Departments of Medicine and Surgery, Duke Cancer Institute, Duke University, Durham, NC.
Tulane Cancer Center, Tulane University School of Medicine, New Orleans, LA.
Clin Genitourin Cancer. 2020 Aug;18(4):284-294. doi: 10.1016/j.clgc.2019.12.019. Epub 2020 Jan 7.
Clinical trials have demonstrated the efficacy of several life-prolonging therapies for metastatic castration-resistant prostate cancer (mCRPC); however, real-world data on their use, survival effect, and safety are limited. Using electronic health record data from the Flatiron Health database, we studied real-world treatment patterns and health outcomes in patients with mCRPC.
We conducted a retrospective, non-interventional cohort analysis of electronic health record data of patients with confirmed mCRPC between January 2013 and September 2017. The primary objective was to describe real-world treatment patterns, including treatment type, duration, and sequencing. Secondary objectives included describing patient characteristics and clinical outcomes.
Of 2559 patients with mCRPC, 1980 (77%) received at least 1 line of life-prolonging therapy (abiraterone, enzalutamide, docetaxel, cabazitaxel, sipuleucel-T, or radium-223). Of patients receiving first-line therapy, 49% received second-line therapy, and of these, 43% received third-line therapy. Abiraterone/prednisone and enzalutamide accounted for 65% of first-line therapies and 54% of second-line therapies. Docetaxel was the most common third-line therapy (24%). Back-to-back use of abiraterone/prednisone and enzalutamide was common. Radium-223 monotherapy use was 2% in the first-line setting, 3% in the second-line setting, and 8% in the third-line setting. The median overall survival was longer in patients who received life-prolonging therapies (23.7 months; 95% confidence interval: 22.3-25.1 months) than in those who did not (10.1 months; 95% confidence interval: 9.1-11.5 months).
These real-world insights on over 2500 patients with mCRPC supplement findings from randomized controlled trials and may help to inform clinical trial design, treatment guidelines, and clinical decision-making.
多项临床试验已证实，对于转移性去势抵抗性前列腺癌（mCRPC）患者，几种延长生存期的疗法具有疗效；然而，其实际应用、生存效果和安全性的数据有限。本研究使用 Flatiron Health 数据库的电子健康记录数据，研究了 mCRPC 患者的真实世界治疗模式和健康结局。
我们对 2013 年 1 月至 2017 年 9 月期间确诊为 mCRPC 的患者的电子健康记录数据进行了回顾性、非干预性队列分析。主要目的是描述真实世界中的治疗模式，包括治疗类型、持续时间和顺序。次要目标包括描述患者特征和临床结局。
在 2559 例 mCRPC 患者中，1980 例（77%）接受了至少 1 线延长生存期的治疗（阿比特龙、恩扎卢胺、多西他赛、卡巴他赛、sipuleucel-T 或镭-223）。接受一线治疗的患者中，49%接受了二线治疗，其中 43%接受了三线治疗。阿比特龙/泼尼松和恩扎卢胺分别占一线治疗和二线治疗的 65%和 54%。多西他赛是最常见的三线治疗药物（24%）。阿比特龙/泼尼松和恩扎卢胺的序贯应用很常见。镭-223 单药治疗在一线治疗中的使用率为 2%，在二线治疗中的使用率为 3%，在三线治疗中的使用率为 8%。接受延长生存期治疗的患者的总生存期中位数较长（23.7 个月；95%置信区间：22.3-25.1 个月），而未接受治疗的患者总生存期中位数较短（10.1 个月；95%置信区间：9.1-11.5 个月）。
这些针对超过 2500 例 mCRPC 患者的真实世界数据补充了随机对照试验的结果，可能有助于为临床试验设计、治疗指南和临床决策提供信息。
