Prostate cancer and prostatic diseases · 2025
DARolutamide ObservationaL (DAROL) study in patients with nonmetastatic castration-resistant prostate cancer: prespecified third interim analysis.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Yu Evan Y, Suzuki Hiroyoshi, Pieczonka Christopher M, Gotto Geoffrey, Briganti Alberto, Luz Murilo, Murphy Declan, Malone Ryan, Hamilton Joelle, Chan Jonathan E, Sieber Paul, Given Robert W, Hellmis Eva, Kretz Thomas, Spiegelhalder Philipp, Gómez-Caamaño Antonio, Amela Yaovi Messan, Artignan Xavier, Uemura Hiroji, Fujita Naoki, Adorjan Patrick, Ghadessi Mercedeh, Verholen Frank, Armstrong Andrew J
Аннотация
BACKGROUND: DAROL is an ongoing study of real-world safety and effectiveness of darolutamide in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC).
SUBJECTS/METHODS: This prespecified interim analysis included 550 patients with nmCRPC who completed ≥6 months of treatment with darolutamide 600 mg twice daily.
RESULTS: Darolutamide showed consistent safety and effectiveness in DAROL vs ARAMIS. Most treatment-emergent adverse events were grade 1/2. Two-year overall survival and metastasis-free survival rates and prostate-specific antigen responses were similar to ARAMIS.
CONCLUSIONS: These findings indicate that darolutamide offers effectiveness and a favorable safety profile in the broad range of patients seen in clinical practice.
SUBJECTS/METHODS: This prespecified interim analysis included 550 patients with nmCRPC who completed ≥6 months of treatment with darolutamide 600 mg twice daily.
RESULTS: Darolutamide showed consistent safety and effectiveness in DAROL vs ARAMIS. Most treatment-emergent adverse events were grade 1/2. Two-year overall survival and metastasis-free survival rates and prostate-specific antigen responses were similar to ARAMIS.
CONCLUSIONS: These findings indicate that darolutamide offers effectiveness and a favorable safety profile in the broad range of patients seen in clinical practice.