The results of an international, randomized, double-blind, placebo-controlled phase III clinical trial indicate that the addition of the androgen receptor inhibitor darolutamide to androgen deprivation therapy and chemotherapy prolongs the survival of men with metastatic, hormone-sensitive prostate cancer
The combination of the three drugs prolongs the survival of patients with metastatic, hormone-sensitive prostate cancer
Published Feb. 22, 2022 11:32
rak prostaty
The results of an international, randomized, double-blind, placebo-controlled phase III clinical trial indicate that the addition of the androgen receptor inhibitor darolutamide to androgen deprivation therapy and chemotherapy prolongs the survival of men with metastatic disease. hormone-sensitive cancer of the prostate. The study, which was conducted by a team of researchers at Massachusetts General Hospital (MGH), was published in the New England Journal of Medicine .
Standard treatment for patients with metastatic, hormone-sensitive prostate cancer includes the addition of androgen deprivation therapy, the chemotherapy drug docetaxel, or the androgen receptor inhibitor darolutamide to the therapy. Clinical trials that combined all three treatments have so far produced conflicting results. To obtain conclusive results, researchers designed a large international study, ARASENS, involving 1,306 patients with metastatic hormone-sensitive prostate cancer, who were divided into two equal groups. The first group received an oral androgen receptor inhibitor, darolutamide, and the second placebo, along with androgen deprivation therapy and chemotherapy.
Median follow-up of patients was approximately 3.5 years, and the survival rates of the two groups were compared after the death of 533 patients. Patients who received darolutamide had a 32.5% lower risk of death than those who did not take darolutamide. In addition, slower development of castration-resistant prostate tumors, less pain and the need for other anti-cancer therapies have been observed in patients taking darolutamide. The combination of the three drugs did not produce any more toxic effects as compared to the combination of only the two treatments.
"Despite advances in recent years, the survival time for patients with metastatic prostate cancer is short. The results of the ARASENS study are an important step forward, and darolutamide triplet therapy should become the new standard of care for patients with metastatic hormone-sensitive prostate cancer, ”says lead author Matthew R. Smith, MD, Director of the Genitourinary Oncology Program at the Mass. General Cancer Center, professor at Harvard Medical School.
The study was supported by Bayer and Orion Pharma.
Source: ScienceDaily
