Bevacizumab with erlotinib as first-line therapy in Asian patients with advanced hepatocellular carcinoma: A multicenter phase II study

Chih Hung Hsu, Yoon Koo Kang, Tsai Shen Yang, Chia Tung Shun, Yu Yun Shao, Wu Chou Su, Jennifer Sandoval-Tan, Tzeon Jye Chiou, Kate Jin, Chiun Hsu, Ann Lii Cheng

Research output: Contribution to journalArticlepeer-review

35 Citations (Scopus)

Abstract

Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)44-52
Number of pages9
JournalOncology (Switzerland)
Volume85
Issue number1
DOIs
Publication statusPublished - 2013 Jul

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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