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Darolutamide Prolongs OS in Metastatic, Hormone-Sensitive Prostate Cancer: Results From the ARASENS Trial
Darolutamide added to androgen-deprivation therapy (ADT) and docetaxel significantly reduced risk of death among patients with metastatic, hormone-sensitive prostate cancer compared to those treated with ADT and docetaxel alone, according to results from the ARASENS trial.
“Darolutamide is a potent androgen-receptor inhibitor that has been associated with increased overall survival [OS] among patients with nonmetastatic, castration-resistant prostate cancer. Whether a combination of darolutamide, [ADT], and docetaxel would increase survival among patients with metastatic, hormone-sensitive prostate cancer is unknown,” wrote lead author Matthew Smith, MD, PhD, Massachusetts General Hospital Cancer and Harvard Medical School, Boston, and colleagues.
In the international, phase 3 trial, researchers randomized 1306 patients in a 1:1 ratio to receive darolutamide (at a dose of 600 mg twice daily) or matched placebo, both in combination with ADT and docetaxel. Of the cohort, 86.1% had disease that was metastatic at the time of the initial diagnosis. The data cutoff date for the primary analysis was October 25, 2021.
At data cutoff, the risk of death was 32.5% lower in the darolutamide group than in the placebo group (hazard ratio 0.68; 95% confidence interval, 0.57 to 0.80; P <.001)
The incidence of adverse events occurring in ≥10% of the patients was highest during the overlapping docetaxel treatment period in both groups. The frequency of grade 3 or 4 adverse events was 66.1% in the darolutamide group and 63.5% in the placebo group; neutropenia was the most common grade 3 or 4 adverse event (33.7% and 34.2%, respectively).
Source:
Smith M, Hussain M, Saad F, et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. Published online February 17, 2022. doi:10.1056/NEJMoa2119115.
