Category: Federal Forum Posters
Purpose: In 2017, the FDA granted accelerated approval for nivolumab for use in advanced (unresectable, transplant ineligible) hepatocellular carcinoma after disease progression on sorafenib. At the Audie L. Murphy Veterans Affairs Memorial Hospital in San Antonio, use of nivolumab in patients with Child Pugh Class B is discouraged based on national VA criteria for use. However, prior to the publishing of this criteria some patients did receive nivolumab to treat HCC with Child Pugh Class B7 and B8. The objective of this study is to compare outcomes of nivolumab use in hepatocellular carcinoma patients with varying degrees of liver dysfunction.
Methods: This retrospective, single-center study will be submitted to the Institutional Review Board for approval. Patients were included in the study if they were 18 years of age or older, had a diagnosis of advanced hepatocellular carcinoma, was receiving nivolumab, had previously received sorafenib or regorafenib, and had Child Pugh Score Class A or B. Patients were excluded if they were less than 18 years old, had malignancies other than hepatocellular carcinoma, were Child Pugh Class C, or received nivolumab as first-line therapy. Using electronic health records at STVHCS, a historical chart review will be performed to evaluate outcomes for patients receiving nivolumab for advanced HCC with Child Pugh Class A vs. Child Pugh Class B. The primary endpoint will be progression-free survival. Secondary endpoints include overall response rate, overall survival, and incidence of adverse events. Data to be collected will include age, sex, Child Pugh score parameters, date of progression, date of death, cause of death, previous TACE/Y-90, previous sorafenib or regorafenib use, date of first nivolumab treatment, time to progression, total number of nivolumab doses, frequency of infusion, and reason for nivolumab discontinuation. Data collected will be analyzed using student T test, chi square test, and Kaplan Meier curves.
Results: not applicable
Conclusion: not applicable
David Pham– Pharm.D. Candidate, University of Houston College of Pharmacy, Houston, TX