Lowentritt Benjamin H, Rossi Carmine, Muser Erik, Kinkead Frederic, Moore Bronwyn, Lefebvre Patrick, Pilon Dominic, Du Shawn
Chesapeake Urology Associates.
Analysis Group, Inc., Montréal, Canada.
J Health Econ Outcomes Res. 2024 Aug 19;11(2):41-48. doi: 10.36469/001c.121233. eCollection 2024.
The use of androgen receptor signaling inhibitors, including apalutamide, in combination with androgen deprivation therapy is recommended for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). To describe real-world treatment patterns and clinical outcomes among patients with mCSPC or nmCRPC who initiated apalutamide in the United States. A retrospective cohort study of patients with mCSPC or nmCRPC who initiated apalutamide was conducted using electronic medical record data from US community-based urology practices (Feb. 1, 2017-April 1, 2022). Persistence with apalutamide was reported at 6-, 12-, and 18-months post treatment initiation. Clinical outcomes described up to 24 months after apalutamide initiation using Kaplan-Meier analyses included progression to castration resistance, castration resistance-free survival (CRFS), and metastasis-free survival (MFS). Outcomes were reported separately based on mCSPC or nmCRPC status and race (ie, Black or non-Black). This study included 589 patients with mCSPC (mean age, 75.9 years) and 406 patients with nmCRPC (mean age, 78.8 years). Using a treatment gap of >90 days, persistence with apalutamide at 12 months remained high for both the mCSPC (94.9%) and nmCRPC (92.7%) cohorts, and results were descriptively similar among Black and non-Black patients, and when a treatment gap of >60 days was considered. In patients with mCSPC, overall progression to castration resistance rates at 12 and 24 months were 20.9% and 33.5%, and overall CRFS rates were 76.2% and 62.0%, respectively. In patients with nmCRPC, overall MFS rates at 12 and 24 months were 89.7% and 75.4%, respectively. Rates of these clinical outcomes were descriptively similar between Black and non-Black patients. While clinical trials have demonstrated the efficacy and safety of apalutamide, there is limited real-world data describing treatment persistence and clinical outcomes among patients with mCSPC and nmCRPC who initiated apalutamide. In this real-world study of patients with mCSPC or nmCRPC initiated on apalutamide, treatment persistence was high and apalutamide demonstrated robust real-world effectiveness with respect to progression to castration resistance, CRFS, and MFS, overall and among Black and non-Black patients.
推荐使用雄激素受体信号抑制剂（包括阿帕鲁胺）联合雄激素剥夺疗法来治疗转移性去势敏感性前列腺癌（mCSPC）和非转移性去势抵抗性前列腺癌（nmCRPC）。目的是描述在美国开始使用阿帕鲁胺的mCSPC或nmCRPC患者的真实世界治疗模式和临床结局。利用美国社区泌尿外科实践的电子病历数据（2017年2月1日至2022年4月1日），对开始使用阿帕鲁胺的mCSPC或nmCRPC患者进行了一项回顾性队列研究。报告了治疗开始后6个月、12个月和18个月时阿帕鲁胺的持续使用情况。使用Kaplan-Meier分析描述了阿帕鲁胺开始使用后长达24个月的临床结局，包括进展为去势抵抗、无去势抵抗生存期（CRFS）和无转移生存期（MFS）。结局根据mCSPC或nmCRPC状态以及种族（即黑人或非黑人）分别报告。本研究纳入了589例mCSPC患者（平均年龄75.9岁）和406例nmCRPC患者（平均年龄78.8岁）。使用>90天的治疗间隔，mCSPC队列（94.9%）和nmCRPC队列（92.7%）在12个月时阿帕鲁胺的持续使用率仍然很高，黑人和非黑人患者之间的结果在描述上相似，当考虑>60天的治疗间隔时也是如此。在mCSPC患者中，12个月和24个月时进展为去势抵抗的总体发生率分别为20.9%和33.5%，总体CRFS率分别为76.2%和62.0%。在nmCRPC患者中，12个月和24个月时的总体MFS率分别为89.7%和75.4%。这些临床结局的发生率在黑人和非黑人患者之间在描述上相似。虽然临床试验已经证明了阿帕鲁胺的有效性和安全性，但关于开始使用阿帕鲁胺的mCSPC和nmCRPC患者的治疗持续性和临床结局的真实世界数据有限。在这项针对开始使用阿帕鲁胺的mCSPC或nmCRPC患者的真实世界研究中，治疗持续性很高，并且阿帕鲁胺在进展为去势抵抗、CRFS和MFS方面，总体以及在黑人和非黑人患者中都显示出强大的真实世界有效性。
