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Roma Raj*1, Nihal Aykun1, Chase J. Wehrle1, Marianna Maspero1, Bassam Estfan2,1, Suneel Kamath2,1, Smitha Krishnamurthi2,1, Federico Aucejo1
1Digestive Diseases and Surgery Institute, Department of Hepatopancreatobiliary & Liver Transplant Surgery, Cleveland Clinic, Cleveland, OH; 2Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, OH

Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related deaths worldwide. Recently, immune checkpoint inhibitor (ICI) regimens have shown superiority to sorafenib in the first line. However, evidence of superiority of one over the other remains scarce.

Patients with advanced HCC who received either Atezolizumab/Bevacizumab (AB) combination or Nivolumab between 2016 and 2022 were identified in our Liver Cancer Database. We performed a retrospective review of data with the aim of observing response to AB combination compared to Nivolumab alone.

A total of 96 patients received AB combination (n=61) or Nivolumab (n=35). Median age at diagnosis was 66.5 years (IQR 62-73), and 81% were white males. 76 patients classified as Child Pugh A (81%) followed by Child Pugh B (n=14, 15%). The average MELD-NA score (2016) was 9 (IQR 7-13). 63 patients had cirrhosis due to HCV (n=46, 63%), followed by EtOH (n=22, 23%). 70 patients received prior liver-directed and/or systemic therapy and 26 patients were treatment naïve. 39 had macrovascular invasion (41%) and mean pre-treatment AFP was 116 ng/mL (IQR 14-2343).

Median follow up was 19 months (IQR 22-26) and response was determined using the modified response evaluation criteria in solid tumors (mRECIST). Confirmed objective response (complete or partial) was seen in 29% (n=27) with a disease control rate of 41% (n=40).
Of the 27 patients who showed confirmed objective response, 19 received AB combination and 8 received Nivolumab. Seven out of nine patients with complete response received AB combination. Logistic regression model did not show any significant difference in response to Nivolumab vs AB combination (OR=2.8, 95% CI: 0.61-13.11, p=0.183).

Two of the complete responders with AB therapy underwent surgery after receiving immunotherapy, and histopathology from one reported no viable tumor (Figure 1).

Univariate analysis (Table 1) demonstrated an association between pre-treatment AFP >400 ng/mL and objective response (OR=4.5, 95% CI: 1.7-11.9, p=0.0015), while prior liver directed radiotherapy (OR=0.14, 95% CI: 0.01-1.1, p=0.033) or systemic chemotherapy (OR=0.25, 95% CI: 0.08-0.81, p=0.017) were associated with poor response. On multivariate analysis only AFP> 400 ng/mL remained significantly associated with response (OR=3.7, 95% CI: 1.3-10.5, p=0.014). Median overall survival at one and three years in responders was 86% and 43%, and in non-responders was 45% and 29% respectively.

In our institutional experience, neither of the two treatment regimens showed statistically significant response superiority, while treatment naivety and pre-treatment AFP >400 ng/mL were associated with better objective response. Further studies aimed at identifying factors and ICI associated with better outcomes may improve survival and patient selection for these therapies.

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