| アブストラクト | BACKGROUND: 5-Fluorouracil (5-FU)-induced hyperammonaemic encephalopathy is a rare but serious 5-FU adverse drug reaction (ADR). Given the growing number of cancers treated with 5-FU and the paucity of data regarding this ADR, we performed a retrospective national survey to better characterise 5-FU-induced hyperammonaemic encephalopathy. PATIENTS AND METHODS: Since inception of the French pharmacovigilance database, we identified all patients who experienced 5-FU-induced hyperammonaemic encephalopathy. Variables regarding demographics, characteristics, management and outcome of patients were collected. RESULTS: From 1986 to 2018, 30 patients were included. 5-FU-induced hyperammonaemic encephalopathy started 2 [1-4] days after 5-FU infusion onset. Most common neurological disorders were consciousness impairment, seizures and confusion. hyperammonaemia tended to be higher in patients with the lowest Glasgow score and admitted in intensive care unit (ICU) compared to non-ICU patients (250 [133-522] versus 139 [68-220] mumol/L respectively, p = NS). Dihydropyrimidine dehydrogenase deficiency was found in 27% of tested patients (n = 3/11). Encephalopathy-induced mortality was 17%, 57% of patients were admitted in ICU and 70% had a complete neurological recovery within 5 [2-10] days. A 5-FU rechallenge was considered in 14 (67%) patients with neurological recovery and a relapse was observed in 57% of them. No 5-FU-induced hyperammonaemic encephalopathy relapse was observed as long as 5-FU rechallenge was performed with decreased 5-FU dosage. CONCLUSION: We report the largest cohort of 5-FU-induced hyperammonaemic encephalopathy cases so far. This ADR should be suspected and ammonaemia measured in all patients experiencing neurological disorders after 5-FU administration. In patients with complete neurological recovery, a 5-FU rechallenge could be cautiously considered. |
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| 投稿者 | Boileve, Alice; Thomas, Laure; Lillo-Le Louet, Agnes; Gaboriau, Louise; Chouchana, Laurent; Ducreux, Michel; Malka, David; Boige, Valerie; Hollebecque, Antoine; Hillaire-Buys, Dominique; Jozwiak, Mathieu |
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| 組織名 | Departement de Medecine Oncologique, Institut Gustave Roussy, Villejuif, France.;Electronic address: alice.boileve@gmail.com.;Centre Regional de PharmacoVigilance, Assistance Publique des Hopitaux de Paris,;Hopitaux Universitaires Paris-Est, Hopital Henri Mondor, Creteil, France.;Hopitaux Universitaires Paris-Centre, Hopital Europeen Georges Pompidou, Paris,;France.;Centre Regional de PharmacoVigilance, Hopital Universitaire de Lille, Lille,;Hopitaux Universitaires Paris-Centre, Hopital Cochin, Paris, France.;Departement de Medecine Oncologique, Institut Gustave Roussy, Villejuif, France;;Universite Paris-Saclay, Villejuif, France.;Centre Regional de PharmacoVigilance, Hopital Universitaire de Montpellier,;Montpellier France.;Service de Medecine Intensive Reanimation, Assistance Publique des Hopitaux de;Paris, Hopitaux Universitaires Paris-Centre, Hopital Cochin, Paris, France. |
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