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Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study
M. Santoni, T. Büttner, P. Rescigno, O. Fiala, N. Cavasin, U. Basso, T. Taha, F. Massari, ZW. Myint, L. Formisano, L. Galli, S. Scagliarini, MR. Matrana, G. Facchini, A. Bamias, C. Messina, F. Zacchi, RK. Manneh, G. Roviello, D. Santini, A....
Jazyk angličtina Země Nizozemsko
Typ dokumentu časopisecké články, multicentrická studie
- MeSH
- lidé středního věku MeSH
- lidé MeSH
- metastázy nádorů MeSH
- nádory prostaty rezistentní na kastraci farmakoterapie patologie mortalita MeSH
- prostatický specifický antigen krev MeSH
- protinádorové látky terapeutické užití MeSH
- retrospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- thiohydantoiny * terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
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.
Biomedical Center Faculty of Medicine in Pilsen Charles University Pilsen Czechia
Clinical Oncology Sociedad de Oncología y Hematología del Cesar Valledupar Colombia
Department of Internal Medicine Hematology Oncology Ochsner Medical Center New Orleans LA USA
Department of Medical and Surgical Sciences University of Bologna Bologna Italy
Department of Medicine and Surgery Federico 2 University Naples Italy
Department of Medicine and Surgery University of Parma Parma Italy
Department of Urology University Hospital Bonn Bonn Germany
Division of Cancer Prevention and Genetics IRCCS European Institute of Oncology Milan Italy
Division of Medical Oncology A Policlinico Umberto 1 Rome Italy
Hospital Beneficência Portuguesa São Paulo Brazil
Hospital Israelita Albert Einstein São Paulo Brazil
Hospital Sírio Libanês Brasília Brazil
IRCCS Istituto Tumori Giovanni Paolo 2 Bari Italy
Latin American Cooperative Oncology Group Porto Alegre Brazil
Masaryk Memorial Cancer Institute Faculty of Medicine Masaryk University Brno Czechia
Medical Oncology 1 IRCCS Regina Elena National Cancer Institute Rome Italy
Medical Oncology 1 Unit Department of Oncology Istituto Oncologico Veneto IRCCS Padova Italy
Medical Oncology Department Tawam Hospital Al Ain United Arab Emirates
Medical Oncology IRCCS Azienda Ospedaliero Universitaria di Bologna Bologna Italy
Medical Oncology Santa Chiara Hospital APSS Trento Trento Italy
Medical Oncology Unit 2 Azienda Ospedaliera Universitaria Pisana Pisa Italy
Medical Oncology Unit Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari Bari Italy
Medical Oncology Unit IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo Foggia Italy
Medical Oncology Unit Macerata Hospital Macerata Italy
Medical Oncology Unit University Hospital of Parma Parma Italy
Northern Centre for Cancer Care Freeman Hospital Newcastle upon Tyne UK
Oncology Unit ARNAS Civico Palermo Italy
Oncology Unit S Maria Delle Grazie Hospital Pozzuoli Naples Italy
Royal Marsden NHS Foundation Trust London UK
Section of Biomedicine Innovation Oncology University of Verona Verona Italy
UOC di Oncologia Azienda Ospedaliera di Rilievo Nazionale Cardarelli di Napoli Naples Italy
Citace poskytuje Crossref.org
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