Enzalutamide in metastatic hormone-sensitive prostate cancer: results from the international, multicentre, real-world ARON-3 study

• Autoři: BUTTNER Thomas; RIZZO Mimma; LAURA Bernal Vaca; MOLINA-CERRILLO Javier; ALONSO-GORDOA Teresa; JUAREZ Alvaro; BUCHLER Tomas; SERONT Emmanuel; KUCHARZ Jakub; NATALIA Gandur Quiroga Maria; BOURLON Maria T; BOGEMANN Martin; KOPECKY Jindrich; RESCIGNO Pasquale; FIALA Ondrej; RODRIGUEZ-VIDA Alejo; MYINT Zin W; URUN Yuksel; SCAGLIARINI Sarah; POPRACH Alexandr; MATTHEWS Diana; LI Haoran; RIZZO Alessandro; MOSCA Alessandra; LENCI Edoardo; MELICHAR Bohuslav; WENZEL Mike; MANDELL Philipp; MASSARI Francesco; ANTONARAKIS Emmanuel S; SANTONI Matteo
• Rok publikování: 2026
• Druh: Recenzovaný odborný článek
• Časopis / Zdroj: Prostate Cancer And Prostatic Diseases
• Fakulta / Pracoviště MU: Lékařská fakulta
• www: https://www.nature.com/articles/s41391-025-01067-3
• Doi: https://doi.org/10.1038/s41391-025-01067-3
• Klíčová slova: metastatic hormone-sensitive prostate cancer; enzalutamide; real-world study; ARON-3; treatment outcomes
• Popis: Background: Enzalutamide (ENZA), a next-generation non-steroidal androgen receptor (AR) inhibitor, plays a pivotal role in the management of both hormone-sensitive (HSPC) and androgen deprivation-resistant prostate cancer (ARPC). This paper presents real-world clinical outcomes of ENZA in a subgroup of metastatic HSPC (mHSPC) patients included in the ARON-3 study. Methods: Clinical information was extracted retrospectively from medical records at 29 cancer centres in 9 countries worldwide. Overall Survival (OS) was calculated from starting ENZA to death from any cause and the time on treatment (ToT) from ENZA initiation to discontinuation for any reason. The Kaplan-Meier method was used to estimate OS and ToT. PSA90 was defined as a >= 90% PSA reduction from baseline, and PSA0.2 as the achievement of an ultra-low PSA level <= 0.2 ng/ml. Adverse events (AEs) were categorised according to Common Terminology Criteria for Adverse Events v5.0. Results: The study population comprised 424 patients treated with ENZA for mHSPC, of whom 80 (19%) had lymph node-only metastases, 265 (63%) bone-only metastases, and 50 (12%) visceral metastases. 273 patients (64%) had synchronous metastases and 151 (36%) had developed metachronous metastases. A total of 228 patients were diagnosed with low-volume disease, and 196 patients (46%) with high-volume disease. The median ToT was 31.8 months, and the median OS was not reached. The median time to PSA90 (achieved in 76% of patients) and PSA0.2 (59% of patients) was 6.0 months and 8.3 months, respectively. Statistically significant associations were identified between lymph node-only patterns, PSA90 and ultra-low PSA responses, and longer treatment duration and better overall survival. Grade 3-4 AEs were observed in 9% of patients <70 years and in 10% >= 70 years. Conclusions: Real-world clinical practice corroborates the findings from clinical trials, confirming the effectiveness and safety of ENZA in mHSPC patients.