| アブストラクト | BACKGROUND/AIM: Gemcitabine-induced thrombotic microangiopathy (G-TMA) is associated with a high mortality rate. However, owing to its low incidence, data on G-TMA remain limited. Therefore, a detailed review of G-TMA cases is critical to understand this adverse event. In addition, reviewing literature and pharmacovigilance analytics may be useful to characterise G-TMA. Here, time to onset of G-TMA was analysed based on available data. PATIENTS AND METHODS: We collected data for a case of TMA following gemcitabine administration at the Tokyo Metropolitan Geriatric Hospital. We also reviewed the literature on G-TMA cases in Japan from April 2000 to March 2022 to provide a case series. Moreover, we performed time-to-onset analysis of G-TMA using the data from the Japanese Adverse Drug Event Report (JADER) database. RESULTS: Our case involved a patient with pancreatic cancer who developed thrombotic thrombocytopenic purpura 13 months after starting gemcitabine treatment. From the literature reviewed, in 14 out of 17 cases, G-TMA occurred 5-8 months after treatment initiation. The analysis of data from the JADER database showed that the median time to onset of G-TMA was 161 days. Weibull shape parameter analysis showed that the pattern of onset of G-TMA represented a random failure. CONCLUSION: This study elucidated the time to onset of G-TMA in a Japanese population. Weibull shape parameter analysis showed that G-TMA may not necessarily develop in a dose-dependent manner. These results may be useful for monitoring G-TMA in the clinical setting. |
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| ジャーナル名 | Cancer diagnosis & prognosis |
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| 投稿日 | 2023/1/13 |
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| 投稿者 | Takigawa, Masaki; Tanaka, Hiroyuki; Washiashi, Hiromi; Onoda, Toshihisa; Ishigami, Akihito; Ishii, Toshihiro |
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| 組織名 | Department of Pharmacy, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan.;Molecular Regulation of Aging, Tokyo Metropolitan Institute of Gerontology,;Tokyo, Japan.;Department of Practical Pharmacy, Faculty of Pharmaceutical Sciences, Toho;University, Funabashi, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36632593/ |
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