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Efficacy, Prognostic Factors, and Safety Profile of Enzalutamide for Non-metastatic and Metastatic Castration-Resistant Prostate Cancer: A Retrospective Single-Center Analysis in Japan

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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 < lower limit of normal range, neutrophil to lymphocyte ratio > 3.0, and 4-week PSA decline < 50% as the predictive factors for shorter OS. Our respective prognostic models using these factors successfully demonstrated distinctly separated survival curves (p < 0.001). In addition, among these patients, 30 (16.3%) experienced adverse events and 16 (8.7%) experienced adverse events resulting in the discontinuation of therapy. Fatigue (14%) and appetite loss (7%) were the most common such events.

Conclusions

Both the survival period and risk factors were extracted from a relatively long-term observation period. Since enzalutamide was approved for administration to patients with castration-sensitive prostate cancer earlier this year (2020), we believe that the data presented here will be useful for both physicians and patients in clinical practice.

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Authors and Affiliations

  1. Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan

    Motohiro Fujiwara, Takeshi Yuasa, Yoshinobu Komai, Noboru Numao, Shinya Yamamoto, Iwao Fukui & Junji Yonese

Authors
  1. Motohiro Fujiwara
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  2. Takeshi Yuasa
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  3. Yoshinobu Komai
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  4. Noboru Numao
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  5. Shinya Yamamoto
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  6. Iwao Fukui
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  7. Junji Yonese
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Corresponding author

Correspondence to Motohiro Fujiwara.

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Funding

This study was partly funded by the Smoking Research Foundation and JSPS KAKENHI Grant Number 16K11035 (TY).

Conflict of interest

T. Yuasa received remuneration for a lecture from Astellas (Tokyo, Japan). M. Fujiwara, Y. Komai, N. Numao, S. Yamamoto, and J. Yonese declare that they have no conflicts of interest that might be relevant to the contents of this article.

Author contributions

MF and TY contributed to the conception and design of the study; MF contributed to the analysis and interpretation of the data, carried out the statistical analysis, and drafted the manuscript; all authors contributed to the acquisition of data, critical revision of the manuscript, and approval of the final submitted version.

Ethics approval, consent to participate, and consent for publication

This retrospective study was conducted with approval from the institutional review board of the Cancer Institute Hospital, Japanese Foundation for Cancer Research.

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Fujiwara, M., Yuasa, T., Komai, Y. et al. Efficacy, Prognostic Factors, and Safety Profile of Enzalutamide for Non-metastatic and Metastatic Castration-Resistant Prostate Cancer: A Retrospective Single-Center Analysis in Japan. Targ Oncol 15, 635–643 (2020). https://doi.org/10.1007/s11523-020-00759-1

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  • DOI: https://doi.org/10.1007/s11523-020-00759-1

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