目前可用的事后 3 期试验数据表明，接受 apalutamide 治疗的转移性激素敏感型前列腺癌 (mHSPC) 患者的癌症控制效果更好，达到（超）低前列腺特异性抗原 (PSA) 最低点。本研究旨在验证超低 PSA 最低限度。依靠机构前列腺癌数据库，产生了 107 名符合条件的患者。目前可用的 PSA 最低截止值（SWOG 试验：<0.2 ng/ml；超低 TITAN 试验：≤0.02 vs 0.02-0.2 vs >0.2 ng/ml）和 PSA 反应 (≥99%) 测试了去势抵抗前列腺的时间使用阿帕鲁胺治疗的 mHSPC 患者的癌症 (ttCRPC) 和总生存期 (OS)。最后，与阿比特龙 mHSPC 治疗进行比较。总体而言，纳入了 107 名接受阿帕鲁胺治疗的 mHSPC 患者，中位年龄为 68 岁，基线 PSA 为 29 ng/ml。纳入的患者比例最高 (40.2%) 达到 ≤0.02 ng/ml 的超低 PSA 最低值。达到 SWOG 9346 定义的 PSA 最低值 <0.2 ng/ml 和超低 PSA 最低值 ≤0.02 ng/ml 的患者，其转移性去势抵抗性前列腺癌 (mCRPC) 和 OS 的时间最长（所有 p < 0.05）。此外，接受阿帕鲁胺治疗的 mHSPC 患者中有 80% 的 PSA 反应达到≥99%。相对于 PSA 应答 <99% 的患者（均 p < 0.05），这些患者的 mCRPC 时间和 OS 结果也更长。在分析的第二步中，与阿比特龙患者的比较显示，达到 ≤0.02 ng/ml 的超低 PSA 最低点的比率显着更高：阿帕鲁胺与阿比特龙相比，分别为 40.2% 和 8.8%，从而导致阿帕鲁胺的 ttCRPC 显着延长。即使经过多变量调整和仅对高危 mHSPC 患者进行敏感性分析，治疗组（37 个月）的治疗组（37 个月）仍高于阿比特龙治疗组（22 个月）（p = 0.001）。该研究因其回顾性设计而受到限制。在现实世界中，大多数接受阿帕鲁胺治疗的 mHSPC 患者达到了超低 PSA 最低值，这与更好的癌症控制结果相关。此外，≥99% 的 PSA 反应预示着更好的结果。在头对头比较中，阿帕鲁胺比阿比特龙实现了更好的 PSA 动力学和 ttCRPC 结果。前列腺特异性抗原 (PSA) 最低值 <0.02 ng/ml 和 PSA 反应≥99% 与转移性癌症更好的癌症控制结果相关使用阿帕鲁胺治疗的激素敏感型前列腺癌患者。版权所有 © 2024 作者。由 Elsevier B.V. 出版。保留所有权利。

Currently available post hoc phase 3 trial-derived data suggest better cancer-control outcomes in apalutamide-treated metastatic hormone-sensitive prostate cancer (mHSPC) patients achieving an (ultra)low prostate-specific antigen (PSA) nadir. This study aims to validate ultralow PSA nadir cutoffs.Relying on an institutional prostate cancer database, 107 eligible patients were yielded. The currently available PSA nadir cutoffs (SWOG trial: <0.2 ng/ml; ultralow TITAN trial: ≤0.02 vs 0.02-0.2 vs >0.2 ng/ml) and PSA responses (≥99%) were tested for time to castration-resistant prostate cancer (ttCRPC) and overall survival (OS) in mHSPC patients treated with apalutamide. Finally, comparisons were made against abiraterone mHSPC treatment.Overall, 107 mHSPC patients treated with apalutamide at a median age of 68 yr and baseline PSA of 29 ng/ml were included. The highest proportion of included patients (40.2%) achieved an ultralow PSA nadir of ≤0.02 ng/ml. Patients reaching the SWOG 9346-defined PSA nadir of <0.2 ng/ml and ultralow PSA nadir of ≤0.02 ng/ml harbored the longest time to metastatic castration-resistant prostate cancer (mCRPC) and OS (all p < 0.05). Moreover, 80% of mHSPC patients treated with apalutamide achieved a PSA response of ≥99%. These patients also harbored better time to mCRPC and OS outcomes, relative to patients with a <99% PSA response (both p < 0.05). In the second step of analyses, a comparison against abiraterone patients showed a significantly higher rate of achieving an ultralow PSA nadir of ≤0.02 ng/ml: 40.2% versus 8.8% for apalutamide versus abiraterone, resulting in a significantly longer ttCRPC for the apalutamide-treated (37 mo) than for the abiraterone-treated (22 mo) group (p = 0.001), even after multivariable adjustment and in sensitivity analyses for high-risk mHSPC patients only. The study is limited by its retrospective design.In the real-world setting, most mHSPC patients treated with apalutamide achieve an ultralow PSA nadir, which is associated with better cancer-control outcomes. Moreover, a PSA response of ≥99% predicts better outcomes. In head-to-head comparisons, apalutamide achieves better PSA kinetics and ttCRPC outcomes than abiraterone.A prostate-specific antigen (PSA) nadir of <0.02 ng/ml and PSA responses ≥99% are associated with better cancer-control outcomes in metastatic hormone-sensitive prostate cancer patients treated with apalutamide.Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.