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与阿比特龙醋酸盐和卡巴他赛相比,恩杂鲁胺在一线多西他赛后延长了用药持续时间:一项大型日本数据库研究。

Enzalutamide Prolonged the Duration of Drug Use in Comparison to Abiraterone Acetate and Cabazitaxel after Upfront Docetaxel: A Large Japanese Database Study.

作者信息

Yamaguchi Katsuya, Kawahara Takashi, Hashizume Akihito, Ousaka Kimito, Uemura Koichi, Ito Yusuke, Ito Hiroki, Makiyama Kazuhide, Uemura Hiroji

机构信息

Departments of Urology and Renal Transplantation, Yokohama City University Medical Center, Yokohama 2320024, Japan.

Department of Urology, Yokohama City University, Graduate School of Medicine, Yokohama 2360004, Japan.

出版信息

Diseases. 2024 Jul 18;12(7):162. doi: 10.3390/diseases12070162.

Abstract

INTRODUCTION

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.

MATERIALS AND 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 ( = 0.017, HR 0.94) (ENZ: ABI = 0.54, HR 0.94; ABI: CBZ = 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, = 0.85; HR 1.03).

CONCLUSION

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.

摘要

引言

在美国,2022年共有268490名男性被诊断患有前列腺癌,使其成为男性中最常见的癌症,占男性所有癌症的27%。在男性所有癌症中,它是第五大死亡原因,死亡人数为34500人,死亡率为11%。2019年,病例总数为94748例,使其成为男性主要癌症,占所有男性癌症的11%。在死亡率方面,它排名第七,死亡人数为13217人,死亡率为1.6%。然而,转移性去势敏感性前列腺癌(mCSPC)出现了新的治疗选择。多西他赛已被证明对mCSPC和去势抵抗性前列腺癌(CRPC)均有效。一线使用多西他赛在日本尚未获批,也未在大规模研究中得到验证。此外,多西他赛治疗后可使用几种药物,但哪种最有效尚不清楚。我们使用了一个大型日本医疗保险数据库来确定哪种药物作为接受多西他赛治疗患者的二线治疗最为有效。

材料与方法

我们使用了采用诊断程序组合(DPC)的医疗机构的数据,该组合可对医疗分类进行全面评估。医疗数据视觉数据库覆盖了日本约23%的DPC医院。本研究分析了2008年4月至2021年12月期间接受多西他赛治疗后发生CRPC的2938例mCSPC患者。该研究聚焦于三种药物:恩杂鲁胺、醋酸阿比特龙和卡巴他赛。由于患者数量较少,其他药物被排除。分析了以下数据:年龄、CRPC诊断日期、骨转移情况、药物类型和预后。

结果

本研究纳入了1997例接受mCSPC一线多西他赛治疗后发生CRPC的患者(恩杂鲁胺[ENZ]组,n = 998;醋酸阿比特龙[ABI]组,n = 617;卡巴他赛[CBZ]组,n = 382)。恩杂鲁胺组从开始用药起的总生存期(OS)为456天,显著长于卡巴他赛组(P = 0.017,HR 0.94)(ENZ:ABI,P = 0.54,HR 0.94;ABI:CBZ,P = 0.14,HR 0.75)。还比较了接受恩杂鲁胺作为二线药物的组、使用醋酸阿比特龙作为三线药物的组(ENZ - ABI组)以及使用醋酸阿比特龙作为二线药物的组中三线药物的OS。比较了ENZ - ABI组和接受恩杂鲁胺作为三线药物的ABI - ENZ组从开始使用三线药物起的OS,但无显著差异(269天对281天,P = 0.85;HR 1.03)。

结论

多西他赛停药后,与卡巴他赛相比,恩杂鲁胺可延长OS。与ABI和CBZ相比,恩杂鲁胺的用药持续时间更长。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65b3/11276074/b463641daa94/diseases-12-00162-g001.jpg

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