A Randomized Phase II Open-Label Multi-Institution Study of the Combination of Bevacizumab and Erlotinib Compared to Sorafenib in the First-Line Treatment of Patients with Advanced Hepatocellular Carcinoma.

<bold><italic>Objectives:</italic></bold> To investigate the clinical efficacy and tolerability of the combination of bevacizumab (B) and erlotinib (E) compared to sorafenib (S) as first-line treatment for patients with advanced hepatocellular carcinoma (HCC). <bold><italic>Methods:</italic></bold> A total of 90 patients with advanced HCC, Child-Pugh class A–B7 cirrhosis, and no prior systemic therapy were randomly assigned (1: 1) to receive either 10 mg/kg B intravenously every 14 days and 150 mg E orally daily (<italic>n</italic> = 47) (B+E) or 400 mg S orally twice daily (<italic>n</italic> = 43). The primary endpoint was overall survival (OS). Secondary endpoints included event-free survival (EFS), objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), time to progression, and safety and tolerability. <bold><italic>Results:</italic></bold> The median OS was 8.55 months (95% CI: 7.00–13.9) for patients treated with B+E and 8.55 months (95% CI: 5.69–12.2) for patients receiving S. The hazard ratio (HR) for OS was 0.92 (95% CI: 0.57–1.47). The median EFS was 4.37 months (95% CI: 2.99–7.36) for patients receiving B+E and 2.76 months (95% CI: 1.84–4.80) for patients receiving S. The HR for EFS was 0.67 (95% CI: 0.42–1.07; <italic>p</italic> = 0.09), favoring B+E over S. When OS was assessed among patients who were Child-Pugh class A, the median OS was 11.4 months (95% CI: 7.5–15.7) for patients treated with B+E (<italic>n</italic> = 39) and 10.26 months (95% CI: 5.9–13.0) for patients treated with S (<italic>n</italic> = 38) (HR = 0.88; 95% CI: 0.53–1.46). <bold><italic>Conclusions:</italic></bold> There was no difference in efficacy between the B+E and S arms, although the safety and tolerability profile tended to favor B+E over S based on competing risk analysis. [ABSTRACT FROM AUTHOR]