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A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions
Severe infusion reactions (SIRs) at rates of 5% or less are known side effects of biological agents, including mAbs such as cetuximab. There are currently no prospectively validated risk factors to aid physicians in identifying patients who may be at risk of experiencing an SIR following administrat...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BlackWell Publishing Ltd
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4312116/ https://www.ncbi.nlm.nih.gov/pubmed/25296628 http://dx.doi.org/10.1002/cam4.333 |
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author | Maier, Sabine Chung, Christine H Morse, Michael Platts-Mills, Thomas Townes, Leigh Mukhopadhyay, Pralay Bhagavatheeswaran, Prabhu Racenberg, Jan Trifan, Ovidiu C |
author_facet | Maier, Sabine Chung, Christine H Morse, Michael Platts-Mills, Thomas Townes, Leigh Mukhopadhyay, Pralay Bhagavatheeswaran, Prabhu Racenberg, Jan Trifan, Ovidiu C |
author_sort | Maier, Sabine |
collection | PubMed |
description | Severe infusion reactions (SIRs) at rates of 5% or less are known side effects of biological agents, including mAbs such as cetuximab. There are currently no prospectively validated risk factors to aid physicians in identifying patients who may be at risk of experiencing an SIR following administration of any of these drugs. A retrospective analysis of 545 banked serum or plasma samples from cancer patients participating in clinical trials of cetuximab was designed to evaluate whether the presence of pretreatment IgE antibodies against cetuximab, as determined by a commercially available assay system, is associated with SIRs during the initial cetuximab infusion. Patients with a positive test indicating the presence of pretreatment antibodies had a higher risk of experiencing an SIR; however, at the prespecified cutoff utilized in this analysis, the test has a relatively low-positive predictive value (0.577 [0.369–0.766]) and a negative predictive value of 0.961 (0.912–0.987) in an unselected patient population. Data collected in this large retrospective validation study support prior observations of an association between the presence of pretreatment IgE antibodies cross-reactive with cetuximab and SIRs. Further analysis of the test's ability to predict patients at risk of an SIR would be required before this assay could be used reliably in this patient population. |
format | Online Article Text |
id | pubmed-4312116 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BlackWell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-43121162015-02-09 A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions Maier, Sabine Chung, Christine H Morse, Michael Platts-Mills, Thomas Townes, Leigh Mukhopadhyay, Pralay Bhagavatheeswaran, Prabhu Racenberg, Jan Trifan, Ovidiu C Cancer Med Cancer Research Severe infusion reactions (SIRs) at rates of 5% or less are known side effects of biological agents, including mAbs such as cetuximab. There are currently no prospectively validated risk factors to aid physicians in identifying patients who may be at risk of experiencing an SIR following administration of any of these drugs. A retrospective analysis of 545 banked serum or plasma samples from cancer patients participating in clinical trials of cetuximab was designed to evaluate whether the presence of pretreatment IgE antibodies against cetuximab, as determined by a commercially available assay system, is associated with SIRs during the initial cetuximab infusion. Patients with a positive test indicating the presence of pretreatment antibodies had a higher risk of experiencing an SIR; however, at the prespecified cutoff utilized in this analysis, the test has a relatively low-positive predictive value (0.577 [0.369–0.766]) and a negative predictive value of 0.961 (0.912–0.987) in an unselected patient population. Data collected in this large retrospective validation study support prior observations of an association between the presence of pretreatment IgE antibodies cross-reactive with cetuximab and SIRs. Further analysis of the test's ability to predict patients at risk of an SIR would be required before this assay could be used reliably in this patient population. BlackWell Publishing Ltd 2015-01 2014-10-09 /pmc/articles/PMC4312116/ /pubmed/25296628 http://dx.doi.org/10.1002/cam4.333 Text en © 2014 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. http://creativecommons.org/licenses/by/3.0/ This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Cancer Research Maier, Sabine Chung, Christine H Morse, Michael Platts-Mills, Thomas Townes, Leigh Mukhopadhyay, Pralay Bhagavatheeswaran, Prabhu Racenberg, Jan Trifan, Ovidiu C A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions |
title | A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions |
title_full | A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions |
title_fullStr | A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions |
title_full_unstemmed | A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions |
title_short | A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions |
title_sort | retrospective analysis of cross-reacting cetuximab ige antibody and its association with severe infusion reactions |
topic | Cancer Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4312116/ https://www.ncbi.nlm.nih.gov/pubmed/25296628 http://dx.doi.org/10.1002/cam4.333 |
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