Effectiveness and Safety of Nivolumab in Child-Pugh B Patients with Hepatocellular Carcinoma: A Real-World Cohort Study.

Nivolumab has shown durable response and safety in patients with hepatocellular carcinoma (HCC) in previous trials. However, real-world data of nivolumab in HCC patients, especially those with Child-Pugh class B, are limited. To investigate the effectiveness and safety of nivolumab in a real-world cohort of patients with advanced HCC, we retrospectively evaluated 203 patients with HCC who were treated with nivolumab between July 2017 and February 2019. Of 203 patients, 132 patients were classified as Child-Pugh class A and 71 patients were Child-Pugh class B. Objective response rate was lower in patients with Child-Pugh class B than A (2.8% vs. 15.9%; p = 0.010). Child-Pugh class B was an independent negative predictor for objective response. Median overall survival was shorter in Child-Pugh B patients (11.3 vs. 42.9 weeks; adjusted hazard ratio [AHR], 2.10; p < 0.001). In Child-Pugh B patients, overall survival of patients with Child-Pugh score of 8 or 9 was worse than patients with Child-Pugh score of 7 (7.4 vs. 15.3 weeks; AHR, 1.93; p < 0.020). In conclusion, considering the unsatisfactory response in Child-Pugh B patients, nivolumab may not be used in unselected Child-Pugh B patients. Further studies are needed in this patient population.