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

Jones, Robert Hugh ORCID: https://orcid.org/0000-0003-3576-9496, Fizazi, Karim, James, Nicholas D., Tammela, Teuvo L., Matsubara, Nobuaki, Priou, Frank, Beuzeboc, Philippe, Lesimple, Thierry, Bono, Petri, Kataja, Vesa, Garcia, Jorge A., Protheroe, Andrew, Shore, Neal, Aspegren, John, Joensuu, Heikki, Kuss, Iris, Fiala-Buskies, Sabine and Vjaters, Egils 2023. Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer. Prostate Cancer and Prostatic Diseases 10.1038/s41391-023-00740-9

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Abstract

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.

Item Type:	Article
Date Type:	Published Online
Status:	In Press
Schools:	Medicine
Publisher:	Springer Nature [academic journals on nature.com]
ISSN:	1365-7852
Date of First Compliant Deposit:	27 October 2023
Date of Acceptance:	11 October 2023
Last Modified:	30 Oct 2023 09:45
URI:	https://orca.cardiff.ac.uk/id/eprint/163543

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