The Overall Survival and Safety of Men with Metastatic Hormone-Sensitive Prostate Cancer Treated with Combination Therapy of Novel Androgen Receptor Antagonists and Androgen-Deprivation Therapy: A Systematic Review and Meta-Analysis.

BACKGROUND

Several novel androgen receptor antagonists have been introduced into the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). We conducted a meta-analysis to evaluate the survival and safety of the combination therapy of novel androgen receptor antagonist and androgen-deprivation therapy (ADT) in patients with mHSPC.

METHODS

Electronic databases were searched for randomized controlled trials (RCTs) of ADT combined with novel androgen receptor antagonists compared with ADT alone in men with mHSPC. Revman 5.4 and STATA 14.0 were used to performed the meta-analysis, and hazard ratio (HR) and odds ratio (OR) with 95% confidence intervals (CIs) were used as the measurement indicators of outcome variables.

RESULTS

Six RCTs were eventually identified for meta-analysis. Compared with ADT alone, the combination therapy of novel androgen receptor antagonists and ADT can significantly improve the overall survival (OS) and progression-free survival (PFS), as the pooled HR were 0.66, 95%CI (0.60, 0.72), < 0.00001 and 0.43, 95%CI (0.34, 0.54), < 0.00001, respectively, despite increasing the risk of any serious adverse events (OR: 1.18, 95%CI (1.04, 1.33), =0.008). . This study showed that compared with ADT alone, the combination therapy of novel androgen receptor antagonists and ADT can significantly improve the survival status of mHSPC patients, while it increases the risk of serious adverse events.