RT Journal Article
T1 Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer.
A1 Smith, Matthew R
A1 Hussain, Maha
A1 Saad, Fred
A1 Fizazi, Karim
A1 Sternberg, Cora N
A1 Crawford, E David
A1 Kopyltsov, Evgeny
A1 Park, Chandler H
A1 Alekseev, Boris
A1 Montesa-Pino, Alvaro
A1 Ye, Dingwei
A1 Parnis, Francis
A1 Cruz, Felipe
A1 Tammela, Teuvo L J
A1 Suzuki, Hiroyoshi
A1 Utriainen, Tapio
A1 Fu, Cheng
A1 Uemura, Motohide
A1 Mendez-Vidal, Maria J
A1 Maughan, Benjamin L
A1 Joensuu, Heikki
A1 Thiele, Silke
A1 Li, Rui
A1 Kuss, Iris
A1 Tombal, Bertrand
K1 Neutropenia
K1 Proportional hazards models
K1 Prostatic neoplasms
K1 Prostatic neoplasms, castration-resistant
K1 Pyrazoles
AB Darolutamide is a potent androgen-receptor inhibitor that has been associated with increased overall survival among patients with nonmetastatic, castration-resistant prostate cancer. Whether a combination of darolutamide, androgen-deprivation therapy, and docetaxel would increase survival among patients with metastatic, hormone-sensitive prostate cancer is unknown. In this international, phase 3 trial, we randomly assigned patients with metastatic, hormone-sensitive prostate cancer in a 1:1 ratio to receive darolutamide (at a dose of 600 mg [two 300-mg tablets] twice daily) or matching placebo, both in combination with androgen-deprivation therapy and docetaxel. The primary end point was overall survival. The primary analysis involved 1306 patients (651 in the darolutamide group and 655 in the placebo group); 86.1% of the patients had disease that was metastatic at the time of the initial diagnosis. At the data cutoff date for the primary analysis (October 25, 2021), the risk of death was significantly lower, by 32.5%, in the darolutamide group than in the placebo group (hazard ratio 0.68; 95% confidence interval, 0.57 to 0.80; P In this trial involving patients with metastatic, hormone-sensitive prostate cancer, overall survival was significantly longer with the combination of darolutamide, androgen-deprivation therapy, and docetaxel than with placebo plus androgen-deprivation therapy and docetaxel, and the addition of darolutamide led to improvement in key secondary end points. The frequency of adverse events was similar in the two groups. 
PB Massachusetts Medical Society
YR 2022
FD 2022-02-17
LK http://hdl.handle.net/10668/19663
UL http://hdl.handle.net/10668/19663
LA en
NO Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, et al.  Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142
DS RISalud
RD Apr 9, 2025