背景:在美国,2022年共有268490名男性被发现患有前列腺癌,因此使其成为男性中最常见的癌症,占男性人群所有癌症的27%。在所有男性癌症中,是第五大死因,有34,500人死亡,死亡率为11%。2019年,病例总数为94,748例,是男性中的主要癌症,占所有男性癌症的11%。在死亡率方面,它排名第七,13,217例死亡,死亡率为1.6%。然而,转移性去势敏感性前列腺癌(mCSPC)的新治疗方案已经出现.多西他赛已被证明对mCSPC和去势抵抗前列腺癌(CRPC)均有效。多西他赛尚未在日本获得批准,也没有在大规模研究中得到验证。此外,多西他赛治疗后可以使用几种药物,但尚不清楚哪一种最有效。我们使用了一个大型的日本健康保险数据库,以确定在接受多西他赛的患者中,哪种药物作为下一线治疗最有效。
方法:我们使用了来自医疗机构的数据,使用了诊断程序组合(DPC),它提供了对医学分类的全面评估。医疗数据视觉数据库覆盖了日本约23%的DPC医院。这项研究分析了2938例接受多西他赛的mCSPC患者,其次是CRPC,2008年4月至2021年12月。该研究集中在三种药物上:恩扎鲁他胺,醋酸阿比特龙,和卡巴他赛.由于患者数量少,其他药物被排除在外。分析了以下数据:年龄,CRPC诊断日期,骨转移的存在,药物类型,和预后。
结果:本研究纳入了1997例接受多西他赛预先治疗mCSPC后的CRPC患者(恩扎鲁他胺[ENZ]组,n=998;醋酸阿比特龙[ABI]组,n=617;和卡巴他赛[CBZ]组,n=382)。恩杂鲁胺组自药物开始的总生存期(OS)时间为456天,明显长于卡巴他赛组(p=0.017,HR0.94)(ENZ:ABIp=0.54,HR0.94;ABI:CBZp=0.14,HR0.75)。在接受恩杂鲁胺作为二线药物的组中,还比较了三线药物的OS,使用醋酸阿比特龙作为三线药物的组(ENZ-ABI组),和使用醋酸阿比特龙作为二线药物的组。在ENZ-ABI组和ABI-ENZ组之间比较三线药物开始时的OS,接受恩扎鲁他胺作为三线药物,但没有显着差异(269vs.281天,p=0.85;HR1.03)。
结论:ENZ显示在停止多西他赛后相对于卡巴他赛延长OS。与ABI和CBZ相比,ENZ与更长的药物使用时间相关。
BACKGROUND: In the United States, a total of 268,490 men were found to have prostate cancer in 2022, thus making it the most common cancer in men, accounting for 27% of all cancers in the male population. Among all cancers in men, it was the fifth leading cause of death, with 34,500 deaths and a mortality rate of 11%. In 2019, the total number of cases was 94,748, making it the leading cancer in males, accounting for 11% of all male cancers. In terms of mortality, it ranked seventh, with 13,217 deaths and a mortality rate of 1.6%. However, new treatment options for metastatic castration-sensitive prostate cancer (mCSPC) have emerged. Docetaxel has been shown to be effective for both mCSPC and castration-resistant prostate cancer (
CRPC). Upfront docetaxel has not been approved in Japan, nor has it been validated in large-scale studies. Furthermore, several agents can be used after docetaxel treatment, but it is unclear which is the most effective. We used a large Japanese health insurance database to determine which agent would be the most effective as a next-line therapy in patients who had received docetaxel.
METHODS: We used data from medical institutions using the Diagnosis Procedure Combination (DPC), which provides a comprehensive evaluation of medical classifications. The Medical Data Vision database covers approximately 23% of DPC hospitals in Japan. This study analyzed 2938 patients with mCSPC who received docetaxel, followed by
CRPC, between April 2008 and December 2021. The study focused on three agents: enzalutamide, abiraterone acetate, and cabazitaxel. Other agents were excluded due to the small number of patients. The following data were analyzed: age, date of
CRPC diagnosis, presence of bone metastasis, drug type, and prognosis.
RESULTS: This study included 1997 patients with
CRPC after upfront docetaxel therapy for mCSPC (enzalutamide [ENZ] group, n = 998; abiraterone acetate [ABI] group, n = 617; and cabazitaxel [CBZ] group, n = 382). The overall survival (OS) time from drug initiation was 456 days in the enzalutamide group, which was significantly longer than that in the cabazitaxel group (p = 0.017, HR 0.94) (ENZ: ABI p = 0.54, HR 0.94; ABI: CBZ p = 0.14, HR 0.75). OS was also compared for the third-line drug in the group that received enzalutamide as the second-line drug, the group that used abiraterone acetate as the third-line drug (ENZ-ABI group), and the group that used abiraterone acetate as the second-line drug. OS from the start of the third-line drug was compared between the ENZ-ABI group and the ABI-ENZ group, which received enzalutamide as the third-line drug, but showed no significant difference (269 vs. 281 days, p = 0.85; HR 1.03).
CONCLUSIONS: ENZ was shown to prolong OS relative to cabazitaxel after the cessation of docetaxel. ENZ was associated with a longer duration of drug use than ABI and CBZ.