Category: Federal Forum Posters
Purpose: Pembrolizumab and nivolumab are checkpoint inhibitors which target the interaction between human Programmed Death-1 and Programmed Death Ligand-1 (PD-1/PDL-1) to treat several cancers. Pembrolizumab and nivolumab have several immune-related and non-immune related adverse drug reactions (ADRs). The purpose of this study is to evaluate the prevalence of ADRs in veterans who received pembrolizumab or nivolumab compared to patients in the clinical trials leading to drug approval and determine if these ADRs were similar and managed appropriately. The results of the study will aid in understanding ADRs and modifying treatment approach in veterans due to their unique demographics and co-morbidities.
Methods: The study is under review by the Institutional Review Board. This is a single center, retrospective descriptive study conducted at the Washington DC VA Medical Center. A retrospective chart review of 92 patients on nivolumab or pembrolizumab from January 2015 to July 2018 will be conducted using data from the Computerized Patient Record System (CPRS) and the Veterans Information Systems and Technology Architecture (VistA). Demographic data, including race, age, height, weight, and gender will be collected. Lab values such as kidney function including serum creatinine and estimated glomerular filtration rate (eGFR), white blood cell count, thyroid function including thyroid stimulating hormone (TSH), thyroxine (T4), and triiodothyronine (T3), and liver function including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will be collected. Information from the medication profile, medication administration logs, past medical history, adverse drug events, and allergies will also be collected. The patients’ adverse event profiles will be evaluated before and after initiation of pembrolizumab or nivolumab to eliminate possible confounders caused by other drugs in the patients’ regimen. All data will be recorded without patient identifiers and will be maintained confidentially. Chi-squared tests will be used for analysis of each of the study outcomes.
Results: Not applicable
Conclusion: Not applicable
Eileen Holovac
– Pharmacy Resident, Washington DC Veterans Affairs Medical Center, Rockville, MD139 Views