(75) Comparative Effectiveness of Regorafenib and Nivolumab as Sequential Therapies in Patients After Sorafenib Failure for Hepatocellular Carcinoma Patients: A Cohort Study in Taiwan

Publication Number: 749

Background: Regorafenib and nivolumab were approved to treat sorafenib-failure hepatocellular carcinoma (HCC) patients. However, head-to-head comparisons between these medications remain unclear.

Objectives: Our study was aimed to compare the overall survival (OS) rate between regorafenib and nivolumab in patients with sorafenib-failure in the real-world practice.

Methods: This was a retrospective cohort study by using the electronic medical records database from the largest medical system in Taiwan. We included HCC patients with sorafenib-treatment and newly initiating regorafenib or nivolumab between January 1, 2018 and December 31, 2019. We defined the first prescription of sorafenib as the index date. The primary outcome was the overall survival from index date to the all-cause death or end of June 30, 2021 based on the intention-to-treat analyses. We applied inverse probability of treatment weighting (IPTW) to make two group comparable. An adjusted Kaplan-Meier method was used to estimate median OS between two groups.

Results: We enrolled 249 patients with sorafenib-experience and newly receiving either regorafenib (n=163, 65%) or nivolumab (n=86, 35%) with the mean age of 64.4 years (SD: 11.2). The tumor burden was similar between group (extrahepatic spread: 42% vs. 50%, p = 0.23; macrovascular invasion: 28% vs. 39%, p = 0.09) after IPTW adjustment. The median OS was 25.2 months in regorafenib group and 25.3 months in nivolumab group (log-rank test p = 0.55), respectively.

Conclusions: In our real-world evidence, regorafenib and nivolumab had similar OS in the HCC patients with sorafenib-experience. Future large-scale studies were suggested to confirm our findings.