目的:中国前列腺癌患者长效黄体生成素释放激素(LHRH)激动剂的真实数据有限。本研究旨在确定LHRH激动剂的真实世界有效性和安全性,戈舍瑞林,特别是长效10.8mg的储库制剂,以及中国前列腺癌患者的随访模式。
方法:这是一个多中心,prospective,在激素治疗初治或局部晚期前列腺癌患者中进行观察性研究,这些患者每12周服用一次戈舍瑞林10.8mg或每4周服用一次3.6mg的戈舍瑞林,无论是否服用抗雄激素药物.患者进行了26周的随访评估。主要结果是戈舍瑞林降低血清睾酮和前列腺特异性抗原(PSA)水平的有效性。次要结果包括睾酮和PSA水平,达到化学去势(血清睾酮<50ng/dL),和戈舍瑞林的安全。探索性结果是血清睾酮和PSA的监测模式。所有分析都是描述性的。
结果:在2017年9月至2019年12月之间,共有294名符合条件的患者接受了≥1剂量的戈舍瑞林;287名患者(97.6%)接受了戈舍瑞林10.8mg储库治疗。在第24±2周,血清睾酮(n=99)和PSA(n=131)的基线变化[标准偏差(95%置信区间)]为-401.0ng/dL[308.4ng/dL(-462.5,-339.5ng/dL)]和-35.4ng/mL[104.4ng/mL(-53.5,-17.4ng/mL)],分别。在112名可评估的患者中,100(90.2%)达到血清睾酮水平<50ng/dL。37.1%和10.2%的患者发生治疗引起的不良事件(TEAE)和严重TEAE,分别。睾酮的平均测试频率(标准偏差)为1.6(1.5),PSA为2.2(1.6)。
结论:戈舍瑞林10.8mg储库可有效实现并维持去势,在中国局部和局部晚期前列腺癌患者中耐受性良好。
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.
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.
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.
Goserelin 10.8-mg depot effectively achieved and maintained castration and was well-tolerated in Chinese patients with localized and locally advanced prostate cancer.