Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer.

Autor: Jones RH; Cardiff University and Velindre Cancer Centre, Cardiff, UK. Robert.Hugh.Jones@wales.nhs.uk., Fizazi K; Institut Gustave Roussy, University of Paris Saclay, Villejuif, France., James ND; The Institute of Cancer Research, London, UK., Tammela TL; Tampere University Hospital, Tampere, Finland., Matsubara N; National Cancer Center Hospital East, Chiba, Japan., Priou F; Centre Hospitalier Départemental Vendée, La Roche-Sur-Yon, France., Beuzeboc P; Curie Institute, Paris, France., Lesimple T; Centre Eugène Marquis, Rennes, France., Bono P; Terveystalo Finland and University of Helsinki, Helsinki, Finland., Kataja V; Kuopio University Hospital, Kuopio, Finland., Garcia JA; University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, OH, USA., Protheroe A; Oxford University Hospitals NHS Foundation Trust, Oxford, UK., Shore N; Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC, USA., Aspegren J; Orion Corporation, Espoo, Finland., Joensuu H; Orion Corporation, Espoo, Finland., Kuss I; Bayer AG, Berlin, Germany., Fiala-Buskies S; Bayer AG, Wuppertal, Germany., Vjaters E; P. Stradins Clinical University Hospital, Riga, Latvia.
Jazyk: angličtina
Zdroj: Prostate cancer and prostatic diseases [Prostate Cancer Prostatic Dis] 2024 Dec; Vol. 27 (4), pp. 786-789. Date of Electronic Publication: 2023 Oct 26.
DOI: 10.1038/s41391-023-00740-9
Abstrakt: Background: In patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term safety data are available.
Methods: Treatment-emergent adverse events (TEAEs) for patients receiving darolutamide for a median of 38 months (n = 13) are described in this pooled analysis of individual patient data from phase 1/2 studies.
Results: All patients reported TEAEs (mostly grade 1/2). The most common TEAEs were diarrhea, abdominal pain, and nausea. Serious TEAEs were reported in six patients (none related to darolutamide). All treatment-related TEAEs (n = 5) were grade 1.
Conclusions: Long-term darolutamide treatment was well tolerated; no new safety signals observed. In patients with mCRPC, long-term darolutamide treatment was well tolerated and no new safety signals were observed. These findings are consistent with previous reports, demonstrating a favorable safety and tolerability profile of darolutamide.
(© 2023. The Author(s).)
Databáze: MEDLINE
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