Mathieu Roumiguié1, Xavier Paoletti2,3, Yann Neuzillet4, Romain Mathieu5, Sebastien Vincendeau6, François Kleinclauss7, Arnaud Mejean8, Laurent Guy9, Marc Olivier Timsit10, Thierry Lebret4. 1. Department of Urology, CHU-Institut Universitaire du Cancer de Toulouse, Toulouse, France. 2. Department of Public health, University of Versailles, Saint-Quentin, France. 3. Institut Curie, INSERM U900, Biostatistics for Personalized Medicine, Saint-Cloud, France. 4. Department of Urology, Hôpital Foch, University of Paris-Saclay, Versailles Saint-Quentin-en-Yvelines, Suresnes, France. 5. Department of Urology, Univ rennes, CHU Rennes, Inserm, EHESP, Irset - UMR_S 1085, F 35000 Rennes, France. 6. Department of Urology, Centre Hospitalier Privé Saint Grégoire, Saint-Grégoire, France. 7. Department of Urology, Andrology & Kidney Transplantation, University of Franche-Comté, Besançon, France. 8. Department of Urology, Hôpital Europeen Georges-Pompidou (HEGP), AP-HP, Paris, France. 9. Department of Urology, CHU Clermont-Ferrand, UMR1240 INSERM, Université Clermont-Auvergne, Clermont Ferrand, France. 10. Department of Urology, Hôpital Europeen Georges-Pompidou (HEGP), AP-HP, INSERM, PARCC, Paris, France.
Abstract
Aim: Comparison of the efficacy/safety/health-related quality of life of apalutamide, enzalutamide and darolutamide in Phase III clinical trials involving patients with nonmetastatic castration-resistant prostate cancer was performed. Materials & methods: Relevant studies were identified by searching PubMed as well as conference abstracts reporting updated overall survival. Three pivotal trials were identified, SPARTAN (apalutamide), PROSPER (enzalutamide) and ARAMIS (darolutamide), and form the basis of this analysis. Results: All three drugs significantly prolonged metastasis-free survival, prostate-specific antigen response and overall survival versus placebo, and were generally well tolerated. Conclusion: Drug selection will likely be influenced by tolerability/safety and other factors, such as the propensity for drug-drug interactions and the presence of comorbidities, that affect the risk-benefit balance in individual patients.
Aim: Comparison of the efficacy/safety/health-related quality of life of apalutamide, enzalutamide and darolutamide in Phase III clinical trials involving patients with nonmetastatic castration-resistant prostate cancer was performed. Materials & methods: Relevant studies were identified by searching PubMed as well as conference abstracts reporting updated overall survival. Three pivotal trials were identified, SPARTAN (apalutamide), PROSPER (enzalutamide) and ARAMIS (darolutamide), and form the basis of this analysis. Results: All three drugs significantly prolonged metastasis-free survival, prostate-specific antigen response and overall survival versus placebo, and were generally well tolerated. Conclusion: Drug selection will likely be influenced by tolerability/safety and other factors, such as the propensity for drug-drug interactions and the presence of comorbidities, that affect the risk-benefit balance in individual patients.