Real-world effectiveness and safety of goserelin 10.8-mg depot in Chinese patients with localized or locally advanced prostate cancer

二维码有效期 120s

摘要Objective:Real-word data on long-acting luteinizing hormone-releasing hormone(LHRH)agonists in Chinese patients with prostate cancer are limited.This study aimed to determine the real-world effectiveness and safety of the LHRH agonist,goserelin,particularly the long-acting 10.8-mg depot formulation,and the follow-up patterns among Chinese prostate cancer patients.Methods:This was a multicenter,prospective,observational study in hormone treatment-na?ve patients with localized or locally advanced prostate cancer who were prescribed goserelin 10.8-mg depot every 12 weeks or 3.6-mg depot every 4 weeks with or without an anti-androgen.The patients had follow-up evaluations for 26 weeks.The primary outcome was the effectiveness of goserelin in reducing serum testosterone and prostate-specific antigen(PSA)levels.The secondary outcomes included testosterone and PSA levels,attainment of chemical castration(serum testosterone<50 ng/dL),and goserelin safety.The exploratory outcome was the monitoring pattern for serum testosterone and PSA.All analyses were descriptive.Results:Between September 2017 and December 2019,a total of 294 eligible patients received≥1 dose of goserelin;287 patients(97.6％)were treated with goserelin 10.8-mg depot.At week 24±2,the changes from baseline[standard deviation(95％confidence interval)]in serum testosterone(n = 99)and PSA(n = 131)were-401.0 ng/dL[308.4 ng/dL(-462.5,-339.5 ng/dL)]and-35.4 ng/mL[104.4 ng/mL(-53.5,-17.4 ng/mL)],respectively.Of 112 evaluable patients,100(90.2％)achieved a serum testosterone level<50 ng/dL.Treatment-emergent adverse events(TEAEs)and severe TEAEs occurred in 37.1％and 10.2％of patients,respectively.The mean testing frequency(standard deviation)was 1.6(1.5)for testosterone and 2.2(1.6)for PSA.Conclusions:Goserelin 10.8-mg depot effectively achieved and maintained castration and was well-tolerated in Chinese patients with localized and locally advanced prostate cancer.

作者 Nanhui Chen ^[1] Zengjun Wang ^[2] Ming Chen ^[3] Qi Ma ^[4] Yi He ^[5] Yujie Wang ^[6] Xin Li ^[7] Mingxing Qiu ^[8] Lei Shi ^[9] Shaoxing Zhu ^[10] Qun Xie ^[11] Xiuheng Liu ^[12] Benkang Shi ^[13] Guowen Lin ^[14] Weizhong Yang ^[15] Yongbin Liao ^[16] Haibin Zhang ^[17] Shusheng Wang ^[18] Jiexian Li ^[19] Shaogang Wang ^[20] Lijun Dong ^[21] Hui Chen ^[22] Jiaju Lu ^[23] Yongyi Cheng ^[24] Xiaoping Zhang ^[25] Lulin Ma ^[26] Liqun Zhou ^[27] He Wang ^[28] Shen Li ^[29] Dingwei Ye ^[14] 学术成果认领

作者单位 Department of Urology,Meizhou People's Hospital,Meizhou 514089,China ^[1] Department of Urology,Jiangsu Province Hospital,Nanjing 210029,China ^[2] Department of Urology,Zhongda Hospital Southeast University,Nanjing 210009,China ^[3] Translational Research Laboratory for Urology,Ningbo First Hospital,Ningbo 315016,China ^[4] Department of Urology,First Affiliated Hospital of Jiaxing,Jiaxing 314050,China ^[5] Department of Urology,The First Affiliated Hospital of Xinjiang Medical University,Urumqi 830091,China ^[6] Department of Urology,Baotou Cancer Hospital,Baotou 014016,China ^[7] Department of Urology,The People's Hospital of Sichuan Province,Chengdu 610032,China ^[8] Department of Urology,Yantai Yuhuangding Hospital,Yantai 264008,China ^[9] Department of Urology,Cancer Hospital of The University of Chinese Academy of Sciences,Hangzhou 310022,China ^[10] Department of Urology,Zhuhai Hospital Affiliated with Jinan University,Zhuhai 519000,China ^[11] Department of Urology,Tongji Hospital,Tongji Medical College,HUST,Wuhan 430032,China ^[12] Department of Urology,Qilu Hospital of Shandong University,Jinan 250012,China ^[13] Department of Urology,Fudan University Shanghai Cancer Center,Shanghai 200032,China ^[14] Department of Urology,Huizhou Third People's Hospital,Huizhou 516002,China ^[15] Department of Urology,Jiangmen Central Hospital,Jiangmen 529030,China ^[16] Department of Urology,Foshan First People's Hospital,Foshan 528041,China ^[17] Department of Urology,Guangzhou Province Traditional Chinese Medical Hospital,Guangzhou 510120,China ^[18] Department of Urology,Guangzhou Panyu Central Hospital,Guangzhou 511489,China ^[19] Department of Urology,Renmin Hospital of Wuhan University,Wuhan 430064,China ^[20] Department of Urology,Hebei Petro China Central Hospital(China National Petroleum Corporation Central Hospital),Langfang 065099,China ^[21] Department of Urology,Harbin Medical University Cancer Hospital,Harbin 150086,China ^[22] Department of Urology,Shandong Provincial Hospital,Jinan 250014,China ^[23] Department of Urology,Shaanxi Provincial People's Hospital,Xi'an 710021,China ^[24] Department of Urology,Union Hospital Tongji Medical College Huazhong University of Science and Technology,Wuhan 430032,China ^[25] Department of Urology,Peking University Third Hospital,Beijing 100191,China ^[26] Department of Urology,Peking University First Hospital,Beijing 100034,China ^[27] Department of Urology,Tangdu Hospital,Xi'an 710024,China ^[28] Department of Urology,Shijiazhuang City First Hospital,Shijiazhuang 050012,China ^[29]

关键词 Goserelin hormone-sensitive luteinizing hormone-releasing hormone prostate cancer China real-world

栏目名称 ORIGINAL ARTICLE

DOI 10.20892/j.issn.2095-3941.2023.0335

发布时间 2024-03-06

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