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Multicenter Study
. 2024 Feb 7;54(2):167-174.
doi: 10.1093/jjco/hyad143.

Real-world prostate-specific antigen response and progression to castration-resistant prostate cancer among men with metastatic castration-sensitive prostate cancer treated with apalutamide: a multi-institutional study in the Chu-shikoku Japan Urological Consortium

Yoichiro Tohi  1 , Takuma Kato  1 , Keita Kobayashi  2 , Kei Daizumoto  3 , Hideo Fukuhara  4 , Shin Ohira  5 , Satoshi Katayama  6 , Ryutaro Shimizu  7 , Atsushi Takamoto  8 , Kenichi Nishimura  9 , Kenichiro Ikeda  10 , Taichi Nagami  11 , Yushi Hayashida  12 , Hiromi Hirama  13 , Hirohito Naito  1 , Ryotaro Tomida  3 , Yutaro Sasaki  3 , Shinkuro Yamamoto  4 , Shinjiro Shimizu  5 , Mikio Sugimoto  1 ; Chu-shikoku Japan Urological Consortium
Affiliations
Multicenter Study

Real-world prostate-specific antigen response and progression to castration-resistant prostate cancer among men with metastatic castration-sensitive prostate cancer treated with apalutamide: a multi-institutional study in the Chu-shikoku Japan Urological Consortium

Yoichiro Tohi et al. Jpn J Clin Oncol. .

Abstract

Background: Japanese men receiving apalutamide often experience skin-adverse events (AEs), possibly requiring treatment interruption or dose reduction. However, concerns have arisen regarding the impact of these adjustments on the efficacy of apalutamide. Our study evaluated the efficacy, safety, and persistence of apalutamide in men with metastatic castration-sensitive prostate cancer (mCSPC).

Methods: We retrospectively reviewed the medical records of 108 men with mCSPC from 14 Japanese institutions. The primary outcomes were the efficacy of apalutamide: prostate-specific antigen (PSA) response (50%, 90% and < 0.2 decline) and progression to castration-resistant prostate cancer (CRPC). The secondary outcomes were the skin-AE and compliance of apalutamide.

Results: PSA50%, PSA90% and PSA < 0.2 declines were observed in 89.8, 84.3 and 65.7%, and the median time to CRPC progression was not reached. PSA < 0.2 decline and an initial full dose of apalutamide were significantly associated with a longer time to CRPC. The most common AE was skin-AE (50.9%), and there was no association between the occurrence of skin-AE and the time to CRPC (P = 0.72). The median apalutamide persistence was 29 months, which was longer in the initial full dose recipients than in the reduced dose recipients. The dosage is reduced in about 60% of patients within the first year of treatment in the initial full dose recipients.

Conclusions: Our findings indicate the effectiveness of apalutamide in Japanese men with mCSPC, despite a substantial portion requiring dose reduction within a year among the initial full dose recipients.

Keywords: apalutamide; metastatic castration-sensitive prostate cancer; prostate cancer; prostate-specific antigen (PSA) response; skin rash.

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