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Evaluation of lung toxicity with bevacizumab using the spontaneous reporting database
This study was undertaken to determine the risk of bevacizumab-induced lung toxicity, time to onset, and post hoc outcomes using the Japanese Adverse Drug Event Report database. We analysed data for the period between April 2004 and March 2021. Data on lung toxicities were extracted, and relative ri...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9481601/ https://www.ncbi.nlm.nih.gov/pubmed/36114412 http://dx.doi.org/10.1038/s41598-022-19887-x |
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author | Kanbayashi, Yuko Uchida, Mayako Kashiwagi, Misui Akiba, Hitomi Shimizu, Tadashi |
author_facet | Kanbayashi, Yuko Uchida, Mayako Kashiwagi, Misui Akiba, Hitomi Shimizu, Tadashi |
author_sort | Kanbayashi, Yuko |
collection | PubMed |
description | This study was undertaken to determine the risk of bevacizumab-induced lung toxicity, time to onset, and post hoc outcomes using the Japanese Adverse Drug Event Report database. We analysed data for the period between April 2004 and March 2021. Data on lung toxicities were extracted, and relative risk of adverse events (AEs) was estimated using the reporting odds ratio. We analysed 5,273,115 reports and identified 20,399 reports of AEs caused by bevacizumab. Of these, 1679 lung toxicities were reportedly associated with bevacizumab. Signals were detected for nine lung toxicities. A histogram of times to onset showed occurrence from 35 to 238 days, but some cases occurred even more than one year after the start of administration. Approximately 20% of AEs were thromboembolic events. Among these, pulmonary embolism was the most frequently reported and fatal cases were also reported. The AEs showing the highest fatality rates were pulmonary haemorrhage, pulmonary infarction, and pulmonary thrombosis. In conclusion, we focused on lung toxicities caused by bevacizumab as post-marketing AEs. Some cases could potentially result in serious outcomes, patients should be monitored for signs of onset of AEs not only at the start of administration, but also over a longer period of time. |
format | Online Article Text |
id | pubmed-9481601 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-94816012022-09-18 Evaluation of lung toxicity with bevacizumab using the spontaneous reporting database Kanbayashi, Yuko Uchida, Mayako Kashiwagi, Misui Akiba, Hitomi Shimizu, Tadashi Sci Rep Article This study was undertaken to determine the risk of bevacizumab-induced lung toxicity, time to onset, and post hoc outcomes using the Japanese Adverse Drug Event Report database. We analysed data for the period between April 2004 and March 2021. Data on lung toxicities were extracted, and relative risk of adverse events (AEs) was estimated using the reporting odds ratio. We analysed 5,273,115 reports and identified 20,399 reports of AEs caused by bevacizumab. Of these, 1679 lung toxicities were reportedly associated with bevacizumab. Signals were detected for nine lung toxicities. A histogram of times to onset showed occurrence from 35 to 238 days, but some cases occurred even more than one year after the start of administration. Approximately 20% of AEs were thromboembolic events. Among these, pulmonary embolism was the most frequently reported and fatal cases were also reported. The AEs showing the highest fatality rates were pulmonary haemorrhage, pulmonary infarction, and pulmonary thrombosis. In conclusion, we focused on lung toxicities caused by bevacizumab as post-marketing AEs. Some cases could potentially result in serious outcomes, patients should be monitored for signs of onset of AEs not only at the start of administration, but also over a longer period of time. Nature Publishing Group UK 2022-09-16 /pmc/articles/PMC9481601/ /pubmed/36114412 http://dx.doi.org/10.1038/s41598-022-19887-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This 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/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Kanbayashi, Yuko Uchida, Mayako Kashiwagi, Misui Akiba, Hitomi Shimizu, Tadashi Evaluation of lung toxicity with bevacizumab using the spontaneous reporting database |
title | Evaluation of lung toxicity with bevacizumab using the spontaneous reporting database |
title_full | Evaluation of lung toxicity with bevacizumab using the spontaneous reporting database |
title_fullStr | Evaluation of lung toxicity with bevacizumab using the spontaneous reporting database |
title_full_unstemmed | Evaluation of lung toxicity with bevacizumab using the spontaneous reporting database |
title_short | Evaluation of lung toxicity with bevacizumab using the spontaneous reporting database |
title_sort | evaluation of lung toxicity with bevacizumab using the spontaneous reporting database |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9481601/ https://www.ncbi.nlm.nih.gov/pubmed/36114412 http://dx.doi.org/10.1038/s41598-022-19887-x |
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