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Efficacy, Safety And Feasibility Of Antiemetic Prophylaxis With Fosaprepitant, Granisetron And Dexamethasone In Pediatric Patients With Hemato-Oncological Malignancies

Authors 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, Döring M

Received 3 May 2019

Accepted for publication 29 August 2019

Published 30 September 2019 Volume 2019:13 Pages 3439—3451

DOI https://doi.org/10.2147/DDDT.S214264

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Amy Norman

Peer reviewer comments 2

Editor who approved publication: Prof. Dr. Cristiana Tanase


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 work

Correspondence: Michaela Döring
University Hospital Tübingen - Children’s Hospital, Department I – General Pediatrics, Hematology/Oncology, Hoppe-Seyler-Str. 1, Tübingen 72076, Germany
Tel +49-(0)7071-2981355
Fax +49-(0)7071-295203
Email michaela.doering@med.uni-tuebingen.de

Background: 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<0.0001) and the delayed (71 vs 255 events; p<0.0001) CINV phase. In the control group, the percentage of chemotherapy courses with vomiting was significantly higher during the acute (24%/FG vs 45%/CG; p<0.0001) and delayed CINV phase (28%/FG vs 47%/CG; p=0.0004). Dimenhydrinate (rescue medication) was administered significantly more often in the CG, compared to the FG (114/FG vs 320/CG doses; p<0.0001). Likewise, in the control group, dimenhydrinate was administered in significantly more (p<0.0001) chemotherapy courses during the acute and delayed CINV phases (79 of 150; 52.7%), compared to the fosaprepitant group (45 of 153; 29.4%).
Conclusion: Antiemetic prophylaxis with fosaprepitant and granisetron with or without dexamethasone was well tolerated, safe and effective in pediatric patients. However, larger prospective trials are needed to evaluate these findings.

Keywords: fosaprepitant, granisetron, pediatric, antiemetic prophylaxis, chemotherapy induced vomiting, children

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