Background/Objectives:This post-marketing surveillance study was conducted to evaluate the safety and effectiveness of [177Lu]Lu-DOTA-TATE in patients with GEP-NETs in real-world practice in South Korea.Methods:From July 2020 to July 2024, a total of 89 patients from 6 institutions diagnosed with GEP-NETs, as outlined in the approved indication for [177Lu]Lu-DOTA-TATE, were enrolled. Safety was the primary objective, whereas effectiveness was a secondary objective. In this article, findings were analyzed and compared with the NETTER-1 and NETTER-2 trials.Results:Baseline characteristics were comparable to NETTER-1 and NETTER-2 except for the notably high proportion of G2 (77.1%) among participants. Less than half of patients (41.0%) completed four cycles of [177Lu]Lu-DOTA-TATE treatment, presenting a lower portion of completion rate compared to 75.7% in NETTER-1 and 87.8% in NETTER-2. Among the 83 patients, 60 patients (72.3%, 239 cases) had at least 1 AE, with 6 patients (7.2%, 8 cases) experiencing SAEs. The most common AE was nausea (34.9%, 46 cases), and most AEs were mild in severity (94.6%, 226 cases). Overall, the safety profile in this study presented minimal differences from NETTER-1 and NETTER-2. This study reports 37.7% of ORR which was between 14.7% in NETTER-1 and 43.0% in NETTER-2.Conclusions:This nationwide post-marketing surveillance study complemented the safety and effectiveness of [177Lu]Lu-DOTA-TATE among Koreans, which was not probed in two pivotal trials. The data would support the clinical implication of [177Lu]Lu-DOTA-TATE for the GEP-NETs treatment.
**背景/目的：** 本研究为一项上市后监测研究，旨在评估[¹⁷⁷Lu]Lu-DOTA-TATE在韩国胃肠胰神经内分泌肿瘤患者真实世界实践中的安全性与有效性。 **方法：** 自2020年7月至2024年7月，根据[¹⁷⁷Lu]Lu-DOTA-TATE的获批适应症，从6家机构共纳入89例确诊为GEP-NETs的患者。安全性是主要研究目标，有效性为次要目标。本文对研究结果进行了分析，并与NETTER-1和NETTER-2试验进行了比较。 **结果：** 除参与者中G2级肿瘤比例显著较高（77.1%）外，基线特征与NETTER-1和NETTER-2试验具有可比性。完成四个周期[¹⁷⁷Lu]Lu-DOTA-TATE治疗的患者不足半数（41.0%），其完成率低于NETTER-1试验的75.7%和NETTER-2试验的87.8%。在83例患者中，60例患者（72.3%，共239例次）至少发生1次不良事件，其中6例患者（7.2%，共8例次）发生严重不良事件。最常见的不良事件是恶心（34.9%，共46例次），且大多数不良事件为轻度（94.6%，共226例次）。总体而言，本研究的安全性特征与NETTER-1和NETTER-2试验差异极小。本研究报告的总缓解率为37.7%，介于NETTER-1试验的14.7%和NETTER-2试验的43.0%之间。 **结论：** 这项全国性的上市后监测研究补充了[¹⁷⁷Lu]Lu-DOTA-TATE在韩国人群中的安全性和有效性数据，这是两项关键性试验未曾探究的。该数据将支持[¹⁷⁷Lu]Lu-DOTA-TATE在GEP-NETs治疗中的临床意义。
肿瘤(癌症)患者之家