| アブストラクト | Peptide receptor radionuclide therapy with [(177)Lu]Lu-DOTATATE is an effective treatment for metastatic or inoperable neuroendocrine tumors. While clinical trials have demonstrated its efficacy and safety in a limited number of selected patients, real-world data on [(1)(7)(7)Lu]Lu-DOTATATE remain scarce. This study aims to investigate the safety profile of [(1)(7)(7)Lu]Lu-DOTATATE in a real-world setting using VigiBase, the World Health Organization's global pharmacovigilance database. A retrospective disproportionality analysis was conducted on individual case safety reports from VigiBase using a deduplicated dataset. Signal detection was performed using the information component (IC) with a 95% credibility interval (IC(0)(2)(5)) to assess the association between each adverse drug reaction (ADR) and [(1)(7)(7)Lu]Lu-DOTATATE. A total of 3,984 reports were analyzed. Associations were identified for hematologic malignancies, hematological disorders, hepatic disorders, renal toxicity, and infections (IC(0)(2)(5) = 2.48, 2.15, 1.43, 1.16, and 0.91, respectively). Notably, certain gastrointestinal disorders initially significant saw their IC(0)(2)(5) values turn negative over time, while other ADR categories remained consistently positive. Key overlaps between ADR categories were observed, supported by coherent time-to-onset data and positive [(1)(7)(7)Lu]Lu-DOTATATE dechallenge. This VigiBase analysis reveals essential information on ADR associated with [(177)Lu]Lu-DOTATATE providing a complete safety profile with real-life data enabling better patient management. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1038/s41598-026-36823-5. |
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| 組織名 | Department of Nuclear Medicine and Department of Pharmacy, CHU de Caen Normandie,;Normandie Universite, UNICAEN, Caen, 14000, France.;Department of International Medical Education, Nagoya University, Graduate School;of Medicine, Nagoya, Japan.;Department of Hepato-Gastroenterology and Nutrition, Caen University Hospital,;Caen, F 14000, France.;Normandie Universite, UNICAEN, Caen, 14000, France. vigne-jo@chu-caen.fr.;Centre Cyceron, Normandie Universite, UNICAEN, INSERM U1237, PhIND, Institut;Blood and Brain @ Caen-Normandie, Caen, 14000, France. vigne-jo@chu-caen.fr.;Service de Medecine Nucleaire, CHU Caen Normandie, CAEN Cedex 9, CS 30001-14033,;France. vigne-jo@chu-caen.fr. |
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