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

J 2025

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

SANTONI, Matteo; Thomas BUTTNER; Pasquale RESCIGNO; Ondrej FIALA; Nicolo CAVASIN et. al.

Basic information

Original name

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

Authors

SANTONI, Matteo; Thomas BUTTNER; Pasquale RESCIGNO; Ondrej FIALA; Nicolo 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 (203 Czech Republic, belonging to the institution); Jiří NAVRÁTIL (203 Czech Republic, belonging to the institution); Michal UHER (203 Czech Republic, belonging to the institution); Fabio CALABRO; 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 and Andrey SOARES

Edition

EUROPEAN UROLOGY ONCOLOGY, AMSTERDAM, ELSEVIER, 2025, 2588-9311

Other information

Language

English

Type of outcome

Article in a journal

Field of Study

30204 Oncology

Country of publisher

Netherlands

Confidentiality degree

is not subject to a state or trade secret

References:

URL

Impact factor

Impact factor: 8.300 in 2023

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.euo.2024.11.005

UT WoS

001469988200001

EID Scopus

2-s2.0-105001952240

Keywords in English

Apalutamide; ARON-3 trial; Androgen receptor pathway inhibitor; Castration-sensitive prostate cancer; Hormone sensitive; Prostate cancer

Abstract

In the original language

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.

Cite

SANTONI, Matteo; Thomas BUTTNER; Pasquale RESCIGNO; Ondrej FIALA; Nicolo 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; Jiří NAVRÁTIL; Michal UHER; Fabio CALABRO; 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 and Andrey SOARES. Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study. EUROPEAN UROLOGY ONCOLOGY. AMSTERDAM: ELSEVIER, 2025, vol. 8, No 2, p. 444-451. ISSN 2588-9311. Available from: https://dx.doi.org/10.1016/j.euo.2024.11.005.

@article{2494900,
   author = {Santoni, Matteo and Buttner, Thomas and Rescigno, Pasquale and Fiala, Ondrej and Cavasin, Nicolo and Basso, Umberto and Taha, Tarek and Massari, Francesco and Myint, Zin W and Formisano, Luigi and Galli, Luca and Scagliarini, Sarah and Matrana, Marc R and Facchini, Gaetano and Bamias, Aristotelis and Messina, Carlo and Zacchi, Francesca and Manneh, Ray Kopp and Roviello, Giandomenico and Santini, Daniele and Poprach, Alexandr and Navrátil, Jiří and Uher, Michal and Calabro, Fabio and Pierce, Erin and Berardi, Rossana and Aurilio, Gaetano and Zakopoulou, Roubini and Rizzo, Alessandro and Ansari, Jawaher and Rizzo, Mimma and Bisonni, Renato and Mollica, Veronica and Incorvaia, Lorena and Spinelli, Gianpaolo and Jiang, Xue Yan and Chandler, Robert Adam and Grillone, Francesco and Morelli, Franco and Buti, Sebastiano and Maluf, Fernando C and Monteiro, Fernando Sabino Marques and Battelli, Nicola and Porta, Camillo and Caffo, Orazio and Soares, Andrey},
   article_location = {AMSTERDAM},
   article_number = {2},
   doi = {http://dx.doi.org/10.1016/j.euo.2024.11.005},
   keywords = {Apalutamide; ARON-3 trial; Androgen receptor pathway inhibitor; Castration-sensitive prostate cancer; Hormone sensitive; Prostate cancer},
   language = {eng},
   issn = {2588-9311},
   journal = {EUROPEAN UROLOGY ONCOLOGY},
   title = {Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study},
   url = {https://www.sciencedirect.com/science/article/pii/S2588931124002530?via%3Dihub},
   volume = {8},
   year = {2025}
}

TY  - JOUR
ID  - 2494900
AU  - Santoni, Matteo - Buttner, Thomas - Rescigno, Pasquale - Fiala, Ondrej - Cavasin, Nicolo - 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 - Navrátil, Jiří - Uher, Michal - Calabro, 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 - Monteiro, Fernando Sabino Marques - Battelli, Nicola - Porta, Camillo - Caffo, Orazio - Soares, Andrey
PY  - 2025
TI  - Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study
JF  - EUROPEAN UROLOGY ONCOLOGY
VL  - 8
IS  - 2
SP  - 444-451
EP  - 444-451
PB  - ELSEVIER
SN  - 25889311
KW  - Apalutamide
KW  - ARON-3 trial
KW  - Androgen receptor pathway inhibitor
KW  - Castration-sensitive prostate cancer
KW  - Hormone sensitive
KW  - Prostate cancer
UR  - https://www.sciencedirect.com/science/article/pii/S2588931124002530?via%3Dihub
N2  - 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.
ER  -

SANTONI, Matteo; Thomas BUTTNER; Pasquale RESCIGNO; Ondrej FIALA; Nicolo 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; Jiří NAVRÁTIL; Michal UHER; Fabio CALABRO; 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 and Andrey SOARES. Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study. \textit{EUROPEAN UROLOGY ONCOLOGY}. AMSTERDAM: ELSEVIER, 2025, vol.~8, No~2, p.~444-451. ISSN~2588-9311. Available from: https://dx.doi.org/10.1016/j.euo.2024.11.005.

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