Department of Diagnostic Physics, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway, and University of Oslo, Oslo, Norway
Department of Diagnostic Physics, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway, and University of Oslo, Oslo, Norway.
J Nucl Med. 2018 Apr;59(4):704-710. doi: 10.2967/jnumed.117.195347. Epub 2017 Aug 28.
Lu-lilotomab satetraxetan is a novel antibody-radionuclide conjugate currently in a phase 1/2a first-in-humans dose escalation trial for patients with relapsed CD37-positive indolent non-Hodgkin lymphoma. The aim of this study was to investigate biodistribution and absorbed doses to organs at risk. In total, 7 patients treated with Lu-lilotomab satetraxetan were included for dosimetry. Patients were grouped on the basis of 2 different predosing regimens (with and without predosing with 40 mg of lilotomab) and were treated with different levels of activity per body weight (10, 15, and 20 MBq/kg). All patients were pretreated with rituximab. Serial planar and SPECT/CT images were used to determine time-activity curves and patient-specific masses for organs with Lu-lilotomab satetraxetan uptake. Doses were calculated with OLINDA/EXM. The organs (other than red bone marrow and tumors) with distinct uptake of Lu-lilotomab satetraxetan were the liver, spleen, and kidneys. The highest uptake was found in the spleen, with doses ranging from 1.54 to 3.60 mGy/MBq. The liver received 0.70-1.15 mGy/MBq. The kidneys received the lowest dose of the source organs investigated, 0.16-0.79 mGy/MBq. No statistically significant differences in soft-tissue absorbed doses were found between the two predosing regimens. The whole-body dose ranged from 0.08 to 0.17 mGy/MBq. The biodistribution study for patients treated with Lu-lilotomab satetraxetan revealed the highest physiologic uptake to be in the liver and spleen (besides the red marrow). For all treatment levels investigated, the absorbed doses were found to be modest when compared with commonly assumed tolerance limits.
卢利洛托马昔单抗塞替昔单抗是一种新型的抗体放射性核素偶联物，目前正在进行一项 1/2a 期临床试验，用于治疗复发的 CD37 阳性惰性非霍奇金淋巴瘤患者。本研究旨在探讨其生物分布和靶器官的吸收剂量。共纳入 7 例接受卢利洛托马昔单抗塞替昔单抗治疗的患者进行剂量学研究。根据两种不同的预用药方案（是否预先给予 40mg 利妥昔单抗）和不同的体质量活度水平（10、15 和 20MBq/kg）对患者进行分组。所有患者均接受利妥昔单抗预处理。使用平面和 SPECT/CT 序列图像来确定时间-活性曲线和具有卢利洛托马昔单抗摄取的患者特定器官的质量。使用 OLINDA/EXM 计算剂量。除红骨髓和肿瘤外，具有明显卢利洛托马昔单抗摄取的器官为肝脏、脾脏和肾脏。脾脏摄取最高，剂量范围为 1.54-3.60mGy/MBq。肝脏的摄取剂量为 0.70-1.15mGy/MBq。所研究的源器官中，肾脏的吸收剂量最低，为 0.16-0.79mGy/MBq。两种预用药方案之间的软组织吸收剂量无统计学差异。全身剂量范围为 0.08-0.17mGy/MBq。接受卢利洛托马昔单抗塞替昔单抗治疗的患者的生物分布研究显示，肝脏和脾脏（除红骨髓外）的摄取最高。对于所有研究的治疗水平，与常见的耐受限值相比，吸收剂量适中。
