Department of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Department of Urology, SUBARU Health Insurance Society Ota Memorial Hospital, Gumna, Japan.
Int J Clin Oncol. 2024 Aug;29(8):1191-1197. doi: 10.1007/s10147-024-02548-6. Epub 2024 May 20.
Phase III clinical trials demonstrated the efficacy of enzalutamide and apalutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and PSA doubling time ≤10 months. Although these drugs have been shown to vary in their adverse event (AE) profiles, the differences in their efficacy profiles remain to be evaluated. Therefore, this retrospective study was conducted to evaluate the efficacy of these drugs in patients with nmCRPC.
This study evaluated 191 patients with nmCRPC treated with enzalutamide (n = 137) or apalutamide (n = 54) in the first-line setting at Jikei University Hospital or its affiliated hospitals between May 2014 and November 2022. Endpoints were defined as oncological outcomes (i.e., PSA response, PFS, PSA-PFS, MFS, CSS, and OS) and AEs.
No significant differences were noted in patient backgrounds between the two groups. Patients exhibiting a maximum PSA response of >50% and >90% accounted for 74.5% and 48.9% of patients in the enzalutamide group, and 75.9% and 42.6% of patients in the apalutamide group, respectively, with no significant difference between the groups. The median PSA-PFS was 10 months in the enzalutamide group but not in the apalutamide group, with no significant difference between the groups (P = 0.48). No significant differences were observed in MFS, CSS, or OS between the groups. Patients reporting AEs of all grades and grade 3 or higher accounted for 56.2% and 4.3% of those in the enzalutamide group and 57.4% and 7.4% of those in the apalutamide group, respectively. The most common AE was fatigue (26.3%) in the enzalutamide group and skin rash (27.8%) in the apalutamide group.
In this retrospective study of their efficacy and safety, enzalutamide and apalutamide were shown to exhibit comparable oncological outcomes but quite different AE profiles, suggesting that their differential use may be warranted based on these findings.
III 期临床试验表明，恩扎卢胺和阿帕鲁胺在无转移去势抵抗性前列腺癌（nmCRPC）和 PSA 倍增时间≤10 个月的患者中具有疗效。尽管这些药物在不良反应（AE）谱方面有所不同，但它们的疗效谱差异仍有待评估。因此，进行这项回顾性研究旨在评估这些药物在 nmCRPC 患者中的疗效。
本研究评估了 2014 年 5 月至 2022 年 11 月期间在日本顺天堂大学医院或其附属医院接受一线恩扎卢胺（n=137）或阿帕鲁胺（n=54）治疗的 191 例 nmCRPC 患者。终点定义为肿瘤学结局（即 PSA 反应、无进展生存期、PSA-无进展生存期、总生存期、无进展生存期和总生存期）和 AE。
两组患者的背景无显著差异。在恩扎卢胺组中，PSA 最大反应>50%和>90%的患者分别占 74.5%和 48.9%，而在阿帕鲁胺组中分别占 75.9%和 42.6%，两组之间无显著差异。恩扎卢胺组的中位 PSA-无进展生存期为 10 个月，但阿帕鲁胺组未达到，两组之间无显著差异（P=0.48）。两组之间的 MFS、CSS 或 OS 无显著差异。报告所有等级和 3 级或以上 AE 的患者分别占恩扎卢胺组的 56.2%和 4.3%，阿帕鲁胺组的 57.4%和 7.4%。最常见的 AE 是疲劳（26.3%）在恩扎卢胺组和皮疹（27.8%）在阿帕鲁胺组。
在这项关于其疗效和安全性的回顾性研究中，恩扎卢胺和阿帕鲁胺显示出相当的肿瘤学结局，但 AE 谱差异很大，这表明根据这些发现，它们的差异使用可能是合理的。
