Catherine Garcia1, Niharika Reddy2, Julia Magsam3, John L. Villano2
1University of Texas MD Anderson Cancer Center, 2University of Kentucky, 3Georgetown College
Objective:
To describe cranial neuropathies (CN) as a side effect of immune checkpoint inhibitor (ICI) treatment using the FDA Adverse Event Reporting System (FAERS)
Background:
Neurological immune toxicities after immune checkpoint inhibitors is an increasingly recognized complication. Cranial neuropathies are frequently encountered in cancer patients, but their presentation after ICI is not well described. We aim to use a large database to describe the presentation and outcomes of patients that were reported to have a cranial neuropathy after ICI treatment.
Design/Methods:
We searched the FDA Adverse Event Reporting System (FAERS) database for “cranial neuropathy”, “cranial nerve disorder” “optic neuritis”, “optic neuropathy”, “optic nerve injury”, and “optic nerve disorder” for “ipilimumab”, “durvalumab”, “atezolizumab”, “ipilimumab” and “durvalumab”. Duplicates and patients with cranial nerve disorder related to vasculopathy, or documented leptomeningeal or brain metastases were excluded from the analysis.
Results:
A total of 315 cases were found of which 43.3% were females. Around 19% of patients were treated with more than one ICI. Lung cancer (23.9%) and melanoma (30.5%) were the most frequent primary cancer sites. Presentations included both mononeuropathies and multiple cranial neuropathies including optic nerve disorders, third, fifth, seventh, and hypoglossal nerve paresis. Optic nerve disorders were the most frequent (83%). Over 18% of patients presented with more than one neurological complaint, and around 9% with other immune mediated diseases. Other neurological presentations included neuropathy (2.1%), myalgias/myositis (3.4%), myelitis (1.2%), and autoimmune encephalitis (3%). The outcomes as reported by FAERS, 38.4% of patients required hospitalization, 12.7% had disability, and 6.7% died.
Conclusions:
CN after ICI can have a diverse presentation, most frequently affecting the optic nerve. Patients rarely had other autoimmune diseases (8.9%), but more complex presentations were described. Based on the outcomes reported by FAERS, most patients with CN don’t require hospitalization and recover without disability from the event.
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