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A systematic review and meta-analysis on overall survival, failure-free survival and safety outcomes in patients with metastatic hormone-sensitive prostate cancer treated with new anti-androgens

Objective: Androgen-deprivation therapy (ADT) combined with new antiandrogens have shown to improve the outcomes of patients with hormone-sensitive metastatic prostate cancer. This systematic review and meta-analysis aim to compare the efficacy and toxicity of these agents in this specific scenario.

Methods: Randomized clinical trials (RCT) were identified after systematic searching of databases. A random-effect model was used to determine the pooled hazard ratio (HR) for overall survival (OS) and failure-free survival according to the inverse-variance method. The Mantel-Haenszel method was used to calculate the pooled odds ratio (OR) for treatment-related adverse events (AEs) grade 3 or higher. Heterogeneity was determined using the Tau2 and I2 statistics.

Results: Seven trials were included in this meta-analysis (n = 7544). The addition of ADT plus new-generation anti-androgens, specifically: abiraterone, apalutamide, darolutamide or enzalutamide was associated with improved OS (pooled HR, 0.66; 95% CI, 0.61-0.71; P < 0.00001) with no significant heterogeneity detected among trials. (Tau2 = 0; I2 = 0%; P = 0.88). Failure-free survival was significantly longer in the combination-therapy group than in the control group (pooled HR, 0.43; 95% CI, 0.39-0.47; P < 0.00001) This effect was consistent among trials (Tau2 = 0; I2 = 27%; P = 0.22). The overall OR of AEs grade 3 or higher was significantly increased with the use of the combination therapy (pooled OR, 1.40; 95% CI, 1.13-1.74; P = 0.002), with significant heterogeneity among trials (Tau2 = 0.07; I2 = 82%; P < 0.0001).

Conclusion: The addition of either abiraterone, apalutamide, darolutamide or enzalutamide to ADT improves OS and failure-free survival in hormone-sensitive metastatic prostate cancer, albeit an increase in AEs.

Comments：

The combination of androgen-deprivation therapy and new-generation antiandrogens (abiraterone, apalutamide, darolutamide or enzalutamide) significantly improves overall survival and failure-free survival in hormone-sensitive metastatic prostate cancer patients, but also increases treatment-related adverse events of grade 3 or higher, according to a meta-analysis of 7 randomized clinical trials with a total of 7544 participants.

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S1250 Enzalutamide Enzalutamide is an androgen-receptor (AR) antagonist with IC50 of 36 nM in LNCaP cells. Enzalutamide is shown to increase autophagy.

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Androgen Receptor Autophagy