Author information
1
Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.
2
Gibbs Cancer Center and Research Institute, Spartanburg Regional Healthcare System, Spartanburg, South Carolina, USA.
3
Department of Oncology, University of Virginia, Charlottesville, Virginia, USA.
4
New York-Presbyterian Hospital, Columbia University, New York, New York, USA.
5
GI Oncology Research, Sarah Canon Research Institute, Nashville, Tennessee, USA.
6
California Pacific Medical Center, San Francisco, California, USA.
7
Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, California, USA.
Abstract
OBJECTIVES:
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).
METHODS:
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 (n = 47) (B+E) or 400 mg S orally twice daily (n = 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.
RESULTS:
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; p = 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 (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).
CONCLUSIONS:
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.