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

Research output: Contribution to journalArticleScientificpeer-review

1 Downloads (Pure)

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.

Original languageEnglish
JournalPROSTATE CANCER AND PROSTATIC DISEASES
DOIs
Publication statusE-pub ahead of print - 2023
Publication typeA1 Journal article-refereed

Publication forum classification

  • Publication forum level 1

ASJC Scopus subject areas

  • Oncology
  • Urology
  • Cancer Research

Fingerprint

Dive into the research topics of 'Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer'. Together they form a unique fingerprint.

Cite this