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中国前列腺癌联盟前列腺癌初诊穿刺风险计算器的开发与外部多中心验证

Development and external multicenter validation of Chinese Prostate Cancer Consortium prostate cancer risk calculator for initial prostate biopsy.

作者信息

Chen Rui, Xie Liping, Xue Wei, Ye Zhangqun, Ma Lulin, Gao Xu, Ren Shancheng, Wang Fubo, Zhao Lin, Xu Chuanliang, Sun Yinghao

机构信息

Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.

Department of Urology, First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.

出版信息

Urol Oncol. 2016 Sep;34(9):416.e1-7. doi: 10.1016/j.urolonc.2016.04.004. Epub 2016 May 12.

DOI:10.1016/j.urolonc.2016.04.004
PMID:27185342
Abstract

OBJECTIVE

Substantial differences exist in the relationship of prostate cancer (PCa) detection rate and prostate-specific antigen (PSA) level between Western and Asian populations. Classic Western risk calculators, European Randomized Study for Screening of Prostate Cancer Risk Calculator, and Prostate Cancer Prevention Trial Risk Calculator, were shown to be not applicable in Asian populations. We aimed to develop and validate a risk calculator for predicting the probability of PCa and high-grade PCa (defined as Gleason Score sum 7 or higher) at initial prostate biopsy in Chinese men.

MATERIALS AND METHODS

Urology outpatients who underwent initial prostate biopsy according to the inclusion criteria were included. The multivariate logistic regression-based Chinese Prostate Cancer Consortium Risk Calculator (CPCC-RC) was constructed with cases from 2 hospitals in Shanghai. Discriminative ability, calibration and decision curve analysis were externally validated in 3 CPCC member hospitals.

RESULTS

Of the 1,835 patients involved, PCa was identified in 338/924 (36.6%) and 294/911 (32.3%) men in the development and validation cohort, respectively. Multivariate logistic regression analyses showed that 5 predictors (age, logPSA, logPV, free PSA ratio, and digital rectal examination) were associated with PCa (Model 1) or high-grade PCa (Model 2), respectively. The area under the curve of Model 1 and Model 2 was 0.801 (95% CI: 0.771-0.831) and 0.826 (95% CI: 0.796-0.857), respectively. Both models illustrated good calibration and substantial improvement in decision curve analyses than any single predictors at all threshold probabilities. Higher predicting accuracy, better calibration, and greater clinical benefit were achieved by CPCC-RC, compared with European Randomized Study for Screening of Prostate Cancer Risk Calculator and Prostate Cancer Prevention Trial Risk Calculator in predicting PCa.

CONCLUSIONS

CPCC-RC performed well in discrimination and calibration and decision curve analysis in external validation compared with Western risk calculators. CPCC-RC may aid in decision-making of prostate biopsy in Chinese or in other Asian populations with similar genetic and environmental backgrounds.

摘要

目的

西方人群与亚洲人群在前列腺癌(PCa)检出率和前列腺特异性抗原(PSA)水平的关系上存在显著差异。经典的西方风险计算器,如欧洲前列腺癌筛查随机研究风险计算器和前列腺癌预防试验风险计算器,已被证明不适用于亚洲人群。我们旨在开发并验证一种风险计算器,用于预测中国男性初次前列腺穿刺活检时PCa和高级别PCa(定义为Gleason评分总和为7或更高)的概率。

材料与方法

纳入符合纳入标准并接受初次前列腺穿刺活检的泌尿外科门诊患者。基于多因素逻辑回归的中国前列腺癌联盟风险计算器(CPCC-RC)利用上海两家医院的病例构建而成。在3家CPCC成员医院对其区分能力、校准和决策曲线分析进行外部验证。

结果

在纳入的1835例患者中,开发队列和验证队列中分别有338/924(36.6%)和294/911(32.3%)的男性被诊断为PCa。多因素逻辑回归分析显示,5个预测因素(年龄、logPSA、logPV、游离PSA比值和直肠指检)分别与PCa(模型1)或高级别PCa(模型2)相关。模型1和模型2的曲线下面积分别为0.801(95%CI:0.771-0.831)和0.826(95%CI:0.796-0.857)。在所有阈值概率下,两个模型均显示出良好的校准,且在决策曲线分析中比任何单一预测因素都有显著改善。与欧洲前列腺癌筛查随机研究风险计算器和前列腺癌预防试验风险计算器相比,CPCC-RC在预测PCa方面具有更高的预测准确性、更好的校准和更大的临床获益。

结论

与西方风险计算器相比,CPCC-RC在外部验证的区分能力、校准和决策曲线分析方面表现良好。CPCC-RC可能有助于中国或其他具有相似遗传和环境背景的亚洲人群进行前列腺穿刺活检的决策。

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