LY01005与高慈林埋植物治疗中国前列腺癌患者的疗效和安全性：一项多中心、随机、开放标签、III期、非劣效试验。
Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
发表日期：2023 Apr 03
作者：
Chengyuan Gu, Zengjun Wang, Tianxin Lin, Zhiyu Liu, Weiqing Han, Xuhui Zhang, Chao Liang, Hao Liu, Yang Yu, Zhenzhou Xu, Shuang Liu, Jingen Wang, Linghua Jia, Xin Yao, Wenfeng Liao, Cheng Fu, Zhaohui Tan, Guohua He, Guoxi Zhu, Rui Fan, Wenzeng Yang, Xin Chen, Zhizhong Liu, Liqiang Zhong, Benkang Shi, Degang Ding, Shubo Chen, Junli Wei, Xudong Yao, Ming Chen, Zhanpeng Lu, Qun Xie, Zhiquan Hu, Yinhuai Wang, Hongqian Guo, Tiwu Fan, Zhaozhao Liang, Peng Chen, Wei Wang, Tao Xu, Chunsheng Li, Jinchun Xing, Hong Liao, Dalin He, Zhibin Wu, Jiandi Yu, Zhongwen Feng, Mengxiang Yang, Qifeng Dou, Quan Zeng, Yuanwei Li, Xin Gou, Guangchen Zhou, Xiaofeng Wang, Rujian Zhu, Zhonghua Zhang, Bo Zhang, Wanlong Tan, Xueling Qu, Hongliang Sun, Tianyi Gan, Dingwei Ye
来源：
CHINESE MEDICAL JOURNAL
摘要：
LY01005（戈舍瑞林醋酸盐持续释放微粒注射剂）是一种改良的促性腺激素释放激素（GnRH）激动剂，每月注射一次。这项III期试验的研究目的是评估LY01005在中国前列腺癌患者中的疗效和安全性。我们在中国的49个站点进行了一项随机对照、开放标签、非劣效性试验。本研究包括了290名接受LY01005或戈舍瑞林每28天注射3次的前列腺癌患者。主要疗效终点是在第29天前睾酮抑制≤50 ng/dL的患者百分比和从第29天到第85天睾酮≤50 ng/dL的累积概率。非劣效性预设为-10%。次要终点包括重复注射后72小时内的明显去势（≤20 ng/dL）、促黄体生成素、促卵泡生成素和前列腺特异性抗原水平的变化。在第29天，LY01005和戈舍瑞林植入组的睾酮浓度分别下降至低于医学去势水平的99.3％（142/143）和100％（140/140）的患者，两组之间的差异为-0.7％（95％置信区间[CI]，-3.9％，2.0％）。从第29天到第85天，维持去势的累积概率分别为99.3％和97.8％，两组之间的差异为1.5％（95％ CI，-1.3％，4.4％）。两个结果都满足非劣效性标准。两组次要终点相似。两种治疗都耐受良好。LY01005与戈舍瑞林植入物相比，注射部位反应较少（0％对1.4％[2/145]）。LY01005在降低睾酮到去势水平方面与戈舍瑞林植入物一样有效，安全性相似。ClinicalTrials.gov，NCT04563936。©2023年中国医学会，由Wolters Kluwer，Inc.在CC-BY-NC-ND许可下生产。
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.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.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%, 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%, 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]).LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.ClinicalTrials.gov, NCT04563936.Copyright © 2023 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.