Abstract：
OBJECTIVE: To evaluate the real-world added value of androgen deprivation therapy (ADT) in addition to external beam radiotherapy (EBRT) in men with high-risk non-metastatic prostate cancer, in view of advances in radiotherapy and diagnostics.
METHODS: All Dutch men diagnosed with high-risk non-metastatic prostate cancer (defined as: ≥cT2c-T3b N0M0, PSA ≥20-50 ng/ml, and/or Gleason score ≥8 (International Society of Urological Pathology [ISUP] grade ≥4)) from 2009 through 2019 and treated with EBRT with or without ADT were identified in the population-based Netherlands Cancer Registry. Propensity scores were used to match (1:1) men that received ADT to men that did not receive ADT. Subsequently, OS was compared. Analyses were also stratified by number of high-risk features, 1 (either ≥cT2c, PSA >20 ng/ml or Gleason score ≥8) versus ≥2 (out of ≥cT2c, PSA >20 ng/ml and Gleason score ≥8).
RESULTS: A total of 14,773 men with high-risk non-metastatic prostate cancer were identified, 3,958 (27%) of which received EBRT alone. After matching, 3,427 men remained in both groups and baseline characteristics were well-balanced. After a median follow-up of 92 months, OS was better in men treated with EBRT and ADT compared to men treated with EBRT alone (10-year OS: 66.4% versus 61.8%; HR 0.88 [95%CI: 0.80-0.96]). There was no statistically significant difference in OS in the subgroup of men with only 1 high-risk feature (10-year OS 67.7% versus 64.9%; HR 0.95 [95%CI: 0.85-1.07]).
CONCLUSIONS: In a contemporary cohort of men treated for high-risk non-metastatic prostate cancer with EBRT, an OS benefit of adding ADT was only observed in men with at least 2 high-risk features. These results suggest that improvements in diagnostics and treatment in recent decades have resulted in a stage shift of men benefiting from the addition of ADT to EBRT.
METHODS: All Dutch men diagnosed with high-risk non-metastatic prostate cancer (defined as: ≥cT2c-T3b N0M0, PSA ≥20-50 ng/ml, and/or Gleason score ≥8 (International Society of Urological Pathology [ISUP] grade ≥4)) from 2009 through 2019 and treated with EBRT with or without ADT were identified in the population-based Netherlands Cancer Registry. Propensity scores were used to match (1:1) men that received ADT to men that did not receive ADT. Subsequently, OS was compared. Analyses were also stratified by number of high-risk features, 1 (either ≥cT2c, PSA >20 ng/ml or Gleason score ≥8) versus ≥2 (out of ≥cT2c, PSA >20 ng/ml and Gleason score ≥8).
RESULTS: A total of 14,773 men with high-risk non-metastatic prostate cancer were identified, 3,958 (27%) of which received EBRT alone. After matching, 3,427 men remained in both groups and baseline characteristics were well-balanced. After a median follow-up of 92 months, OS was better in men treated with EBRT and ADT compared to men treated with EBRT alone (10-year OS: 66.4% versus 61.8%; HR 0.88 [95%CI: 0.80-0.96]). There was no statistically significant difference in OS in the subgroup of men with only 1 high-risk feature (10-year OS 67.7% versus 64.9%; HR 0.95 [95%CI: 0.85-1.07]).
CONCLUSIONS: In a contemporary cohort of men treated for high-risk non-metastatic prostate cancer with EBRT, an OS benefit of adding ADT was only observed in men with at least 2 high-risk features. These results suggest that improvements in diagnostics and treatment in recent decades have resulted in a stage shift of men benefiting from the addition of ADT to EBRT.
摘要：
目的：评估雄激素剥夺治疗（ADT）以及外束放疗（EBRT）在男性高危非转移性前列腺癌患者中的实际附加值，鉴于放射治疗和诊断的进展。
方法：所有诊断为高风险非转移性前列腺癌的荷兰男性（定义为：≥cT2c-T3bN0M0，PSA≥20-50ng/ml，和/或Gleason评分≥8分(国际泌尿外科病理学会[ISUP]≥4级),2009年至2019年期间,在基于人群的荷兰癌症注册中心中发现了接受有或没有ADT的EBRT治疗的患者.倾向评分用于将接受ADT的男性与未接受ADT的男性进行匹配（1：1）。随后，比较了OS。分析还按高风险特征的数量进行了分层，1(要么≥cT2c，PSA>20ng/ml或Gleason评分≥8)与≥2(超过≥cT2c，PSA>20ng/ml，格里森评分≥8）。
结果：共发现14,773名男性高危非转移性前列腺癌患者，3,958（27％）仅接受EBRT。匹配后,两组中仍有3,427名男性，基线特征平衡良好。经过92个月的中位随访，与单独使用EBRT治疗的男性相比，使用EBRT和ADT治疗的男性的OS更好（10年OS：66.4％对61.8％；HR0.88[95CI：0.80-0.96]）。在仅有1个高危特征的男性亚组中，OS差异无统计学意义（10年OS67.7%对64.9%；HR0.95[95CI:0.85-1.07]）。
结论：在接受EBRT治疗高风险非转移性前列腺癌的当代男性队列中，仅在具有至少2个高危特征的男性中观察到增加ADT的OS获益.这些结果表明，近几十年来诊断和治疗的改善导致男性从ADT添加到EBRT中受益的阶段转变。
方法：所有诊断为高风险非转移性前列腺癌的荷兰男性（定义为：≥cT2c-T3bN0M0，PSA≥20-50ng/ml，和/或Gleason评分≥8分(国际泌尿外科病理学会[ISUP]≥4级),2009年至2019年期间,在基于人群的荷兰癌症注册中心中发现了接受有或没有ADT的EBRT治疗的患者.倾向评分用于将接受ADT的男性与未接受ADT的男性进行匹配（1：1）。随后，比较了OS。分析还按高风险特征的数量进行了分层，1(要么≥cT2c，PSA>20ng/ml或Gleason评分≥8)与≥2(超过≥cT2c，PSA>20ng/ml，格里森评分≥8）。
结果：共发现14,773名男性高危非转移性前列腺癌患者，3,958（27％）仅接受EBRT。匹配后,两组中仍有3,427名男性，基线特征平衡良好。经过92个月的中位随访，与单独使用EBRT治疗的男性相比，使用EBRT和ADT治疗的男性的OS更好（10年OS：66.4％对61.8％；HR0.88[95CI：0.80-0.96]）。在仅有1个高危特征的男性亚组中，OS差异无统计学意义（10年OS67.7%对64.9%；HR0.95[95CI:0.85-1.07]）。
结论：在接受EBRT治疗高风险非转移性前列腺癌的当代男性队列中，仅在具有至少2个高危特征的男性中观察到增加ADT的OS获益.这些结果表明，近几十年来诊断和治疗的改善导致男性从ADT添加到EBRT中受益的阶段转变。
