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

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

doi:10.1016/j.euo.2024.11.005

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

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 SantiniAlexandr 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

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

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. 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. 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. 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. 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.

Original language	English
Pages (from-to)	444-451
Number of pages	8
Journal	European urology oncology
Volume	8
Issue number	2
DOIs	https://doi.org/10.1016/j.euo.2024.11.005
State	Published - Apr 1 2025

Bibliographical note

Publisher Copyright:
Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.

Keywords

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

ASJC Scopus subject areas

Surgery
Oncology
Radiology Nuclear Medicine and imaging
Urology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.euo.2024.11.005

Cite this

Santoni, M., Büttner, T., Rescigno, P., Fiala, O., Cavasin, N., Basso, U., Taha, T., Massari, F., Myint, Z. W., Formisano, L., Galli, L., Scagliarini, S., Matrana, M. R., Facchini, G., Bamias, A., Messina, C., Zacchi, F., Manneh, R. K., Roviello, G., ... Soares, A. (2025). Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study. European urology oncology, 8(2), 444-451. https://doi.org/10.1016/j.euo.2024.11.005

@article{bf774683bde44e369b0048dcd8fbd5be,

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

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. 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. 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. 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. 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.",

keywords = "ARON-3 trial, Androgen receptor pathway inhibitor, Apalutamide, Castration-sensitive prostate cancer, Hormone sensitive, Prostate cancer",

author = "Matteo Santoni and Thomas B{\"u}ttner and Pasquale Rescigno and Ondrej Fiala and Nicol{\`o} Cavasin and Umberto Basso and Tarek Taha and Francesco Massari and Myint, \{Zin W.\} and Luigi Formisano and Luca Galli and Sarah Scagliarini and Matrana, \{Marc R.\} and Gaetano Facchini and Aristotelis Bamias and Carlo Messina and Francesca Zacchi and Manneh, \{Ray Kopp\} and Giandomenico Roviello and Daniele Santini and Alexandr Poprach and Jiri Navratil and Michal Uher and Fabio Calabr{\`o} and Erin Pierce and Rossana Berardi and Gaetano Aurilio and Roubini Zakopoulou and Alessandro Rizzo and Jawaher Ansari and Mimma Rizzo and Renato Bisonni and Veronica Mollica and Lorena Incorvaia and Gianpaolo Spinelli and Jiang, \{Xue Yan\} and Chandler, \{Robert Adam\} and Francesco Grillone and Franco Morelli and Sebastiano Buti and Maluf, \{Fernando C.\} and \{Marques Monteiro\}, \{Fernando Sabino\} and Nicola Battelli and Camillo Porta and Orazio Caffo and Andrey Soares",

year = "2025",

month = apr,

day = "1",

doi = "10.1016/j.euo.2024.11.005",

language = "English",

volume = "8",

pages = "444--451",

number = "2",

}

Santoni, M, Büttner, 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, Calabrò, 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, Marques Monteiro, FS, Battelli, N, Porta, C, Caffo, O & Soares, A 2025, 'Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study', European urology oncology, vol. 8, no. 2, pp. 444-451. https://doi.org/10.1016/j.euo.2024.11.005

TY - JOUR

T1 - Apalutamide in Metastatic Castration-sensitive Prostate Cancer

T2 - Results from the Multicenter Real-world ARON-3 Study

AU - Santoni, Matteo

AU - Büttner, Thomas

AU - Rescigno, Pasquale

AU - Fiala, Ondrej

AU - Cavasin, Nicolò

AU - Basso, Umberto

AU - Taha, Tarek

AU - Massari, Francesco

AU - Myint, Zin W.

AU - Formisano, Luigi

AU - Galli, Luca

AU - Scagliarini, Sarah

AU - Matrana, Marc R.

AU - Facchini, Gaetano

AU - Bamias, Aristotelis

AU - Messina, Carlo

AU - Zacchi, Francesca

AU - Manneh, Ray Kopp

AU - Roviello, Giandomenico

AU - Santini, Daniele

AU - Poprach, Alexandr

AU - Navratil, Jiri

AU - Uher, Michal

AU - Calabrò, Fabio

AU - Pierce, Erin

AU - Berardi, Rossana

AU - Aurilio, Gaetano

AU - Zakopoulou, Roubini

AU - Rizzo, Alessandro

AU - Ansari, Jawaher

AU - Rizzo, Mimma

AU - Bisonni, Renato

AU - Mollica, Veronica

AU - Incorvaia, Lorena

AU - Spinelli, Gianpaolo

AU - Jiang, Xue Yan

AU - Chandler, Robert Adam

AU - Grillone, Francesco

AU - Morelli, Franco

AU - Buti, Sebastiano

AU - Maluf, Fernando C.

AU - Marques Monteiro, Fernando Sabino

AU - Battelli, Nicola

AU - Porta, Camillo

AU - Caffo, Orazio

AU - Soares, Andrey

PY - 2025/4/1

Y1 - 2025/4/1

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. 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. 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. 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. 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.

AB - 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. 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. 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. 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. 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.

KW - ARON-3 trial

KW - Androgen receptor pathway inhibitor

KW - Apalutamide

KW - Castration-sensitive prostate cancer

KW - Hormone sensitive

KW - Prostate cancer

UR - https://www.scopus.com/pages/publications/105001952240

UR - https://www.scopus.com/inward/citedby.url?scp=105001952240&partnerID=8YFLogxK

U2 - 10.1016/j.euo.2024.11.005

DO - 10.1016/j.euo.2024.11.005

M3 - Article

C2 - 39613567

AN - SCOPUS:105001952240

VL - 8

SP - 444

EP - 451

JO - European urology oncology

JF - European urology oncology

IS - 2

ER -

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

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