| Title: |
Extended Safety and Tolerability of Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer and Adverse Event Time Course in ARAMIS |
| Authors: |
Gratzke, Christian; feyerabend, susan; Werbrouck, Patrick; Vjaters, Egils; Shore, Neal; Carles, Joan |
| Contributors: |
Institut Català de la Salut; Shore ND Carolina Urologic Research Center, Myrtle Beach, SC, USA. Gratzke C Department of Urology, University Hospital Freiburg, Freiburg, Germany. Feyerabend S Studienpraxis Urologie, Nürtingen, Germany. Werbrouck P Department of Urology, AZ Groeninge, Kortrijk, Belgium. Carles J Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vjaters E Urological Center, Pauls Stradiņš Clinical University Hospital, Riga, Latvia; Vall d'Hebron Barcelona Hospital Campus |
| Source: |
Scientia |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2024 |
| Subject Terms: |
Pròstata - Càncer - Tractament; Antiandrògens - Receptors; Avaluació de resultats (Assistència sanitària); DISEASES::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms; Male::Prostatic Neoplasms::Prostatic Neoplasms; Castration-Resistant; Other subheadings::Other subheadings::Other subheadings::/drug therapy; CHEMICALS AND DRUGS::Hormones; Hormone Substitutes; and Hormone Antagonists::Hormone Antagonists::Androgen Antagonists::Androgen Receptor Antagonists; Other subheadings::Other subheadings::/therapeutic use; ANALYTICAL; DIAGNOSTIC AND THERAPEUTIC TECHNIQUES; AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales masculinos::neoplasias de la próstata::neoplasias prostáticas resistentes a la castración; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; COMPUESTOS QUÍMICOS Y DROGAS::hormonas; sustitutos de hormonas y antagonistas de hormonas::antagonistas de hormonas::antagonistas de andrógenos::antagonistas de receptores de andrógenos; Otros calificadores::Otros calificadores::/uso terapéutico; TÉCNICAS Y EQUIPOS ANALÍTICOS; DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento |
| Description: |
Androgen receptor inhibitor; Nonmetastatic castration-resistant prostate cancer; Tolerability ; Inhibidor del receptor de andrógenos; Cáncer de próstata no metastásico resistente a la castración; Tolerabilidad ; Inhibidor del receptor d'andrògens; Càncer de pròstata no metastàtic resistent a la castració; Tolerabilitat ; Background Patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) are usually asymptomatic and seek treatments that improve survival but have a low risk of adverse events. Darolutamide, a structurally distinct androgen receptor inhibitor (ARi), significantly reduced the risk of metastasis and death versus placebo in ARAMIS. We assessed the extended safety and tolerability of darolutamide and the time-course profile of treatment-emergent adverse events (TEAEs) related to ARis and androgen-suppressive treatment. Patients and Methods Patients with nmCRPC were randomized 2:1 to darolutamide (n = 955) or placebo (n = 554). After trial unblinding, patients could receive open-label darolutamide. Tolerability and TEAEs were assessed every 16 weeks. Time interval–specific new and cumulative event rates were determined during the first 24 months of the double-blind period. Results Darolutamide remained well tolerated during the double-blind and open-label periods, with 98.8% of patients receiving the full planned dose. The incidence of TEAEs of interest in the darolutamide group was low and ≤2% different from that in the placebo group, except for fatigue. When incidences were adjusted for exposure time, there were minimal differences between the darolutamide double-blind and double-blind plus open-label periods. The rate of initial onset and cumulative incidence of grade 3/4 TEAEs and serious TEAEs were similar for darolutamide and placebo groups over 24 months. Conclusion Extended treatment with darolutamide was well tolerated and no new safety signals were observed. Most ARi-associated and androgen-suppressive treatment–related TEAEs occurred at low incidences with darolutamide, were ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
The Oncologist;29(7); https://doi.org/10.1093/oncolo/oyae019; https://hdl.handle.net/11351/11678; 001170119000001 |
| DOI: |
10.1093/oncolo/oyae019 |
| Availability: |
https://hdl.handle.net/11351/11678; https://doi.org/10.1093/oncolo/oyae019 |
| Rights: |
Attribution-NonCommercial 4.0 International ; http://creativecommons.org/licenses/by-nc/4.0/ ; info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.707BD27B |
| Database: |
BASE |