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

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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.Trial registration::ClinicalTrials.gov, NCT04563936.

abstractsBackground::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.Trial registration::ClinicalTrials.gov, NCT04563936.

作者 Gu Chengyuan ^[1] Wang Zengjun ^[2] Lin Tianxin ^[3] Liu Zhiyu ^[4] Han Weiqing ^[5] Zhang Xuhui ^[6] Liang Chao ^[2] Liu Hao ^[3] Yu Yang ^[4] Xu Zhenzhou ^[5] Liu Shuang ^[6] Wang Jingen ^[7] Jia Linghua ^[7] Yao Xin ^[8] Liao Wenfeng ^[8] Fu Cheng ^[9] Tan Zhaohui ^[10] He Guohua ^[11] Zhu Guoxi ^[12] Fan Rui ^[13] Yang Wenzeng ^[14] Chen Xin ^[15] Liu Zhizhong ^[16] Zhong Liqiang ^[17] Shi Benkang ^[18] Ding Degang ^[19] Chen Shubo ^[20] Wei Junli ^[20] Yao Xudong ^[21] Chen Ming ^[22] Lu Zhanpeng ^[23] Xie Qun ^[24] Hu Zhiquan ^[25] Wang Yinhuai ^[26] Guo Hongqian ^[27] Fan Tiwu ^[28] Liang Zhaozhao ^[29] Chen Peng ^[30] Wang Wei ^[31] Xu Tao ^[32] Li Chunsheng ^[33] Xing Jinchun ^[34] Liao Hong ^[35] He Dalin ^[36] Wu Zhibin ^[37] Yu Jiandi ^[38] Feng Zhongwen ^[39] Yang Mengxiang ^[40] Dou Qifeng ^[41] Zeng Quan ^[42] Li Yuanwei ^[43] Gou Xin ^[44] Zhou Guangchen ^[45] Wang Xiaofeng ^[46] Zhu Rujian ^[47] Zhang Zhonghua ^[48] Zhang Bo ^[49] Tan Wanlong ^[50] Qu Xueling ^[51] Sun Hongliang ^[51] Gan Tianyi ^[51] Ye Dingwei ^[1] 学术成果认领

作者单位 Department of Urology, Fudan University Shanghai Cancer Center, Shanghai 200032, China ^[1] Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China ^[2] Department of Urology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510120, China ^[3] Department of Urology, The Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116023, China ^[4] Department of Urology, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Center, Changsha, Hunan 410013, China ^[5] Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030000, China ^[6] Department of Urology, Jiangxi Provincial People’s Hospital, School of Medicine, Nanchang University, Nanchang, Jiangxi 330006, China ^[7] Department of Urology, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China ^[8] Department of Urology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, Liaoning 110043, China ^[9] Department of Urology, Inner Mongolia People’s Hospital, Hohhot, Inner Mongolia 010010, China ^[10] Department of Urinary Surgery, Taizhou Hospital of Traditional Chinese Medicine, Taizhou, Jiangsu 225300, China ^[11] Department of Urology, Linfen People’s Hospital, Linfen, Shanxi 041000, China ^[12] Department of Urology, Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan 450006, China ^[13] Department of Urology, The Affiliated Hospital of Hebei University, Baoding, Hebei 071000, China ^[14] Department of Urology, Chifeng Municipal Hospital, Chifeng Clinical Medical College of Inner Mongolia Medical University, Chifeng, Inner Mongolia 024000, China ^[15] Department of Urology, Baogang Hospital, Baotou, Inner Mongolia 014010, China ^[16] Department of Oncology, The Second People’s Hospital of Yibin, Yibin, Sichuan 644000, China ^[17] Department of Urology, Qilu Hospital of Shandong University, Jinan, Shandong 250014, China ^[18] Department of Urology, Henan Provincial People’s Hospital, The People’s Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China ^[19] Department of Urology, Xingtai People’s Hospital, Hebei Medical University, Xingtai, Hebei 054001, China ^[20] Department of Urology, Shanghai Tenth People’s Hospital, School of Medicine, Tongji University, Shanghai 200072, China ^[21] Department of Urology, Zhongda Hospital, Southeast University, Nanjing, Jiangsu 210009, China ^[22] Department of Urology, Jining No. 1 People’s Hospital, Jining, Shandong 272011, China ^[23] Department of Urology, Zhuhai People’s Hospital, Zhuhai Hospital Affiliated with Jinan University, Zhuhai, Guangdong 519000, China ^[24] Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China ^[25] Department of Urology, The Second Xiangya Hospital, Central South University, Changsha, Hunan 410000, China ^[26] Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University, Nanjing, Jiangsu 210008, China ^[27] Department of Urology, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi 046011, China ^[28] Department of Urology, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022, China ^[29] Department of Urology, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, Xinjiang 830011, China ^[30] Department of Urology Surgery, Liuzhou People’s Hospital Affiliated to Guangxi University of Science and Technology, Liuzhou, Guangxi 545200, China ^[31] Department of Urology, Peking University People’s Hospital, Beijing 100044, China ^[32] Department of Urology, Affiliated Hospital of Chifeng University, Chifeng, Inner Mongolia 024036, China ^[33] Department of Urology Surgery, The Key Laboratory of Urinary Tract Tumors and Calculi, The First Affiliated Hospital, School of Medicine, Xiamen University, Xiamen, Fujian 361003, China ^[34] Department of Urology, Radiation Oncology Key Laboratory of Sichuan Province, Sichuan Cancer Hospital, Chengdu, Sichuan 610047, China ^[35] Department of Urology, First Affiliated Hospital of Medical School, Xi’an Jiaotong University, Xi’an, Shaanxi 710061, China ^[36] Department of Oncology, Affiliated Zhejiang Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310030, China ^[37] Department of Urology, Zhejiang Hospital, Hangzhou, Zhejiang 310030, China ^[38] Department of Urology, Grand Hospital of Jincheng, Jincheng, Shanxi 048006, China ^[39] Department of Oncology, Liaocheng People’s Hospital, Liaocheng, Shandong 252004, China ^[40] Department of Urology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan 453100, China ^[41] Department of Urology, The Affiliated Hospital of Jiujiang University, Jiujiang, Jiangxi 332000, China ^[42] Department of Urology, Hunan Provincial People’s Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, Hunan 410005, China ^[43] Department of Urology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China ^[44] Department of Urology, Subei People’s Hospital of Jiangsu Province (Clinical Medical College, Yangzhou University), Yangzhou, Jiangsu 225001, China ^[45] Department of Urology, Peking University International Hospital, Beijing 102206, China ^[46] Department of Urology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai 201300, China ^[47] Department of Urology, Xinyu People’s Hospital, Xinyu, Jiangxi 338000, China ^[48] Department of Urology, Tangdu Hospital, The Air Force Medical University, Xi’an, Shaanxi 710038, China ^[49] Department of Urology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong 510000, China ^[50] Clinical Research Center of Luye Pharma Group Ltd, Beijing 264003, China ^[51]

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

栏目名称 Original Article

DOI 10.1097/CM9.0000000000002638

发布时间 2025-03-04