Thomas MB, et al. - Bevacizumab (B) combined with erlotinib (E) vs sorafenib (S) was tested for clinical efficacy and tolerability when administered as first-line therapy in patients with advanced hepatocellular carcinoma (HCC). In terms of efficacy, no difference was seen between the B+E and S arms. On the basis of competing risk analysis, a favorable safety and tolerability profile of B+E, compared to S, was demonstrated.

Methods

• In a random fashion (1:1), either 10 mg/kg B intravenously every 14 days and 150 mg E orally daily (n = 47) (B+E) or 400 mg S orally twice daily (n = 43) was administered to 90 patients with advanced HCC, Child-Pugh class A–B7 cirrhosis, and no prior systemic therapy.
• Overall survival (OS) was the primary endpoint.
• 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 were included as secondary endpoints.

Results

• For those receiving B+E and for patients receiving S, the reported median OS was 8.55 months (95% CI: 7.00–13.9) and 8.55 months (95% CI: 5.69–12.2), respectively.
• The hazard ratio (HR) for OS was 0.92 (95% CI: 0.57–1.47).
• For the B+E group and for the S group, the observed median EFS was 4.37 months (95% CI: 2.99–7.36) and 2.76 months (95% CI: 1.84–4.80), respectively.
• Researchers found that the HR for EFS was 0.67 (95% CI: 0.42–1.07; p=0.09), favoring B+E over S.
• Among patients who were Child-Pugh class A, median OS was evaluated to be 11.4 months (95% CI: 7.5–15.7) for patients treated with B+E (n = 39) and 10.26 months (95% CI: 5.9–13.0) for patients treated with S (n = 38) (HR = 0.88; 95% CI: 0.53–1.46).