Mamiko, Toyozumi Yasuo, Arima Nobuyuki

机构信息

Surgery, Kumamoto City Hospital, Kumamoto, Japan.

Breast and Endocrine Surgery, Kumamoto City Hospital, Kumamoto, Japan.

出版信息

PLoS One. 2015 Jul 15;10(7):e0119565. doi: 10.1371/journal.pone.0119565. eCollection 2015.

Abstract

The Ki-67 index is an important biomarker for indicating the proliferation of cancer cells and is considered to be an effective prognostic factor for breast cancer. However, a standard cut-off point for the Ki-67 index has not yet been established. Therefore, the aim of this retrospective study was to determine an optimal cut-off point in order to establish it as a more accurate prognostic factor. Immunohistochemical analysis of the Ki-67 index was performed on 4329 patients with primary breast cancer from August 1987 to March 2012. Out of this sample, there were 3186 consecutive cases from September 1997 with simultaneous evaluations of ER, PgR and HER2 status. Cox's proportional hazard model was used to perform univariate and multivariate analyses of the factors related to OS. The hazard ratios (HR) and the p values were then compared to determine the optimal cut-off point for the Ki-67 index. The median Ki-67 index value was 20.5% (mean value 26.2%). The univariate analysis revealed that there was a statistically significant negative correlation with DFS and OS and the multivariate analysis revealed that the Ki-67 index value was a significant factor for DFS and OS. The top seven cut-off points were then carefully chosen based on the results of the univariate analysis using the lowest p-values and the highest HR as the main selection criteria. The multivariate analysis of the factors for OS showed that the cut-off point of 20% had the highest HR in all of the cases. However, the cutoff point of 20% was only a significant factor for OS in the Luminal/HER2- subtype. There was no correlation between the Ki-67 index value and OS in any of the other subtypes. These data indicate that the optimal cut-off point of 20% is the most effective prognostic factor for Luminal/HER2- breast cancer.

摘要

Ki-67指数是一种重要的生物标志物,用于指示癌细胞的增殖,被认为是乳腺癌有效的预后因素。然而,Ki-67指数的标准临界值尚未确定。因此,本回顾性研究的目的是确定一个最佳临界值,以便将其确立为更准确的预后因素。对1987年8月至2012年3月期间的4329例原发性乳腺癌患者进行了Ki-67指数的免疫组织化学分析。在该样本中,有1997年9月起的3186例连续病例同时评估了雌激素受体(ER)、孕激素受体(PgR)和人表皮生长因子受体2(HER2)状态。采用Cox比例风险模型对与总生存期(OS)相关的因素进行单因素和多因素分析。然后比较风险比(HR)和p值,以确定Ki-67指数的最佳临界值。Ki-67指数的中位数为20.5%(平均值为26.2%)。单因素分析显示,其与无病生存期(DFS)和OS存在统计学上的显著负相关,多因素分析显示,Ki-67指数值是DFS和OS的显著因素。然后根据单因素分析结果,以最低p值和最高HR作为主要选择标准,精心挑选了前七个临界值。OS因素的多因素分析显示,20%的临界值在所有病例中具有最高的HR。然而,20%的临界值仅在Luminal/HER2-亚型中是OS的显著因素。在任何其他亚型中,Ki-67指数值与OS均无相关性。这些数据表明,20%的最佳临界值是Luminal/HER2-乳腺癌最有效的预后因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfb0/4503758/e107598f71c2/pone.0119565.g001.jpg

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