Phase II, open-label study of brivanib as first-line therapy in patients with advanced hepatocellular carcinoma

Joong Won Park, Richard S. Finn, Jun Suk Kim, Mark Karwal, Ruby K. Li, Fuad Ismail, Melanie Thomas, Rosemarie Harris, Christine Baudelet, Ian Walters, Jean Luc Raoul

Research output: Contribution to journalArticlepeer-review

130 Citations (Scopus)

Abstract

Purpose: Brivanib, a selective dual inhibitor of fibroblast growth factor and VEGF signaling, has demonstrated encouraging antitumor activity in preclinical and phase I studies. We performed a phase II open-label study of brivanib as first-line therapy in patients with unresectable, locally advanced, or metastatic hepatocellular carcinoma. Experimental Design: Brivanib was administered orally at a dose of 800 mg once daily. The primary objective was 6-month progression-free survival, progression-free survival rate; secondary objectives were tumor response rate, time to response, duration of response, median progression-free survival, median overall survival, disease control rate (complete response, partial response, or stable disease ≥ 42 days), and safety and tolerability. Results: Between March 2007 and May 2009, 55 patients were treated and were evaluable for response. Patients were assessed using modified World Health Organization (mWHO) criteria. According to mWHO criteria and as assessed by Independent Response Review Committee, the six-month progression-free survival rate (95% CI) was 18.2% (9.1%-30.9%). Median progression-free survival (95% CI) was 2.7 months (1.4-3.0). One patient achieved a complete response and three achieved a partial response. Twenty-two had stable disease. Median overall survival (95% CI) was 10 (6.8-15.2) months. Brivanib was generally well tolerated; the most common adverse events included fatigue, hypertension, and diarrhea. Conclusion: Brivanib as first-line therapy demonstrates promising antitumor activity and a manageable safety profile in patients with advanced, unresectable HCC.

Original languageEnglish
Pages (from-to)1973-1983
Number of pages11
JournalClinical Cancer Research
Volume17
Issue number7
DOIs
Publication statusPublished - 2011 Apr 1

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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