Prognostic value of Ki-67 compared to S-phase fraction in axillary node-negative breast cancer.
Prognostic value of Ki-67 compared to S-phase fraction in axillary node-negative breast cancer.
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发表时间：
1996-03
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通讯作者：
Richard W. Brown;C. Allred;G. Clark;C. Osborne;S. Hilsenbeck
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作者：
Richard W. Brown;C. Allred;G. Clark;C. Osborne;S. Hilsenbeck
本研究的主要目的是评估Ki-67（一种细胞增殖相关抗原）在一大组（n = 674）腋窝淋巴结阴性乳腺癌病例中的预后意义，并进行长期随访，并将Ki-67抗原表达与S期分数相关联。Ki-67免疫染色进行了半定量和定量评估。统计分析集中在Ki-67定量方法之间的一致性、Ki-67与S期分数之间的一致性、Ki-67与其他临床变量之间的关联性以及Ki-67的预后价值。两种Ki-67评估方法之间具有极好的一致性（斯皮尔曼等级相关性，rsp = 0.91; P = 0.0001; n = 674），但半定量或定量Ki-67与S期分数之间仅有弱相关性（分别为rsp = 0.12和rsp = 0.15）。Ki-67（总体中位数，2%）与肿瘤大小无关，与肿瘤侵袭性的其他指标适度相关。使用5%（肿瘤细胞百分比）的临界点，Ki-67高的病例显示无病生存期显著缩短（Padj = 0.004）。在多变量分析中，高Ki-67与复发风险增加1.8倍相关（P = 0.001）。在具有S期数据的亚组中，校正的相对风险（风险比，1.9; P = 0.02）未因模型中包含S期而改变。这表明Ki-67除了包含在肿瘤大小和S期分数中之外，还提供了重要的独立预后信息。
The primary purpose of this study was to evaluate the prognostic significance of Ki-67, a cell proliferation-associated antigen, in a large group (n = 674) of axillary node-negative breast cancer cases with long-term follow-up and to correlate Ki-67 antigen expression with S-phase fraction. Ki-67 immunostaining was assessed both semiquantitatively and quantitatively. The statistical analysis focused on agreement between methods of Ki-67 quantification, agreement between Ki-67 and S-phase fraction, associations between Ki-67 and other clinical variables, and prognostic value of Ki-67. There was excellent agreement between the two methods of Ki-67 assessment (Spearman rank correlation, rsp = 0.91; P = 0.0001; n = 674) but only weak correlation between either semiquantitative or quantitative Ki-67 and S-phase fraction (rsp = 0.12 and rsp = 0.15, respectively). Ki-67 (overall median, 2%) was independent of tumor size and modestly related to other measures of tumor aggressiveness. Using a cutpoint of 5% (percentage of tumor cells), cases with high Ki-67 exhibited a significantly shorter disease-free survival (Padj = 0.004). In multivariate analysis, high Ki-67 was associated with a 1.8-fold increased risk of recurrence (P = 0.001). In the subgroup with S-phase data, the adjusted relative risk (hazard ratio, 1.9; P = 0.02) was unchanged by inclusion of S phase in the model. This suggests that Ki-67 provides significant independent prognostic information in addition to that contained in tumor size and S-phase fraction.