Summary

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• This summary is based on the review of 35 systematic review(s)/meta-analysis(es). ^[1-35]
• Darolutamide combined with Docetaxel and androgen deprivation therapy (ADT) demonstrated the highest likelihood of improved overall survival (OS) in high-volume metastatic hormone-sensitive prostate cancer (mHSPC) with a hazard ratio (HR) of 0.49 (95% confidence interval (CI): 0.39-0.62), and ranked first in multiple studies (Surface Under the Cumulative Ranking curve (SUCRA) 84.3 for OS).
• In terms of progression-free survival (PFS), Darolutamide + Docetaxel + ADT showed superior outcomes with an HR of 0.68 (95% CI: 0.57-0.82), while triplet therapies like Abiraterone + Docetaxel + ADT and Enzalutamide + Docetaxel + ADT were also highly ranked for PFS (SUCRA = 74.9 and SUCRA = 74.3, respectively).
• Triplet therapies provided significant OS benefits for patients with high-volume disease, whereas in low-volume disease, doublet therapies such as Enzalutamide + ADT remained highly effective.
• Performance status did not significantly impact the benefits observed from systemic therapies, indicating that treatment intensification may be warranted even in patients with worse performance status (Eastern Cooperative Oncology Group (ECOG) ≥1).
• Darolutamide was generally well-tolerated, exhibiting a safety profile comparable to placebo, with an increased risk of bone fractures indicated by a pooled odds ratio (OR) of 1.523 (95% CI: 1.081-2.146).
• Specific adverse events included a higher incidence of cognitive and functional toxic effects associated with Enzalutamide, with relative risks (RR) for cognitive toxic effects at 2.10 (95% CI: 1.30-3.38) and for falls at 1.87 (95% CI: 1.27-2.75).
• Darolutamide demonstrated a lower risk of cardiovascular events compared to other androgen receptor pathway inhibitors (ARPIs) like Abiraterone and Enzalutamide, which were linked to increased risks of cardiac disorder, heart failure, and hypertension.
• There is no population types or subgroups information available in the reviewed studies.