Abstract
Peptide receptor radionuclide therapy with [177Lu]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 [¹⁷⁷Lu]Lu-DOTATATE remain scarce. This study aims to investigate the safety profile of [¹⁷⁷Lu]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 (IC₀₂₅) to assess the association between each adverse drug reaction (ADR) and [¹⁷⁷Lu]Lu-DOTATATE. A total of 3,984 reports were analyzed. Associations were identified for hematologic malignancies, hematological disorders, hepatic disorders, renal toxicity, and infections (IC₀₂₅ = 2.48, 2.15, 1.43, 1.16, and 0.91, respectively). Notably, certain gastrointestinal disorders initially significant saw their IC₀₂₅ 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 [¹⁷⁷Lu]Lu-DOTATATE dechallenge. This VigiBase analysis reveals essential information on ADR associated with [177Lu]Lu-DOTATATE providing a complete safety profile with real-life data enabling better patient management.
Data availability
Data for this study are available at http://www.vigiaccess.org/. Dissemination to study participants is not possible.
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Acknowledgements
The supplied data from VigiBase® come from various sources. The likelihood of a causal relationship is not the same in all reports. The information does not represent the opinion of WHO.
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All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Typhanie Ladrière, Charles Dolladille and Jonathan Vigne. The first draft of the manuscript was written by Typhanie Ladrière, Charles Dolladille and Jonathan Vigne and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript (Typhanie Ladrière, Basile Chrétien, Anne-Laure Bignon, Karine Bouhier-Leporrier, Charles Dolladille, and Jonathan Vigne).
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Ladrière, T., Chrétien, B., Bignon, AL. et al. Global insights into [177Lu]Lu-DOTATATE safety: a comprehensive disproportionality analysis from the WHO pharmacovigilance database. Sci Rep (2026). https://doi.org/10.1038/s41598-026-36823-5
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DOI: https://doi.org/10.1038/s41598-026-36823-5
