Phase 2 study of bevacizumab plus erlotinib in patients with advanced hepatocellular cancer
Philip A Philip1, Michelle R Mahoney, Kyle D Holen
1Karmanos Cancer Institute, Detroit, Michigan 48201, USA. philipp@karmanos.org
Background:
Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) are rational targets for therapy in hepatocellular cancer (HCC).
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 150 mg daily and bevacizumab 10 mg/kg on days 1 and 15 every 28 days. Objective tumor response was the primary end point.
Results:
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.
Conclusions:
In this trial, erlotinib combined with bevacizumab had minimal activity in patients with advanced HCC based on objective response and progression-free survival. The role of targeting EGFR and VEGF in HCC needs further evaluation in molecularly selected patients.
Insights
Erlotinib and bevacizumab showed minimal activity in advanced hepatocellular cancer (HCC). Further research is needed to evaluate targeted therapies like epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) inhibitors in HCC.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- Hepatocellular cancer (HCC) is a significant global health concern.
- Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) are recognized as key targets for HCC therapy.
Purpose of the Study:
- To evaluate the efficacy and safety of combining erlotinib (EGFR inhibitor) with bevacizumab (VEGF inhibitor) in patients with advanced HCC.
- To determine the objective tumor response rate as the primary endpoint.
Main Methods:
- A 2-stage phase 2 trial included 27 patients with advanced HCC.
- Patients had ECOG performance status 0-1, Child's Pugh A or B, and prior systemic therapy.
- Treatment involved daily erlotinib and bi-monthly bevacizumab.
Main Results:
- One patient achieved a partial response; 11 (48%) had stable disease.
- Median time to disease progression was 3.0 months.
- Median survival time was 9.5 months, with grade 3 toxicities including rash, hypertension, fatigue, and diarrhea.
Conclusions:
- The combination of erlotinib and bevacizumab demonstrated limited activity in advanced HCC.
- Targeting EGFR and VEGF in HCC requires further investigation, potentially in molecularly selected patient populations.
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