Outcomes of lenvatinib therapy for advanced hepatocellular carcinoma: a real-world Egyptian cohort study

Abstract Introduction Lenvatinib was authorized for use as a first-line medication for unresectable hepatocellular carcinoma (HCC). This study examined the safety and efficacy of lenvatinib in a cohort of Egyptian patients with HCC in a real-world context. Methods We performed a prospective cohort study for lenvatinib-treated advanced HCC (from June 2023 to March 2024) with follow-up extending until December 2024. Demographic characteristics, tumor features, lenvatinib dosage, adverse events (AEs), and tumor response were gathered. The main objective was overall survival (OS). Results This longitudinal cohort research comprised 23 patients with cirrhosis. The majority of patients were male (91.3%), with a median age of 65 years. 65.2% were attributable to hepatitis C. Nine patients (39.1%) were administered lenvatinib at a dosage of 8 mg/day, whereas 14 patients (60.9%) received a dosage of 12 mg/day. The median treatment duration was 70 days (IQR: 48–177). Adverse events occurred in 16 patients (72.7%). Elevated liver enzymes occurred most frequently at 34.8%, followed by jaundice at 17.3%. Grade 3 AEs were documented in 7 patients (43.75%). By the study end, seven individuals (30.43%) had succumbed. Eight patients (34.78%) exhibited stable disease, whereas three individuals (13.04%) demonstrated progressing disease. The median survival, as determined by the Kaplan–Meier curve, was 14.16 months. OS exhibited a substantial positive correlation with treatment duration ( r = 0.664, p -value = 0.001). Multivariate COX analysis indicated that the Child–Pugh score was the independent variable correlated with increased mortality (hazard ratio 8.001, 95% confidence interval 1.312–48.803, P -value 0.024). Conclusion Lenvatinib is a safe and well-tolerated therapeutic option for Egyptian patients eligible for systemic treatment of HCC.