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177Lu-PSMA-I&T for Treatment of Metastatic Castration-Resistant Prostate Cancer: Prognostic Value of Scintigraphic and Clinical Biomarkers
The Journal of Nuclear Medicine ( IF 9.3 ) Pub Date : 2023-03-01 , DOI: 10.2967/jnumed.122.264402
Amir Karimzadeh 1, 2 , Matthias Heck 3 , Robert Tauber 3 , Karina Knorr 4 , Bernhard Haller 5 , Calogero D'Alessandria 4 , Wolfgang A Weber 4 , Matthias Eiber 4 , Isabel Rauscher 4
Affiliation  

The aim of this retrospective analysis was to determine prostate-specific antigen (PSA) response, PSA progression-free survival (PFS), and overall survival (OS) in a large cohort of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA-I&T and to identify clinical and scintigraphic prognostic factors for outcome. Methods: In total, 301 consecutive mCRPC patients were included in this analysis. Prognostic factors included clinical parameters, routine laboratory parameters, and findings on posttreatment scintigraphy. Scintigraphic tumor uptake of 177Lu-PSMA-I&T was compared with salivary gland uptake and classified as high or low. The longest extent of skeletal metastatic disease was measured, and its changes during therapy were used to define scintigraphic progression, response, and stable disease. A PSA response of at least 50%, PSA PFS, and OS were calculated. Results: In total, 1,138 cycles (median, 3 cycles per patient) of 177Lu-PSMA-I&T using a standard activity of 7.4 GBq were applied intravenously every 4–10 wk (median, 6 wk). Overall, 34% (95% CI, 28%–38%) of patients showed a PSA response of at least 50%, and the median PSA PFS and OS of the total patient cohort were 16.0 wk (95% CI, 12.1–19.9) and 13.8 mo (95% CI, 12.4–15.5), respectively. Patients with high scintigraphic tumor uptake showed a higher PSA response rate of at least 50% (45.7% vs. 10.4%; P < 0.0001) and a significantly reduced risk of PSA progression (median event time, 24.9 vs. 9.0 wk; hazard ratio, 0.3; 95% CI, 0.2–0.5; P < 0.0001). In our data, risk of death was not significantly different between patients with high scintigraphic uptake and those with low scintigraphic uptake (median, 14.4 vs. 12.4 mo; hazard ratio, 0.9; 95% CI, 0.6–1.3; P = 0.6). In a multivariable analysis, the following pretherapeutic prognostic factors for OS were identified: alkaline phosphatase, lactate dehydrogenase, and PSA levels; prior chemotherapy; and the presence of visceral metastases. Scintigraphic response was a strong prognostic factor for PSA response, PSA PFS, and OS after 1 treatment cycle. Conclusion: This retrospective analysis of a large group of consecutive patients corroborates previous clinical experience for 177Lu-PSMA-I&T in mCRPC and establishes previously proposed prognostic factors. The skeletal tumor extent and its changes were identified as new potential biomarkers to predict the outcome of therapy after the first treatment cycle.



中文翻译:

177Lu-PSMA-I&T 治疗转移性去势抵抗性前列腺癌:闪烁显像和临床生物标志物的预后价值

这项回顾性分析的目的是确定一大群接受治疗的转移性去势抵抗性前列腺癌 (mCRPC) 患者的前列腺特异性抗原 (PSA) 反应、PSA 无进展生存期 (PFS) 和总生存期 (OS)与177 Lu-PSMA-I&T 并确定临床和闪烁显像预后因素的结果。方法:总共有 301 名连续的 mCRPC 患者被纳入该分析。预后因素包括临床参数、常规实验室参数和治疗后闪烁扫描结果。闪烁显像肿瘤摄取177将 Lu-PSMA-I&T 与唾液腺摄取进行比较,并将其分类为高或低。测量骨骼转移性疾病的最长范围,并使用其在治疗期间的变化来定义闪烁显像进展、反应和疾病稳定。计算出至少 50% 的 PSA 反应、PSA PFS 和 OS。结果:总共 1,138 个周期(中位数,每位患者 3 个周期),共177Lu-PSMA-I&T 使用 7.4 GBq 的标准活性,每 4-10 周(中位数,6 周)静脉内应用一次。总体而言,34%(95% CI,28%–38%)的患者表现出至少 50% 的 PSA 反应,总患者队列的中位 PSA PFS 和 OS 为 16.0 周(95% CI,12.1–19.9 ) 和 13.8 个月 (95% CI, 12.4–15.5)。高闪烁显像肿瘤摄取的患者表现出更高的 PSA 反应率至少 50%(45.7% 对 10.4%;P < 0.0001)并且 PSA 进展的风险显着降低(中位事件时间,24.9 对 9.0 周;风险比, 0.3; 95% CI, 0.2–0.5; P< 0.0001)。在我们的数据中,闪烁显像摄取高的患者和闪烁显像摄取低的患者之间的死亡风险没有显着差异(中位数,14.4 与 12.4 个月;风险比,0.9;95% CI,0.6–1.3;P = 0.6 。在多变量分析中,确定了以下 OS 的治疗前预后因素:碱性磷酸酶、乳酸脱氢酶和 PSA 水平;先前的化疗;和内脏转移的存在。闪烁显像反应是 1 个治疗周期后 PSA 反应、PSA PFS 和 OS 的重要预后因素。结论:这项对大量连续患者的回顾性分析证实了之前177 名患者的临床经验mCRPC 中的 Lu-PSMA-I&T 并建立了先前提出的预后因素。骨骼肿瘤的范围及其变化被确定为新的潜在生物标志物,用于预测第一个治疗周期后的治疗结果。

更新日期:2023-03-02
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