摘要
前列腺癌是常见的泌尿系统恶性肿瘤,和其他实体瘤相比疾病进展较为缓慢,具有独特的疾病特征。针对晚期前列腺癌如何选择合理的临床试验终点,科学客观地评价药物的临床价值,节约研发时间,让患者及早获得有效治疗,药品审评中心起草了《晚期前列腺癌临床试验终点技术指导原则》供业界参考。该指导原则公开征求意见过程中多家企业建议明确在转移性激素敏感性前列腺癌(mHSPC)受试者开展临床研究时中如何选择主要研究终点。药品审评中心召开专家咨询会进行讨论,本文将结合具体案例及会议讨论意见,阐述不同情形下综合影像学无进展生存期(rPFS)和总生存期(OS)数据支持药品注册的审评考虑。
Prostate cancer is a common malignant tumor of the urinary system.Compared with other solid tumors,the disease progress is relatively slow and has unique characteristics.The Center for Drug Evaluation(CDE)has drafted the Guidelines for Terminal Points of Clinical Trials of Advanced Prostate Cancer for reference by the industry.This guideline aims to clarify how to select an appropriate clinical trial endpoint for advanced prostate cancer,scientifically and objectively evaluate the clinical value of drugs,save research and development time,and enable patients to receive adequate treatment as early as possible.In the process of public solicitation for opinions on this guideline,many enterprises suggested clarifying how to select the primary clinical endpoint when conducting clinical research for subjects with metastatic hormone-sensitive prostate cancer(mHSPC).CDE held an expert consultation meeting to discuss this problem.This paper will elaborate on the review consideration of drug registration supported by radiographic progression free survival and overall survival data under different circumstances.
作者
仝昕
吕俊
郝瑞敏
胡文娟
杨志敏
TONG Xin;Lü Jun;HAO Rui-min;HU Wen-juan;YANG Zhi-min(Center for Drug Evaluation,China National Medical Products Administration,Beijing 100022,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2023年第6期903-906,共4页
The Chinese Journal of Clinical Pharmacology
关键词
转移性激素敏感性前列腺癌
影像学无进展生存期
总生存期
药物研发
metastatic hormone-sensitive prostate cancer
radiographic progression free survival
overall survival
drug research and development
