Tohi Yoichiro, Kobayashi Keita, Daizumoto Kei, Sekino Yohei, Fukuhara Hideo, Niigawa Heima, Katayama Satoshi, Shimizu Ryutaro, Takamoto Atsushi, Nishimura Kenichi, Nagami Taichi, Hayashida Yushi, Hirama Hiromi, Shiraishi Koji, Tomida Ryotaro, Kobatake Kohei, Inoue Keiji, Miyaji Yoshiyuki, Bekku Kensuke, Morizane Shuichi, Miura Noriyoshi, Wada Koichiro, Sugimoto Mikio
Department of Urology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan.
Department of Urology, Graduate School of Medicine, Yamaguchi University, 1-1-1, Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan.
Jpn J Clin Oncol. 2025 Jun 5;55(6):643-649. doi: 10.1093/jjco/hyaf025.
To evaluate the real-world clinical usage and effectiveness of apalutamide in men with nonmetastatic castration-resistant prostate cancer (nmCRPC).
We retrospectively reviewed the data of 186 men who received apalutamide across 17 institutions. The primary outcomes were the clinical usage of apalutamide for nmCRPC: prior usage of other androgen receptor signaling inhibitors (ARSIs), prior radical treatment, and the distribution of the prostate-specific antigen (PSA) doubling time (PSA-DT) at the initial administration of apalutamide. The secondary outcomes were the efficacy of apalutamide: PSA response (50% or 90% decline), progression-free survival, and skin-adverse events (AEs).
We identified 75 patients with nmCRPC. A total of 31 (41.3%) patients received prior treatment with other ARSIs. A total of 42 men (56%) did not receive any prior radical treatment. The PSA-DT was <3.0, 3.0-5.9, 6.0-10, and > 10 months in 34.7%, 40%, 14.7%, and 10.6% of the patients, respectively. Patients receiving prior treatment with other ARSIs showed a significantly lower PSA response (PSA 50% decline, 88.4% vs. 18.8%; PSA 90% decline, 60.5% vs. 6.2%, P < .001, respectively) and significantly shorter progression-free survival (median: 37 months vs. 4 months; log-rank P < .001) than those without prior ARSI treatment, although cancer status did not differ between the groups. Skin-AEs were observed in 42.7%.
This real-world study revealed that apalutamide was used for the treatment after other ARSIs in >40% of patients with nmCRPC and showed limited efficacy in this context, although the effectiveness of apalutamide without prior other ARSI treatment was comparable with that reported in clinical trial results.
评估阿帕鲁胺在非转移性去势抵抗性前列腺癌（nmCRPC）男性患者中的真实世界临床应用情况及疗效。
我们回顾性分析了17家机构中186例接受阿帕鲁胺治疗的男性患者的数据。主要结局指标为阿帕鲁胺用于nmCRPC的临床应用情况：其他雄激素受体信号抑制剂（ARSIs）的既往使用情况、既往根治性治疗情况以及首次使用阿帕鲁胺时前列腺特异性抗原（PSA）倍增时间（PSA-DT）的分布。次要结局指标为阿帕鲁胺的疗效：PSA反应（下降50%或90%）、无进展生存期以及皮肤不良事件（AEs）。
我们确定了75例nmCRPC患者。共有31例（41.3%）患者既往接受过其他ARSIs治疗。共有42例男性（56%）未接受过任何既往根治性治疗。患者的PSA-DT<3.0、3.0 - 5.9、6.0 - 10以及>10个月的比例分别为34.7%、40%、14.7%和10.6%。与未接受过既往ARSIs治疗的患者相比，接受过其他ARSIs既往治疗的患者PSA反应显著更低（PSA下降50%，88.4%对18.8%；PSA下降90%，60.5%对6.2%，P均<0.001），无进展生存期显著更短（中位数：37个月对4个月；对数秩检验P<0.001），尽管两组间癌症状态无差异。42.7%的患者观察到皮肤AEs。
这项真实世界研究表明，超过40%的nmCRPC患者在使用其他ARSIs后使用阿帕鲁胺进行治疗，在此情况下其疗效有限，尽管未接受过其他ARSIs既往治疗时阿帕鲁胺的疗效与临床试验结果报告的相当。
