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

Autor: Santoni M; Medical Oncology Unit, Macerata Hospital, Macerata, Italy., Büttner T; Department of Urology, University Hospital Bonn, Bonn, Germany., Rescigno P; Translational and Clinical Research Institute, Centre for Cancer, Newcastle University, Newcastle upon Tyne, UK. Electronic address: pasquale.rescigno@newcastle.ac.uk., Fiala O; Department of Oncology and Radiotherapeutics, Faculty of Medicine, University Hospital in Pilsen, Charles University, Pilsen, Czechia; Biomedical Center, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czechia., Cavasin N; Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IRCCS, Padova, Italy., Basso U; Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IRCCS, Padova, Italy., Taha T; Royal Marsden NHS Foundation Trust, London, UK., Massari F; Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy., Myint ZW; Division of Medical Oncology, Department of Internal Medicine, Markey Cancer Center, University of Kentucky, Lexington, KY, USA., Formisano L; Department of Medicine and Surgery, Federico II University, Naples, Italy., Galli L; Medical Oncology Unit 2, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy., Scagliarini S; UOC di Oncologia, Azienda Ospedaliera di Rilievo Nazionale Cardarelli di Napoli, Naples, Italy., Matrana MR; Department of Internal Medicine, Hematology/Oncology, Ochsner Medical Center, New Orleans, LA, USA., Facchini G; Oncology Unit, S. Maria Delle Grazie Hospital, Pozzuoli, Naples, Italy., Bamias A; 2nd Propaedeutic Department of Internal Medicine, ATTIKON University Hospital, National and Kapodistrian University of Athens, Athens, Greece., Messina C; Oncology Unit, ARNAS Civico, Palermo, Italy., Zacchi F; Section of Biomedicine Innovation-Oncology, University of Verona, Verona, Italy; Section of Oncology, Department of Medicine, University of Verona, Verona University Hospital, Verona, Italy., Manneh RK; Clinical Oncology, Sociedad de Oncología y Hematología del Cesar, Valledupar, Colombia., Roviello G; Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, Florence, Italy., Santini D; Division of Medical Oncology A, Policlinico Umberto 1, Rome, Italy., Poprach A; Masaryk Memorial Cancer Institute, Faculty of Medicine, Masaryk University, Brno, Czechia., Navratil J; Masaryk Memorial Cancer Institute, Faculty of Medicine, Masaryk University, Brno, Czechia., Uher M; Masaryk Memorial Cancer Institute, Faculty of Medicine, Masaryk University, Brno, Czechia., Calabrò F; Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Pierce E; UOC di Oncologia, Azienda Ospedaliera di Rilievo Nazionale Cardarelli di Napoli, Naples, Italy., Berardi R; Clinica Oncologica e Centro Regionale di Genetica Oncologica, Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy., Aurilio G; Division of Cancer Prevention and Genetics, IRCCS European Institute of Oncology, Milan, Italy., Zakopoulou R; Oncology Unit, S. Maria Delle Grazie Hospital, Pozzuoli, Naples, Italy., Rizzo A; IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy., Ansari J; Medical Oncology Department, Tawam Hospital, Al Ain, United Arab Emirates., Rizzo M; Medical Oncology Unit, Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari, Italy., Bisonni R; UOC Oncologia Medica, Ospedale A. Murri, Fermo, Italy., Mollica V; Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Incorvaia L; Department of Precision Medicine in Medical, Surgical and Critical Care, Section of Medical Oncology, University of Palermo, Palermo, Italy., Spinelli G; UOC Oncologia Territoriale Ausl Latina, Aprilia, Italy., Jiang XY; Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, UK., Chandler RA; Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, UK., Grillone F; Unità Operativa di Oncologia Presidio Pugliese-Ciaccio, Azienda Ospedaliera Universitaria Renato Dulbecco, Catanzaro, Italy., Morelli F; Medical Oncology Unit, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy., Buti S; Department of Medicine and Surgery, University of Parma, Parma, Italy; Medical Oncology Unit, University Hospital of Parma, Parma, Italy., Maluf FC; Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Beneficência Portuguesa, São Paulo, Brazil., Marques Monteiro FS; Hospital Sírio-Libanês, Brasília, Brazil; Latin American Cooperative Oncology Group, Porto Alegre, Brazil., Battelli N; Medical Oncology Unit, Macerata Hospital, Macerata, Italy., Porta C; Interdisciplinary Department of Medicine, Aldo Moro University of Bari, Division of Medical Oncology, AOU Consorziale Policlinico di Bari, Bari, Italy., Caffo O; Medical Oncology, Santa Chiara Hospital, APSS Trento, Trento, Italy., Soares A; Latin American Cooperative Oncology Group, Porto Alegre, Brazil; Hospital Israelita Albert Einstein, São Paulo, Brazil.
Jazyk: angličtina
Zdroj: European urology oncology [Eur Urol Oncol] 2024 Nov 28. Date of Electronic Publication: 2024 Nov 28.
DOI: 10.1016/j.euo.2024.11.005
Abstrakt: 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.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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