Cetuximab infusion reactions: French pharmacovigilance database analysis

Grandvuillemin, Aurélie; Disson-Dautriche, Anne; Miremont-Salamé, Ghada; Fourrier‐Réglat, Annie; Sgro, C

doi:10.1177/1078155212457965

Cited by 21 publications

(20 citation statements)

References 14 publications

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“…Data from the French pharmacovigilance database analysis suggest that (severe) infusion reactions were more common in SCCHN than in colorectal cancer patients,101 confirming an earlier report from North Carolina 102…”

Section: Safety and Tolerabilitysupporting

confidence: 68%

Cetuximab: its unique place in head and neck cancer treatment

Specenier¹,

Vermorken²

2013

BTT

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Head and neck cancer is the sixth most common cancer worldwide. At present, globally about 650,000 new cases of squamous cell carcinoma of the head and neck (SCCHN) are diagnosed each year. The epidermal growth factor receptor (EGFR) is almost invariably expressed in SCCHN. Overexpression of the EGFR is a strong and independent unfavorable prognostic factor in SCCHN. Cetuximab is a chimeric monoclonal antibody, which binds with high affinity to the extracellular domain of the human EGFR, blocking ligand binding, resulting in inhibition of the receptor function. It also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody dependent cell-mediated cytotoxicity). The addition of cetuximab to radiotherapy (RT) improves locoregional control and survival when compared to RT alone. The addition of cetuximab to platinum-based chemoradiation (CRT) is feasible but does not lead to an improved outcome. Cetuximab plus RT has never been compared prospectively to CRT, which therefore remains the standard treatment for patients with locoregionally advanced SCCHN for whom surgery is not considered the optimal treatment, provided they can tolerate CRT. The addition of cetuximab to platinum-based chemotherapy prolongs survival in patients with recurrent or metastatic SCCHN. The combination of a platinum-based regimen and cetuximab should be considered as the standard first line regimen for patients who can tolerate this treatment.

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Section: Safety and Tolerabilitysupporting

confidence: 68%

Cetuximab: its unique place in head and neck cancer treatment

Specenier¹,

Vermorken²

2013

BTT

View full text Add to dashboard Cite

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“…The WHO Programme for International Drug Monitoring, starting in 1968, is a cornerstone of world-wide pharmacovigilance, and the Uppsala Monitoring Centre, Uppsala, Sweden, maintains the WHO Global Individual Case Safety Report Database, VigiBase 81-84. In France, pharmacovigilance activities are carried out by 31 regional centers based in clinical pharmacology departments of university hospitals 85, 86, and the French Pharmacovigilance Database has been used to analyze the safety profiles of various drugs 87-91. Additionally, two European databases, that is, the General Practitioners Research Database (GPRD) in the UK, and the PHARMO Record Linkage System in the Netherlands, are also frequently used for analytical studies 92.…”

Section: Closing Remarksmentioning

confidence: 99%

Data Mining of the Public Version of the FDA Adverse Event Reporting System

Sakaeda¹,

Tamon²,

Kadoyama³

et al. 2013

Int. J. Med. Sci.

550

412

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The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, reporting has markedly increased. Data mining algorithms have been developed for the quantitative detection of signals from such a large database, where a signal means a statistical association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM). A survey of our previous reports suggested that the ROR provided the highest number of signals, and the EBGM the lowest. Additionally, an analysis of warfarin-, aspirin- and clopidogrel-associated adverse events suggested that all EBGM-based signals were included in the PRR-based signals, and also in the IC- or ROR-based ones, and that the PRR- and IC-based signals were in the ROR-based ones. In this article, the latest information on this area is summarized for future pharmacoepidemiological studies and/or pharmacovigilance analyses.

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“…The frequency of severe reactions to cetuximab varies in the literature from 1.2%–22%, depending on different areas of the world 1–6,11. Fatal reactions, as in one of our cases, have been reported 12–14. Clinicians often underestimate this complication until they themselves are confronted with such a case.…”

Section: Discussionmentioning

confidence: 76%

Case Report about Fatal or Near-Fatal Hypersensitivity Reactions to Cetuximab: Anticetuximab IgE as a Valuable Screening Test

Dupont

Mariotte

Moldovan³

et al. 2014

Clin Med Insights Oncol

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Hypersensitivity reactions are a classic side effect of cetuximab. We report the cases of three patients who developed life-threatening hypersensitivity to cetuximab, which could have been predicted by assessing the concentration of serum anticetuximab immunoglobulin (Ig)E. The anticetuximab IgE concentration could be an interesting test to predict which patients are at risk of experiencing severe hypersensitivity reactions to cetuximab.

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Cetuximab infusion reactions: French pharmacovigilance database analysis

Cited by 21 publications

References 14 publications

Cetuximab: its unique place in head and neck cancer treatment

Cetuximab: its unique place in head and neck cancer treatment

Data Mining of the Public Version of the FDA Adverse Event Reporting System

Case Report about Fatal or Near-Fatal Hypersensitivity Reactions to Cetuximab: Anticetuximab IgE as a Valuable Screening Test

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