Background and objective Apalutamide (APA) is a treatment for metastatic castration-sensitive prostate cancer (mCSPC). In the ARON-3 study we investigated real-world experiences with APA treatment for mCSPC. Methods We retrospectively assessed real-world clinical outcomes for patients with mCSPC treated with APA in the ARON-3 study. Overall survival (OS) was calculated from APA initiation to death from any cause. PSA90 was defined as a prostate-specific antigen decline of ≥90% from baseline, and PSA0.2 as achievement of a PSA level ≤0.2 ng/ml. Data for adverse events were retrospectively collected from electronic and paper charts and categorized according to Common Terminology Criteria for Adverse Events v5.0. Key findings and limitations We included 531 patients with mCSPC treated with APA. High-volume disease was reported for 214 patients (40%), and 56 (11%) had visceral metastases. Median OS was not reached. PSA90 was experienced by 461 patients (87%) and PSA0.2 by 368 (69%). Median OS was significantly longer for patients with PSA90 or PSA0.2 than for subjects without these responses (p < 0.001). The incidence of grade 3–4 fatigue was higher among elderly patients (≥80 yr) than among younger patients (19% vs 5%), but the incidence of other adverse events was comparable between the age groups. Conclusions and clinical implications APA is an effective and tolerable treatment for mCSPC in the real-world setting.

Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study / Santoni, Matteo; Büttner, Thomas; Rescigno, Pasquale; Fiala, Ondrej; Cavasin, Nicolò; Basso, Umberto; Taha, Tarek; Massari, Francesco; Myint, Zin W.; Formisano, Luigi; Galli, Luca; Scagliarini, Sarah; Matrana, Marc R.; Facchini, Gaetano; Bamias, Aristotelis; Messina, Carlo; Zacchi, Francesca; Manneh, Ray Kopp; Roviello, Giandomenico; Santini, Daniele; Poprach, Alexandr; Navratil, Jiri; Uher, Michal; Calabrò, Fabio; Pierce, Erin; Berardi, Rossana; Aurilio, Gaetano; Zakopoulou, Roubini; Rizzo, Alessandro; Ansari, Jawaher; Rizzo, Mimma; Bisonni, Renato; Mollica, Veronica; Incorvaia, Lorena; Spinelli, Gianpaolo; Jiang, Xue Yan; Chandler, Robert Adam; Grillone, Francesco; Morelli, Franco; Buti, Sebastiano; Maluf, Fernando C.; Marques Monteiro, Fernando Sabino; Battelli, Nicola; Porta, Camillo; Caffo, Orazio; Soares, Andrey. - In: EUROPEAN UROLOGY ONCOLOGY. - ISSN 2588-9311. - (2024). [10.1016/j.euo.2024.11.005]

Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study

Buti, Sebastiano
Investigation
;
2024-01-01

Abstract

Background and objective Apalutamide (APA) is a treatment for metastatic castration-sensitive prostate cancer (mCSPC). In the ARON-3 study we investigated real-world experiences with APA treatment for mCSPC. Methods We retrospectively assessed real-world clinical outcomes for patients with mCSPC treated with APA in the ARON-3 study. Overall survival (OS) was calculated from APA initiation to death from any cause. PSA90 was defined as a prostate-specific antigen decline of ≥90% from baseline, and PSA0.2 as achievement of a PSA level ≤0.2 ng/ml. Data for adverse events were retrospectively collected from electronic and paper charts and categorized according to Common Terminology Criteria for Adverse Events v5.0. Key findings and limitations We included 531 patients with mCSPC treated with APA. High-volume disease was reported for 214 patients (40%), and 56 (11%) had visceral metastases. Median OS was not reached. PSA90 was experienced by 461 patients (87%) and PSA0.2 by 368 (69%). Median OS was significantly longer for patients with PSA90 or PSA0.2 than for subjects without these responses (p < 0.001). The incidence of grade 3–4 fatigue was higher among elderly patients (≥80 yr) than among younger patients (19% vs 5%), but the incidence of other adverse events was comparable between the age groups. Conclusions and clinical implications APA is an effective and tolerable treatment for mCSPC in the real-world setting.
2024
Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study / Santoni, Matteo; Büttner, Thomas; Rescigno, Pasquale; Fiala, Ondrej; Cavasin, Nicolò; Basso, Umberto; Taha, Tarek; Massari, Francesco; Myint, Zin W.; Formisano, Luigi; Galli, Luca; Scagliarini, Sarah; Matrana, Marc R.; Facchini, Gaetano; Bamias, Aristotelis; Messina, Carlo; Zacchi, Francesca; Manneh, Ray Kopp; Roviello, Giandomenico; Santini, Daniele; Poprach, Alexandr; Navratil, Jiri; Uher, Michal; Calabrò, Fabio; Pierce, Erin; Berardi, Rossana; Aurilio, Gaetano; Zakopoulou, Roubini; Rizzo, Alessandro; Ansari, Jawaher; Rizzo, Mimma; Bisonni, Renato; Mollica, Veronica; Incorvaia, Lorena; Spinelli, Gianpaolo; Jiang, Xue Yan; Chandler, Robert Adam; Grillone, Francesco; Morelli, Franco; Buti, Sebastiano; Maluf, Fernando C.; Marques Monteiro, Fernando Sabino; Battelli, Nicola; Porta, Camillo; Caffo, Orazio; Soares, Andrey. - In: EUROPEAN UROLOGY ONCOLOGY. - ISSN 2588-9311. - (2024). [10.1016/j.euo.2024.11.005]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/3008413
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