演題抄録

臓器別シンポジウム

開催概要
開催回
第58回・2020年・京都
 

第2世代抗アンドロゲン剤(エンザルタミド,アパルタミド)

演題番号 : SY8-1

[筆頭演者]
井口 太郎:1 
[共同演者]
加藤 実:1、山﨑 健史:1、安田 早也香:1、玉田 聡:1

1:大阪市立大学・泌尿器病態学

 

In 2019, enzalutamide (ENZA) was shown to be effective for mCSPC based on the results of the ARCHES and ENZAMET studies, and apalutamide (APA) was also shown to be effective based on the results of the TITAN study, and upfront treatment with second-generation antiandrogen plus ADT has been added to the standard of care.
ARCHES was a double-blind, randomized, controlled trial in which patients with mCSPC were randomized 1:1 to 160 mg of ENZA plus ADT or placebo (PBO) plus ADT. The primary endpoint was radiographic progression free survival (rPFS), which was significantly improved by ENZA (HR: 0.39, 95% CI, 0.30-0.50). The main secondary endpoints of time to PSA progression (PSA-PFS), time to new antineoplastic therapy, PSA undetectable rate, and objective response rate were also significantly improved by ENZA. However, overall survival (OS) was not significantly different due to the small number of events at the time of analysis.
ENZAMET was an open-label, randomized, controlled trial in which mCSPC patients were randomized 1:1 to receive 160 mg of ENZA plus ADT or nonsteroidal antiandrogens (NSAA) plus ADT. The primary endpoint was OS, which was significantly improved by ENZA (HR: 0.67, 95% CI, 0.52-0.86). The primary secondary endpoints of PSA-PFS and clinically progression-free survival were also significantly improved by ENZA.
TITAN was a double-blind, randomized, controlled trial in which patients with mCSPC were randomized 1:1 to receive 240 mg of APA plus ADT or PBO plus ADT. The primary endpoints were rPFS and OS, which were significantly improved by APA (rPFS, HR: 0.48, 95% CI, 0.39-0.60; OS, HR: 0.67, 95% CI, 0.51-0.89).
The results of the ARCHES, ENZAMET and TITAN studies suggest that ENZA and APA may be the standard of care for mCSPC patients in Japan, but it has not been compared with CAB therapy widely used in Japan, and it is not clear whether it will become the standard of care for all mCSPC patients.

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臓器別:前立腺・男性生殖器

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