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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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Berlin Heidelberg
2020
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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. |
format | Online Article Text |
id | pubmed-7085480 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
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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