Grassi Ilaria, Nicolini Silvia, Marini Irene, Matteucci Federica, Ranallo Nicoletta, Di Iorio Valentina, Sarnelli Anna, Foca Flavia, Monti Manuela, Fabbri Lucia, Fantini Lorenzo, Rossi Alice, Paganelli Giovanni, Severi Stefano, Sansovini Maddalena
Nuclear Medicine Department, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST), Meldola, Italy.
Medical Oncology Department, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST), Meldola, Italy.
Neuroendocrinology. 2025;115(5):434-445. doi: 10.1159/000542328. Epub 2024 Nov 21.
Lu-PRRT in neuroendocrine tumors is usually delivered with a total cumulative activity (TCA) of 29.6 GBq, divided into 4 cycles and with fixed interval between cycles (IBCs) of 8 weeks. Based on previous radiobiological studies, reducing IBC could improve efficacy without increasing toxicity. The purpose of this study was to evaluate safety of Lu-PRRT with two different IBC: intensive (every 5 weeks) or standard (every 8-10 weeks).
From May 2016 to July 2018, patients with advanced and progressive GEP and bronchial NENs were enrolled in a prospective randomized phase II study. Patients with risk factors for toxicity (RF) were planned for a TCA of 18.5 GBq, patients without RF of 27.8 GBq, divided into 5 cycles. Patients were then randomly assigned to be treated according to the intensive or to the standard IBC. Toxicity was monitored according to CTCAE.
One hundred and twenty patients (61 in the intensive group and 59 in the standard one) were evaluable for overall toxicity. Five patients (4.1%) had major (G3) hematological toxicity, 2 in the intensive group and 3 in the standard one. Other G3 toxicities related to creatinine, alanine aminotransferase, nausea, and asthenia were observed in the intensive group. 112 patients (54 in the intensive group and 58 in the standard one) performed at least 2 cycles and were also evaluable for cycle-by-cycle toxicity, resulting similar between the two groups.
According to our preliminary results, Lu-PRRT administered intensively could be considered as safe as the standard schedule, when TCA is chosen according to the RF. Further data are needed to confirm these results.
神经内分泌肿瘤的镥-肽受体放射性核素治疗（Lu-PRRT）通常总累积活度（TCA）为29.6GBq，分为4个周期，周期之间的固定间隔（IBC）为8周。基于先前的放射生物学研究，缩短IBC可提高疗效而不增加毒性。本研究的目的是评估两种不同IBC（强化方案：每5周一次；标准方案：每8 - 10周一次）的Lu-PRRT的安全性。
2016年5月至2018年7月，晚期进展性胃肠胰（GEP）和支气管神经内分泌肿瘤（NENs）患者被纳入一项前瞻性随机II期研究。有毒性风险因素（RF）的患者计划给予TCA为18.5GBq，无RF的患者为27.8GBq，均分为5个周期。然后患者被随机分配接受强化或标准IBC治疗。根据美国国立癌症研究所不良事件通用术语标准（CTCAE）监测毒性。
120例患者（强化组61例，标准组59例）可评估总体毒性。5例患者（4.1%）发生严重（3级）血液学毒性，强化组2例，标准组3例。强化组还观察到其他与肌酐、丙氨酸转氨酶、恶心和乏力相关的3级毒性。112例患者（强化组54例，标准组58例）至少完成2个周期，也可评估逐周期毒性，两组结果相似。
根据我们的初步结果，当根据RF选择TCA时，强化给药的Lu-PRRT可被认为与标准方案一样安全。需要进一步的数据来证实这些结果。
