Liquid formulation of ifosfamide increased risk of encephalopathy: A case-control study in a pediatric population

Therapies - Tập 75 - Trang 471-480 - 2020
Dominique Hillaire-Buys1, Mégane Mousset1, Marion Allouchery2, Brahim Azzouz3, Marina Babin4, Florelle Bellet5, Johana Béné6, Anne Default7, Geneviève Durrieu8, Hélène Géniaux9, Aurélie Grandvuillemin10, Valérie Gras-Champel11, Hélène Jantzem12, Aude Lambert13, Marion Lepelley14, Nathalie Massy15, Nadine Petitpain16, Fanny Rocher17, Paola Sanchez-Pena18, Marion Sassier19
1Department of medical pharmacology and toxicology, CRPV, CHU de Montpellier, 371, avenue Doyen-Giraud, 34295 Montpellier, France
2Department of clinical pharmacology and vigilances, CPRV, CHU de Poitiers, 86021 Poitiers, France
3Department of pharmacovigilance and pharmacoepidemiology, CRPV, CHU de Reims, 51092 Reims, France
4Department of pharmacology and toxicologie, CRPV, CHU d’Angers, 49933 Angers, France
5Department of pharmacovigilance, CRPV, CHU de Saint-Étienne, 42055 Saint-Étienne, France
6Department of pharmacovigilance, CRPV, CHU de Lille, 59045 Lille, France
7Department of clinical pharmacology, CRPV, Sainte-Margueritte hospital, AP–AHM, 13274 Marseille, France
8Department of clinical pharmacology, CRPV, CHU de Toulouse, 31000 Toulouse, France
9Department of pharmacology, toxicology and pharmacovigilance, CRPV, CHU de Limoges, 87000 Limoges, France
10Department of vigilances, CRPV, CHU de Dijon, 21079 Dijon, France
11Department of human biology, CRPV, CHU d’Amiens-Picardie, 80054 Amiens, France
12Department of pharmacovigilance, CRPV, CHU de Brest, 29609 Brest, France
13Department of pharmaocvigilance, CRPV, Civil hospital of Strasbourg, 67091 Strasbourg, France
14Department of public health, CRPV, CHU Grenoble-Alpes, 38700 Grenoble, France
15Department of clinical biology, CRPV, CHU de Rouen, 76031 Rouen, France
16Department of clinical pharmacology and toxicology, CRPV, CHU de Nancy, 54511 Nancy, France
17Department of pharmacovigilance, CRPV, Cimiez hospital, CHU de Nice, 06003 Nice, France
18Department of medical pharmacology, CRPV, Pellegrin hospital, CHU de Bordeaux, 33300 Bordeaux, France
19Department of pharmacology, CRPV, CHU de Caen, 14000 Caen, France

Tài liệu tham khảo

ANSM, 2016 Gaudin, 2016 Chambord, 2019, Ifosfamide-induced encephalopathy: Brand-name (Holoxan®) vs generic formulation (Ifosfamide EG®), J Clin Pharm Ther, 44, 372, 10.1111/jcpt.12823 Miremont Salamé, 2016, Causality assessment in pharmacovigilance: the French method and its successive updates, Therapie, 71, 179, 10.1016/j.therap.2016.02.010 Highley, 2015, The neurotoxicity and pharmacokinetics of oral ifosfamide, J Anal Oncol, 4, 13, 10.6000/1927-7229.2015.04.01.3 Sauerbier, 1990 Mirejovsky, 2005 Daftary, 2007 Van Dyk, 1972, Unexpected toxicity in patients treated with iphosphamide, Cancer Res, 32, 921 Manegold, 1992, Oral ifosfamide-mesna: a clinical investigation in advanced non-small-cell lung cancer, Ann Oncol, 3, 723, 10.1093/oxfordjournals.annonc.a058327 Cerny, 1992, The enigma of ifosfamide encephalopathy, Ann Oncol, 3, 679, 10.1093/oxfordjournals.annonc.a058317 Goren, 1986, Dechloroethylation of ifosfamide and neurotoxicity, Lancet, 2, 1219, 10.1016/S0140-6736(86)92227-0 Kaijser, 1996, Pharmacokinetics of ifosfamide, 2- and 3-dechloroethylifosfamide, in plasma and urine of cancer patients treated with a 10-day continuous infusion of ifosfamide, Anticancer Res, 16, 3247 Visarius, 1998, Thiodiglycolic acid is excreted by humans receiving ifosfamide and inhibits mitochondrial function in rats, Drug Metab Dispos, 26, 193 Chatton, 2001, Insights into the mechanisms of ifosfamide encephalopathy: drug metabolites have agonistic effects on alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)/kainite receptors and induce cellular acidification in mouse cortical neurons, J Pharmacol Exp Ther, 299, 1161 Küpfer, 1996, Methylene blue and the neurotoxic mechanisms of ifosfamide encephalopathy, Eur J Clin Pharmacol, 50, 249, 10.1007/s002280050102 Küpfer, 1994, Prophylaxis and reversal of ifosfamide encephalopathy with methylene blue, Lancet, 343, 763, 10.1016/S0140-6736(94)91839-2 Zhang, 2005, Metabolism and transport of oxazaphosphorines and the clinical implications, Drug Metab Rev, 37, 611, 10.1080/03602530500364023 Kaijser, 1998, Pharmacokinetics of ifosfamide and some metabolites in children, Anticancer Res, 18, 1941 Yule, 1997, Cyclophosphamide and ifosfamide metabolites in the cerebrospinal fluid of children, Clin Cancer Res, 3, 1985 Kerbusch, 2001, Clinical pharmacokinetics and pharmacodynamics of ifosfamide and its metabolites, Clin Pharmacokinet, 40, 41, 10.2165/00003088-200140010-00004 Kerbusch, 2001, Distribution of ifosfamide and metabolites between plasma and erythrocytes, Biopharm Drug Disp, 22, 99, 10.1002/bdd.257 Howell, 2008, Characterization of the occurrence of ifosfamide-induced neurotoxicity with concomitant aprepitant, J Oncol Pharm Pract, 14, 157, 10.1177/1078155208093930 Hansen, 2010, Aprepitant-associated ifosfamide neurotoxicity, J Oncol Pharm Pract, 16, 137 Chenaf, 2017, Incidence of encephalopathy and associeted risk factors in two different ifosfamide formulations, a retrospective bicentric study. 21st Annual Meeting of French Society of Pharmacology and Therapeutics, 19–21 April 2017, Rouen, France, Fundam Clin Pharmacol, 31, 1 Dushenkov, 2017, Drug interactions with aprepitant and fosaprepitant: review of literature and implications for clinical practice, J Oncol Pharm Pract, 23, 296, 10.1177/1078155216631408 Patel, 2017, Aprepitant and fosaprepitant drug interactions: a systematic review, Br J Clin Pharmacol, 83, 2148, 10.1111/bcp.13322 Tajino, 2010, Ifosfamide encephalopathy associated with chemotherapy for musculoskeletal sarcomas: incidence, severity, and risk factors, J Orthop Sci, 15, 104, 10.1007/s00776-009-1431-y Szabatura, 2015, An assessment of risk factors associated with ifosfamide-induced encephalopathy in a large academic cancer center, J Oncol Pharm Pract, 21, 188, 10.1177/1078155214527143