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

Robert Hugh Jones; Karim Fizazi; Nicholas D. James; Teuvo L. Tammela; Nobuaki Matsubara; Frank Priou; Philippe Beuzeboc; Thierry Lesimple; Petri Bono; Vesa Kataja; Jorge A. Garcia; Andrew Protheroe; Neal Shore; John Aspegren; Heikki Joensuu; Iris Kuss; Sabine Fiala-Buskies; Egils Vjaters

doi:10.1038/s41391-023-00740-9

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

Robert Hugh Jones, Karim Fizazi, Nicholas D. James, Teuvo L. Tammela, Nobuaki Matsubara, Frank Priou, Philippe Beuzeboc, Thierry Lesimple, Petri Bono, Vesa Kataja, Jorge A. Garcia, Andrew Protheroe, Neal Shore, John Aspegren, Heikki Joensuu, Iris Kuss, Sabine Fiala-Buskies, Egils Vjaters

Résultats de recherche: Contribution à un journal › Article › Revue par des pairs

Résumé

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. Tweetable abstract: 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.

langue originale	Anglais
journal	Prostate Cancer and Prostatic Diseases
Les DOIs	https://doi.org/10.1038/s41391-023-00740-9
état	Accepté/sous presse - 1 janv. 2023

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10.1038/s41391-023-00740-9

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Jones, R. H., Fizazi, K., James, N. D., Tammela, T. L., Matsubara, N., Priou, F., Beuzeboc, P., Lesimple, T., Bono, P., Kataja, V., Garcia, J. A., Protheroe, A., Shore, N., Aspegren, J., Joensuu, H., Kuss, I., Fiala-Buskies, S., & Vjaters, E. (Accepté/en presse). Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer. Prostate Cancer and Prostatic Diseases. https://doi.org/10.1038/s41391-023-00740-9

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

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. Tweetable abstract: 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.",

author = "Jones, {Robert Hugh} and Karim Fizazi and James, {Nicholas D.} and Tammela, {Teuvo L.} and Nobuaki Matsubara and Frank Priou and Philippe Beuzeboc and Thierry Lesimple and Petri Bono and Vesa Kataja and Garcia, {Jorge A.} and Andrew Protheroe and Neal Shore and John Aspegren and Heikki Joensuu and Iris Kuss and Sabine Fiala-Buskies and Egils Vjaters",

note = "Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

month = jan,

day = "1",

doi = "10.1038/s41391-023-00740-9",

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journal = "Prostate Cancer and Prostatic Diseases",

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Jones, RH, Fizazi, K, James, ND, Tammela, TL, Matsubara, N, Priou, F, Beuzeboc, P, Lesimple, T, Bono, P, Kataja, V, Garcia, JA, Protheroe, A, Shore, N, Aspegren, J, Joensuu, H, Kuss, I, Fiala-Buskies, S & Vjaters, E 2023, 'Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer', Prostate Cancer and Prostatic Diseases. https://doi.org/10.1038/s41391-023-00740-9

TY - JOUR

T1 - Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer

AU - Jones, Robert Hugh

AU - Fizazi, Karim

AU - James, Nicholas D.

AU - Tammela, Teuvo L.

AU - Matsubara, Nobuaki

AU - Priou, Frank

AU - Beuzeboc, Philippe

AU - Lesimple, Thierry

AU - Bono, Petri

AU - Kataja, Vesa

AU - Garcia, Jorge A.

AU - Protheroe, Andrew

AU - Shore, Neal

AU - Aspegren, John

AU - Joensuu, Heikki

AU - Kuss, Iris

AU - Fiala-Buskies, Sabine

AU - Vjaters, Egils

PY - 2023/1/1

Y1 - 2023/1/1

N2 - 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. Tweetable abstract: 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.

AB - 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. Tweetable abstract: 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.

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