Lenvatinib

An international, open-label, phase III, noninferiority trial (E7080-G000-304 [NCT01761266]) that included patients from 20 countries in Asia, Europe, and North America enrolled 954 patients with advanced HCC and Child-Pugh class A disease. Patients were randomly assigned in a 1:1 ratio to receive either lenvatinib (12 mg qd for body weight >60 kg or 8 mg for body weight <60 kg) or sorafenib (400 mg bid in 28-day cycles).[14] Patients with more than 50% liver involvement and portal vein invasion were excluded.

An international, open-label, phase III, noninferiority trial (E7080-G000-304 [NCT01761266]) that included patients from 20 countries in Asia, Europe, and North America enrolled 954 patients with advanced HCC and Child-Pugh class A disease. Patients were randomly assigned in a 1:1 ratio to receive either lenvatinib (12 mg qd for body weight >60 kg or 8 mg for body weight <60 kg) or sorafenib (400 mg bid in 28-day cycles).[14] Patients with more than 50% liver involvement and portal vein invasion were excluded.

The median OS was 13.6 months, which reached noninferiority, for patients who received lenvatinib and 12.3 months for patients who received sorafenib (HR, 0.92; 95% CI, 0.79–1.06).[14][Level of evidence B1]

An international, open-label, phase III, noninferiority trial (E7080-G000-304 [NCT01761266]) that included patients from 20 countries in Asia, Europe, and North America enrolled 954 patients with advanced HCC and Child-Pugh class A disease. Patients were randomly assigned in a 1:1 ratio to receive either lenvatinib (12 mg qd for body weight >60 kg or 8 mg for body weight <60 kg) or sorafenib (400 mg bid in 28-day cycles).[14] Patients with more than 50% liver involvement and portal vein invasion were excluded.

The median PFS was 7.4 months for patients who received lenvatinib and 3.7 months for patients who received sorafenib (HR, 0.66; 95% CI, 0.57–0.77).

An international, open-label, phase III, noninferiority trial (E7080-G000-304 [NCT01761266]) that included patients from 20 countries in Asia, Europe, and North America enrolled 954 patients with advanced HCC and Child-Pugh class A disease. Patients were randomly assigned in a 1:1 ratio to receive either lenvatinib (12 mg qd for body weight >60 kg or 8 mg for body weight <60 kg) or sorafenib (400 mg bid in 28-day cycles).[14] Patients with more than 50% liver involvement and portal vein invasion were excluded.

Treatment-related adverse events were similar between the lenvatinib arm and the sorafenib arm.

An international, open-label, phase III, noninferiority trial (E7080-G000-304 [NCT01761266]) that included patients from 20 countries in Asia, Europe, and North America enrolled 954 patients with advanced HCC and Child-Pugh class A disease. Patients were randomly assigned in a 1:1 ratio to receive either lenvatinib (12 mg qd for body weight >60 kg or 8 mg for body weight <60 kg) or sorafenib (400 mg bid in 28-day cycles).[14] Patients with more than 50% liver involvement and portal vein invasion were excluded. › Treatment-related adverse events were similar between the lenvatinib arm and the sorafenib arm.

In the lenvatinib arm, the most common side effects were hypertension (any grade, 42%), diarrhea (39%), decreased appetite (34%), and decreased weight (31%), with 11 treatment-related deaths (hepatic failure, hemorrhage, and respiratory failure).

An international, open-label, phase III, noninferiority trial (E7080-G000-304 [NCT01761266]) that included patients from 20 countries in Asia, Europe, and North America enrolled 954 patients with advanced HCC and Child-Pugh class A disease. Patients were randomly assigned in a 1:1 ratio to receive either lenvatinib (12 mg qd for body weight >60 kg or 8 mg for body weight <60 kg) or sorafenib (400 mg bid in 28-day cycles).[14] Patients with more than 50% liver involvement and portal vein invasion were excluded. › Treatment-related adverse events were similar between the lenvatinib arm and the sorafenib arm.

In the sorafenib arm, the most common side effects were palmar-plantar erythrodysesthesia (any grade, 52%), diarrhea (46%), hypertension (30%), and decreased appetite (27%), with four treatment-related deaths (hemorrhage, stroke, respiratory failure, and sudden death).