Department of Urology, Hospital Universitario Miguel Servet. IIS Aragon., Zaragoza, Spain.
Department of Urology, Instituto Valenciano de Oncología, Valencia, Spain.
Prostate Cancer Prostatic Dis. 2019 Mar;22(1):84-90. doi: 10.1038/s41391-018-0074-5. Epub 2018 Aug 14.
Management of active surveillance (AS) in low-risk prostate cancer (PCa) patients could be improved with new biomarkers, such as the 4Kscore test. We analyze its ability to predict tumor reclassification by upgrading at the confirmatory biopsy at 6 months.
Observational, prospective, blinded, and non-randomized study, within the Spanish National Registry on AS (AEU/PIEM/2014/0001; NCT02865330) with 181 patients included after initial Bx and inclusion criteria: PSA ≤10 ng/mL, cT1c-T2a, Grade group 1, ≤2 cores, and ≤5 mm/50% length core involved. Central pathological review of initial and confirmatory Bx was performed on all biopsy specimens. Plasma was collected 6 months after initial Bx and just before confirmatory Bx to determine 4Kscore result. In order to predict reclassification defined as Grade group ≥2, we analyzed 4Kscore, percent free to total (%f/t) PSA ratio, prostate volume, PSA density, family history, body mass index, initial Bx, total cores, initial Bx positive cores, initial Bx % of positive cores, initial Bx maximum cancer core length and initial Bx cancer % involvement. Wilcoxon rank-sum test, non-parametric trend test or Fisher's exact test, as appropriate established differences between groups of reclassification.
A total of 137 patients met inclusion criteria. Eighteen patients (13.1%) were reclassified at confirmatory Bx. The %f/t PSA ratio and 4Kscore showed differences between the groups of reclassification (Yes/No). Using 7.5% as cutoff for the 4Kscore, we found a sensitivity of 89% and a specificity of 29%, with no reclassifications to Grade group 3 for patients with 4Kscore below 7.5% and 2 (6%) missed Grade group 2 reclassified patients. Using this threshold value there is a biopsy reduction of 27%. Additionally, 4Kscore was also associated with changes in tumor volume.
Our preliminary findings suggest that the 4Kscore may be a useful tool in the decision-making process to perform a confirmatory Bx in active surveillance management.
在低危前列腺癌（PCa）患者中，主动监测（AS）的管理可以通过新的生物标志物（如 4Kscore 测试）得到改善。我们分析了它在 6 个月确认性活检时预测肿瘤升级的能力。
这是一项在西班牙 AS 国家登记处（AEU/PIEM/2014/0001；NCT02865330）内进行的观察性、前瞻性、盲法和非随机研究，纳入了 181 名符合初始活检标准且符合以下纳入标准的患者：PSA≤10ng/mL、cT1c-T2a、Gleason 分组 1、≤2 个核心、≤5mm/50%核心长度受累。对所有活检标本进行初始和确认性活检的中央病理复查。在初始活检后 6 个月且在确认性活检前采集血浆以确定 4Kscore 结果。为了预测定义为 Gleason 分组≥2 的重新分类，我们分析了 4Kscore、游离 PSA 与总 PSA 比值（%f/t）、前列腺体积、PSA 密度、家族史、体重指数、初始活检、总核心数、初始活检阳性核心数、初始活检阳性核心百分比、初始活检最大癌核心长度和初始活检癌受累百分比。Wilcoxon 秩和检验、非参数趋势检验或 Fisher 确切概率检验用于确定重新分类组之间的差异。
共有 137 名患者符合纳入标准。18 名患者（13.1%）在确认性活检时被重新分类。%f/t PSA 比值和 4Kscore 在重新分类组之间存在差异（是/否）。当使用 7.5%作为 4Kscore 的截断值时，我们发现其灵敏度为 89%，特异性为 29%，4Kscore 低于 7.5%的患者无 3 级分组的重新分类，2 例（6%）Gleason 分组 2 的患者被漏诊。使用该阈值，活检的数量减少了 27%。此外，4Kscore 还与肿瘤体积的变化有关。
我们的初步发现表明，4Kscore 可能是主动监测管理中进行确认性活检决策过程中的有用工具。
