Department of Radiology and Nuclear medicine, Erasmus University Medical Center, Rotterdam, The Netherlands; Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Eur Urol. 2019 Nov;76(5):693-702. doi: 10.1016/j.eururo.2019.07.041. Epub 2019 Aug 24.
Men with prostate cancer (PCa) on active surveillance (AS) are followed through regular prostate biopsies, a burdensome and often unnecessary intervention, not without risks. Identifying men with at a low risk of disease reclassification may help reduce the number of biopsies.
To assess the external validity of two Canary Prostate Active Surveillance Study Risk Calculators (PASS-RCs), which estimate the probability of reclassification (Gleason grade ≥7 with or without >34% of biopsy cores positive for PCa) on a surveillance biopsy, using a mix of months since last biopsy, age, body mass index, prostate-specific antigen, prostate volume, number of prior negative biopsies, and percentage (or ratio) of positive cores on last biopsy.
DESIGN, SETTING, AND PARTICIPANTS: We used data up to November 2017 from the Movember Foundation's Global Action Plan (GAP3) consortium, a global collaboration between AS studies.
External validity of the PASS-RCs for estimating reclassification on biopsy was assessed by calibration, discrimination, and decision curve analyses.
Five validation cohorts (Prostate Cancer Research International: Active Surveillance, Johns Hopkins, Toronto, Memorial Sloan Kettering Cancer Center, and University of California San Francisco), comprising 5105 men on AS, were eligible for analysis. The individual cohorts comprised 429-2416 men, with a median follow-up between 36 and 84 mo, in both community and academic practices mainly from western countries. Abilities of the PASS-RCs to discriminate between men with and without reclassification on biopsy were reasonably good (area under the receiver operating characteristic curve values 0.68 and 0.65). The PASS-RCs were moderately well calibrated, and had a greater net benefit than most default strategies between a predicted 10% and 30% risk of reclassification.
Both PASS-RCs improved the balance between detecting reclassification and performing surveillance biopsies by reducing unnecessary biopsies. Recalibration to the local setting will increase their clinical usefulness and is therefore required before implementation.
Unnecessary prostate biopsies while on active surveillance (AS) should be avoided as much as possible. The ability of two calculators to selectively identify men at risk of progression was tested in a large cohort of men with low-risk prostate cancer on AS. The calculators were able to prevent unnecessary biopsies in some men. Usefulness of the calculators can be increased by adjusting them to the characteristics of the population of the clinic in which the calculators will be used.
接受主动监测（AS）的前列腺癌（PCa）男性患者需要定期进行前列腺活检，这是一种繁琐且通常不必要的干预措施，并非没有风险。识别出疾病重新分类风险较低的男性，可能有助于减少活检的数量。
评估 Canary 前列腺主动监测研究风险计算器（PASS-RC）的外部有效性，该计算器使用自上次活检以来的月份数、年龄、体重指数、前列腺特异性抗原、前列腺体积、先前阴性活检次数以及上次活检中阳性核心的百分比（或比例）等混合因素，估计监测活检中重新分类（Gleason 分级≥7 且≥34%的活检核心阳性）的概率。
设计、地点和参与者：我们使用了截至 2017 年 11 月来自 Movember 基金会全球行动计划（GAP3）联盟的数据，该联盟是 AS 研究之间的全球合作。
通过校准、区分和决策曲线分析评估 PASS-RC 用于估计活检中重新分类的外部有效性。
有 5 个验证队列（前列腺癌研究国际：主动监测、约翰霍普金斯大学、多伦多、纪念斯隆凯特琳癌症中心和加利福尼亚大学旧金山分校），包括 5105 名接受 AS 的男性，符合分析条件。每个队列包含 429-2416 名男性，中位数随访时间为 36-84 个月，主要来自西方国家的社区和学术实践。PASS-RC 区分有和无活检重新分类的能力相当好（受试者工作特征曲线下面积值为 0.68 和 0.65）。PASS-RC 具有中等程度的校准能力，并且与大多数默认策略相比，在预测的 10%-30%的重新分类风险之间具有更大的净收益。
这两个 PASS-RC 通过减少不必要的活检，提高了检测重新分类和进行监测活检之间的平衡。在实施之前，需要对本地设置进行重新校准，以提高其临床实用性。
在主动监测（AS）期间，应尽可能避免不必要的前列腺活检。在接受 AS 的低危前列腺癌男性的大队列中，对两种计算器选择性识别进展风险的能力进行了测试。该计算器可以防止一些男性进行不必要的活检。通过调整计算器以适应计算器将使用的诊所人群特征，可以提高计算器的有用性。
