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

AbstractPURPOSE:
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.
AuthorsRichard S Finn, Yoon-Koo Kang, Mary Mulcahy, Blase N Polite, Ho Yeong Lim, Ian Walters, Christine Baudelet, Demetrios Manekas, Joong-Won Park
JournalClinical cancer research : an official journal of the American Association for Cancer Research (Clin Cancer Res) Vol. 18 Issue 7 Pg. 2090-8 (Apr 01 2012) ISSN: 1557-3265 [Electronic] United States
PMID22238246 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)
Copyright©2012 AACR.
Chemical References
  • AFP protein, human
  • Collagen Type IV
  • Triazines
  • alpha-Fetoproteins
  • brivanib
  • Alanine
Topics
  • Administration, Oral
  • Adult
  • Aged
  • Aged, 80 and over
  • Alanine (adverse effects, analogs & derivatives, therapeutic use)
  • Appetite (drug effects)
  • Carcinoma, Hepatocellular (blood, drug therapy)
  • Collagen Type IV (blood)
  • Disease-Free Survival
  • Drug Administration Schedule
  • Fatigue (chemically induced)
  • Female
  • Humans
  • Hypertension (chemically induced)
  • Liver Neoplasms (blood, drug therapy)
  • Male
  • Middle Aged
  • Nausea (chemically induced)
  • Treatment Outcome
  • Triazines (adverse effects, therapeutic use)
  • Young Adult
  • alpha-Fetoproteins (analysis)

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