Abstract 156P
Background
A recent phase III trial showed that ipilimumab plus nivolumab (Ipi/Nivo) therapy significantly improved overall survival (OS) compared with sorafenib or lenvatinib in patients with advanced hepatocellular carcinoma (HCC). However, evidence for the efficacy of Ipi/Nivo in high-risk patients with advanced HCC, such as those with Vp4 portal vein tumor thrombus, bile duct invasion, or liver infiltration ≥ 50%, is lacking. Hence, we evaluated the efficacy of Ipi/Nivo in patients with Vp4 portal vein thrombus and liver infiltration ≥ 50% in real-world settings.
Methods
We included patients treated with Ipi/Nivo for advanced HCC from three referral hospitals between March 2020 and September 2023. All patients had Child-Pugh A liver disease and received Ipi (3 mg/kg) plus Nivo (1 mg/kg) every 3 weeks (four doses) followed by Nivo (240 mg) every 2 weeks.
Results
A total of 71 patients were analyzed, and baseline characteristics were as follows: median age of 60 years (range, 37-79); hepatitis B (n = 58, 81.7%); BCLC C (n = 67, 94.4%); extrahepatic metastasis (n = 62, 87.3%); liver infiltration ≥ 50%, (n = 20, 28.2%). Forty-six patients (64.8%) were previously exposed to immune checkpoint inhibitors and 65 (91.5%) received Ipi/Nivo in the third or later lines of systemic treatment. Regarding portal vein tumor thrombosis, 44 (80.0%), 0, 1 (1.7%), 4 (6.7%), and 6 (10.0%) patients were categorized as Vp0, Vp1, Vp2, Vp3, and Vp4, respectively. For 70 evaluable patients, the objective response rates (ORRs) were 28.6% (20/70), 25.0% (16/64), and 66.7% (4/6) in all patients, those without Vp4, and those with Vp4, respectively. Additionally, the ORRs were 36.0% (18/50) and 10.0% (2/20) in those with liver infiltration of <50% and ≥50%, respectively. After a median follow-up of 29.7 months, OS did not differ significantly between patients with and without Vp4 (median: not reached vs. 7.3 months, p = 0.113). However, patients with liver infiltration ≥ 50% had significantly shorter OS than those with <50% infiltration (2.0 vs. 15.8 months, p < 0.001).
Conclusions
Main portal vein tumor thrombus may not affect the survival of patients treated with Ipi/Nivo for advanced HCC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
H.J. Chon: Financial Interests, Personal, Advisory Board: Eisai, Roche, Bayer, Ono, MSD, BMS, Sanofi, Servier, AstraZeneca, BeiGene; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Eisai, Bayer, BMS, Servier, Sanofi, Dong-A ST. All other authors have declared no conflicts of interest.