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初筛阴性 4 年后前列腺癌风险计算器:ERSPC 鹿特丹研究结果。

A Calculator for Prostate Cancer Risk 4 Years After an Initially Negative Screen: Findings from ERSPC Rotterdam.

机构信息

Department of Urology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.

出版信息

Eur Urol. 2013 Apr;63(4):627-33. doi: 10.1016/j.eururo.2012.07.029. Epub 2012 Jul 20.

DOI:10.1016/j.eururo.2012.07.029
PMID:22841675
Abstract

BACKGROUND

Inconclusive test results often occur after prostate-specific antigen (PSA)-based screening for prostate cancer (PCa), leading to uncertainty on whether, how, and when to repeat testing.

OBJECTIVE

To develop and validate a prediction tool for the risk of PCa 4 yr after an initially negative screen.

DESIGN, SETTING, AND PARTICIPANTS: We analyzed data from 15 791 screen-negative men aged 55-70 yr at the initial screening round of the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Follow-up and repeat screening at 4 yr showed either no PCa, low-risk PCa, or potentially high-risk PCa (defined as clinical stage >T2b and/or biopsy Gleason score ≥ 7 and/or PSA ≥ 10.0 ng/ml). A multinomial logistic regression analysis included initial screening data on age, PSA, digital rectal examination (DRE), family history, prostate volume, and having had a previous negative biopsy. The 4-yr risk predictions were validated with additional follow-up data up to 8 yr after initial screening.

RESULTS AND LIMITATIONS

Positive family history and, especially, PSA level predicted PCa, whereas a previous negative biopsy or a large prostate volume reduced the likelihood of future PCa. The risk of having PCa 4 yr after an initially negative screen was 3.6% (interquartile range: 1.0-4.7%). Additional 8-yr follow-up data confirmed these predictions. Although data were based on sextant biopsies and a strict protocol-based biopsy indication, we suggest that men with a low predicted 4-yr risk (eg, ≤ 1.0%) could be rescreened at longer intervals or not at all, depending on competing risks, while men with an elevated 4-yr risk (eg, ≥ 5%) might benefit from immediate retesting. These findings need to be validated externally.

CONCLUSIONS

This 4-yr future risk calculator, based on age, PSA, DRE, family history, prostate volume, and previous biopsy status, may be a promising tool for reducing uncertainty, unnecessary testing, and overdiagnosis of PCa.

摘要

背景

基于前列腺特异性抗原(PSA)的前列腺癌(PCa)筛查后,常会出现结果不确定的情况,导致人们难以确定是否、如何以及何时重复检测。

目的

开发并验证一种用于预测初次筛查阴性 4 年后 PCa 风险的工具。

设计、地点和参与者:我们分析了来自欧洲前列腺癌筛查随机研究鹿特丹分部的 15791 名初次筛查时年龄为 55-70 岁的筛查阴性男性的数据。

结局测量和统计学分析

在 4 年的随访和重复筛查中,患者的 PCa 情况分别为无 PCa、低危 PCa 或可能的高危 PCa(定义为临床分期>T2b 和/或活检 Gleason 评分≥7 和/或 PSA≥10.0ng/ml)。多变量逻辑回归分析纳入了初次筛查时的年龄、PSA、直肠指检(DRE)、家族史、前列腺体积和既往阴性活检史等数据。使用初次筛查后额外的 8 年随访数据对 4 年风险预测进行验证。

结果和局限性

阳性家族史,特别是 PSA 水平,预测 PCa 的发生,而既往阴性活检或较大的前列腺体积降低了未来 PCa 的可能性。初次筛查后 4 年时患 PCa 的风险为 3.6%(四分位距:1.0-4.7%)。额外的 8 年随访数据证实了这些预测。尽管数据基于六分区活检和严格的基于方案的活检指征,但我们建议,对于预测 4 年风险较低(如,≤1.0%)的男性,可以根据竞争风险,延长间隔或完全不进行再次筛查,而对于预测 4 年风险较高(如,≥5%)的男性,可能受益于立即重复检测。这些发现需要外部验证。

结论

该基于年龄、PSA、DRE、家族史、前列腺体积和既往活检状态的 4 年未来风险计算器,可能是降低 PCa 不确定性、不必要检测和过度诊断的有前途的工具。

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