Real-world effectiveness and safety of goserelin 10.8-mg depot in Chinese patients with localized or locally advanced prostate cancer.

Autor:	Chen N; Department of Urology, Meizhou People's Hospital, Meizhou 514089, China., Wang Z; Department of Urology, Jiangsu Province Hospital, Nanjing 210029, China., Chen M; Department of Urology, Zhongda Hospital Southeast University, Nanjing 210009, China., Ma Q; Translational Research Laboratory for Urology, Ningbo First Hospital, Ningbo 315016, China., He Y; Department of Urology, First Affiliated Hospital of Jiaxing, Jiaxing 314050, China., Wang Y; Department of Urology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi 830091, China., Li X; Department of Urology, Baotou Cancer Hospital, Baotou 014016, China., Qiu M; Department of Urology, The People's Hospital of Sichuan Province, Chengdu 610032, China., Shi L; Department of Urology, Yantai Yuhuangding Hospital, Yantai 264008, China., Zhu S; Department of Urology, Cancer Hospital of The University of Chinese Academy of Sciences, Hangzhou 310022, China., Xie Q; Department of Urology, Zhuhai Hospital Affiliated with Jinan University, Zhuhai 519000, China., Liu X; Department of Urology, Tongji Hospital, Tongji Medical College, HUST, Wuhan 430032, China., Shi B; Department of Urology, Qilu Hospital of Shandong University, Jinan 250012, China., Lin G; Department of Urology, Fudan University Shanghai Cancer Center, Shanghai 200032, China., Yang W; Department of Urology, Huizhou Third People's Hospital, Huizhou 516002, China., Liao Y; Department of Urology, Jiangmen Central Hospital, Jiangmen 529030, China., Zhang H; Department of Urology, Foshan First People's Hospital, Foshan 528041, China., Wang S; Department of Urology, Guangzhou Province Traditional Chinese Medical Hospital, Guangzhou 510120, China., Li J; Department of Urology, Guangzhou Panyu Central Hospital, Guangzhou 511489, China., Wang S; Department of Urology, Renmin Hospital of Wuhan University, Wuhan 430064, China., Dong L; Department of Urology, Hebei Petro China Central Hospital (China National Petroleum Corporation Central Hospital), Langfang 065099, China., Chen H; Department of Urology, Harbin Medical University Cancer Hospital, Harbin 150086, China., Lu J; Department of Urology, Shandong Provincial Hospital, Jinan 250014, China., Cheng Y; Department of Urology, Shaanxi Provincial People's Hospital, Xi'an 710021, China., Zhang X; Department of Urology, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan 430032, China., Ma L; Department of Urology, Peking University Third Hospital, Beijing 100191, China., Zhou L; Department of Urology, Peking University First Hospital, Beijing 100034, China., Wang H; Department of Urology, Tangdu Hospital, Xi'an 710024, China., Li S; Department of Urology, Shijiazhuang City First Hospital, Shijiazhuang 050012, China., Ye D; Department of Urology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
Jazyk:	angličtina
Zdroj:	Cancer biology & medicine [Cancer Biol Med] 2024 Feb 05; Vol. 20 (12).
DOI:	10.20892/j.issn.2095-3941.2023.0335
Abstrakt:	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. Competing Interests: This study was funded by AstraZeneca China. The sponsor was involved in study design, data analysis and interpretation, and writing the report. The manuscript was written with editorial support from medical writers. No other potential conflicts of interests are disclosed by authors. (Copyright © 2023 Cancer Biology & Medicine.)
Databáze:	MEDLINE
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