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. 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.
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.
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.
European urology oncology. 2024 Nov 28 [Epub ahead of print]
Matteo Santoni, Thomas Büttner, Pasquale Rescigno, Ondrej Fiala, Nicolò Cavasin, Umberto Basso, Tarek Taha, Francesco Massari, Zin W Myint, Luigi Formisano, Luca Galli, Sarah Scagliarini, Marc R Matrana, Gaetano Facchini, Aristotelis Bamias, Carlo Messina, Francesca Zacchi, Ray Kopp Manneh, Giandomenico Roviello, Daniele Santini, Alexandr Poprach, Jiri Navratil, Michal Uher, Fabio Calabrò, Erin Pierce, Rossana Berardi, Gaetano Aurilio, Roubini Zakopoulou, Alessandro Rizzo, Jawaher Ansari, Mimma Rizzo, Renato Bisonni, Veronica Mollica, Lorena Incorvaia, Gianpaolo Spinelli, Xue Yan Jiang, Robert Adam Chandler, Francesco Grillone, Franco Morelli, Sebastiano Buti, Fernando C Maluf, Fernando Sabino Marques Monteiro, Nicola Battelli, Camillo Porta, Orazio Caffo, Andrey Soares
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