Powell Kerrington, Burns Michael C, Prasad Vinay
College of Medicine, Texas A&M Health Science Center, Bryan, TX, USA.
Department of Hematology-Oncology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Eur Urol. 2023 Feb;83(2):101-102. doi: 10.1016/j.eururo.2022.08.029. Epub 2022 Sep 22.
We highlight concerns regarding the approval of relugolix for patients with prostate cancer. These include the unsuitable comparator arm and primary endpoint in the HERO trial, as well as potential selection bias and the poor representativeness of the trial population. Dosing adherence to a daily tablet may also be an issue in comparison to injections at 3-mo intervals. Rigorous postmarketing trials of relugolix assessing clinically meaningful endpoints for these patients are needed.
我们强调了关于瑞卢戈利用于前列腺癌患者获批的相关问题。这些问题包括HERO试验中不合适的对照臂和主要终点，以及潜在的选择偏倚和试验人群代表性不足。与每3个月注射一次相比，每日服用片剂的给药依从性可能也是一个问题。需要对瑞卢戈利进行严格的上市后试验，以评估这些患者具有临床意义的终点。
