Santoni M, Buttner T, Rescigno P, Fiala O, Cavasin N, Basso U, Taha T, Massari F, Myint ZW, Formisano L, Galli L, Scagliarini S, Matrana MR, Facchini G, Bamias A, Messina C, Zacchi F, Manneh RK, Roviello G, Santini D, Poprach A, Navratil J, Uher M, Calabro F, Pierce E, Berardi R, Aurilio G, Zakopoulou R, Rizzo A, Ansari J, Rizzo M, Bisonni R, Mollica V, Incorvaia L, Spinelli G, Jiang XY, Chandler RA, Grillone F, Morelli F, Buti S, Maluf FC, Monteiro FSM, Battelli N, Porta C, Caffo O, Soares A
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. PSA(90) was defined as a prostate-specific antigen decline of >= 90% from baseline, and PSA(0.2) 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. PSA(90) was experienced by 461 patients (87%) and PSA(0.2) by 368 (69%). Median OS was significantly longer for patients with PSA(90) or PSA(0.2) 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. Patient summary: The ARON-3 project collects data for patients with prostate cancer treated in multiple centers worldwide to assess outcomes in the real-world setting. We analyzed data for patients with metastatic hormone-sensitive prostate cancer receiving apalutamide. Our results show that apalutamide is a safe and effective drug in the real-world setting as well as in clinical trials. (c) 2024 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).
