Efficacy, Prognostic Factors, and Safety Profile of Enzalutamide for Non-metastatic and Metastatic Castration-Resistant
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ORIGINAL RESEARCH ARTICLE
Efficacy, Prognostic Factors, and Safety Profile of Enzalutamide for Non‑metastatic and Metastatic Castration‑Resistant Prostate Cancer: A Retrospective Single‑Center Analysis in Japan Motohiro Fujiwara1 · Takeshi Yuasa1 · Yoshinobu Komai1 · Noboru Numao1 · Shinya Yamamoto1 · Iwao Fukui1 · Junji Yonese1 Published online: 10 October 2020 © Springer Nature Switzerland AG 2020
Abstract Background Enzalutamide is a novel, non-steroidal anti-androgen that has demonstrated excellent anti-tumor activity for both non-metastatic and metastatic castration-resistant prostate cancer (nmCRPC and mCRPC) patients, and that is being rapidly introduced into clinical practice in Japan. Objective We retrospectively investigated the treatment efficacy, safety profile, and prognostic factors of enzalutamide over a relatively long observation period in Japanese patients with nmCRPC and mCRPC. Patients and methods The medical records of 184 consecutive Japanese patients with nmCRPC and mCRPC who started enzalutamide treatment in our institution between January 2012 and April 2018 were reviewed. Efficacy and safety profiles were assessed and statistically analyzed. Results Among these 184 patients, 44 (23.9%) nmCRPC patients, 89 (48.4%) docetaxel-naïve mCRPC patients, and 51 docetaxel-pretreated (27.7%) mCRPC patients underwent enzalutamide therapy. The median prostate-specific antigen progression-free survival (PSA-PFS) and overall survival (OS) periods for nmCRPC patients were 39.2 months and not reached; those for docetaxel-naïve mCRPC patients were 16.5 months and 59.8 months; and those for docetaxel-pretreated mCRPC patients were 7.0 months and 30.4 months, respectively. Multivariate analysis identified performance status ≥ 2, PSA > 8.89 ng/mL (median value), hemoglobin 3.0, and 4-week PSA decline
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