RT Journal Article
SR Electronic
T1 Real-world effectiveness and safety of goserelin 10.8-mg depot in Chinese patients with localized or locally advanced prostate cancer
JF Cancer Biology & Medicine
JO Cancer Biology & Medicine
FD China Anti-Cancer Association
SP 1047
OP 1059
DO 10.20892/j.issn.2095-3941.2023.0335
VO 20
IS 12
A1 Chen, Nanhui
A1 Wang, Zengjun
A1 Chen, Ming
A1 Ma, Qi
A1 He, Yi
A1 Wang, Yujie
A1 Li, Xin
A1 Qiu, Mingxing
A1 Shi, Lei
A1 Zhu, Shaoxing
A1 Xie, Qun
A1 Liu, Xiuheng
A1 Shi, Benkang
A1 Lin, Guowen
A1 Yang, Weizhong
A1 Liao, Yongbin
A1 Zhang, Haibin
A1 Wang, Shusheng
A1 Li, Jiexian
A1 Wang, Shaogang
A1 Dong, Lijun
A1 Chen, Hui
A1 Lu, Jiaju
A1 Cheng, Yongyi
A1 Zhang, Xiaoping
A1 Ma, Lulin
A1 Zhou, Liqun
A1 Wang, He
A1 Li, Shen
A1 Ye, Dingwei
YR 2023
UL http://www.cancerbiomed.org/content/20/12/1047.abstract
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.