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美国真实临床环境中转移性去势抵抗性前列腺癌患者的治疗模式和结局。

Treatment Patterns and Outcomes in Patients With Metastatic Castration-resistant Prostate Cancer in a Real-world Clinical Practice Setting in the United States.

机构信息

Departments of Medicine and Surgery, Duke Cancer Institute, Duke University, Durham, NC.

Tulane Cancer Center, Tulane University School of Medicine, New Orleans, LA.

出版信息

Clin Genitourin Cancer. 2020 Aug;18(4):284-294. doi: 10.1016/j.clgc.2019.12.019. Epub 2020 Jan 7.

Abstract

BACKGROUND

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.

PATIENTS AND METHODS

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.

RESULTS

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).

CONCLUSION

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.

摘要

背景

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。

患者和方法

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。

结果

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)。

结论

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。

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