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LY01005和诺雷得 ®治疗绝经前乳腺癌的多中心随机对照Ⅲ期临床研究

Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex® for patients with premenopausal breast cancer

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收录情况： ◇ 统计源期刊 ◇ 北大核心 ◇ 卓越：领军期刊 ◇ 中华系列

作者：

机构： [1]浙江省肿瘤医院乳腺肿瘤内科，杭州 310022 [2]哈尔滨医科大学附属肿瘤医院内三科，哈尔滨 150001 [3]运城市中心医院乳腺科，运城 044099 [4]大连医科大学附属第二医院肿瘤内科，大连 116000 [5]临沂市肿瘤医院乳腺二科，临沂 276034 [6]河北省沧州中西医结合医院乳腺外科，沧州 061012 [7]烟台毓璜顶医院乳腺外科，烟台 264099 [8]湘潭市中心医院普通外科，湘潭 411100 [9]中南大学湘雅三医院乳甲外科，长沙 410013 [10]常州市肿瘤医院乳腺外科，常州 213000 [11]安徽医科大学第二附属医院肿瘤科，合肥 230601 [12]威海市妇幼保健院乳腺外科，威海 264299 [13]聊城市人民医院两腺外科，聊城 252000 [14]新疆医科大学附属肿瘤医院乳腺外科二病区，乌鲁木齐 830011 [15]辽宁省肿瘤医院乳腺内科，沈阳 110041 [16]重庆医科大学附属第一医院乳腺甲状腺外科，重庆 400016 [17]山东省肿瘤医院乳腺外科1 病区，济南 250117 [18]徐州市肿瘤医院肿瘤内科，徐州 221005 [19]内蒙古医科大学附属医院肿瘤内科，呼和浩特 010010 [20]厦门大学附属第一医院乳腺外科，厦门 361003 [21]淄博市中心医院乳腺甲状腺外科，淄博 255020 [22]厦门大学附属第一医院肿瘤内科，厦门 361003 [23]厦门大学附属中山医院乳腺外科，厦门 361003 [24]长治医学院附属和平医院普通外科，长治 046000 [25]河北大学附属医院肿瘤内科，保定 050031 [26]中南大学湘雅二医院普通外科，长沙 410011 [27]湖南省人民医院湖南师范大学附属第一医院乳甲外科，长沙 410011 [28]河北省人民医院腺体外科，石家庄 050000 [29]中山大学孙逸仙纪念医院乳腺肿瘤中心，广州 510006 [30]中国医科大学附属第一医院肿瘤内科，沈阳 110002 [31]四川省肿瘤医院乳腺外科，成都 610042 [32]云南省肿瘤医院乳腺外三科，昆明 650118 [33]西安交通大学第一附属医院肿瘤内科，西安 710061 [34]解放军总医院第五医学中心肿瘤内科，北京 100071

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关键词： 乳腺肿瘤　促性腺激素释放激素激动剂　LY01005 　诺雷得® 　疗效　安全性　药效学　药代动力学

摘要：

Background: To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex® in Chinese patients with premenopausal breast cancer. Methods: From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex® every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results: A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex®. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex®. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex® group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion: LY01005 is as effective as Zoladex® in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

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第一作者机构： [1]浙江省肿瘤医院乳腺肿瘤内科，杭州 310022

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LY01005和诺雷得 ®治疗绝经前乳腺癌的多中心随机对照Ⅲ期临床研究

Phase &#x2162;, multicenter, randomized comparative study of LY01005 and Zoladex&#xae; for patients with premenopausal breast cancer

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Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex® for patients with premenopausal breast cancer