Association between serious immune-related adverse events and survival in patients with advanced HCC treated by nivolumab: A single-center experience.

Abstract

e16661 Background: Nivolumab received accelerated approval by the FDA in 2017 for the treatment of advanced hepatocellular carcinomas (HCC). This study is aimed at evaluating the relationship between serious irAEs leading to treatment pause and survival of patients treated with nivolumab in our center. Methods: we performed a retrospective analysis of the patients treated at our center. The Kaplan Meir method was used to evaluate overall survival(OS). Log-rank test was conducted to compare groups in terms of OS. Adverse events were assessed using NCI CTCAE version 4.03 criteria. Results: Twenty patients with advanced HCC received nivolumab as palliative therapy between 2017-2019. 12/20 received nivolumab as first line treatment, 7/20 as second line. 6/20 patients stopped nivolumab due to serious irAEs including pancreatitis, kidney dysfunction and colitis leading to definitively stop of the therapy. The majority of patients received nivolumab in second line (5/6). The 1 year OS was 44% at the non-serious irAEs group and 84% in the serious irAEs group (p value = 0.0166). Median overall survival for the entire cohort was 11.4 months. The median OS was 8.11 months in patients without serious irAEs and 18.2 months in the group with toxicity. Conclusions: the occurrence of serious irAEs was associated with longer OS at our single center review. These results are in line with reports in other diseases such as lung cancer and melanoma. These retrospective data warrant further evaluation.