Carolina Urologic Research Center, Myrtle Beach, SC, USA.
Department of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Prostate Cancer Prostatic Dis. 2020 Dec;23(4):680-688. doi: 10.1038/s41391-020-0236-0. Epub 2020 May 13.
In this study, we evaluated real-world data on radium-223 plus abiraterone/prednisone or enzalutamide. Previously, the ERA 223 trial (NCT02043678) demonstrated increased fracture risk with concurrent treatment with radium-223 and abiraterone plus prednisone/prednisolone in patients with metastatic castration-resistant prostate cancer (mCRPC).
We used the Flatiron Health database to perform a retrospective study of patients with mCRPC treated with radium-223. Treatment with radium-223 plus abiraterone/prednisone or enzalutamide was defined as concurrent if both drugs started within 30 days of one another, or layered when the second drug started ≥30 days after the first. The index date was defined as the day of the first radium-223 dose. Outcome measures included symptomatic skeletal events (SSEs), overall survival (OS), and patterns of treatments received.
Of the 625 patients treated with radium-223, 22% received it together with abiraterone/prednisone and 27% with enzalutamide. When these agents were combined, they were often initiated in a layered fashion (73% layered, 23% concurrent). Prior or concomitant bone health agents (BHAs) were received by 67% and 55% of patients, respectively. Median follow-up was 9 months. Overall, incidence rates for SSEs and pathologic fractures were 0.35 and 0.11 patients per person-year, respectively. Median OS from mCRPC diagnosis was 28.1 months.
In this real-world setting, combination treatments with radium-223 and abiraterone/prednisone or enzalutamide were common. These agents were more commonly given in a layered than a concurrent fashion. Incidence rates for SSEs were reduced when BHAs were used; however, BHAs were underutilized.
本研究评估镭-223 联合阿比特龙/泼尼松或恩扎鲁胺的真实世界数据。此前，ERA 223 试验（NCT02043678）表明，转移性去势抵抗性前列腺癌（mCRPC）患者同时接受镭-223 和阿比特龙/泼尼松/强的松治疗会增加骨折风险。
我们使用 Flatiron Health 数据库对接受镭-223 治疗的 mCRPC 患者进行回顾性研究。如果两种药物开始治疗的时间相差 30 天以内，则定义为联合治疗；如果第二种药物开始治疗的时间相差 30 天以上，则定义为分层治疗。指数日期定义为第一次镭-223 剂量的日期。结局指标包括症状性骨骼事件（SSEs）、总生存期（OS）和接受的治疗模式。
在 625 例接受镭-223 治疗的患者中，22%的患者同时接受阿比特龙/泼尼松治疗，27%的患者同时接受恩扎鲁胺治疗。当这些药物联合使用时，它们通常以分层的方式开始使用（73%分层，23%联合）。分别有 67%和 55%的患者接受了骨健康药物（BHA）的治疗。中位随访时间为 9 个月。总体而言，SSEs 和病理性骨折的发生率分别为 0.35 和 0.11 例/人年。从 mCRPC 诊断到死亡的中位 OS 为 28.1 个月。
在真实世界环境中，镭-223 与阿比特龙/泼尼松或恩扎鲁胺联合治疗很常见。这些药物更常以分层而非联合的方式给药。当使用 BHA 时，SSEs 的发生率降低；然而，BHA 的利用率较低。
