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<p>Peptide receptor radionuclide therapy with [<sup>177</sup>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 [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 [<sup>177</sup>Lu]Lu-DOTATATE providing a complete safety profile with real-life data enabling better patient management.</p>

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Global insights into [177Lu]Lu-DOTATATE safety: a comprehensive disproportionality analysis from the WHO pharmacovigilance database

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月11日

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  • Typhanie Ladrière,
  • Basile Chrétien,
  • Anne-Laure Bignon,
  • Karine Bouhier-Leporrier,
  • Charles Dolladille,
  • Jonathan Vigne

摘要

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.