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% CI: 0.39-0.62), and ranked first in multiple studies (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 (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.