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Phase 2 study of bevacizumab plus erlotinib in patients with advanced hepatocellular cancer†
Article first published online: 27 SEP 2011
Copyright © 2011 American Cancer Society
Volume 118, Issue 9, pages 2424–2430, 1 May 2012
How to Cite
Philip, P. A., Mahoney, M. R., Holen, K. D., Northfelt, D. W., Pitot, H. C., Picus, J., Flynn, P. J. and Erlichman, C. (2012), Phase 2 study of bevacizumab plus erlotinib in patients with advanced hepatocellular cancer. Cancer, 118: 2424–2430. doi: 10.1002/cncr.26556
This study is registered as NCT00365391 at www.clinicaltrials.gov.
- Issue published online: 20 APR 2012
- Article first published online: 27 SEP 2011
- Manuscript Accepted: 6 JUL 2011
- Manuscript Revised: 23 MAY 2011
- Manuscript Received: 6 APR 2011
- hepatocellular cancer;
- vascular endothelial growth factor;
- epidermal growth factor receptor
Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) are rational targets for therapy in hepatocellular cancer (HCC).
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.
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.
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. Cancer 2012. © 2011 American Cancer Society.