口服Relugolix在晚期前列腺癌雄激素阻断治疗。

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海岸ND, Saad F, Cookson女士,乔治DJ, Saltzstein博士,Tutrone R, Akaza H,西,van Veenhuyzen DF,塞尔比B,风扇X,康V,墙体J, Tombal B

口服Relugolix在晚期前列腺癌雄激素阻断治疗。

郑传经地中海J。2020年6月4日;382 (23):2187 - 2196。doi: 10.1056 / NEJMoa2004325。2020年5月29日Epub。

PubMed ID

32469183 (在PubMed

]

文摘

背景:注射促黄体激素释放激素受体激动剂(如leuprolide)是前列腺癌的标准代理实现雄激素剥夺尽管初始睾丸激素激增和延迟治疗效果。relugolix的疗效和安全性,口服促性腺激素释放激素拮抗剂,相比leuprolide还不为人知。方法:在这个阶段3的试验中,我们随机分配的晚期前列腺癌患者,在2:1的比例,获得relugolix(120毫克口服每天一次)或leuprolide(每3个月注射)48周。主要终点是持续睾酮抑制阉割水平(< 50每分升ng)通过48周。次要终点包括对非主要终点,阉割的睾丸激素水平4天,而深刻的阉割水平(< 20 ng每分升)15天。睾丸激素恢复在一亚组病人评估。结果:共有622名患者接受relugolix和308年收到leuprolide。男人收到relugolix, 96.7%(95%可信区间(CI), 94.9 - 97.9)维护阉割通过48周,相比之下,88.8% (95% CI, 84.6 - 91.8)的男性接受leuprolide。的差异7.9 (95% CI, 4.1 - 11.8)显示,非劣性和优越性的relugolix优势(P < 0.001)。所有其他关键辅助结束点显示的优越性relugolix leuprolide (P < 0.001)。 The percentage of patients with castrate levels of testosterone on day 4 was 56.0% with relugolix and 0% with leuprolide. In the subgroup of 184 patients followed for testosterone recovery, the mean testosterone levels 90 days after treatment discontinuation were 288.4 ng per deciliter in the relugolix group and 58.6 ng per deciliter in the leuprolide group. Among all the patients, the incidence of major adverse cardiovascular events was 2.9% in the relugolix group and 6.2% in the leuprolide group (hazard ratio, 0.46; 95% CI, 0.24 to 0.88). CONCLUSIONS: In this trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that with leuprolide, with a 54% lower risk of major adverse cardiovascular events. (Funded by Myovant Sciences; HERO ClinicalTrials.gov number, NCT03085095.).

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药物

Relugolix