PMID- 33288609 OWN - NLM STAT- MEDLINE DCOM- 20201217 LR - 20211204 IS - 1791-7530 (Electronic) IS - 0250-7005 (Linking) VI - 40 IP - 12 DP - 2020 Dec TI - Efficacy and Safety of Enzalutamide in a Real-World Cohort of Japanese Patients With Castration-resistant Prostate Cancer. PG - 7101-7108 LID - 10.21873/anticanres.14739 [doi] AB - BACKGROUND/AIM: It has been reported that some adverse events (AEs) of enzalutamide (ENZ) occur more frequently in Japanese patients with castration-resistant prostate cancer (CRPC) due to higher steady-state trough plasma concentrations of ENZ (C(SS, ENZ)) and its active metabolite (NDE), (C(SS, NDE)). Thus, we investigated the efficacy, safety, and pharmacokinetics of ENZ in Japanese patients with CRPC. PATIENTS AND METHODS: Fourteen patients were administered ENZ at a standard dose (160 mg/day) or reduced doses (80 or 120 mg/day). Prostate-specific antigen (PSA), AEs, C(SS, ENZ), and C(SS, NDE) were examined. RESULTS: A maximum PSA decrement of >/=50% from baseline was achieved in 92% of patients. AEs were few (>20%) and mild. No differences in C(SS, ENZ) and C(SS, NDE) between other ethnic groups in previous literature and our subjects was observed. CONCLUSION: ENZ shows adequate efficacy and safety in Japanese patients with CRPC, even if administered at reduced doses in real-world conditions. CI - Copyright (c) 2020 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved. FAU - Hori, Akiyo AU - Hori A AD - Department of Pharmacy, Gifu Municipal Hospital, Gifu, Japan. FAU - Sahashi, Haruka AU - Sahashi H AD - Laboratory of Pharmaceutics, Department of Biomedical Pharmaceutics, Gifu Pharmaceutical University, Gifu, Japan. FAU - Sano, Sora AU - Sano S AD - Laboratory of Pharmaceutics, Department of Biomedical Pharmaceutics, Gifu Pharmaceutical University, Gifu, Japan. FAU - Matsumiya, Emiri AU - Matsumiya E AD - Laboratory of Pharmaceutics, Department of Biomedical Pharmaceutics, Gifu Pharmaceutical University, Gifu, Japan. FAU - Ariga, Maho AU - Ariga M AD - Laboratory of Pharmaceutics, Department of Biomedical Pharmaceutics, Gifu Pharmaceutical University, Gifu, Japan. FAU - Asano, Akari AU - Asano A AD - Laboratory of Pharmaceutics, Department of Biomedical Pharmaceutics, Gifu Pharmaceutical University, Gifu, Japan. FAU - Soda, Midori AU - Soda M AD - Laboratory of Pharmaceutics, Department of Biomedical Pharmaceutics, Gifu Pharmaceutical University, Gifu, Japan. FAU - Goto, Chitoshi AU - Goto C AD - Department of Pharmacy, Gifu Municipal Hospital, Gifu, Japan. FAU - Mizui, Takashi AU - Mizui T AD - Department of Pharmacy, Gifu Municipal Hospital, Gifu, Japan. FAU - Komeda, Hisao AU - Komeda H AD - Department of Urology, Gifu Municipal Hospital, Gifu, Japan. FAU - Kitaichi, Kiyoyuki AU - Kitaichi K AD - Laboratory of Pharmaceutics, Department of Biomedical Pharmaceutics, Gifu Pharmaceutical University, Gifu, Japan kitaichi@gifu-pu.ac.jp. LA - eng PT - Journal Article PL - Greece TA - Anticancer Res JT - Anticancer research JID - 8102988 RN - 0 (Benzamides) RN - 0 (Nitriles) RN - 2010-15-3 (Phenylthiohydantoin) RN - 93T0T9GKNU (enzalutamide) SB - IM MH - Aged MH - Benzamides MH - Cohort Studies MH - Humans MH - Japan MH - Male MH - Nitriles MH - Phenylthiohydantoin/*analogs & derivatives/pharmacology/therapeutic use MH - Prostatic Neoplasms, Castration-Resistant/*drug therapy/epidemiology OTO - NOTNLM OT - Enzalutamide OT - N-desmethyl enzalutamide OT - castration-resistant prostate cancer OT - pharmacokinetics OT - reduced dose EDAT- 2020/12/09 06:00 MHDA- 2020/12/18 06:00 CRDT- 2020/12/08 05:39 PHST- 2020/10/09 00:00 [received] PHST- 2020/10/19 00:00 [revised] PHST- 2020/10/20 00:00 [accepted] PHST- 2020/12/08 05:39 [entrez] PHST- 2020/12/09 06:00 [pubmed] PHST- 2020/12/18 06:00 [medline] AID - 40/12/7101 [pii] AID - 10.21873/anticanres.14739 [doi] PST - ppublish SO - Anticancer Res. 2020 Dec;40(12):7101-7108. doi: 10.21873/anticanres.14739.