Abstract：
OBJECTIVE: Descriptive study focusing on real-world utilization and characteristics of men with prostate cancer tested with the 17-gene Genomic Prostate Score® (GPS™) assay by linking administrative claims and electronic health record (EHR) data with GPS results.
METHODS: This retrospective, observational cohort study (January 1, 2013 to December 31, 2020) included men aged 40-80 years with localized prostate cancer claims, continuous enrollment in Optum\'s Integrated Claims data set, ≥1 day of EHR clinical activity, and a GPS result. Men were classified as undergoing definitive therapy (DT) (prostatectomy, radiation, or focal therapy) or active surveillance (AS). AS and DT distribution were analyzed across GPS results, National Comprehensive Cancer Network® (NCCN®) risk, and race. Costs were assessed 6 months after the first GPS result (index); clinical outcomes and AS persistence were assessed during the variable follow-up. All variables were analyzed descriptively.
RESULTS: Of 834 men, 650 (77.9%) underwent AS and 184 (22.1%) DT. Most men had Quan-Charlson comorbidity scores of 1-2 and a tumor stage of T1c (index). The most common Gleason patterns were 3 + 3 (79.6%) (AS cohort) and 3 + 4 (55.9%) (DT cohort). The mean (standard deviation) GPS results at index were 23.2 (11.3) (AS) and 30.9 (12.9) (DT). AS decreased with increasing GPS result and NCCN risk. Differences between races were minimal. Total costs were substantially higher in the DT cohort.
CONCLUSIONS: Most men with GPS-tested localized prostate cancer underwent AS, indicating the GPS result can inform clinical management. Decreasing AS with increasing GPS result and NCCN risk suggests the GPS complements NCCN risk stratification.
METHODS: This retrospective, observational cohort study (January 1, 2013 to December 31, 2020) included men aged 40-80 years with localized prostate cancer claims, continuous enrollment in Optum\'s Integrated Claims data set, ≥1 day of EHR clinical activity, and a GPS result. Men were classified as undergoing definitive therapy (DT) (prostatectomy, radiation, or focal therapy) or active surveillance (AS). AS and DT distribution were analyzed across GPS results, National Comprehensive Cancer Network® (NCCN®) risk, and race. Costs were assessed 6 months after the first GPS result (index); clinical outcomes and AS persistence were assessed during the variable follow-up. All variables were analyzed descriptively.
RESULTS: Of 834 men, 650 (77.9%) underwent AS and 184 (22.1%) DT. Most men had Quan-Charlson comorbidity scores of 1-2 and a tumor stage of T1c (index). The most common Gleason patterns were 3 + 3 (79.6%) (AS cohort) and 3 + 4 (55.9%) (DT cohort). The mean (standard deviation) GPS results at index were 23.2 (11.3) (AS) and 30.9 (12.9) (DT). AS decreased with increasing GPS result and NCCN risk. Differences between races were minimal. Total costs were substantially higher in the DT cohort.
CONCLUSIONS: Most men with GPS-tested localized prostate cancer underwent AS, indicating the GPS result can inform clinical management. Decreasing AS with increasing GPS result and NCCN risk suggests the GPS complements NCCN risk stratification.
摘要：
目的：描述性研究，重点是通过将行政索赔和电子健康记录（EHR）数据与GPS结果联系起来，使用17基因基因组前列腺评分®（GPS™）测定法测试了前列腺癌男性的现实世界利用和特征。
方法：本回顾性研究，观察性队列研究（2013年1月1日至2020年12月31日）包括患有局限性前列腺癌的40-80岁男性，在Optum的集成索赔数据集中连续注册，EHR临床活动≥1天，和GPS结果。男性被归类为接受确定性治疗(DT)(前列腺切除术，辐射,或局部治疗)或主动监测(AS)。分析了GPS结果中的AS和DT分布，国家综合癌症网络®（NCCN®）风险，和种族。首次GPS结果（指数）后6个月评估成本；在可变随访期间评估临床结果和AS持久性。对所有变量进行描述性分析。
结果：在834名男性中，650例（77.9％）接受AS和184例（22.1％）DT。大多数男性的Quan-Charlson合并症评分为1-2，肿瘤分期为T1c（指数）。最常见的格里森模式是3+3(79.6%)(AS队列)和3+4(55.9%)(DT队列)。指数的平均（标准偏差）GPS结果为23.2（11.3）（AS）和30.9（12.9）（DT）。AS随着GPS结果和NCCN风险的增加而降低。种族之间的差异很小。DT队列中的总成本高得多。
结论：大多数患有GPS检测的局限性前列腺癌的男性都患有AS，指示GPS结果可以为临床管理提供信息。随着GPS结果和NCCN风险的增加，AS降低表明GPS补充了NCCN风险分层。
方法：本回顾性研究，观察性队列研究（2013年1月1日至2020年12月31日）包括患有局限性前列腺癌的40-80岁男性，在Optum的集成索赔数据集中连续注册，EHR临床活动≥1天，和GPS结果。男性被归类为接受确定性治疗(DT)(前列腺切除术，辐射,或局部治疗)或主动监测(AS)。分析了GPS结果中的AS和DT分布，国家综合癌症网络®（NCCN®）风险，和种族。首次GPS结果（指数）后6个月评估成本；在可变随访期间评估临床结果和AS持久性。对所有变量进行描述性分析。
结果：在834名男性中，650例（77.9％）接受AS和184例（22.1％）DT。大多数男性的Quan-Charlson合并症评分为1-2，肿瘤分期为T1c（指数）。最常见的格里森模式是3+3(79.6%)(AS队列)和3+4(55.9%)(DT队列)。指数的平均（标准偏差）GPS结果为23.2（11.3）（AS）和30.9（12.9）（DT）。AS随着GPS结果和NCCN风险的增加而降低。种族之间的差异很小。DT队列中的总成本高得多。
结论：大多数患有GPS检测的局限性前列腺癌的男性都患有AS，指示GPS结果可以为临床管理提供信息。随着GPS结果和NCCN风险的增加，AS降低表明GPS补充了NCCN风险分层。
