四激肽原panel 预测前列腺重复活检：来自荷兰鹿特丹欧洲前列腺癌筛查随机研究的数据。

A four-kallikrein panel for the prediction of repeat prostate biopsy: data from the European Randomized Study of Prostate Cancer screening in Rotterdam, Netherlands.

机构信息

Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA.

出版信息

Br J Cancer. 2010 Aug 24;103(5):708-14. doi: 10.1038/sj.bjc.6605815. Epub 2010 Jul 27.

DOI:10.1038/sj.bjc.6605815

PMID:20664589

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2938258/

Abstract

BACKGROUND

Most men with elevated levels of prostate-specific antigen (PSA) do not have prostate cancer, leading to a large number of unnecessary biopsies. A statistical model based on a panel of four kallikreins has been shown to predict the outcome of a first prostate biopsy. In this study, we apply the model to an independent data set of men with previous negative biopsy but persistently elevated PSA.

METHODS

The study cohort consisted of 925 men with a previous negative prostate biopsy and elevated PSA (>or=3 ng ml(-1)), with 110 prostate cancers detected (12%). A previously published statistical model was applied, with recalibration to reflect the lower positive biopsy rates on rebiopsy.

RESULTS

The full-kallikrein panel had higher discriminative accuracy than PSA and DRE alone, with area under the curve (AUC) improving from 0.58 (95% confidence interval (CI): 0.52, 0.64) to 0.68 (95% CI: 0.62, 0.74), P<0.001, and high-grade cancer (Gleason >or=7) at biopsy with AUC improving from 0.76 (95% CI: 0.64, 0.89) to 0.87 (95% CI: 0.81, 0.94), P=0.003). Application of the panel to 1000 men with persistently elevated PSA after initial negative biopsy, at a 15% risk threshold would reduce the number of biopsies by 712; would miss (or delay) the diagnosis of 53 cancers, of which only 3 would be Gleason 7 and the rest Gleason 6 or less.

CONCLUSIONS

Our data constitute an external validation of a previously published model. The four-kallikrein panel predicts the result of repeat prostate biopsy in men with elevated PSA while dramatically decreasing unnecessary biopsies.

摘要

背景

大多数前列腺特异性抗原（PSA）水平升高的男性并没有前列腺癌，这导致了大量不必要的活检。基于一组 4 种激肽释放酶的统计模型已被证明可以预测首次前列腺活检的结果。在这项研究中，我们将该模型应用于一组先前有过阴性活检但 PSA 持续升高的男性的独立数据集。

方法

研究队列包括 925 名 PSA 升高（>或=3ng/ml）且先前有过阴性前列腺活检的男性，共发现 110 例前列腺癌（12%）。应用了先前发表的统计模型，并进行了重新校准，以反映在重复活检时阳性活检率较低的情况。

结果

完整激肽组的鉴别准确率高于 PSA 和 DRE 单独检测，曲线下面积（AUC）从 0.58（95%置信区间[CI]：0.52，0.64）提高到 0.68（95%CI：0.62，0.74），P<0.001，活检时高级别癌症（Gleason>或=7）的 AUC 从 0.76（95%CI：0.64，0.89）提高到 0.87（95%CI：0.81，0.94），P=0.003）。将该模型应用于 1000 名初次阴性活检后 PSA 持续升高的男性，在 15%的风险阈值下，可减少 712 例活检；会漏诊（或延迟）53 例癌症，其中只有 3 例为 Gleason 7 级，其余为 Gleason 6 级或更低级别的癌症。