Summary

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• Erleada (apalutamide) is indicated for the treatment of patients with metastatic castration-sensitive prostate cancer and for the treatment of patients with non-metastatic castration-resistant prostate cancer.
• This summary is based on the review of 28 systematic review(s)/meta-analysis(es). ^[1-28]
• Apalutamide combined with ADT significantly improves OS in hormone-sensitive metastatic prostate cancer (mHSPC) with hazard ratios (HR) between 0.61 to 0.88, particularly in high-volume disease and docetaxel-naive patients.
• Compared to other treatments, Apalutamide (HR = 0.70) is less favorable than darolutamide plus docetaxel (HR = 0.49) and abiraterone plus docetaxel (HR = 0.52) in high-volume mHSPC.
• Apalutamide is particularly effective for low-volume disease and docetaxel-naive settings.
• Apalutamide combined with ADT significantly improves failure-free survival (HR = 0.43) compared to ADT alone and improves metastasis-free survival (MFS) in non-metastatic castration-resistant prostate cancer (nmCRPC).
• Enzalutamide and darolutamide show superior MFS in nmCRPC compared to Apalutamide, with abiraterone showing better PFS in high-volume mHSPC.
• Apalutamide combined with ADT increases the risk of grade 3 or higher adverse events (OR = 1.40), including cognitive toxic effects, fatigue, falls, hypertension, and cardiovascular events, with a higher rate of AE-related drug withdrawals compared to enzalutamide and darolutamide.
• Apalutamide has elevated risks of cognitive toxic effects (RR, 2.10), fatigue (RR, 1.34), falls, hypertension, and cardiovascular events, comparable to enzalutamide but less frequent than with abiraterone.
• Darolutamide generally presents the most favorable safety profile with the lowest incidence of severe AEs among the drugs compared.
• Apalutamide is effective in high-volume and low-volume disease settings, with notable efficacy in low-volume disease and docetaxel-naive patients; increased age is associated with a higher risk of fatigue, and greater benefits are observed in patients with ECOG performance status 0, with consistent benefits across varying PSA-doubling times.