Three-drug combination prolongs survival in men with metastatic, hormone-sensitive prostate cancer

Date:
February 18, 2022
Source:
Massachusetts General Hospital
Summary:
Results from an international, randomized, double-blind, placebo-
controlled, phase 3 clinical trial indicate that adding the
androgen- receptor inhibitor darolutamide to androgen-deprivation
therapy and chemotherapy prolongs the survival of men with
metastatic, hormone- sensitive prostate cancer.



FULL STORY ========================================================================== Results from an international, randomized, double-blind,
placebo-controlled, phase 3 clinical trial indicate that adding
the androgen-receptor inhibitor darolutamide to androgen-deprivation
therapy and chemotherapy prolongs the survival of men with metastatic, hormone-sensitive prostate cancer, a disease that is fatal in most
cases. The study, which was conducted by a team led by investigators at Massachusetts General Hospital (MGH), is published in the New England
Journal of Medicine.


========================================================================== Standard treatment for patients with metastatic, hormone-sensitive
prostate cancer includes the addition of either the chemotherapy
drug docetaxel or an androgen-receptor pathway inhibitor to androgen-deprivation therapy, with the latter two treatments acting to
lower the effects of androgen hormones, such as testosterone. Clinical
trials that have combined all three treatments have generated
conflicting results. To provide clarity, investigators designed the
large, international ARASENS Trial and randomly assigned 1,306 patients
with metastatic, hormone-sensitive prostate cancer in a 1:1 ratio to
receive the oral androgen-receptor inhibitor darolutamide or placebo,
both in combination with androgen-deprivation therapy and docetaxel.

Survival rates in the two groups were compared after 533 patients
had died.

Patients were followed for a median of approximately 3.5 years, and those
who received darolutamide had a 32.5% lower risk of dying during that time
than patients not taking darolutamide. Patients taking darolutamide also experienced greater delays in developing castration-resistant prostate
cancer (which no longer responds to treatments that lower testosterone),
pain, and the need for other anti-cancer therapies. The combination of
three medications did not result in more toxic effects compared with
the combination of androgen- deprivation therapy and docetaxel alone.

"Despite progress in recent years, survival is short for patients with metastatic prostate cancer. Results from ARASENS are an important
step forward, and triplet therapy with darolutamide should become a
new standard of care for the treatment of patients with metastatic hormone-sensitive prostate cancer," says lead author Matthew R. Smith,
MD, PhD, director of the Genitourinary Oncology Program at the Mass
General Cancer Center and an associate professor of medicine at Harvard
Medical School.

The study was supported by Bayer and Orion Pharma.

========================================================================== Story Source: Materials provided by Massachusetts_General_Hospital. Note: Content may be edited for style and length.


========================================================================== Journal Reference:
1. Matthew R. Smith, Maha Hussain, Fred Saad, Karim Fizazi, Cora N.

Sternberg, E. David Crawford, Evgeny Kopyltsov, Chandler H. Park,
Boris Alekseev, A'lvaro Montesa-Pino, Dingwei Ye, Francis
Parnis, Felipe Cruz, Teuvo L.J. Tammela, Hiroyoshi Suzuki, Tapio
Utriainen, Cheng Fu, Motohide Uemura, Mari'a J. Me'ndez-Vidal,
Benjamin L. Maughan, Heikki Joensuu, Silke Thiele, Rui Li, Iris
Kuss, Bertrand Tombal. Darolutamide and Survival in Metastatic,
Hormone-Sensitive Prostate Cancer. New England Journal of Medicine,
2022; DOI: 10.1056/NEJMoa2119115 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2022/02/220218110716.htm

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