MP27-13 LONG-TERM SAFETY OF DAROLUTAMIDE AMONG PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO RECEIVED MORE THAN 4 YEARS OF THERAPY (2022)

You have accessJournal of UrologyCME1 May 2022MP27-13 LONG-TERM SAFETY OF DAROLUTAMIDE AMONG PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO RECEIVED MORE THAN 4 YEARS OF THERAPY Robert Hugh Jones, Karim Fizazi, Nicholas D. James, Teuvo L. Tammela, Nobuaki Matsubara, Frank Priou, Phillipe Beuzeboc, Thierry Lesimple, Petri Bono, Vesa Kataja, Jorge A. Garcia, Andrew Protheroe, John Aspegren, Heikki Joensuu, Iris Kuss, Silke Thiele, Sabine Fiala-Buskies, and Eglis Vjaters Robert Hugh JonesRobert Hugh Jones More articles by this author , Karim FizaziKarim Fizazi More articles by this author , Nicholas D. JamesNicholas D. James More articles by this author , Teuvo L. TammelaTeuvo L. Tammela More articles by this author , Nobuaki MatsubaraNobuaki Matsubara More articles by this author , Frank PriouFrank Priou More articles by this author , Phillipe BeuzebocPhillipe Beuzeboc More articles by this author , Thierry LesimpleThierry Lesimple More articles by this author , Petri BonoPetri Bono More articles by this author , Vesa KatajaVesa Kataja More articles by this author , Jorge A. GarciaJorge A. Garcia More articles by this author , Andrew ProtheroeAndrew Protheroe More articles by this author , John AspegrenJohn Aspegren More articles by this author , Heikki JoensuuHeikki Joensuu More articles by this author , Iris KussIris Kuss More articles by this author , Silke ThieleSilke Thiele More articles by this author , Sabine Fiala-BuskiesSabine Fiala-Buskies More articles by this author , and Eglis VjatersEglis Vjaters More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002570.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Darolutamide (DARO) is a structurally distinct and highly potent androgen receptor inhibitor that demonstrated a consistently favorable safety and tolerability profile in previously reported phase 1/2 studies as well as in the phase 3 ARAMIS trial. In this analysis, long-term safety with extended treatment with DARO >4 years was evaluated in patients with metastatic castration-resistant prostate cancer (mCRPC) from the phase 1 ARAFOR study (NCT01784757). METHODS: This 2-part, multicenter, international study evaluated the pharmacokinetics of DARO in a 3-period crossover study that was followed by an open-label extension to assess long-term safety and tolerability. Descriptive results of patient characteristics, treatment duration, and adverse events (AEs) are summarized. RESULTS: Thirty patients were enrolled, 6 of whom received >4 years of DARO treatment at 600 mg twice daily. The median age was 69 years (range 58–73) and all patients were Caucasian. The median duration of treatment in ARAFOR was 63 months (range 49–90); 1 patient completed ARAFOR and entered the DARO roll-over study (NCT04464226). At baseline, normal renal function was reported for 5 patients, with 1 patient having mild renal impairment; 3 patients had normal hepatic function and 3 had mild hepatic impairment. Eastern Cooperative Oncology Group performance status was 0 for 5 patients and 1 for 1 patient, and Gleason score was 7 for 4 patients at baseline. No patient received prior chemotherapy. All 6 patients reported AEs; 3 patients reported diarrhea, and 2 patients each reported abdominal pain, nausea, arthralgia, hematuria, influenza, anemia, dysuria, fall/accident, rib fracture, solar dermatitis, and decreased weight. Grade 3 AEs occurred in 5 patients and serious AEs in 4 patients; no individual grade 3 or serious AE occurred in more than 1 patient and none were judged to be related to darolutamide. Treatment-related AEs (tinnitus, fatigue, solar dermatitis) were reported in 2 patients and were grade 1 in worst severity. No patients discontinued DARO due to AEs. CONCLUSIONS: In this small group of mCRPC patients from the phase 1 ARAFOR study, long-term treatment with DARO beyond 4 years was generally well tolerated and no new safety signals were observed. Source of Funding: Bayer AG and Orion Pharma © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e455 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Robert Hugh Jones More articles by this author Karim Fizazi More articles by this author Nicholas D. James More articles by this author Teuvo L. Tammela More articles by this author Nobuaki Matsubara More articles by this author Frank Priou More articles by this author Phillipe Beuzeboc More articles by this author Thierry Lesimple More articles by this author Petri Bono More articles by this author Vesa Kataja More articles by this author Jorge A. Garcia More articles by this author Andrew Protheroe More articles by this author John Aspegren More articles by this author Heikki Joensuu More articles by this author Iris Kuss More articles by this author Silke Thiele More articles by this author Sabine Fiala-Buskies More articles by this author Eglis Vjaters More articles by this author Expand All Advertisement PDF downloadLoading ...