Background and Objective:Prostate cancer (PC) is the most common cancer among males in the Western World. Androgens are key growth regulators both in normal and malignant prostate growth. Several new types of androgen pathway inhibitors (ARPIs) have been developed for the treatment of PC. Despite the lack of evidence, sequential use of ARPIs has been adopted into everyday clinical practice. This study aimed to assess real-life ARPI use patterns, especially sequential use and treatment costs, in Finland.Methods:Nationwide register data on all ARPI (enzalutamide, apalutamide, darolutamide, abiraterone) purchases recorded in the National Health Insurance scheme register maintained by the Social Insurance Institution of Finland from January 2012 to December 2023 were used. The data included patient demographics and medicine purchase details, which were descriptively analysed.Results:During the study period, 8369 patients initiated ARPIs. The median age of the users was 75.1 years. Of these, 32.1% (n= 2685) used at least two ARPIs sequentially. The proportion of treatment initiations leading to sequential use increased from 36% in 2012 to 56% in 2017, then decreased to 14% in 2022. The total cost of sequential use was €43.8 million. Limitations include the unrecorded phase of PC. The study’s strength is its inclusion of all reimbursed ARPI purchases nationwide.Conclusions: Despite the lack of evidence, sequential ARPI use was initially prevalent but declined after the introduction of new guidelines. Randomised trials are needed to guide the sequential use of these medicines.Patient summary:Androgen pathway inhibitors (ARPIs) are widely used in prostate cancer in Finland. One-third of patients use at least two ARPIs sequentially to inhibit testosterone effect. However, there are no large clinical trials published demonstrating the benefits of sequential treatment. More evidence is needed to justify sequential use.
背景与目的:前列腺癌是西方世界男性中最常见的恶性肿瘤。雄激素在正常及恶性前列腺生长过程中均扮演关键调控角色。多种新型雄激素通路抑制剂已开发用于前列腺癌治疗。尽管缺乏循证依据,序贯使用雄激素通路抑制剂的方案已在临床实践中广泛应用。本研究旨在评估芬兰临床实践中雄激素通路抑制剂的实际使用模式,特别是序贯治疗方案及其治疗成本。 方法:研究采用芬兰社会保险机构管理的国民健康保险计划登记系统中2012年1月至2023年12月期间所有雄激素通路抑制剂(包括恩扎卢胺、阿帕鲁胺、达洛鲁胺、阿比特龙)的采购记录。数据涵盖患者人口统计学特征及药物采购详细信息,并进行描述性统计分析。 结果:研究期间共有8369例患者启动雄激素通路抑制剂治疗,使用者中位年龄为75.1岁。其中32.1%(n=2685)的患者至少序贯使用过两种雄激素通路抑制剂。导致序贯治疗的治疗启动比例从2012年的36%上升至2017年的56%,随后在2022年降至14%。序贯治疗总成本达4380万欧元。研究局限性包括未记录前列腺癌分期信息,主要优势在于纳入了全国范围内所有医保报销的雄激素通路抑制剂采购数据。 结论:尽管缺乏循证依据,序贯使用雄激素通路抑制剂在初期较为普遍,但在新指南发布后呈下降趋势。需要开展随机对照试验来指导这类药物的序贯使用方案。 患者概要:雄激素通路抑制剂在芬兰前列腺癌治疗中应用广泛,约三分之一患者序贯使用至少两种该类药物以抑制睾酮效应。然而目前尚未有大型临床试验证实序贯治疗的获益,需要更多证据支持序贯治疗的合理性。