Real-World Treatment Patterns and Clinical Outcomes in Patients with Unresectable Hepatocellular Carcinoma: Results from the OREIOS Study

Background: OREIOS (NCT05239507) study determined the clinical characteristics, management patterns, and survival outcomes in patients with unresectable HCC (uHCC) from 12 countries across Asia, Latin America, and Middle East and Africa. Methods: This non-interventional, retrospective study enrolled patients with Barcelona Clinic Liver Cancer (BCLC) stage B or C unresectable or advanced/metastatic hepatocellular carcinoma (HCC) at index date, diagnosed between January 2017 and December 2019. The primary outcomes were median overall survival (mOS) and landmark survival (12 and 24 months) and secondary outcomes were clinicodemographic characteristics, treatment patterns, and median progression-free survival (mPFS). Results: A total of 1,116 patients (median [range] age: 63.0 [18.0–97.0] years) were recruited; 83.2% (929/1,116) were males, 49.5% (422/852) were current/ex-smokers, and 21.3% (122/572) consumed alcohol. At the index date, 22.3% (249/1,116) and 77.7% (867/1,116) of patients presented with BCLC stage B and C, respectively, with main portal vein invasion in 23.5% (263/1,116), >50% liver involvement in 23.1% (250/1,082), and extrahepatic metastases in 48.5% (541/1,116). Transarterial chemoembolization was performed before and after the index dates in 22.9% (255/1,112) and 20.8% (232/1,116) of patients, respectively. In the first-line of therapy (LOT), majority of patients received tyrosine multikinase inhibitors (TKIs) – sorafenib (68.3% [684/1,002] and lenvatinib (10.2% [102/1,002]). Irrespective of LOT, the mPFS and mOS were 6.1 (95% confidence interval [CI]: 5.5–6.7) and 13.1 (95% CI: 11.6, 14.1) months for the overall cohort. The survival rates at 12 and 24 months for the overall cohort were 52.1% (95% CI: 49.1–55.1) and 30.6% (95% CI: 27.8–33.4). Conclusion: Our study provides retrospective view of treatment strategies in patients with advanced uHCC prior to advent of immunotherapy and combination therapy. Majority of patients received TKIs, as per then recommended and available treatment options. The mOS in our study was similar to that observed in pivotal clinical trials for TKIs. With novel agents and combination therapies being approved for uHCC, integrating them into routine care is important to improve survival.