Efficacy and safety of darolutamide in Japanese patients with nonmetastatic castration-resistant prostate cancer: a sub-
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ORIGINAL ARTICLE
Efficacy and safety of darolutamide in Japanese patients with nonmetastatic castration‑resistant prostate cancer: a sub‑group analysis of the phase III ARAMIS trial Hiroji Uemura1 · Hisashi Matsushima2 · Kazuki Kobayashi3 · Hiroya Mizusawa4 · Hiroaki Nishimatsu5 · Karim Fizazi6 · Matthew Smith7 · Neal Shore8 · Teuvo Tammela9 · Ken‑ichi Tabata10 · Nobuaki Matsubara11 · Masahiro Iinuma12 · Hirotsugu Uemura13 · Mototsugu Oya14 · Tetsuo Momma15 · Mutsushi Kawakita16 · Satoshi Fukasawa17 · Tadahiro Kobayashi18 · Iris Kuss19 · Marie‑Aude Le Berre20 · Amir Snapir21,23 · Toni Sarapohja21 · Kazuhiro Suzuki22 Received: 28 June 2020 / Accepted: 21 October 2020 © The Author(s) 2020
Abstract Background Darolutamide, an oral androgen receptor inhibitor, has been approved for treating nonmetastatic castrationresistant prostate cancer (nmCRPC), based on significant improvements in metastasis-free survival (MFS) in the ARAMIS clinical trial. Efficacy and safety of darolutamide in Japanese patients are reported here. Methods In this randomized, double-blind, placebo-controlled phase III trial, 1509 patients with nmCRPC and prostatespecific antigen (PSA) doubling time ≤ 10 months were randomized 2:1 to darolutamide 600 mg twice daily or matched placebo while continuing androgen deprivation therapy. The primary endpoint was MFS. Results In Japan, 95 patients were enrolled and randomized to darolutamide (n = 62) or placebo (n = 33). At the primary analysis (cut-off date: September 3, 2018), after 20 primary end-point events had occurred, median MFS was not reached with darolutamide vs. 18.2 months with placebo (HR 0.28, 95% CI 0.11–0.70). Median OS was not reached due to limited numbers of events in both groups but favored darolutamide in the Japanese subgroup. Time to pain progression, time to PSA progression, and PSA response also favored darolutamide. Among Japanese patients randomized to darolutamide vs. placebo, incidences of treatment-emergent adverse events (TEAEs) were 85.5 vs. 63.6%, and incidences of treatment discontinuation due to TEAEs were 8.1 vs. 6.1%. Conclusions Efficacy outcomes favored darolutamide in Japanese patients with nmCRPC, supporting the clinical benefit of darolutamide in this patient population. Darolutamide was well tolerated; however, due to the small sample size, it is impossible to conclude with certainty whether differences in the safety profile exist between Japanese and overall ARAMIS populations. Keywords Nonmetastatic castration-resistant prostate cancer · Androgen receptor inhibitor · Metastasis-free survival · Efficacy · Safety · Japanese
Introduction
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10147-020-01824-5) contains supplementary material, which is available to authorized users. * Hiroji Uemura hu0428@yokohama‑cu.ac.jp Extended author information available on the last page of the article
Globally, prostate cancer poses a major health issue among men. In 2018, there were an estimated 1,276,106 new diagnoses
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