Department of Nuclear Medicine, Münster University Hospital.
Department of Urology, Münster University Hospital.
Theranostics. 2019 Jul 9;9(17):4841-4848. doi: 10.7150/thno.35759. eCollection 2019.
The purpose of this study was to identify previous treatments and biomarker profile features that prognosticate overall survival (OS) in patients with mCRPC receiving Lu-PSMA-617. 109 mCRPC patients treated with a median of 3 cycles of Lu-PSMA-617 were included. Data were analyzed according to OS as well as PSA response patterns with regard to prior therapies, laboratory biomarkers and metastatic extent in univariate as well as multivariate Cox's proportional hazards models. PSA decline was assessed using the lowest PSA levels after the first cycle of therapy (initial PSA response) and during the entire observation period (best PSA response). In total, 54 patients (49.5%) died during the observation period. First and second line chemotherapy were performed in 85% and 26%, and Abiraterone and Enzalutamide were administered in 83% and 85%, respectively. Any initial PSA decline occurred in 55% while 25% showed a PSA decline of ≥50%. The median estimated OS was 9.9 months (95% CI: 7.2-12.5) for all patients. Any initial decline of PSA was associated with significantly prolonged OS (15.5 vs. 5.7 months, 0.002). Second line cabazitaxel chemotherapy (6.7 15.7 months, 0.002) and presence of visceral metastases (5.9 16.4 months, <0.001) were associated with shorter OS. Only visceral metastases remained significant in a multivariate analysis. Lu-PSMA-617 is an effective therapy for patients with mCRPC. However, the present data indicate that its beneficial effects on OS are strongly influenced by pretreatment (history of second line chemotherapy with cabazitaxel) and the presence of visceral metastases at onset of Lu-PSMA-617 treatment.
本研究旨在确定接受 Lu-PSMA-617 治疗的 mCRPC 患者的既往治疗和生物标志物特征，以预测总生存期（OS）。共纳入 109 例接受中位数为 3 个周期 Lu-PSMA-617 治疗的 mCRPC 患者。根据 OS 以及 PSA 反应模式，对既往治疗、实验室生物标志物和转移范围进行单因素和多因素 Cox 比例风险模型分析。使用治疗第一周期（初始 PSA 反应）后和整个观察期间（最佳 PSA 反应）的最低 PSA 水平评估 PSA 下降情况。在观察期间，共有 54 例患者（49.5%）死亡。85%的患者接受了一线化疗，26%的患者接受了二线化疗，83%的患者接受了阿比特龙治疗，85%的患者接受了恩杂鲁胺治疗。55%的患者出现初始 PSA 下降，25%的患者 PSA 下降≥50%。所有患者的中位估计 OS 为 9.9 个月（95%CI：7.2-12.5）。任何初始 PSA 下降均与显著延长的 OS 相关（15.5 个月比 5.7 个月， 0.002）。二线卡巴他赛化疗（6.7 15.7 个月， 0.002）和存在内脏转移（5.9 16.4 个月，<0.001）与 OS 缩短相关。在多因素分析中，只有内脏转移仍具有显著意义。Lu-PSMA-617 是 mCRPC 患者的有效治疗方法。然而，目前的数据表明，其对 OS 的有益影响受到预处理（二线化疗史，包括卡巴他赛）和 Lu-PSMA-617 治疗开始时存在内脏转移的强烈影响。
