Efficacy and safety of degarelix in patients with prostate cancer:Results from a phase III study in China  

作　　者：Yinghao Sun Liping Xie Tao Xu Jorn S.Jakobsen Weiqing Han Per S.Sorensen Xiaofeng Wang 

机构地区：[1]Department of Urology,Changhai Hospital,Second Military Medical University,Shanghai,China [2]Department of Urology,First Affiliated Hospital,Zhejiang University,Hangzhou,China [3]Department of Urology,Peking University People’s Hospital,Beijing,China [4]Global Clinical Research and Development,Ferring Pharmaceuticals A/S,Copenhagen,Denmark [5]Department of Urology,Hunan Cancer Hospital,Hunan Province,China

出　　处：《Asian Journal of Urology》2020年第3期301-308,共8页亚洲泌尿外科杂志（英文）

摘　　要：Objective:To establish non-inferiority of gonadotropin-releasing hormone degarelix compared with goserelin in suppressing and maintaining castrate testosterone levels from Day 28 to Day 364 in Chinese patients with prostate cancer.Methods:This is an open-label,multi-centre study in which men aged18 years were randomised in a 1:1 ratio to once-a-month subcutaneous injection of either degarelix(240/80 mg)or goserelin(3.6 mg)for 12 months.The primary endpoint was difference in 1-year cumulative probability of suppressing testosterone to ≤0.5 ng/mL.Non-inferiority was to be established if the lower 95% confidence interval(CI)limit for difference in cumulative probability between the treatment arms was greater than -10%.Secondary endpoints included cumulative probability of prostate-specific-antigen-progression-free-survival(PSA-PFS).Safety was also assessed.Results:Baseline demographics and disease characteristics were similar between degarelix(n=142)and goserelin(n=141)treatment arms.The difference in cumulative probability of maintaining castrate levels from Day 28-364 was 3.6%(95%CI:-1.5%,8.7%),demonstrating non-inferiority of degarelix.The cumulative probability of PSA-PFS at Day 364 was higher for degarelix(82.3%,95%CI:74.7%,87.7%)versus goserelin(71.7%,95%CI:63.2%,78.5%,p=0.038).Adverse events(AEs)were similar between treatment arms,except for more injection site reactions with degarelix versus goserelin.Four(2.8%)and nine(6.4%)patients discontinued due to AEs in degarelix and goserelin groups,respectively.

关 键 词：DEGARELIX GOSERELIN GnRH antagonist GnRH agonist Prostate cancer China 

分 类 号：R737.25[医药卫生—肿瘤]