López-Abad Alicia, Belmonte Mario, Ramírez Backhaus Miguel, Server Gómez Gerardo, Cao Avellaneda Enrique, Moreno Alarcón Cristóbal, López Cubillana Pedro, Yago Giménez Pablo, de Pablos Rodríguez Pedro, Juan Fita María José, Climent Durán Miguel Ángel, Guardiola Ruiz Iris, Vidal Crespo Natalia, Moreno Avilés Juan, Guzmán Martínez-Valls Pablo Luis, López González Pedro Ángel
Department of Urology, Virgen de la Arrixaca Hospital, El Palmar, 30120 Murcia, Spain.
Department of Experimental and Clinical Medicine, University of Florence, 50121 Florence, Italy.
J Clin Med. 2024 Oct 18;13(20):6221. doi: 10.3390/jcm13206221.
Androgen receptor-targeted agents have significantly improved the prognosis of metastatic hormone-sensitive prostate cancer (mHSPC). Prostate-specific antigen (PSA) levels are key prognostic markers, with rapid and deep reductions associated with better outcomes. This study aims to assess the association between the new PSA cut-offs and survival in mHSPC patients treated with Apalutamide. We conducted a multicentre, retrospective analysis of mHSPC patients treated with Apalutamide between March 2021 and January 2023. Overall survival (OS) and radiographic progression-free survival (rFPS) were analyzed and stratified by the following PSA ranges: <0.02 ng/mL (ultralow), 0.02-0.2 ng/mL, and >0.2 ng/mL. Cox regression was applied to identify variables associated with OS and rPFS. : Among 193 patients, 34.2% had de novo mHSPC, with the majority classified as M1b. A total of 58.2% (110) of our cohort achieved ultralow PSA levels, with 20.6% between 0.02 and 0.2 ng/mL, and 21.2% of PSA levels > 0.2 ng/mL. Most patients reached ultralow PSA within six months. Low-volume, metachronous, and M1a subgroups displayed a higher prevalence of patients reaching ultralow PSA levels. At 18 months, OS was 100% in the ultralow PSA group, 94.4% for the 0.02-0.2 ng/mL group, and 67.7% in the >0.2 ng/mL group. Similarly, rPFS at 18 months was 100%, 93.5%, and 50.7%, respectively. Cox regression revealed that both ultralow PSA levels and ISUP grade had a significant impact on OS (HR of 8.256 and 0.164, respectively). For rPFS, only ultralow PSA levels had a significant impact (HR = 0.085). : This real-world study of mHSPC patients treated with Apalutamide plus ADT revealed that achieving ultralow PSA levels is strongly associated with better oncological outcomes.
雄激素受体靶向药物显著改善了转移性激素敏感性前列腺癌（mHSPC）的预后。前列腺特异性抗原（PSA）水平是关键的预后标志物，其快速且深度降低与更好的预后相关。本研究旨在评估新的PSA临界值与接受阿帕他胺治疗的mHSPC患者生存之间的关联。我们对2021年3月至2023年1月期间接受阿帕他胺治疗的mHSPC患者进行了多中心回顾性分析。通过以下PSA范围对总生存期（OS）和影像学无进展生存期（rFPS）进行分析和分层：<0.02 ng/mL（超低）、0.02 - 0.2 ng/mL和>0.2 ng/mL。应用Cox回归来确定与OS和rPFS相关的变量。在193例患者中，34.2%为初发mHSPC，大多数归类为M1b。我们队列中共有（110例）58.2%的患者达到超低PSA水平，0.02至0.2 ng/mL之间的占20.6%，PSA水平>0.2 ng/mL的占21.2%。大多数患者在六个月内达到超低PSA水平。低瘤负荷、异时性和M1a亚组中达到超低PSA水平的患者比例更高。18个月时，超低PSA组的OS为100%，0.02 - 0.2 ng/mL组为94.4%，>0.2 ng/mL组为67.7%。同样，18个月时的rPFS分别为100%、93.5%和50.7%。Cox回归显示，超低PSA水平和ISUP分级均对OS有显著影响（HR分别为8.256和0.164）。对于rPFS，只有超低PSA水平有显著影响（HR = 0.085）。这项对接受阿帕他胺加雄激素剥夺治疗（ADT）的mHSPC患者的真实世界研究表明，达到超低PSA水平与更好的肿瘤学结局密切相关。
