Department of Urology, Klinikum Rechts der Isar, School of Medicine, Technical University of Munich, Munich, Germany;
Department of Nuclear Medicine, Klinikum Rechts der Isar, School of Medicine, Technical University of Munich, Munich, Germany; and.
J Nucl Med. 2023 Aug;64(8):1244-1251. doi: 10.2967/jnumed.122.265259. Epub 2023 Jun 15.
Lu-labeled prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) is a new treatment option for metastatic castration-resistant prostate cancer (mCRPC). Its low toxicity profile favors use in elderly patients or in patients with critical comorbidities. The purpose of this analysis was to evaluate the efficacy and safety of [Lu]-PSMA RLT in mCRPC patients at least 80 y old. Eighty mCRPC patients at least 80 y old underwent [Lu]-PSMA-I&T RLT and were retrospectively selected. The patients were previously treated by androgen receptor-directed therapy, received taxane-based chemotherapy, or were chemotherapy-ineligible. The best prostate-specific antigen (PSA) response was calculated, as well as clinical progression-free survival (cPFS) and overall survival (OS). Toxicity data were acquired until 6 mo after the last treatment cycle. Of 80 patients, 49 (61.3%) were chemotherapy-naïve and 16 (20%) had visceral metastases. The median number of previous mCRPC treatment regimens was 2. In total, 324 cycles (median, 4 cycles; range, 1-12) with a median cumulative activity of 23.8 GBq (interquartile range, 14.8-42.2) were applied. A PSA decline of 50% was achieved in 37 (46.3%) patients. Chemotherapy-naïve patients showed higher 50% PSA response rates than chemotherapy-pretreated patients (51.0% vs. 38.7%, respectively). Overall, median cPFS and OS were 8.7 and 16.1 mo, respectively. The median cPFS and OS of chemotherapy-naïve patients were significantly longer than those of chemotherapy-pretreated patients (10.5 vs. 6.5 mo and 20.7 vs. 11.8 mo, respectively, < 0.05). A lower hemoglobin level and higher lactate dehydrogenase level at baseline were independent predictors of shorter cPFS and OS. Treatment-emergent grade 3 toxicities were anemia in 4 patients (5%), thrombocytopenia in 3 patients (3.8%), and renal impairment in 4 patients (5%). No nonhematologic grade 3 and no grade 4 toxicities were observed. The most frequent clinical side effects were grade 1-2 xerostomia, fatigue, and inappetence. [Lu]-PSMA-I&T RLT in mCRPC patients at least 80 y old is safe and effective, comparable to previously published data on non-age-selected cohorts with a low rate of high-grade toxicities. Chemotherapy-naïve patients showed a better and longer response to therapy than taxane-pretreated patients. [Lu]-PSMA RLT seems to be a meaningful treatment option for older patients.
Lu 标记的前列腺特异性膜抗原（PSMA）放射性配体治疗（RLT）是一种治疗转移性去势抵抗性前列腺癌（mCRPC）的新方法。其低毒性特征有利于在老年患者或有严重合并症的患者中使用。本分析的目的是评估至少 80 岁的 mCRPC 患者接受 [Lu]-PSMA RLT 的疗效和安全性。
至少 80 岁的 80 名 mCRPC 患者接受了 [Lu]-PSMA-I&T RLT，并进行了回顾性选择。这些患者之前接受过雄激素受体靶向治疗、紫杉烷类化疗或不适合化疗。计算了最佳前列腺特异性抗原（PSA）反应率，以及临床无进展生存期（cPFS）和总生存期（OS）。毒性数据在最后一次治疗周期后 6 个月内获得。
80 名患者中，49 名（61.3%）为化疗初治患者，16 名（20%）有内脏转移。中位既往 mCRPC 治疗方案数为 2 个。共进行了 324 个周期（中位数为 4 个周期；范围为 1-12 个），累积活性中位数为 23.8GBq（四分位距，14.8-42.2）。37 名（46.3%）患者的 PSA 下降了 50%。化疗初治患者的 50%PSA 反应率高于化疗预处理患者（分别为 51.0%和 38.7%）。总体而言，中位 cPFS 和 OS 分别为 8.7 和 16.1 个月。化疗初治患者的中位 cPFS 和 OS 明显长于化疗预处理患者（分别为 10.5 和 6.5 个月和 20.7 和 11.8 个月，<0.05）。基线时血红蛋白水平较低和乳酸脱氢酶水平较高是 cPFS 和 OS 较短的独立预测因素。治疗后出现的 3 级毒性有 4 例（5%）贫血、3 例（3.8%）血小板减少和 4 例（5%）肾功能损害。未观察到非血液学 3 级和 4 级毒性。最常见的临床副作用是 1-2 级口干、疲劳和食欲不振。
[Lu]-PSMA-I&T RLT 在至少 80 岁的 mCRPC 患者中是安全有效的，与之前发表的非年龄选择队列的数据相当，毒性发生率较低。化疗初治患者的治疗反应优于紫杉烷预处理患者。[Lu]-PSMA RLT 似乎是老年患者的一种有意义的治疗选择。
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