PT  - JOURNAL ARTICLE
AU  - Chen, Nanhui
AU  - Wang, Zengjun
AU  - Chen, Ming
AU  - Ma, Qi
AU  - He, Yi
AU  - Wang, Yujie
AU  - Li, Xin
AU  - Qiu, Mingxing
AU  - Shi, Lei
AU  - Zhu, Shaoxing
AU  - Xie, Qun
AU  - Liu, Xiuheng
AU  - Shi, Benkang
AU  - Lin, Guowen
AU  - Yang, Weizhong
AU  - Liao, Yongbin
AU  - Zhang, Haibin
AU  - Wang, Shusheng
AU  - Li, Jiexian
AU  - Wang, Shaogang
AU  - Dong, Lijun
AU  - Chen, Hui
AU  - Lu, Jiaju
AU  - Cheng, Yongyi
AU  - Zhang, Xiaoping
AU  - Ma, Lulin
AU  - Zhou, Liqun
AU  - Wang, He
AU  - Li, Shen
AU  - Ye, Dingwei
TI  - Real-world effectiveness and safety of goserelin 10.8-mg depot in Chinese patients with localized or locally advanced prostate cancer
AID  - 10.20892/j.issn.2095-3941.2023.0335
DP  - 2023 Dec 15
TA  - Cancer Biology & Medicine
PG  - 1047--1059
VI  - 20
IP  - 12
4099  - http://www.cancerbiomed.org/content/20/12/1047.short
4100  - http://www.cancerbiomed.org/content/20/12/1047.full
SO  - Cancer Biology & Medicine2023 Dec 15; 20
AB  - Objective: Real-word data on long-acting luteinizing hormone-releasing hormone (LHRH) agonists in Chinese patients with prostate cancer are limited. This study aimed to determine the real-world effectiveness and safety of the LHRH agonist, goserelin, particularly the long-acting 10.8-mg depot formulation, and the follow-up patterns among Chinese prostate cancer patients.Methods: This was a multicenter, prospective, observational study in hormone treatment-naïve patients with localized or locally advanced prostate cancer who were prescribed goserelin 10.8-mg depot every 12 weeks or 3.6-mg depot every 4 weeks with or without an anti-androgen. The patients had follow-up evaluations for 26 weeks. The primary outcome was the effectiveness of goserelin in reducing serum testosterone and prostate-specific antigen (PSA) levels. The secondary outcomes included testosterone and PSA levels, attainment of chemical castration (serum testosterone <50 ng/dL), and goserelin safety. The exploratory outcome was the monitoring pattern for serum testosterone and PSA. All analyses were descriptive.Results: Between September 2017 and December 2019, a total of 294 eligible patients received ≥ 1 dose of goserelin; 287 patients (97.6%) were treated with goserelin 10.8-mg depot. At week 24 ± 2, the changes from baseline [standard deviation (95% confidence interval)] in serum testosterone (n = 99) and PSA (n = 131) were −401.0 ng/dL [308.4 ng/dL (−462.5, −339.5 ng/dL)] and −35.4 ng/mL [104.4 ng/mL (−53.5, −17.4 ng/mL)], respectively. Of 112 evaluable patients, 100 (90.2%) achieved a serum testosterone level < 50 ng/dL. Treatment-emergent adverse events (TEAEs) and severe TEAEs occurred in 37.1% and 10.2% of patients, respectively. The mean testing frequency (standard deviation) was 1.6 (1.5) for testosterone and 2.2 (1.6) for PSA.Conclusions: Goserelin 10.8-mg depot effectively achieved and maintained castration and was well-tolerated in Chinese patients with localized and locally advanced prostate cancer.The data generated in this study are available upon reasonable request from the corresponding author.