Supplementary Material for: Bevacizumab with Erlotinib as First-line Therapy in Asian Patients with Advanced Hepatocellular Carcinoma: A Multicenter Phase II Study
Hsu C.-H.
Kang Y.K.
Yang T.-S.
Shun C.-T.
Shao Y.-Y.
Su W.-C.
Sandoval-Tan J.
Chiou T.-J.
Jin K.
Hsu C.
10.6084/m9.figshare.5124985.v1
https://karger.figshare.com/articles/dataset/Supplementary_Material_for_Bevacizumab_with_Erlotinib_as_First-line_Therapy_in_Asian_Patients_with_Advanced_Hepatocellular_Carcinoma_A_Multicenter_Phase_II_Study/5124985
<b><i>Objectives:</i></b> The bevacizumab/erlotinib combination was reported with high clinical activity for advanced hepatocellular carcinoma (HCC) by a phase II study conducted in the USA. This multicenter study across several Asian countries was to evaluate the safety and efficacy of the combination in this population. <b><i>Methods:</i></b> Patients with histology-proven HCC, advanced disease and Child-Pugh class A liver function received bevacizumab 5 mg/kg intravenously every 2 weeks and erlotinib 150 mg/day orally as first-line therapy. The primary end point was progression-free survival at 16 weeks (PFS-16W). The expression of epidermal growth factor receptor (EGFR), phospho-AKT and vascular endothelial growth factor, the microvessel density and the EGFR gene copy number in HCC tissues were correlated with treatment efficacy. <b><i>Results:</i></b> Fifty-one patients were enrolled. The PFS-16W was 35.3% (95% CI 22.4-49.9), the median PFS was 2.9 months (95% CI, 1.3-4.4) and the median overall survival was 10.7 months (95% CI, 6.2-15.2). Grade 3/4 toxicities were uncommon, including rash, acne (10% each), diarrhea (6%) and gastrointestinal bleeding (4%). None of the evaluated biomarkers correlated with disease control or PFS. <b><i>Conclusions:</i></b> Bevacizumab plus erlotinib showed good tolerability and modest activity in this Asian cohort. Further studies are warranted to identify the predictive biomarkers of this combination.
2013-07-04 00:00:00
Bevacizumab
Erlotinib
Hepatocellular carcinoma
Phase II study