Abstract
BackgroundThe purpose of the study is to evaluate real-world effectiveness and safety of enzalutamide in men with nonmetastatic castration-resistant prostate cancer (nmCRPC) in Japan.MethodsThis was a retrospective evaluation of medical records from men in Japan who started enzalutamide treatment from November 1, 2014, to March 31, 2018, and received androgen deprivation therapy throughout. The primary endpoint was time to prostate-specific antigen (PSA) progression. Secondary endpoints included PSA response rate, time to first use of new antineoplastic therapy, time to first use of cytotoxic chemotherapy, and enzalutamide treatment duration. An exploratory analysis of metastasis-free survival (MFS) was also performed. Adverse events (AEs) were analyzed to assess safety.ResultsBased on data from medical records of 205 men in Japan, median time to PSA progression was 27 months (95% confidence interval [CI] 19–not reached [NR]), with 82.5% and 52.0% of men achieving PSA response rates of ≥ 50% and ≥ 90%, respectively. Median time to first use of new antineoplastic therapy was 36 months (95% CI 27−NR) and median enzalutamide treatment duration was 13 months (interquartile range: 7–24). Median time to first use of cytotoxic chemotherapy was NR (95% CI 41−NR). Median MFS was 29 months (95% CI 23−35). In total, 51.7% of men experienced AEs, with malaise (18.5%), decreased appetite (10.7%), and nausea (4.9%) the most frequently reported.ConclusionsThis is the first study to demonstrate the real-world effectiveness and safety of enzalutamide in men with nmCRPC in Japan, further informing healthcare providers about available treatment options for this patient population.
Highlights
The incidence of prostate cancer has been increasing worldwide in recent years
To further inform healthcare providers of the treatment options for men with nonmetastatic castration-resistant prostate cancer (nmCRPC) in Japan, we evaluated the real-world effectiveness and safety of enzalutamide in this patient population
Median time to first use of new antineoplastic therapy was 36 months and median enzalutamide treatment duration was 13 months
Summary
The incidence of prostate cancer has been increasing worldwide in recent years. In Asian countries, the steady increase in prostate cancer incidence is thought to be associated with a number of factors, including increased prostate-specific antigen (PSA) testing, the development of cancer registries, an aging population, and environmental factors such as diet and obesity [1]. Enzalutamide has been approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of men with castration-resistant prostate cancer (CRPC) since 2014 [4], based on multiple studies [5–7]. The PROSPER study demonstrated the efficacy and safety of enzalutamide in men with nmCRPC; Japanese men were not included in this study population [10] Both apalutamide and darolutamide have been approved for the treatment of men with nmCRPC in Japan [11–14]. The purpose of the study is to evaluate real-world effectiveness and safety of enzalutamide in men with nonmetastatic castration-resistant prostate cancer (nmCRPC) in Japan. Conclusions This is the first study to demonstrate the real-world effectiveness and safety of enzalutamide in men with nmCRPC in Japan, further informing healthcare providers about available treatment options for this patient population
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