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下一代激素药物对转移性激素敏感前列腺癌患者治疗模式的影响:来自美国、五个欧洲国家和日本的真实世界研究。

Impact of next-generation hormonal agents on treatment patterns among patients with metastatic hormone-sensitive prostate cancer: a real-world study from the United States, five European countries and Japan.

机构信息

Adelphi Real World, Bollington, UK.

Merck & Co., Inc., Kenilworth, NJ, USA.

出版信息

BMC Urol. 2022 Mar 11;22(1):33. doi: 10.1186/s12894-022-00979-9.

Abstract

BACKGROUND

Until five years ago, the metastatic hormone-sensitive prostate cancer (mHSPC) treatment landscape was dominated by the use of androgen deprivation therapy (ADT) alone. However, novel hormonal agents (NHAs) and chemotherapy are now approved for male patients with mHSPC. This study aimed to understand the impact NHA approvals had on mHSPC real-world treatment patterns and to identify the key factors associated with NHA or chemotherapy (± ADT) usage vs ADT alone.

METHODS

Data were collected from the Adelphi Prostate Cancer Disease Specific Programme (DSP)™, a point-in-time survey of physicians and their consulting patients conducted in the United States (US), five European countries (France, Germany, Italy, Spain, and the United Kingdom), and Japan between January and August 2020. Data were analysed using descriptive statistics for individual countries, regions, and all countries combined. Pairwise analyses were used to further investigate differences between treatment groups at global level.

RESULTS

336 physicians provided data on 1195 mHSPC patients. Globally, at data collection, the most common mHSPC regimen initiated first was ADT alone (47%), followed by NHAs (± ADT) (31%, of which 21% was abiraterone, 8% was enzalutamide, and 2% was apalutamide) and chemotherapy (± ADT) (19%). The highest rates of ADT alone usage were observed in Japan (78%) and Italy (66%), and the lowest in Spain (34%) and in the US (36%). Our results showed that clinical decision making was driven by patient fitness, compliance, tolerance of adverse events, and balance of impact on quality of life vs overall survival.

CONCLUSIONS

This real-world survey offered early insights into the evolving mHSPC treatment paradigm. It showed that in 2020, ADT alone remained the most common initial mHSPC therapy, suggesting that physicians may prefer using treatments which they are familiar and have experience with, despite clinical trial evidence of improved survival with NHAs or chemotherapy (± ADT) vs ADT alone. Results also indicated that physicians prescribed specific mHSPC treatments primarily based on the following criteria: patient preference, disease burden/severity, and the performance status and comorbidities of the patient. To fully appreciate the rapidly changing mHSPC treatment landscape and monitor NHA uptake, additional real-world studies are required.

摘要

背景

直到五年前,转移性激素敏感型前列腺癌(mHSPC)的治疗方法还主要依赖于单独使用雄激素剥夺疗法(ADT)。然而,目前已经有新型激素药物(NHAs)和化疗药物被批准用于 mHSPC 男性患者。本研究旨在了解 NHA 获批对 mHSPC 真实世界治疗模式的影响,并确定与使用 NHA 或化疗(±ADT)与单独使用 ADT 相关的关键因素。

方法

数据来自 Adelphi 前列腺癌疾病专项调研(DSP),这是一项于 2020 年 1 月至 8 月在美国、五个欧洲国家(法国、德国、意大利、西班牙和英国)和日本进行的、针对医生及其就诊患者的即时性调查。对各国、各地区和所有国家的数据分别采用描述性统计进行分析。在全球范围内,采用两两比较分析进一步研究了不同治疗组之间的差异。

结果

336 名医生提供了 1195 例 mHSPC 患者的数据。总体而言,在数据收集时,最常起始的 mHSPC 方案是单独使用 ADT(47%),其次是使用 NHA(±ADT)(31%,其中 21%是阿比特龙,8%是恩杂鲁胺,2%是阿帕鲁胺)和化疗(±ADT)(19%)。单独使用 ADT 的比例最高的国家是日本(78%)和意大利(66%),最低的是西班牙(34%)和美国(36%)。我们的研究结果表明,临床决策是由患者的健康状况、依从性、对不良反应的耐受性以及治疗对生活质量和总生存期的影响之间的平衡所驱动的。

结论

这项真实世界的调查提供了 mHSPC 治疗模式不断演变的早期见解。结果表明,2020 年,单独使用 ADT 仍然是最常见的初始 mHSPC 治疗方法,这表明尽管临床试验证据表明使用 NHAs 或化疗(±ADT)可改善生存,但医生可能更愿意使用他们熟悉和有经验的治疗方法。结果还表明,医生主要根据以下标准开具特定的 mHSPC 治疗方案:患者偏好、疾病负担/严重程度以及患者的表现状态和合并症。为了充分了解 mHSPC 治疗领域的快速变化并监测 NHA 的使用情况,还需要开展更多的真实世界研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e48b/8915525/3b54e0724914/12894_2022_979_Fig1_HTML.jpg

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