Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial
Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma.
In a multi‑centre, open‑label, phase‑3, non‑inferiority randomized controlled trial, 954 patients with unresectable hepatocellular carcinoma (HCC) were assigned 1:1 to lenvatinib or sorafenib as first‑line therapy. The primary endpoint of overall survival (OS) was non‑inferior for lenvatinib (median OS 13.6 months) compared with sorafenib (12.7 months; hazard ratio 0.92, 95% CI 0.79–1.706). Common grade ≥1 adverse events included hypertension, diarrhoea and decreased appetite. Lenvatinib showed a safety profile consistent with prior observations.
Hepatocellular carcinoma remains a leading cause of cancer-related mortality worldwide. This study demonstrates that lenvatinib offers a comparable survival benefit to the established first‑line therapy sorafenib, providing clinicians with an alternative treatment option, particularly for patients who may not tolerate sorafenib’s side‑effect profile.
Evidence level: Sejtvonalas. Laboratóriumi sejtekben vizsgálták.
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