Efficacy of Bevacizumab plus Erlotinib for Advanced Hepatocellular Carcinoma and Predictors of Outcome: Final Results of a Phase II TrialKaseb A.O. · Garrett-Mayer E. · Morris J.S. · Xiao L. · Lin E. · Onicescu G. · Hassan M.M. · Hassabo H.M. · Iwasaki M. · Deaton F.L. · Abbruzzese J.L. · Thomas M.B.
Departments of aGastrointestinal Medical Oncology and bBiostatistics, University of Texas MD Anderson Cancer Center, Houston, Tex., and cDepartment of Medical Oncology, Hollings Cancer Center, Medical University of South Carolina, Charleston, S.C., USA
Objective: A phase II study was performed to evaluate the efficacy and tolerability of bevacizumab and erlotinib in advanced hepatocellular carcinoma (HCC) patients, and to investigate clinical and molecular predictors of outcome. Methods: 59 patients with advanced HCC received 10 mg/kg i.v. of bevacizumab every 14 days and 150 mg p.o. of erlotinib daily. The primary endpoint was progression-free survival (PFS) at 16 weeks. Clinical characteristics and plasma biomarkers expression levels were analyzed. Results: PFS at 16 weeks was 64% (95% CI 51–76): 14 patients achieved partial response (24%), 33 had stable disease (56%), 6 progressed (10%), and 6 were not evaluable (10%). Median overall survival was 13.7 months (95% CI 9.6–19.7), and median PFS was 7.2 months (95% CI 5.6–8.3). Grade 3–4 adverse events included fatigue (30%), diarrhea (17%), hypertension (14%), elevated transaminases (12%), and gastrointestinal hemorrhage (10%). High plasma angiopoietin-2, epidermal growth factor receptor, and endothelin-1, and lack of acneiform rash were associated with poor outcome. Conclusions: The combination of bevacizumab with erlotinib achieved encouraging results in patients with advanced HCC. Current correlatives may help to guide future HCC studies.
Ahmed O. Kaseb, MD
Department of Gastrointestinal Medical Oncology
Unit 426, University of Texas MD Anderson Cancer Center
1515 Holcombe Blvd, Houston, TX 77030 (USA)
Tel. +1 713 792 2828, E-Mail firstname.lastname@example.org
This research was supported by Genentech BioOncology.
Received: October 28, 2011
Accepted after revision: December 8, 2011
Published online: February 7, 2012
Number of Print Pages : 8
Number of Figures : 1, Number of Tables : 5, Number of References : 30
Additional supplementary material is available online - Number of Parts : 2
Oncology (International Journal for Cancer Research and Treatment)
Vol. 82, No. 2, Year 2012 (Cover Date: March 2012)
Journal Editor: Markman M. (Philadelphia, Pa.)
ISSN: 0030-2414 (Print), eISSN: 1423-0232 (Online)
For additional information: http://www.karger.com/OCL