Phase 2 study of bevacizumab plus erlotinib in patients with advanced hepatocellular cancer
Philip PA et al. – In this trial, erlotinib combined with bevacizumab had minimal activity in patients with advanced hepatocellular cancer (HCC) based on objective response and progression–free survival. The role of targeting epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) in HCC needs further evaluation in molecularly selected patients.Methods
- Patients with histologically proven HCC and not amenable to curative or liver directed therapy were included in this 2-stage phase 2 trial.
- Eligibility included an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 and Child's Pugh score of A or B, and 1 prior systemic therapy.
- Patients received erlotinib 150mg daily and bevacizumab 10mg/kg on days 1 and 15 every 28days.
- Objective tumor response was the primary end point.
- Twenty-seven patients with advanced HCC (median age, 60 years) were enrolled in this multi-institutional study.
- The proportion of patients with Child's A classification was 74%.
- One patient had a confirmed partial response and 11 (48%) achieved stable disease.
- Median time to disease progression was 3.0 months (95% confidence interval [CI], 1.8-7.1).
- Median survival time was 9.5 months (95% CI, 7.1-17.1).
- Grade 3 toxicities included rash, hypertension, fatigue, and diarrhea.