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

Richard S. Finn*, Yoon Koo Kang, Mary Mulcahy, Blase N. Polite, Ho Yeong Lim, Ian Walters, Christine Baudelet, Demetrios Manekas, Joong Won Park

*Corresponding author for this work

Research output: Contribution to journalArticle

115 Scopus citations

Abstract

Purpose: Brivanib, a selective dual inhibitor of fibroblast growth factor and VEGF signaling, has recently been shown to have activity as first-line treatment for patients with advanced hepatocellular carcinoma (HCC). This phase II open-label study assessed brivanib as second-line therapy in patients with advanced HCC who had failed prior antiangiogenic treatment. Experimental Design: Brivanib was administered orally at a dose of 800 mg once daily. The primary objectives were tumor response rate, time to response, duration of response, progression-free survival, overall survival (OS), disease control rate, time to progression (TTP), and safety and tolerability. Results: Forty-six patients were treated. Best responses to treatment with brivanib (N = 46 patients) using modified World Health Organization criteria were partial responses for two patients (4.3%), stable disease for 19 patients (41.3%), and progressive disease for 19 patients (41.3%). The tumor response rate was 4.3%; the disease control rate was 45.7%. Median OS was 9.79 months. Median TTP as assessed by study investigators following second-line treatment with brivanib was 2.7 months. The most common adverse events were fatigue, decreased appetite, nausea, diarrhea, and hypertension. Conclusion: Brivanib had a manageable safety profile and is one of the first agents to show promising antitumor activity in advanced HCC patients treated with prior sorafenib.

Original languageEnglish (US)
Pages (from-to)2090-2098
Number of pages9
JournalClinical Cancer Research
Volume18
Issue number7
DOIs
StatePublished - Apr 1 2012

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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