The efficacy and safety of abiraterone acetate in patients with high-risk prostate cancer: a meta-analysis based on six randomized control trials.

BACKGROUND

Abiraterone acetate, a CYP17 enzyme inhibitor, can block the synthesis of androgens in the adrenal gland, prostate, and testis. The purpose of this study was to investigate the efficacy and safety of abiraterone acetate in high-risk prostate cancer patients, including metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC).

METHODS

A meta-analysis based on 6 randomized controlled trials (RCTs) was undertaken in compliance with the guidelines of systematic reviews and meta-analyses. Databases including PubMed, EMBASE, and Cochrane library were searched for relevant literature through to September 2019.

RESULTS

The pooled analysis reported abiraterone acetate showed significant efficacy in high-risk prostate cancer patients, including overall survival (OS) [HR 0.66, 95% confidence interval (CI), 0.61-0.73, P<0.001], the time to prostate-specific antigen (PSA) progression (HR 0.45, 95% CI, 0.34-0.59, P<0.001), progression-free survival (PFS) (according to radiographic evidence) (HR 0.55, 95% CI, 0.45-0.68, P<0.001) and PSA response rate (RR 2.49, 95% CI, 1.47-4.22, P<0.001). A subgroup analysis was carried out due to the significant heterogeneity between the studies. The incidence of arthralgia (RR 1.19), hypokalemia (RR 2.47), cardiac disorder (RR 1.48), and hypertension (RR 1.57) in the abiraterone acetate group was moderately higher than the control group.

CONCLUSIONS

The efficacy and safety of abiraterone acetate as an androgen receptor (AR) pathway targeted drug in high-risk prostate cancer patients was confirmed.