在一个回顾性德国临床队列中对斯德哥尔摩 3 指数进行外部验证。

IF 5.4 3区 材料科学 Q2 CHEMISTRY, PHYSICAL ACS Applied Energy Materials Pub Date : 2024-08-06 DOI:10.1016/j.euf.2024.07.009
Derya Tilki, Niclas Rejek, Florian Nohe, Alexander Haese, Markus Graefen, Imke Thederan
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引用次数: 0

摘要

背景和目的:Stockholm3是一种综合血液检测方法,融合了蛋白质生物标记物、遗传指标和临床数据,可预测具有临床意义的前列腺癌风险(国际泌尿病理学会活检分级≥2)。我们的研究旨在对斯德哥尔摩3进行外部验证,并将其性能与使用前列腺特异性抗原(PSA)和鹿特丹前列腺癌风险计算器(RPCRC)进行临床重大前列腺癌检测进行比较:我们收集了2014年至2017年期间在德国马蒂尼医院接受前列腺活检的男性数据。参与者是根据 PSA 水平升高或可疑的数字直肠检查结果选出的,他们都接受了 10-12 核心的系统性活检,但没有进行磁共振成像靶向活检。我们评估了斯德哥尔摩3和RPCRC在临床重大前列腺癌检测方面的性能。此外,我们还比较了针对PSA≥3 ng/ml推荐进行活检的男性比例以及Stockholm3和RPCRC的活检结果:我们的研究涵盖了 405 名活检男性,他们的中位年龄为 66 岁(四分位间距 [IQR]:60-72),PSA 水平为 7 ng/ml(IQR:5.2-10.8),Stockholm3 评分为 18(IQR:10-34)。其中,128 名男性(31%)被确诊为具有临床意义的前列腺癌。与使用 PSA≥3 纳克/毫升作为活检标准相比,采用推荐的斯德哥尔摩 3 临界值(≥15)可将不必要的活检减少 52%,同时检测出 92% 有临床意义的病例。Stockholm3和RPCRC都具有很强的区分度,曲线下面积值分别为0.80(95%置信区间[CI]:0.76-0.85)和0.75(95%置信区间:0.70-0.80)。与观察结果相比,Stockholm3 显示出良好的校准性,而 RPCRC 则低估了风险。此外,Stockholm3 的临床净效益为正,而 RPCRC 的临床相关阈值净效益为负:患者总结:在德国一个由 405 名男性组成的临床队列中,用于早期前列腺癌检测的血液检测方法 Stockholm3 显示出了良好的临床效益。它发现了大量有临床意义的病例,同时将未患前列腺癌和无临床意义前列腺癌的男性不必要的活检次数减少了一半以上。
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External Validation of Stockholm3 in a Retrospective German Clinical Cohort.

Background and objective: Stockholm3 is a comprehensive blood test amalgamating protein biomarkers, genetic indicators, and clinical data to predict clinically significant prostate cancer risk (International Society of Urological Pathology grade ≥2 upon biopsy). Our study aims to externally validate Stockholm3 and compare its performance with the use of prostate-specific antigen (PSA) and the Rotterdam Prostate Cancer Risk Calculator (RPCRC) for clinically significant prostate cancer detection.

Methods: We gathered data from men subjected to prostate biopsies at the Martini-Klinik, Germany, between 2014 and 2017. Participants were selected based on elevated PSA levels or suspicious digital rectal examinations, all undergoing a 10-12-core systematic biopsy without a magnetic resonance imaging-targeted biopsy. We assessed Stockholm3 and RPCRC performance for clinically significant prostate cancer detection. Furthermore, we compared the proportion of men recommended for biopsy and biopsy outcomes with Stockholm3 and RPCRC against PSA ≥3 ng/ml.

Key findings and limitations: Our study encompassed 405 biopsied men, with a median age of 66 yr (interquartile range [IQR]: 60-72), PSA levels at 7 ng/ml (IQR: 5.2-10.8), and Stockholm3 scores at 18 (IQR: 10-34). Among them, 128 men (31%) received clinically significant prostate cancer diagnoses. Employing the recommended Stockholm3 threshold (≥15) could have reduced unnecessary biopsies by 52%, while detecting 92% of clinically significant cases compared with using PSA ≥3 ng/ml as a biopsy criterion. Both Stockholm3 and RPCRC exhibited strong discrimination, with area under the curve values of 0.80 (95% confidence interval [CI]: 0.76-0.85) and 0.75 (95% CI: 0.70-0.80), respectively. Stockholm3 demonstrated good calibration, while RPCRC underestimated the risk compared with observed outcomes. Moreover, Stockholm3 yielded positive clinical net benefits, whereas RPCRC yielded negative net benefits for clinically relevant thresholds.

Conclusions and clinical implications: Stockholm3 utilization could detect 92% of clinically significant prostate cancer cases while simultaneously reducing unnecessary biopsies by 52%, compared with the PSA ≥3 ng/ml criterion, based on our analysis within a cohort of men who underwent systematic biopsies.

Patient summary: In a German clinical cohort of 405 men, Stockholm3, a blood test for early prostate cancer detection, exhibited favorable clinical benefits. It identified a substantial number of clinically significant cases while reducing unnecessary biopsies by over half in men without the disease and those with clinically nonsignificant prostate cancer.

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来源期刊
ACS Applied Energy Materials
ACS Applied Energy Materials Materials Science-Materials Chemistry
CiteScore
10.30
自引率
6.20%
发文量
1368
期刊介绍: ACS Applied Energy Materials is an interdisciplinary journal publishing original research covering all aspects of materials, engineering, chemistry, physics and biology relevant to energy conversion and storage. The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrate knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important energy applications.
期刊最新文献
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