{"id":1288,"date":"2020-07-03T07:07:00","date_gmt":"2020-07-03T07:07:00","guid":{"rendered":"https:\/\/aceoncology.org\/oral-relugolix-best-for-adt-in-advanced-prostate-cancer"},"modified":"2021-03-05T05:12:31","modified_gmt":"2021-03-05T05:12:31","slug":"oral-relugolix-best-for-adt-in-advanced-prostate-cancer","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/oral-relugolix-best-for-adt-in-advanced-prostate-cancer\/","title":{"rendered":"Oral Relugolix Best for ADT in Advanced Prostate Cancer"},"content":{"rendered":"\n<p>For men diagnosed with prostate cancer, the leading cause of death is cardiovascular (CV) disease rather than the cancer itself. Around a third of patients with prostate cancer have pre-existing CV disease, and many have other co-morbidities, including obesity, diabetes, hypertension and hyperlipidemia. Androgen deprivation therapy (ADT) with either injectable long acting luteinizing hormone-releasing hormone (LHRH) receptor agonists or gonadotropin-releasing hormone (GnRH) antagonists is the mainstay of treatment for patients with advanced prostate cancer, with the main goal of lowering testosterone levels to &lt;50 ng\/dL. However, LHRH agonists, such as the commonly used leuprolide acetate, cause an initial surge of testosterone with a flare of symptoms and a possible delay of therapeutic effect. In addition, they fail to fully suppress follicle-stimulating hormone (FSH), a potential mitogenic growth factor for prostate cancer cells. Conversely, the GnRH antagonist degarelix results in a <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/19035858\/\" rel=\"noreferrer noopener\" target=\"_blank\">rapid suppression of testosterone levels<\/a> without an initial testosterone surge; however, frequent injection-site reactions have probably limited its clinical use. <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3047399\/\" rel=\"noreferrer noopener\" target=\"_blank\">Evidence<\/a> also suggests a possible link between ADT and an increased risk of cardiovascular disease. Relugolix is a novel, oral, highly selective GnRH receptor antagonist that achieves hormone suppression by a direct inhibitory effect on the pituitary GnRH receptors.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The multi-national, randomized, open-label, phase III HERO trial was designed to evaluate the efficacy and safety of relugolix in men with androgen sensitive advanced prostate cancer. The <a href=\"https:\/\/meetinglibrary.asco.org\/record\/191602\/abstract\" rel=\"noreferrer noopener\" target=\"_blank\">results<\/a> from this study were presented at the ASCO 2020 virtual meeting by <em>Neal Shore, MD, FACS<\/em> (Carolina Urologic Research Center, South Carolina, USA) and were simultaneously published in the <em><a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2004325\" rel=\"noreferrer noopener\" target=\"_blank\">New England Journal of Medicine<\/a><\/em>. A total of 934 eligible men were randomly assigned in a 2:1 ratio to receive either oral relugolix (120 mg daily after one loading dose of 360 mg) or standard dose injection of leuprolide acetate (every 3 months) for 48 weeks. The primary endpoint was sustained testosterone suppression to castrate levels (&lt;50ng\/dL) through 48 weeks; key secondary endpoints included non-inferiority to leuprolide, castrate testosterone levels on day 4 and 15, profound castration levels (&lt;20ng\/dL) on day 15, prostate-specific antigen (PSA) response (a decrease of &gt;50%) at day 15, and FSH levels at the end of week 24. In addition, testosterone recovery to normal levels within 90 days after drug discontinuation was evaluated in a subgroup of patients. The median follow-up was 52 weeks.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The primary endpoint of the trial was met with 96.7% of men achieving sustained testosterone suppression with relugolix compared with 88.8% for leuprolide. Notably, relugolix was shown to be both non-inferior and superior to leuprolide in sustaining castration rates (<em>P <\/em>&lt; 0.0001); superiority was also shown in all key secondary endpoints (<em>P <\/em>&lt; 0.0001). By day 4, testosterone levels were &lt;50ng\/dL with relugolix, which was maintained throughout the study; in contrast, leuprolide administration led to a surge in testosterone on day 4, decreasing to castrate levels by day 29. Testosterone recovery occurred in 54% and 3% of patients treated with relugolix and leuprolide, respectively. The overall incidence of adverse events (AEs) was comparable between the treatment groups, with \u2265 grade 3 treatment-related AEs occurring in 3.4% and 2.6% of patients in the relugolix and leuprolide groups, respectively, and treatment-related deaths occurred in 1.1% versus 2.9% of patients. Notably, the incidence of major adverse cardiovascular events (MACE) after 48 weeks of treatment was lower with relugolix than leuprolide (2.9% versus 6.2%, respectively), and among 129 men who had a history of MACE (&gt; 6 months before entering the trial), the incidence of MACE was 3.6% versus 17.8%, respectively. Overall, the risk of MACE was 54% lower with relugolix compared with leuprolide (hazard ratio 0.46).<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><em>Dr Shore<\/em> concluded that the HERO trial achieved the primary and all key secondary endpoints, and that relugolix \u201chas the potential to become a new standard of care for ADT for patients with advanced prostate cancer\u201d. A discussant for the trial, <em>Elahe A Mostaghel, MD, PhD <\/em>(University of Washington, Seattle, Washington, USA) commented on the clear significance of the \u201cmore rapid onset of castration, lack of flare response, and decrease in MACE\u201d with relugolix treatment.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><strong>Reference<\/strong><\/p>\n\n\n\n<p>Shore ND, et al. <em>J Clin Oncol<\/em>. 2020; 38 (suppl; abstract 5602).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>For men diagnosed with prostate cancer, the leading cau [&hellip;]<\/p>\n","protected":false},"author":434,"featured_media":733,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[41],"tags":[],"class_list":["post-1288","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-41"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.8 - 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