1. Efficacy, Safety And Feasibility Of Antiemetic Prophylaxis With Fosaprepitant, Granisetron And Dexamethasone In Pediatric Patients With Hemato-Oncological Malignancies
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Cabanillas Stanchi KM, Ebinger M, Hartmann U, Queudeville M, Feucht J, Ost M, Koch MS, Malaval C, Mezger M, Schober S, Weber S, Michaelis S, Lange V, Lang P, Handgretinger R, and Döring M
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Fosaprepitant ,aprepitant ,granisetron ,pediatric ,antiemetic prophylaxis ,chemotherapy ,CINV ,chemotherapy induced nausea and vomiting ,chemotherapy induced vomiting ,CIV ,5-HT¬3R-antagonist ,NK1R-antagonists ,dexamethasone ,Therapeutics. Pharmacology ,RM1-950 - Abstract
Karin Melanie Cabanillas Stanchi,1,* Martin Ebinger,1,* Ulrike Hartmann,2 Manon Queudeville,1 Judith Feucht,1 Michael Ost,1 Marie-Sarah Koch,1 Carmen Malaval,1 Markus Mezger,1 Sarah Schober,1 Simone Weber,1 Sebastian Michaelis,1 Veit Lange,1 Peter Lang,1 Rupert Handgretinger,1 Michaela Döring1 1Department of General Pediatrics, Hematology/Oncology, University Children‘s Hospital Tübingen, Tübingen 72076, Germany; 2University Pharmacy, Eberhard-Karls-University of Tübingen, Tübingen 72076, Germany*These authors contributed equally to this workCorrespondence: Michaela DöringUniversity Hospital Tübingen - Children’s Hospital, Department I – General Pediatrics, Hematology/Oncology, Hoppe-Seyler-Str. 1, Tübingen 72076, GermanyTel +49-(0)7071-2981355Fax +49-(0)7071-295203Email michaela.doering@med.uni-tuebingen.deBackground: Chemotherapy-induced nausea and vomiting (CINV) are a major burden for patients undergoing emetogenic chemotherapy. International guidelines recommend an antiemetic prophylaxis with corticosteroids, 5-HT3R-antagonists and NK1R-antagonists. The NK1R-antagonist fosaprepitant has shown favorable results in pediatric and adult patients. There is little pediatric experience with fosaprepitant.Methods: This non-interventional observation study analyzed 303 chemotherapy courses administered to 83 pediatric patients with a median age of 9 years (2–17 years), who received antiemetic prophylaxis either with fosaprepitant and granisetron with or without dexamethasone (fosaprepitant group/FG; n=41), or granisetron with or without dexamethasone (control group/CG; n=42), during moderately (CINV risk 30–90%) or highly (CINV risk>90%) emetogenic chemotherapy. The two groups’ results were compared with respect to the safety and efficacy of the antiemetic prophylaxis during the acute (0-24hrs after chemotherapy), delayed (>24–120hrs after chemotherapy) and both CINV phases. Laboratory and clinical adverse events were compared between the two cohorts.Results: Adverse events were not significantly different in the two groups (p>0.05). Significantly fewer vomiting events occurred during antiemetic prophylaxis with fosaprepitant in the acute (23 vs 142 events; p
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- 2019