Journal article
Phase II, Open-Label Study of Brivanib as First-Line Therapy in Patients with Advanced Hepatocellular Carcinoma
Clinical cancer research, Vol.17(7), pp.1973-1983
04/01/2011
DOI: 10.1158/1078-0432.CCR-10-2011
PMID: 21349999
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. Clin Cancer Res; 17(7); 1973-83. (C)2011 AACR.
Details
- Title: Subtitle
- Phase II, Open-Label Study of Brivanib as First-Line Therapy in Patients with Advanced Hepatocellular Carcinoma
- Creators
- Joong-Won Park - Natl Canc Ctr, Ctr Liver Canc, Goyang 411764, Gyeonggi, South KoreaRichard S. Finn - David Geffen School of Medicine at UCLAJun Suk Kim - Korea Univ, Guro Hosp, Seoul, South KoreaMark Karwal - Univ Iowa, Holden Comprehens Canc Ctr, Iowa City, IA USARuby K. Li - St Lukes Hosp, Quezon City, PhilippinesFuad Ismail - Hosp Univ Kebang Saan, Kuala Lumpur, MalaysiaMelanie Thomas - Medical University of South CarolinaRosemarie Harris - Bristol Myers Squibb Co, Princeton, NJ USAChristine Baudelet - Bristol Myers Squibb Co, Princeton, NJ USAIan Walters - Bristol Myers Squibb Co, Princeton, NJ USAJean-Luc Raoul - Inserm
- Resource Type
- Journal article
- Publication Details
- Clinical cancer research, Vol.17(7), pp.1973-1983
- Publisher
- Amer Assoc Cancer Research
- DOI
- 10.1158/1078-0432.CCR-10-2011
- PMID
- 21349999
- ISSN
- 1078-0432
- eISSN
- 1557-3265
- Number of pages
- 11
- Grant note
- CA182006 / Bristol-Myers Squibb
- Language
- English
- Date published
- 04/01/2011
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359685902771
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