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Darolutamide is a potent androgen receptor inhibitor that improves overall survival in patients with non-metastatic, castration-resistant prostate cancer
.
However, it is unclear whether the combination of darolutamide, androgen deprivation therapy, and docetaxel improves survival in patients with metastatic hormone-sensitive prostate cancer
This study, an international phase 3 clinical trial, randomized (1:1) patients with metastatic hormone-sensitive prostate cancer to receive either Darolutamide (600 mg twice a day) or matching placebo plus androgen Deprivation therapy and docetaxel treatment
.
The primary endpoint was overall survival
The overall survival rate of the two groups of patients
A total of 1306 patients were included in the primary analysis: 651 in the darolutamide group and 655 in the placebo group; 86.
1% of patients had developed metastases at the time of initial diagnosis
.
At the end of the primary analysis (October 25, 2021), the risk of death was 32.
The risk of death in the darolutamide group was 32.
Secondary endpoints and subgroup analyses
Darolutamide was also associated with benefit in secondary endpoints and pre-determined subgroup analyses: patients in the Darolutamide group also had significantly longer time to progression to castration-resistant disease and pain than the placebo group (HR 0.
36, p<0.
001 and HR 0.
79, p=0.
001)
.
In addition, patients in the Darolutamide group were superior to the placebo group in terms of productivity of asymptomatic bone events, time to first symptomatic bone event, and time to initiation of subsequent systemic antitumor therapy (HR 0.
The time to progression to castration-resistant disease and pain was also significantly longer in the Darolutamide group than in the placebo group.
The incidence of adverse events in the two groups
The incidence of adverse events in the two groups was similar , and the most common adverse events occurred most frequently during docetaxel overlap treatment
.
Grade 3-4 adverse events occurred in 66.
The incidence of adverse reactions in the two groups was similar The incidence of adverse reactions in the two groups was similar 33.
Darolutamide in combination with androgen deprivation therapy and docetaxel significantly improved overall survival in patients with metastatic hormone-sensitive prostate cancer compared with androgen deprivation therapy and docetaxel alone Darolutamide combined with androgen deprivation therapy and docetaxel significantly improves overall survival in patients with metastatic hormone-sensitive prostate cancer
Original source:
Original source:Matthew R.
Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer.
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