Nivolumab, an anti-PD-1 antibody showed durable responses and long-term survival in patients with hepatocellular carcinoma (HCC) and was approved by FDA as 2nd line treatment after sorafenib treatment in 2017. We present real-world experience with nivolumab in HCC.
We retrospectively reviewed the medical records of HCC patients who had nivolumab treatment at Samsung Medical Center. Nivolumab treatment was given every two weeks until progression or intolerable toxicity. Response evaluation was done based on RECIST v1.1.
A total of 76 patients were treated with nivolumab between March 2017 and May 2018. The median age was 60 years (range; 30-83 years) and 86% were male patients. The cohorts included 56 patients with hepatitis B viral infection, 7 with hepatitis C viral infection and 19 without viral infection. Most of patients (96.0%) were ECOG performance statue 0 or 1 and patients with Child-Pugh A were 59 (77.6%). 70 patients (92.1%) had previous sorafenib therapy and 8 patients received nivolumab as 3rd or more line (10.5%). There were three patients with previous history of liver transplantation. With median follow-up duration of 15 weeks (range, 5-39), the median treatment cycle was 4 (range,1-26). 17 patients (22.4%) received standard dose of 3mg/kg, whereas 59 patients (77.6%) received less than 3mg/kg of nivolumab. Partial response was observed in 6 patients (ORR 7.9%) and they all are on nivolumab therapy for 4-13 months. Disease control rate was 39.5%. The most common adverse events (AEs) were anorexia(15.6%) and puritus(15.8%)., nausea (13.1%), liver dysfunction (21%) and fatigue(7.9%). However, these were almost grade 1 or 2 except for two cases of grade 3 liver dysfunction and grade 3 diabetes. There was no HBV reactivation observed.
Compared to phase I/II study of nivolumab (CheckMate 040), our real-world data showed lesser ORR and DCR. Move advanced disease status, liver dysfunction and short follow-up duration might explain it. However, nivolumab showed a manageable safety profile even in transplanted patients.
Clinical trial identification
Legal entity responsible for the study
Samsung Medical Center.
Has not received any funding.
All authors have declared no conflicts of interest.