Leapman Michael S, Ho Julian, Liu Yang, Filson Christopher, Zhao Xin, Hakansson Alexander, Proudfoot James A, Davicioni Elai, Martin Darryl T, An Yi, Seibert Tyler M, Lin Daniel W, Spratt Daniel E, Cooperberg Matthew R, Sprenkle Preston C, Ross Ashley E
Department of Urology, Yale School of Medicine, New Haven, CT, USA; Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, CT, USA.
Veracyte Inc, San Francisco, CA, USA.
Eur Urol Oncol. 2024 Aug 3. doi: 10.1016/j.euo.2024.07.010.
Although the prognostic significance of the Decipher prostate cancer genomic classifier (GC) has been established largely from analyses of archival tissue, less is known about the associations between the results of Decipher testing and oncologic outcomes among patients receiving contemporaneous testing and treatment in the real-world practice setting. Our objective was to assess the associations between the Decipher GC and risks of metastasis and biochemical recurrence (BCR) following prostate biopsy and radical prostatectomy (RP) among patients tested and treated in the real-world setting.
A retrospective cohort study was conducted using a novel longitudinal linkage of transcriptomic data from the Decipher GC and real-world clinical data (RWD) aggregated from insurance claims, pharmacy records, and electronic health record data across payors and sites of care. Kaplan-Meier and Cox proportional hazards regressions were used to examine the associations between the GC and study outcomes, adjusting for clinical and pathologic factors.
Metastasis from prostate cancer and BCR after radical prostatectomy, Decipher GC continuous score, and risk categories were evaluated. We identified 58 935 participants who underwent Decipher testing, including 33 379 on a biopsy specimen and 25 556 on an RP specimen. The median age was 67 yr (interquartile range [IQR] 62-72) at biopsy testing and 65 yr (IQR 59-69) at RP. The median GC score was 0.43 (IQR 0.27-0.66) among biopsy-tested patients and 0.54 (0.32-0.79) among RP-tested patients. The GC was independently associated with the risk of metastasis among biopsy-tested (hazard ratio [HR] per 0.1 unit increase in GC 1.21 [95% confidence interval {CI} 1.16-1.27], p < 0.001) and RP-tested (HR 1.20 [95% CI 1.17-1.24], p < 0.001) patients after adjusting for baseline clinical and pathologic risk factors. In addition, the GC was associated with the risk of BCR among RP-tested patients (HR 1.12 [95% CI 1.10-1.14], p < 0.001) in models adjusted for age and Cancer of the Prostate Risk Assessment postsurgical score.
This real-world study of a novel transcriptomic linkage conducted at a national scale supports the external prognostic validity of the Decipher GC among patients managed in contemporary practice.
This study looked at the use of the Decipher genomic classifier, a test used to help understand the aggressiveness of a patient's prostate cancer. Looking at the results of 58 935 participants who underwent testing, we found that the Decipher test helped estimate the risk of cancer recurrence and metastasis.
尽管前列腺癌基因组分类器（GC）的预后意义很大程度上已通过对存档组织的分析得以确立，但在现实临床实践环境中，接受同步检测与治疗的患者中，关于Decipher检测结果与肿瘤学结局之间的关联却知之甚少。我们的目的是评估在现实环境中接受检测与治疗的患者，其Decipher GC与前列腺活检及根治性前列腺切除术（RP）后转移风险和生化复发（BCR）之间的关联。
采用一项回顾性队列研究，利用来自Decipher GC的转录组数据与从保险理赔、药房记录以及不同医保支付方和医疗机构的电子健康记录数据汇总而来的现实临床数据（RWD）进行新型纵向关联分析。采用Kaplan-Meier法和Cox比例风险回归分析来检验GC与研究结局之间的关联，并对临床和病理因素进行校正。
评估了前列腺癌转移、根治性前列腺切除术后的BCR、Decipher GC连续评分以及风险类别。我们确定了58935名接受Decipher检测的参与者，其中33379名的检测样本为活检标本，25556名的检测样本为RP标本。活检检测时的中位年龄为67岁（四分位间距[IQR]62 - 72），RP检测时的中位年龄为65岁（IQR 59 - 69）。活检检测患者的GC评分中位数为0.43（IQR 0.27 - 0.66），RP检测患者的GC评分中位数为0.54（0.32 - 0.79）。在对基线临床和病理风险因素进行校正后，GC与活检检测患者（GC每增加0.1单位，风险比[HR]为1.21[95%置信区间{CI}1.16 - 1.27]，p < 0.001）及RP检测患者（HR 1.20[95% CI 1.17 - 1.24]，p < 0.001）的转移风险独立相关。此外，在对年龄和前列腺癌风险评估术后评分进行校正的模型中，GC与RP检测患者的BCR风险相关（HR 1.12[95% CI 1.10 - 1.14]，p < 0.001）。
这项在全国范围内开展的关于新型转录组关联的现实研究支持了Decipher GC在当代临床实践中对患者的外部预后有效性。
本研究观察了Decipher基因组分类器的应用，该检测用于帮助了解患者前列腺癌的侵袭性。通过观察58935名接受检测的参与者的结果，我们发现Decipher检测有助于评估癌症复发和转移的风险。
