Observational studyEuropean journal of clinical pharmacology2013
Spontaneous reporting of serious cutaneous reactions with protein kinase inhibitors.
Observational study in European journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed, 29 citations in OpenAlex.
- A case of crescentic glomerulonephritis induced by afatinib for lung adenocarcinoma.CEN case reports · 2023Article
- Sex, Gender, and the Regulation of Prescription Drugs: Omissions and Opportunities.International journal of environmental research and public health · 2023Review
- A Sex- and Gender-Based Analysis of Adverse Drug Reactions: A Scoping Review of Pharmacovigilance Databases.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Prediction of Side Effects Using Comprehensive Similarity Measures.BioMed research international · 2020Article
- Cutaneous leukocytoclastic vasculitis associated with erlotinib treatment: A case report and review of the literature.Experimental and therapeutic medicine · 2019Article
- Adverse Drug Reactions Involving Protein Kinase Inhibitors: A French Pharmacovigilance Database Study Comparing Safety in Younger and Older Patients (≥ 75 years) with Cancer.Pharmaceutical medicine · 2019Observational
- Preventable and potentially preventable serious adverse reactions induced by oral protein kinase inhibitors through a database of adverse drug reaction reports.Targeted oncology · 2015Article
- Advanced hepatocellular carcinoma and sorafenib: Diagnosis, indications, clinical and radiological follow-up.World journal of hepatology · 2015Review
- A case of necrotizing vasculitis with panniculitis, during sorafenib treatment for hepatocellular carcinoma, appeared in disease progression.Journal of gastrointestinal oncology · 2014Article
- Undesirable effects related to oral antineoplastic drugs: comparison between patients' internet narratives and a national pharmacovigilance database.Drug safety · 2014Article
- Phototoxic Reaction Induced by Pazopanib.Case reports in dermatologyArticle
- Pazopanib-Induced Cutaneous Leukocytoclastic Vasculitis: An Exclusion Diagnosis of a Multidisciplinary Approach.Case reports in oncologyArticle
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeOur aim was to describe all serious cutaneous adverse drug reactions (ADRs) spontaneously reported in France for all oral protein kinase inhibitors, their characteristics and whether they were labeled (reported in the Summary of Product Characteristics) or not.
methodsWe performed a retrospective observational study in the French PharmacoVigilance Database, selecting for analysis serious cutaneous reactions of patients due to treatment with oral protein kinase inhibitors (erlotinib, gefitinib, imatinib, nilotinib, dasatinib, sunitinib, sorafenib, pazopanib, lapatinib, everolimus) between 1 January 2008 and 31 December 31 2010.
resultsNinety-four patients suffered from 115 serious cutaneous reactions due to oral protein kinase inhibitors. Serious cutaneous reactions more frequently reported were maculo-papular rash (mostly with imatinib), followed by hand-foot syndrome (specifically with sorafenib) and papulopustular rash (particularly with erlotinib). Patients were mostly males (63 %) with a mean age of 62.6 ± 15.4 years. Drug withdrawal was observed in 73.1 % of cases because of these cutaneous reactions. Delay of occurrence of the ADR varied from 11.5 to 58.5 days. Unlabeled serious reactions were found (17.4 %), including skin ulceration, vasculitis or purpura with sorafenib or sunitinib and drug rash with eosinophilia and systemic symptoms with imatinib.
conclusionSome of the serious ADRs spontaneously reported with oral protein kinase inhibitors are labeled and commonly reported in the literature, but others occur only rarely and unlabeled. In our study, most serious ADRs occurred in males within the 2 first months of treatment and were responsible for the withdrawal of therapy with protein kinase inhibitors.
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