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Shore, Neal D; Gratzke, Christian; Feyerabend, Susan; Werbrouck, Patrick; Carles, Joan; Vjaters, Egils; Tammela, Teuvo L J; Morris, David; Aragon-Ching, Jeanny B; Concepcion, Raoul S; Emmenegger, Urban; Fleshner, Neil; Grabbert, Markus; Lietuvietis, Vilnis; Mahammedi, Hakim; Cruz, Felipe M; Paula, Adriano; Pieczonka, Christopher; Rannikko, Antti; Richardet, Martin; Silveira, Glauco; Kuss, Iris; Le Berre, Marie-Aude; Verholen, Frank; Sarapohja, Toni; Smith, Matthew R; Fizazi, Karim
The oncologist (Dayton, Ohio), 07/2024, Volume: 29, Issue: 7Journal Article
Patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) are usually asymptomatic and seek treatments that improve survival but have a low risk of adverse events. Darolutamide, a structurally distinct androgen receptor inhibitor (ARi), significantly reduced the risk of metastasis and death versus placebo in ARAMIS. We assessed the extended safety and tolerability of darolutamide and the time-course profile of treatment-emergent adverse events (TEAEs) related to ARis and androgen-suppressive treatment. Patients with nmCRPC were randomized 2:1 to darolutamide (n = 955) or placebo (n = 554). After trial unblinding, patients could receive open-label darolutamide. Tolerability and TEAEs were assessed every 16 weeks. Time interval-specific new and cumulative event rates were determined during the first 24 months of the double-blind period. Darolutamide remained well tolerated during the double-blind and open-label periods, with 98.8% of patients receiving the full planned dose. The incidence of TEAEs of interest in the darolutamide group was low and ≤2% different from that in the placebo group, except for fatigue. When incidences were adjusted for exposure time, there were minimal differences between the darolutamide double-blind and double-blind plus open-label periods. The rate of initial onset and cumulative incidence of grade 3/4 TEAEs and serious TEAEs were similar for darolutamide and placebo groups over 24 months. Extended treatment with darolutamide was well tolerated and no new safety signals were observed. Most ARi-associated and androgen-suppressive treatment-related TEAEs occurred at low incidences with darolutamide, were similar to placebo, and showed minimal increase over time with continued treatment. ClinicalTrials.gov identifier NCT02200614.
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