Dataset Information

Osimertinib: A Novel Dermatologic Adverse Event Profile in Patients with Lung Cancer.

ABSTRACT: Dermatologic adverse events (dAEs) are common with the use of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy. First- and second-generation agents (erlotinib, gefitinib, and afatinib) are frequently associated with acneiform rash, pruritus, xerosis, and paronychia; the incidence and characterization of these dAEs have been well described. However, there is evidence that the dAE profile is different with third-generation EGFR-TKIs. Herein, we describe the dAEs associated with third-generation EGFR-TKIs and our clinical experience with osimertinib, a third-generation EGFR-TKI approved by the U.S. Food and Drug Administration for the treatment of metastatic, EGFR T790M mutation-positive non-small cell lung cancer in patients whose disease has progressed on or after EGFR-TKI therapy. Case summaries of patients from two of our institutions who received osimertinib and were referred to a dermatologist for dAEs are also presented. Overall, the evidence suggests that osimertinib is associated with less severe and less frequent dAEs than first- and second-generation EGFR-TKIs and that therefore a different approach is warranted. Finally, we outline dAE management approaches for osimertinib in the context of those typically employed with first- and second-generation EGFR-TKIs.

Implications for practice

Appropriate prevention and management of dermatologic adverse events (dAEs) associated with the use of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) may help patients to continue therapy and lessen any negative impact on their quality of life. EGFR-TKIs are frequently associated with acneiform rash, pruritus, xerosis, and paronychia; however, dAEs associated with third-generation EGFR-TKIs are lower in frequency and severity. Before therapy, health care providers should discuss the potential osimertinib-associated dAEs and encourage patients to report their dAEs. Patients should also be educated on prophylactic measures to minimize the severity of dAEs and the importance of adherence to the treatment regimen.

SUBMITTER: Chu CY

PROVIDER: S-EPMC6156184 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Osimertinib: A Novel Dermatologic Adverse Event Profile in Patients with Lung Cancer.

Chu Chia-Yu CY Choi Jennifer J Eaby-Sandy Beth B Langer Corey J CJ Lacouture Mario E ME

The oncologist 20180412 8

Dermatologic adverse events (dAEs) are common with the use of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy. First- and second-generation agents (erlotinib, gefitinib, and afatinib) are frequently associated with acneiform rash, pruritus, xerosis, and paronychia; the incidence and characterization of these dAEs have been well described. However, there is evidence that the dAE profile is different with third-generation EGFR-TKIs. Herein, we describe the dAEs associ ...[more]

PMID: 29650685

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Project description:BackgroundImmune checkpoint inhibitors (ICIs) and bevacizumab-based therapy are a promising treatment approach to significantly improving overall survival (OS) of non-small cell lung cancer (NSCLC) patients. However, the incidence of adverse events induced by a combination treatment with programmed cell death-1 or programmed death ligand 1 [PD-(L)1] inhibitor and bevacizumab remains unknown. The current evidence from prospective studies is limited. Thus, efforts using real-world data to further improve our understanding of the potential adverse events will be necessary.MethodsThe present study included 15,872 participants with NSCLC in the FDA Adverse Event Reporting System (FAERS) database from April 2013 to September 2019. The definition of adverse events (AEs) relied on the Medical Dictionary for Regulatory Activities (MedDRA). Statistical analysis was performed, and odds ratio (ORs) with 95% confidence intervals (CIs) were calculated.ResultsOf the 15,872 participants with NSCLC, 15,463 cases were treated with the PD-(L)1 inhibitor monotherapy, while 409 cases were treated with both PD-(L)1 inhibitor and bevacizumab. Compared with monotherapy, combination therapy had lower risks of pneumonitis, respiratory failure, edema, disease progression, and death; however, combination therapy was also associated with significantly higher risks of pyrexia, general physical health deterioration, stomatitis, dehydration, thrombocytopenia, peripheral neuropathy, nephritis, bone marrow failure, immune thrombocytopenic purpura, neutropenia, and serious AEs. The results of the multivariate analysis suggested that combination therapy was the independent risk factor for pyrexia, neutropenia, nephritis, ITP, and the independent protective factor for respiratory failure.ConclusionsWe observed that the spectrum and risk of irAEs differed widely between therapeutic regimens, and irAEs involved multiple organ systems both in monotherapy or combination therapy. Deepening our understanding of irAEs has a great clinical value for improving individualized clinical patient management and the safety of medication use.

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Dataset Information

Osimertinib: A Novel Dermatologic Adverse Event Profile in Patients with Lung Cancer.

Implications for practice

Publications

Osimertinib: A Novel Dermatologic Adverse Event Profile in Patients with Lung Cancer.

Similar Datasets

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