Ueda Takashi, Hayakawa Keita, Horiguchi Go, Murashita Junki, Shiraishi Takumi, Fujimoto Saizo, Miyashita Masatsugu, Saito Yumiko, Gabata Yusuke, Sako Satoshi, Takahashi Hikaru, Fujihara Atsuko, Minami Takafumi, Yamamoto Yutaka, Okumi Masayoshi, Hongo Fumiya, Okihara Koji, Fujita Kazutoshi, Ukimura Osamu
Department of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Department of Biostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Prostate. 2025 May;85(6):524-530. doi: 10.1002/pros.24855. Epub 2025 Jan 15.
Differences in the effectiveness of second-generation androgen receptor axis-targeted agents (ARATs) in high-risk metastatic hormone-sensitive prostate cancer (mHSPC) remain unclear. This study aimed to identify the factors influencing the efficacy of ARATs in patients with high-risk mHSPC and compare their long-term effectiveness.
Four hundred and sixty-six patients with mHSPC treated with ARATs were retrospectively recruited from our hospital and affiliated hospitals of the Kindai Oncology Study Group and Kyoto Prefectural University of Medicine Oncology Study Group between December 2013 and March 2024. Cox proportional hazards analysis was performed to identify prognostic factors for overall survival in patients with mHSPC. Propensity score matching was used to adjust for the differences in clinical backgrounds of the patients.
Univariate and multivariable analyses revealed that Gleason pattern 5 and pretreatment ALP levels were notable prognostic factors for overall survival in patients with mHSPC treated with ARATs. In the subgroup of patients with high-risk mHSPC with Gleason pattern 5, apalutamide and enzalutamide showed significantly better outcomes in terms of PSA-PFS, PFS2, and overall survival compared to abiraterone acetate though selection bias and the small number of patients may be associated with the results in this study. Univariate and multivariable analyses suggested that ARATs selection (ABI vs. APA or ENZ) may serve as an independent predictor of overall survival in patients with high-risk mHSPC with Gleason pattern 5 treated with ARATs.
Gleason pattern 5 may be a predictive factor for ARAT efficacy in patients with high-risk mHSPCs.
第二代雄激素受体轴靶向药物（ARATs）在高危转移性激素敏感性前列腺癌（mHSPC）中的疗效差异尚不清楚。本研究旨在确定影响ARATs在高危mHSPC患者中疗效的因素，并比较它们的长期有效性。
回顾性招募了2013年12月至2024年3月期间在我院以及近畿肿瘤研究组附属医院和京都府立医科大学肿瘤研究组附属医院接受ARATs治疗的466例mHSPC患者。进行Cox比例风险分析以确定mHSPC患者总生存的预后因素。采用倾向评分匹配法来调整患者临床背景的差异。
单因素和多因素分析显示，Gleason 5级和治疗前碱性磷酸酶（ALP）水平是接受ARATs治疗的mHSPC患者总生存的显著预后因素。在Gleason 5级高危mHSPC患者亚组中，尽管本研究结果可能与选择偏倚和患者数量少有关，但与醋酸阿比特龙相比，阿帕他胺和恩杂鲁胺在前列腺特异性抗原无进展生存期（PSA-PFS）、第二次无进展生存期（PFS2）和总生存方面显示出显著更好的结果。单因素和多因素分析表明，ARATs的选择（阿比特龙与阿帕他胺或恩杂鲁胺）可能是接受ARATs治疗的Gleason 5级高危mHSPC患者总生存的独立预测因素。
Gleason 5级可能是高危mHSPC患者ARAT疗效的预测因素。
