"Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial"

作者全名："Gu, Chengyuan; Wang, Zengjun; Lin, Tianxin; Liu, Zhiyu; Han, Weiqing; Zhang, Xuhui; Liang, Chao; Liu, Hao; Yu, Yang; Xu, Zhenzhou; Liu, Shuang; Wang, Jingen; Jia, Linghua; Yao, Xin; Liao, Wenfeng; Fu, Cheng; Tan, Zhaohui; He, Guohua; Zhu, Guoxi; Fan, Rui; Yang, Wenzeng; Chen, Xin; Liu, Zhizhong; Zhong, Liqiang; Shi, Benkang; Ding, Degang; Chen, Shubo; Wei, Junli; Yao, Xudong; Chen, Ming; Lu, Zhanpeng; Xie, Qun; Hu, Zhiquan; Wang, Yinhuai; Guo, Hongqian; Fan, Tiwu; Liang, Zhaozhao; Chen, Peng; Wang, Wei; Xu, Tao; Li, Chunsheng; Xing, Jinchun; Liao, Hong; He, Dalin; Wu, Zhibin; Yu, Jiandi; Feng, Zhongwen; Yang, Mengxiang; Dou, Qifeng; Zeng, Quan; Li, Yuanwei; Gou, Xin; Zhou, Guangchen; Wang, Xiaofeng; Zhu, Rujian; Zhang, Zhonghua; Zhang, Bo; Tan, Wanlong; Qu, Xueling; Sun, Hongliang; Gan, Tianyi; Ye, Dingwei"

作者地址："[Gu, Chengyuan; Ye, Dingwei] Fudan Univ, Dept Urol, Shanghai Canc Ctr, Shanghai 200032, Peoples R China; [Gu, Chengyuan; Ye, Dingwei] Fudan Univ, Shanghai Med Coll, Dept Oncol, Shanghai 200032, Peoples R China; [Wang, Zengjun; Liang, Chao] Nanjing Med Univ, Dept Urol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China; [Lin, Tianxin; Liu, Hao] Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Urol, Guangzhou 510120, Guangdong, Peoples R China; [Liu, Zhiyu; Yu, Yang] Dalian Med Univ, Dept Urol, Affiliated Hosp 2, Dalian 116023, Liaoning, Peoples R China; [Han, Weiqing; Xu, Zhenzhou] Cent South Univ, Affiliated Canc Hosp, Dept Urol, Hunan Canc Ctr,Xiangya Sch Med, Changsha 410013, Hunan, Peoples R China; [Zhang, Xuhui; Liu, Shuang] Shanxi Med Univ, Dept Urol, Hosp 1, Taiyuan 030000, Shanxi, Peoples R China; [Wang, Jingen; Jia, Linghua] Nanchang Univ, Sch Med, Jiangxi Prov Peoples Hosp, Dept Urol, Nanchang 330006, Jiangxi, Peoples R China; [Yao, Xin; Liao, Wenfeng] Tianjin Med Univ Canc Inst & Hosp, Dept Urol, Tianjin 300060, Peoples R China; [Fu, Cheng] China Med Univ, Liaoning Canc Hosp & Inst, Dept Urol, Canc Hosp, Shenyang 110043, Liaoning, Peoples R China; [Tan, Zhaohui] Inner Mongolia Peoples Hosp, Dept Urol, Hohhot 010010, Inner Mongolia, Peoples R China; [He, Guohua] Taizhou Hosp Tradit Chinese Med, Dept Urinary Surg, Taizhou 225300, Jiangsu, Peoples R China; [Zhu, Guoxi] Linfen Peoples Hosp, Dept Urol, Linfen 041000, Shanxi, Peoples R China; [Fan, Rui] Zhengzhou Univ, Zhengzhou Cent Hosp, Dept Urol, Zhengzhou 450006, Henan, Peoples R China; [Yang, Wenzeng] Hebei Univ, Dept Urol, Affiliated Hosp, Baoding 071000, Hebei, Peoples R China; [Chen, Xin] Inner Mongolia Med Univ, Dept Urol, Chifeng Municipal Hosp, Chifeng Clin Med Coll, Chifeng 024000, Inner Mongolia, Peoples R China; [Liu, Zhizhong] Baogang Hosp, Dept Urol, Baotou 014010, Inner Mongolia, Peoples R China; [Zhong, Liqiang] Second Peoples Hosp Yibin, Dept Oncol, Yibin 644000, Sichuan, Peoples R China; [Shi, Benkang] Shandong Univ, Dept Urol, Qilu Hosp, Jinan 250014, Shandong, Peoples R China; [Ding, Degang] Zhengzhou Univ, Henan Prov Peoples Hosp, Dept Urol, Peoples Hosp, Zhengzhou 450003, Henan, Peoples R China; [Chen, Shubo; Wei, Junli] Hebei Med Univ, Xingtai Peoples Hosp, Dept Urol, Xingtai 054001, Hebei, Peoples R China; [Yao, Xudong] Tongji Univ, Shanghai Tenth Peoples Hosp, Sch Med, 22Department Urol, Shanghai 200072, Peoples R China; [Chen, Ming] Southeast Univ, Zhongda Hosp, Dept Urol, Nanjing 210009, Jiangsu, Peoples R China; [Lu, Zhanpeng] Jining 1 Peoples Hosp, Dept Urol, Jining 272011, Shandong, Peoples R China; [Xie, Qun] Jinan Univ, Zhuhai Peoples Hosp, Dept Urol, Zhuhai 519000, Guangdong, Peoples R China; [Hu, Zhiquan] Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Urol, Wuhan 430030, Hubei, Peoples R China; [Wang, Yinhuai] Cent South Univ, Xiangya Hosp 2, Dept Urol, Changsha 410000, Hunan, Peoples R China; [Guo, Hongqian] Nanjing Univ, Inst Urol, Med Sch Nanjing Univ, Drum Tower Hosp,Dept Urol, Nanjing 210008, Jiangsu, Peoples R China; [Fan, Tiwu] Changzhi Med Coll, Heping Hosp, Dept Urol, Changzhi 046011, Shanxi, Peoples R China; [Liang, Zhaozhao] Anhui Med Univ, Dept Urol, Affiliated Hosp 1, Hefei 230022, Anhui, Peoples R China; [Chen, Peng] Xinjiang Med Univ, Dept Urol, Affiliated Tumor Hosp, Urumqi 830011, Xinjiang, Peoples R China; [Wang, Wei] Guangxi Univ Sci, Dept Urol Surg, Liuzhou Peoples Hosp, Liuzhou 545200, Guangxi, Peoples R China; [Xu, Tao] Peking Univ, Dept Urol, Peoples Hosp, Beijing 100044, Peoples R China; [Li, Chunsheng] Chifeng Univ, Affiliated Hosp, Dept Urol, Chifeng 024036, Inner Mongolia, Peoples R China; [Xing, Jinchun] Xiamen Univ, Sch Med, Affiliated Hosp 1, Key Lab Urinary Tract Tumors & Calculi,Dept Urol, Xiamen 361003, Fujian, Peoples R China; [Liao, Hong] Sichuan Canc Hosp, Radiat Oncol Key Lab Sichuan Prov, Dept Urol, Chengdu 610047, Sichuan, Peoples R China; [He, Dalin] Xi An Jiao Tong Univ, Dept Urol, Med Sch, Affiliated Hosp 1, Xian 710061, Shaanxi, Peoples R China; [Wu, Zhibin] Zhejiang Univ, Sch Med, Dept Oncol, Affiliated Zhejiang Hosp, Hangzhou 310030, Zhejiang, Peoples R China; [Yu, Jiandi] Zhejiang Hosp, Dept Urol, Hangzhou 310030, Zhejiang, Peoples R China; [Feng, Zhongwen] Grand Hosp Jincheng, Dept Urol, Jincheng 048006, Shanxi, Peoples R China; [Yang, Mengxiang] Liaocheng Peoples Hosp, Dept Oncol, Liaocheng 252004, Shandong, Peoples R China; [Dou, Qifeng] Xinxiang Med Univ, Dept Urol, Affiliated Hosp 1, Xinxiang 453100, Henan, Peoples R China; [Zeng, Quan] Jiujiang Univ, Dept Urol, Affiliated Hosp, Jiujiang 332000, Jiangxi, Peoples R China; [Li, Yuanwei] Hunan Normal Univ, Hunan Prov Peoples Hosp, Dept Urol, Affiliated Hosp 1, Changsha 410005, Hunan, Peoples R China; [Gou, Xin] Chongqing Med Univ, Dept Urol, Affiliated Hosp 1, Chongqing 400016, Peoples R China; [Zhou, Guangchen] Yangzhou Univ, Subei Peoples Hosp Jiangsu Prov, Dept Urol, Clin Med Coll, Yangzhou 225001, Jiangsu, Peoples R China; [Wang, Xiaofeng] Peking Univ, Int Hosp, Dept Urol, Beijing 102206, Peoples R China; [Zhu, Rujian] Fudan Univ, Pudong Med Ctr, Shanghai Pudong Hosp, Dept Urol, Shanghai 201300, Peoples R China; [Zhang, Zhonghua] Xinyu Peoples Hosp, Dept Urol, Xinyu 338000, Jiangxi, Peoples R China; [Zhang, Bo] Air Force Med Univ, Tangdu Hosp, Dept Urol, Xian 710038, Shaanxi, Peoples R China; [Tan, Wanlong] Southern Med Univ, Nanfang Hosp, Dept Urol, Guangzhou 510000, Guangdong, Peoples R China; [Qu, Xueling; Sun, Hongliang; Gan, Tianyi] Luye Pharma Grp Ltd, Clin Res Ctr, Beijing 264003, Peoples R China"

通信作者："Ye, DW (通讯作者)，Fudan Univ, Dept Urol, Shanghai Canc Ctr, Shanghai 200032, Peoples R China.; Ye, DW (通讯作者)，Fudan Univ, Shanghai Med Coll, Dept Oncol, 270 Dongan Rd, Shanghai 200032, Peoples R China."

来源：CHINESE MEDICAL JOURNAL

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001009520500001

JCR分区：Q1

影响因子：7.5

年份：2023

卷号：136

期号：10

开始页：1207

结束页：1215

文献类型：Article

关键词：Prostatic neoplasms; LY01005; Gonadotropin-releasing hormone agonist; Efficacy; Safety

摘要："Background: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. Methods: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression <= 50 ng/dL at day 29 and the cumulative probability of testosterone <= 50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (<= 20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. Results: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs. 1.4% [2/145]). Conclusion: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile."

基金机构：Luye Pharma Group Ltd.

基金资助正文：This study was sponsored by Luye Pharma Group Ltd.