Abstract

We evaluated the efficacy of second-line hormonal therapy for treatment of metastatic castration-resistant prostate cancer (mCRPC) in a real-world retrospective study. We conducted a population-based real-world cohort study of 258 mCRPC patients between 2014 and 2018 using the Chang Gung Research Database (CGRD) of Taiwan. The second-line hormonal therapy included abiraterone acetate and enzalutamide. The clinical efficacy outcomes were overall survival (OS) and prostate-specific antigen (PSA) doubling time. The median PSA level was also assessed. In total, 223 mCRPC patients who underwent second-line hormonal therapy met all of the inclusion and exclusion criteria for this study. Among them, 65 (29.1%) patients were in the PSA response group and 158 (70.9%) were in the non-response group. The median age was 72.9 years. The median OS was 12.3 months (range: 9.9–19.9 months) and 9.6 months (range: 5.3–15.9 months) in the response and non-response groups, respectively, and the respective PSA doubling times were 9.0 months (range: 4.4–11.6 months) and 3.9 months (range: 2.2–9.1 months), with a median follow-up period of 10.5 months. A significantly longer median OS was seen in the PSA response group. This real-world database study demonstrated that clinical outcomes of second-line hormonal therapy were better in patients with a PSA response. Further studies are warranted to achieve a better understanding of second-line hormonal therapy for mCRPC in Asian populations.

Highlights

  • A randomized double-blind controlled study (COU-AA-301) of metastatic CRPC patients post-chemotherapy showed that AA therapy significantly increased overall survival (OS) and radiographic progression-free survival in comparison to placebo[2]

  • The numbers of chemo-naïve and post-chemotherapy patients are listed in Supplementary Table S3. This real-world study supports the hypothesis that second-line hormonal therapy is beneficial for Asian patients with metastatic castrationresistant prostate cancer (mCRPC)

  • We demonstrated that prostate-specific antigen (PSA)-response group had longer OS,PSA doubling time and lower final PSA level compared to non-response group

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Summary

Introduction

A randomized double-blind controlled study (COU-AA-301) of metastatic CRPC patients post-chemotherapy showed that AA therapy significantly increased overall survival (OS) and radiographic progression-free survival (rPFS) in comparison to placebo[2]. The COU-AA-302 trial showed that AA increased OS and rPFS in metastatic CRPC patients pre-chemotherapy[4]. The AFFIRM and PREVAIL studies showed that enzalutamide had significant benefits on OS and rPFS in metastatic CRPC patients, both post- and pre-chemotherapy[3,5]. No comprehensive analysis of the relationship between second-line hormonal therapy and the clinical outcomes of mCRPC in Asian patients has been performed. The aim of this study is to investigate the clinical benefit of second-line hormonal therapy in Asian patients using real-world data from the Chang Gung Research Database (CGRD)

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