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Antiemetic prophylaxis with fosaprepitant and granisetron in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) is a severe and distressing complication during allogeneic hematopoietic stem cell transplantation (alloHSCT). The antiemetic fosaprepitant has shown favorable results in pediatric and adult patients receiving chemotherapy. Data on fosaprep...

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Autores principales: Cabanillas Stanchi, Karin Melanie, Vek, Julia, Schlegel, Patrick, Rupprecht, Joachim Vincent, Flaadt, Tim, Weber, Simone, Michaelis, Sebastian, Lang, Peter, Handgretinger, Rupert, Döring, Michaela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7085480/
https://www.ncbi.nlm.nih.gov/pubmed/32056007
http://dx.doi.org/10.1007/s00432-020-03143-8
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author Cabanillas Stanchi, Karin Melanie
Vek, Julia
Schlegel, Patrick
Rupprecht, Joachim Vincent
Flaadt, Tim
Weber, Simone
Michaelis, Sebastian
Lang, Peter
Handgretinger, Rupert
Döring, Michaela
author_facet Cabanillas Stanchi, Karin Melanie
Vek, Julia
Schlegel, Patrick
Rupprecht, Joachim Vincent
Flaadt, Tim
Weber, Simone
Michaelis, Sebastian
Lang, Peter
Handgretinger, Rupert
Döring, Michaela
author_sort Cabanillas Stanchi, Karin Melanie
collection PubMed
description BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) is a severe and distressing complication during allogeneic hematopoietic stem cell transplantation (alloHSCT). The antiemetic fosaprepitant has shown favorable results in pediatric and adult patients receiving chemotherapy. Data on fosaprepitant in children and adolescents undergoing alloHSCT are missing. METHODS: In this non-interventional observation study, 120 children and adolescents with a median age of 11.8 years undergoing alloHSCT after a moderately or highly emetogenic conditioning (MEC or HEC) were analyzed. They received an antiemetic prophylaxis with granisetron (2 × 40 µg/kg d(−1)) with or without fosaprepitant (4 mg/kg; single dose, max. 1 × 150 mg/kg BW), and were analyzed in the control (CG; n = 60) or fosaprepitant group (FG; n = 60). The efficacy and safety of the two antiemetic prophylaxis regimens were analyzed and compared with respect to the acute (0–24 h) and the delayed (> 24–120 h) CINV phase and > 120–240 h after MEC or HEC administration. RESULTS: During MEC, significantly more patients in the CG experienced vomiting during the first 0–24 h (58.6 vs. 25.0%; p = 0.0156) and during > 24–120 h (93.1% vs. 57.1%; p = 0.0020), compared with the FG. Likewise, significantly more vomiting events (269 vs. 136; p < 0.0001) were registered in the CG. During HEC, significantly more patients in the CG experienced vomiting during the first 0–24 h (32.3 vs. 9.4%; p = 0.0319) compared with the FG. Significantly more vomiting events (241 vs. 99; p < 0.0001) were registered in the CG. Laboratory and clinical adverse events were not significantly different between the two groups (p > 0.05). CONCLUSIONS: Antiemetic prophylaxis with fosaprepitant and granisetron was well tolerated, safe, and effective in pediatric patients undergoing alloHSCT. However, larger prospective trials are necessary to evaluate these findings. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00432-020-03143-8) contains supplementary material, which is available to authorized users.
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spelling pubmed-70854802020-03-23 Antiemetic prophylaxis with fosaprepitant and granisetron in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation Cabanillas Stanchi, Karin Melanie Vek, Julia Schlegel, Patrick Rupprecht, Joachim Vincent Flaadt, Tim Weber, Simone Michaelis, Sebastian Lang, Peter Handgretinger, Rupert Döring, Michaela J Cancer Res Clin Oncol Original Article – Clinical Oncology BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) is a severe and distressing complication during allogeneic hematopoietic stem cell transplantation (alloHSCT). The antiemetic fosaprepitant has shown favorable results in pediatric and adult patients receiving chemotherapy. Data on fosaprepitant in children and adolescents undergoing alloHSCT are missing. METHODS: In this non-interventional observation study, 120 children and adolescents with a median age of 11.8 years undergoing alloHSCT after a moderately or highly emetogenic conditioning (MEC or HEC) were analyzed. They received an antiemetic prophylaxis with granisetron (2 × 40 µg/kg d(−1)) with or without fosaprepitant (4 mg/kg; single dose, max. 1 × 150 mg/kg BW), and were analyzed in the control (CG; n = 60) or fosaprepitant group (FG; n = 60). The efficacy and safety of the two antiemetic prophylaxis regimens were analyzed and compared with respect to the acute (0–24 h) and the delayed (> 24–120 h) CINV phase and > 120–240 h after MEC or HEC administration. RESULTS: During MEC, significantly more patients in the CG experienced vomiting during the first 0–24 h (58.6 vs. 25.0%; p = 0.0156) and during > 24–120 h (93.1% vs. 57.1%; p = 0.0020), compared with the FG. Likewise, significantly more vomiting events (269 vs. 136; p < 0.0001) were registered in the CG. During HEC, significantly more patients in the CG experienced vomiting during the first 0–24 h (32.3 vs. 9.4%; p = 0.0319) compared with the FG. Significantly more vomiting events (241 vs. 99; p < 0.0001) were registered in the CG. Laboratory and clinical adverse events were not significantly different between the two groups (p > 0.05). CONCLUSIONS: Antiemetic prophylaxis with fosaprepitant and granisetron was well tolerated, safe, and effective in pediatric patients undergoing alloHSCT. However, larger prospective trials are necessary to evaluate these findings. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00432-020-03143-8) contains supplementary material, which is available to authorized users. Springer Berlin Heidelberg 2020-02-13 2020 /pmc/articles/PMC7085480/ /pubmed/32056007 http://dx.doi.org/10.1007/s00432-020-03143-8 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Original Article – Clinical Oncology
Cabanillas Stanchi, Karin Melanie
Vek, Julia
Schlegel, Patrick
Rupprecht, Joachim Vincent
Flaadt, Tim
Weber, Simone
Michaelis, Sebastian
Lang, Peter
Handgretinger, Rupert
Döring, Michaela
Antiemetic prophylaxis with fosaprepitant and granisetron in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation
title Antiemetic prophylaxis with fosaprepitant and granisetron in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation
title_full Antiemetic prophylaxis with fosaprepitant and granisetron in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation
title_fullStr Antiemetic prophylaxis with fosaprepitant and granisetron in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation
title_full_unstemmed Antiemetic prophylaxis with fosaprepitant and granisetron in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation
title_short Antiemetic prophylaxis with fosaprepitant and granisetron in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation
title_sort antiemetic prophylaxis with fosaprepitant and granisetron in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation
topic Original Article – Clinical Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7085480/
https://www.ncbi.nlm.nih.gov/pubmed/32056007
http://dx.doi.org/10.1007/s00432-020-03143-8
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