Ling Sui Wai, de Lussanet de la Sablonière Quido, Ananta Michael, de Blois Erik, Koolen Stijn L W, Drexhage Roosmarijn C, Hofland Johannes, Robbrecht Debbie G J, van der Veldt Astrid A M, Verburg Frederik A, Brabander Tessa
Department of Radiology & Nuclear Medicine, Erasmus MC, Rotterdam, The Netherlands.
Department of Hospital Pharmacy, Erasmus MC, Rotterdam, The Netherlands.
Eur J Nucl Med Mol Imaging. 2025 May;52(6):2034-2040. doi: 10.1007/s00259-025-07082-9. Epub 2025 Jan 18.
To report real-world clinical experience with [Lu]Lu-PSMA-I&T targeted radionuclide therapy (TRT) in patients with metastatic castration-resistant prostate cancer (mCRPC) in a single tertiary referral university hospital.
Patients with mCRPC who were treated with [Lu]Lu-PSMA-I&T TRT as standard of care between February 2022 and August 2023 were included in this retrospective study. Patients were treated with a maximum of six cycles with a fixed activity of 7.4 GBq/100µg [Lu]Lu-PSMA-I&T per cycle.
50 patients with mCRPC were included, of them 84% had prior therapy with two lines of taxane-based chemotherapy treated and at least one line of androgen receptor signaling inhibitor. A total of 126 cycles with a median of 2 cycles (IQR 1-6) [ Lu]Lu-PSMA-I&T were administered per patient. PSA declines of ≥ 50% and ≥ 70% were achieved in 16% and 10% of the patients, respectively. Radiological response was achieved in 11% of the patients. In total, 68 treatment-related Adverse Events (TRAEs) were observed, mainly grade 1-2 in 88% of cases. Grade 3/4 TRAEs were observed in 12% of cases. No grade 3 or higher xerostomia was reported. Median progression-free survival was 7.7 months (95% CI 4.0-11.3) and median overall survival was 8.1 months (95% CI 5.0-11.3).
In heavily pretreated patients with mCRPC, treatment of [Lu]Lu-PSMA-I&T TRT is well tolerated and safe, but real-world efficacy of [Lu]Lu-PSMA appears lower compared to data from recent phase-3 clinical trials using a different radioligand [Lu]Lu-PSMA-617. Further studies may show whether patients with mCRPC benefit more from [Lu]Lu-PSMA when initiated at an earlier stage of treatment.
报告在一所三级转诊大学医院中，[镥]镥-PSMA-I&T靶向放射性核素治疗（TRT）用于转移性去势抵抗性前列腺癌（mCRPC）患者的真实世界临床经验。
本回顾性研究纳入了2022年2月至2023年8月期间接受[镥]镥-PSMA-I&T TRT作为标准治疗的mCRPC患者。患者最多接受6个周期的治疗，每个周期的固定活度为7.4GBq/100µg[镥]镥-PSMA-I&T。
纳入了50例mCRPC患者，其中84%曾接受过两线基于紫杉烷的化疗和至少一线雄激素受体信号抑制剂治疗。每位患者共接受了126个周期的[镥]镥-PSMA-I&T治疗，中位数为2个周期（四分位间距1-6）。分别有16%和10%的患者实现了前列腺特异性抗原（PSA）下降≥50%和≥70%。11%的患者获得了放射学缓解。总共观察到68例治疗相关不良事件（TRAEs），88%的病例主要为1-2级。12%的病例观察到3/4级TRAEs。未报告3级或更高等级的口干。无进展生存期的中位数为7.7个月（95%置信区间4.0-11.3），总生存期的中位数为8.1个月（95%置信区间5.0-11.3）。
在接受过大量治疗的mCRPC患者中，[镥]镥-PSMA-I&T TRT治疗耐受性良好且安全，但与使用不同放射性配体[镥]镥-PSMA-617的近期3期临床试验数据相比，[镥]镥-PSMA的真实世界疗效似乎较低。进一步的研究可能会表明，mCRPC患者在治疗早期开始使用[镥]镥-PSMA是否会受益更多。
