ASTRO 2020: Relugolix Versus Leuprolide for Localized and Recurrent Prostate Cancers
Posted: Monday, November 23, 2020
Androgen-deprivation therapy (ADT) with injectable luteinizing hormone-releasing hormone agonists, in combination with radiotherapy, is often used to treat patients with recurrent and localized prostate cancers. David E. Spratt, MD, of the University of Michigan Rogel Cancer Center, Ann Arbor, and colleagues conducted the phase III HERO trial to compare the efficacy of leuprolide versus the novel agent relugolix in this patient population. During the virtual edition of the 2020 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 35), the investigators reported that compared with leuprolide, relugolix achieved more rapid and sustained castration over 48 weeks with fewer adverse cardiovascular events.
This global trial, which ran for 48 weeks, recruited 934 patients with hormone-sensitive prostate cancer. Participants were required to have at least 12 months of ADT prior to the trial, and radiotherapy was authorized 2 months after completion. Men were randomly selected 2:1 to receive oral relugolix at 120 mg daily or a 3-month depot injection of leuprolide. Castration rate, shown by testosterone levels less than 50 ng/dL, testosterone suppression at days 4 and 15, and testosterone recovery after 90 days were analyzed in 184 patients.
The rate of testosterone suppression to castrate levels at 48 weeks for relugolix and leuprolide were 96.7% and 88.8%, levels at day 4 were 56% and 0%, and levels at day 15 were 99% and 12%, respectively. Following 48 weeks of ADT, the testosterone recovery after 90 days was 288.4 ng/dL for relugolix and 58.6 ng/dL for leuprolide, achieving more than 280 ng/dL in 54% and 3% of patients, respectively. Major adverse cardiovascular events occurred in 2.9% of patients on relugolix and 6.2% of those on leuprolide, with a 54% overall risk reduction. A total of 16.9% men received radiotherapy, and castrate testosterone levels by day 15 were 98.7% and 12.1% with relugolix and leuprolide, respectively.
Disclosure: For full disclosures of the study authors, visit redjournal.org.
