Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study
Matteo Santoni, Thomas Büttner, Pasquale Rescigno, Ondřej Fiala, Nicolò Cavasin, Umberto Basso, Tarek Taha, Francesco Massari, Zin Myint, Luigi Formisano, Luca Galli, Sarah Scagliarini, Marc Matrana, Gaetano Facchini, Aristotelis Bamias, Carlo Messina, Francesca Zacchi, Ray Kopp Manneh, Giandomenico Roviello, Daniele Santini, Alexandr Poprach, Jiří Navrátil, Michal Uher, Fabio Calabrò, E Thomas Pierce, Rossana Berardi, Gaetano Aurilio, Roubini Zakopoulou, Alessandro Rizzo, Jawaher Ansari, Mimma Rizzo, Renato Bisonni, Veronica Mollica, Lorena Incorvaia, Gianpaolo Spinelli, Xue Jiang, R. Chandler, Francesco Grillone, Franco Morelli, Sebastiano Buti, Fernando Cotait Maluf, Fernando Sabino Marques Monteiro, Nicola Battelli, Camillo Porta, Orazio Caffo, Andrey Soares
Abstract
ARON-3 is an international, multicenter, retrospective study to collect global experiences in the treatment of patients with advanced prostate cancer. Our results confirm the safety, tolerability, and efficacy of apalutamide in metastatic castration-sensitive prostate cancer in a real-world patient population. 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. 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. 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. APA is an effective and tolerable treatment for mCSPC in the real-world setting. 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.