Lenz Lauren, Clegg Wyatt, Iliev Diana, Kasten Chelsea R, Korman Howard, Morgan Todd M, Hafron Jason, DeHaan Alexander, Olsson Carl, Tutrone Ronald F, Richardson Timothy, Cline Kevin, Yonover Paul M, Jasper Jeff, Cohen Todd, Finch Robert, Slavin Thomas P, Gutin Alexander
Myriad Genetics, Inc., Salt Lake City, UT, USA.
Comprehensive Urology, Royal Oak, MI, USA.
Prostate Cancer Prostatic Dis. 2024 Sep 5. doi: 10.1038/s41391-024-00888-y.
Genomic testing can add risk stratification information to clinicopathological features in prostate cancer, aiding in shared medical decision-making between the clinician and patient regarding whether active surveillance (AS) or definitive treatment (DT) is most appropriate. Here we examined initial AS selection and 3-year AS durability in patients diagnosed with localized intermediate-risk prostate cancer who underwent Prolaris testing before treatment decision-making.
This retrospective observational cohort study included 3208 patients from 10 study sites who underwent Prolaris testing at diagnosis from September 2015 to December 2018. Prolaris utilizes a combined clinical cell cycle risk score calculated at diagnostic biopsy to stratify patients by the Prolaris AS threshold (below threshold, patient recommended to AS or above threshold, patient recommended to DT). AS selection rates and 3-year AS durability were compared in patients recommended to AS or DT by Prolaris testing. Univariable and multivariable logistic regression models and Cox proportional hazard models were used with molecular and clinical variables as predictors of initial treatment decision and AS durability, respectively.
AS selection was ~2 times higher in patients recommended to AS by Prolaris testing than in those recommended to DT (p < 0.0001). Three-year AS durability was ~1.5 times higher in patients recommended to AS by Prolaris testing than in those recommended to DT (p < 0.0001). Prolaris treatment recommendation remained a statistically significant predictor of initial AS selection and AS durability after accounting for CAPRA or Gleason scores.
Prolaris added significant information to clinical risk stratification to aid in treatment decision making. Intermediate-risk prostate cancer patients who were recommended to AS by Prolaris were more likely to initially pursue AS and were more likely to remain on AS at 3 years post-diagnosis than patients recommended to DT.
基因组检测可为前列腺癌的临床病理特征增添风险分层信息，有助于临床医生和患者就是否进行积极监测（AS）或确定性治疗（DT）做出共同的医疗决策。在此，我们研究了在做出治疗决策前接受Prolaris检测的局限性中危前列腺癌患者的初始AS选择及3年AS持续性。
这项回顾性观察性队列研究纳入了来自10个研究地点的3208例患者，这些患者于2015年9月至2018年12月确诊时接受了Prolaris检测。Prolaris利用诊断性活检时计算的综合临床细胞周期风险评分，根据Prolaris AS阈值对患者进行分层（低于阈值，建议患者进行AS；高于阈值，建议患者进行DT）。比较通过Prolaris检测建议进行AS或DT的患者的AS选择率和3年AS持续性。单变量和多变量逻辑回归模型以及Cox比例风险模型分别用于将分子和临床变量作为初始治疗决策和AS持续性的预测因素。
通过Prolaris检测建议进行AS的患者的AS选择率比建议进行DT的患者高约2倍（p<0.0001）。通过Prolaris检测建议进行AS的患者的3年AS持续性比建议进行DT的患者高约1.5倍（p<0.0001）。在考虑CAPRA或Gleason评分后，Prolaris治疗建议仍然是初始AS选择和AS持续性的统计学显著预测因素。
Prolaris为临床风险分层增添了重要信息，有助于治疗决策。与建议进行DT的患者相比，通过Prolaris建议进行AS的中危前列腺癌患者更有可能最初选择AS，并且在诊断后3年更有可能继续进行AS。
