Abstract No. 117 A phase 3, double-blind, randomized study of nivolumab and Ipilimumab), nivolumab monotherapy, or placebo plus transarterial chemoembolization in patients with intermediate-stage hepatocellular carcinoma

Abstract

Purpose: To evaluate potential differences in demographics and survival in 448 patients with unresectable hepatocellular carcinoma (HCC) treated with Y90 radioembolization at transplant centers (TC) versus nontransplant centers (NTC) Materials and Methods: 338 patients from the RESiN Registry (NCT#02685631) were treated at 23 TC and 110 treated at 13 NTC. Demographic differences were assessed using Wilcoxon/ Pearson test for continuous/discrete variables regarding liver function and tumor size. Kaplan-Meier analysis was performed to compare overall survival (OS) and progression-free survival (PFS) with 95% confidence intervals (CI) reported. Liver transplant patients were censored at the time of surgery. Cox Proportional Hazard (CPH) was done to assess factors affecting survival. Results: Compared to NTC patients, TC patients were more racially diverse (28% vs 18% nonwhite, P ¼ 0.05) and more likely to have prior arterial embolization (29% vs 14%, P ¼ 0.02), lower albumin (3.5 vs 3.8 g/dL, P< 0.001), ascites (24% vs 12%, P ¼ 0.009) and encephalopathy (9% vs 0%, P ¼ 0.001). ECOG, MELD and Child-Pugh Scores were similar between groups (all P >0.05). NTC patients more commonly had solitary tumors (49% vs 31%, P ¼ 0.03) and lower total tumor burden (median 6.8 vs 9.2 cm, P< 0.001) than TC patients. Median OS of the 448-patient cohort was 18 months . Median OS of patients from TC and NTC was 17 months (CI 15-22) and 22 months (CI 13-30, P ¼ 0.3), respectively. Median PFS of the entire cohort was 11 months (CI 9-14). PFS was 10 months for TC (CI 8-14) versus 12 months in NTC (CI 11-20, P ¼ 0.2). Twenty-six (5.8%) patients from TC underwent transplant at a median of 454 days from Y90 (range 86-1151). Common new Grade 3 toxicities were encephalopathy (11/448, 2.5%), hyperbilirubinemia (10/448, 2.2%) and ascites (9/448, 2.0%). The most common extrahepatic toxicity was thrombocytopenia (11/448, 2.5%). CPH results are in the Table . Predictors of longer OS were absence of ascites, albumin >3.5 g/dL, disease within Milan criteria and portal vein patency. Conclusions: OS and PFS are similar at TC and NTC, despite more severe comorbidities in TC patients. Hypoalbuminemia, ascites, venous invasion and tumor beyond Milan criteria predict survival better than hyperbilirubinemia, Child-Pugh class and extra-hepatic disease.