For many cancer patients, immune checkpoint inhibitors (ICPIs) can be life-saving. However, the emergency management of immune-related adverse events (irAEs) caused by ICPIs is a clinical challenge. While many cases of irAEs are manageable and reversible, some are severe; and some mild and moderate cases may quickly progress to severe irAEs, become chronic or even fatal. The onset of irAEs often leads to a visit to the Emergency Department (ED). Therefore, early recognition and the decision to either admit, observe or discharge these patients from the ED can be key to a cancer patient’s morbidity and mortality. ED clinicians typically make their decision for disposition (admit or discharge) within 2-6 hours from ED presentation. The ED is a fast-paced setting, and the diagnosis and management of an irAE is particularly challenging because of atypical presentations, the absence of classic symptoms, and delayed availability of some diagnostic results during the ED encounter. In our study of 628 unique ED patients who received ICPIs, 1,026 ED visits after starting ICPIs were reviewed and 682 (66.5%) of these resulted in hospitalization. Up to 25% of the 1,026 visits were directly related to 1 irAE. Importantly, irAEs are differentially associated with overall survival (i.e., pneumonitis was associated with poor survival whereas colitis was associated with improved survival). Recognizing the expansion on the use of ICPIs and the concomitant rise in the volume of patients presenting to EDs with irAEs, we developed ED-specific guidelines for irAEs. Converging lines of evidence suggest that inflammation and immune response underlie the occurrence of irAEs, we therefore advocated for immune biomarkers in the initial workup of ED patients on ICPIs. ICPIs are becoming widely used, and studies have suggested, with variable accuracy, immune/inflammation biomarkers are factors predictive of irAE and severity. At present there is no single sufficiently large ED data source with clinical, biological, laboratory, and imaging data that will allow for the development of a clinical tool that will guide early recognition and appropriate ED disposition of patients with potential irAEs. Accurately making decisions in the ED has implications in providing therapies, including appropriate treatment (initiation of glucocorticoid) or palliation of symptoms and appropriate disposition (hospitalization, observation or discharge) of patients. Therefore, there is an urgent need for an ED-specific tool for appropriate care and disposition of cancer patients treated with ICPIs. Our overall goal is to develop such a tool for use across general EDs. We, being a Comprehensive Oncologic Emergencies Research Network (CONCERN) participation site and in collaboration with 3 other CONCERN sites (Ohio State University, Northwestern University, and University of California in San Diego) serving large populations of racially/ethnically and geographically diverse cancer patients propose the following aims: 1) To develop a probability model (the Immune-related Emergency Disposition Index (IrEDi)) to risk stratify patients treated with ICPIs for ED disposition. We will leverage our existing data (n=~1200) of ED patients who received ICPIs. We hypothesize that host immune response underlie the development of irAEs and that inflammation/immune biomarkers (CRP; ESR; NLR/PLR) available during the ED encounter will improve the prediction of clinical outcomes (i.e., repeat ED visits, hospital length of stay (LOS), intensive care unit (ICU) LOS and 30-day mortality), along with tradit
|Effective start/end date||1/1/22 → 12/31/25|
- University of Texas M. D. Anderson Cancer Center (PRESPEND)
- National Cancer Institute (PRESPEND)
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