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Abstract
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.

Affiliations

Yong-Il Kim 1 2, Hoon Young Suh 3, Yehrim Kang 3, Hojin Cho 4, Seung Hyup Hyun 5, Yoo Sung Song 6, Seunggyun Ha 7, Keon Wook Kang 8 9 10
1Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.
2Theranostics Center, Asan Cancer Institute, Asan Medical Center, Seoul 05505, Republic of Korea.
3Medical Department, Novartis Korea Ltd., Seoul 07326, Republic of Korea.
4Department of Nuclear Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Republic of Korea.
5Department of Nuclear Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Republic of Korea.
6Department of Nuclear Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam 13620, Republic of Korea.
7Division of Nuclear Medicine, Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Republic of Korea.
8Department of Nuclear Medicine, Seoul National University Hospital, Seoul 03080, Republic of Korea.
9Cancer Research Institute, Seoul National University College of Medicine, Seoul 03080, Republic of Korea.
10Bio-MAX Institute, Seoul National University, Seoul 08826, Republic of Korea.