X Y Shao, Q Y Zhang, Z F Niu, M Li, J F Wang, Z Z Chen, R Z Luo, G D Qiao, J G Wang, L Y Qian, R H Yang, Z D Chen, J Wang, Y M Yao, J H Ou, T Sun, Q Cheng, Y S Wang, J Huang, H Y Zhao, W Y Su, Z Ouyang, Y Ding, L L Chen, S M Yang, M S Cui, A M Zang, E X Zhou, P Z Fan, J Zhang, Q Liu, Y E Teng, H Li, J Y Nie, J Yang, X J Wang, Z F Jiang
{"title":"[Ⅲ期，多中心，随机对照研究LY01005和Zoladex®治疗绝经前乳腺癌]。","authors":"X Y Shao, Q Y Zhang, Z F Niu, M Li, J F Wang, Z Z Chen, R Z Luo, G D Qiao, J G Wang, L Y Qian, R H Yang, Z D Chen, J Wang, Y M Yao, J H Ou, T Sun, Q Cheng, Y S Wang, J Huang, H Y Zhao, W Y Su, Z Ouyang, Y Ding, L L Chen, S M Yang, M S Cui, A M Zang, E X Zhou, P Z Fan, J Zhang, Q Liu, Y E Teng, H Li, J Y Nie, J Yang, X J Wang, Z F Jiang","doi":"10.3760/cma.j.cn112152-20240126-00051","DOIUrl":null,"url":null,"abstract":"<p><p><b>Background:</b> To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex<sup>®</sup> in Chinese patients with premenopausal breast cancer. <b>Methods:</b> 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<sup>®</sup> 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. <b>Results:</b> A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex<sup>®</sup>. 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<sup>®</sup>. The between-group difference was 6.8% (95% <i>CI</i>: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex<sup>®</sup> 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. <b>Conclusion:</b> LY01005 is as effective as Zoladex<sup>®</sup> in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":"47 4","pages":"340-348"},"PeriodicalIF":0.0000,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex<sup>®</sup> for patients with premenopausal breast cancer].\",\"authors\":\"X Y Shao, Q Y Zhang, Z F Niu, M Li, J F Wang, Z Z Chen, R Z Luo, G D Qiao, J G Wang, L Y Qian, R H Yang, Z D Chen, J Wang, Y M Yao, J H Ou, T Sun, Q Cheng, Y S Wang, J Huang, H Y Zhao, W Y Su, Z Ouyang, Y Ding, L L Chen, S M Yang, M S Cui, A M Zang, E X Zhou, P Z Fan, J Zhang, Q Liu, Y E Teng, H Li, J Y Nie, J Yang, X J Wang, Z F Jiang\",\"doi\":\"10.3760/cma.j.cn112152-20240126-00051\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Background:</b> To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex<sup>®</sup> in Chinese patients with premenopausal breast cancer. <b>Methods:</b> 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<sup>®</sup> 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. <b>Results:</b> A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex<sup>®</sup>. 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<sup>®</sup>. The between-group difference was 6.8% (95% <i>CI</i>: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex<sup>®</sup> 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. <b>Conclusion:</b> LY01005 is as effective as Zoladex<sup>®</sup> in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.</p>\",\"PeriodicalId\":39868,\"journal\":{\"name\":\"中华肿瘤杂志\",\"volume\":\"47 4\",\"pages\":\"340-348\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-04-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"中华肿瘤杂志\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3760/cma.j.cn112152-20240126-00051\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"中华肿瘤杂志","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3760/cma.j.cn112152-20240126-00051","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
[Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex® for patients with premenopausal breast cancer].
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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