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Phase 2 trial of bevacizumab, capecitabine, and oxaliplatin in treatment of advanced hepatocellular carcinoma
Author(s) -
Sun Weijing,
Sohal Davendra,
Haller Daniel G.,
Mykulowycz Kristine,
Rosen Mark,
Soulen Michael C.,
Caparro Millie,
Teitelbaum Ursina R.,
Giantonio Bruce,
O'Dwyer Peter J.,
Shaked Abraham,
Reddy Rajender,
Olthoff Kim
Publication year - 2011
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.25889
Subject(s) - medicine , capecitabine , oxaliplatin , bevacizumab , hepatocellular carcinoma , gastroenterology , oncology , chemotherapy , colorectal cancer , surgery , cancer
Abstract BACKGROUND: Anti‐angiogenesis agents have shown effectiveness in treatment of hepatocellular carcinoma (HCC). It is important to investigate more effective and safe systemic treatment options for patients with advanced HCC. This phase 2 study was designed to determine the efficacy and toxicity of the combination of bevacizumab, capecitabine, and oxaliplatin in patients with advanced unresectable and untransplantable HCC. METHODS: Chemotherapy‐naive patients with advanced unresectable and untransplantable HCC were treated with bevacizumab 5 mg/kg and oxaliplatin 130 mg/m 2 on day 1 of each cycle, and capecitabine 825 mg/m 2 orally twice a day from days 1 to 14 of a 21‐day cycle. RESULTS: Forty patients were enrolled to the study, in which 40% had Child‐Pugh B disease. Forty percent had an Eastern Cooperative Oncology Group performance status (PS) of 0, 55% had PS of 1, and 5% had PS of 2. Forty percent of patients had hepatitis B virus infection. The median progression‐free survival was 6.8 months (95% CI, 3.4‐9.1 months), and the median overall survival was 9.8 months (95% CI, 5.2‐12.1 months). Eight patients (20%) achieved partial response; 23 patients had stable disease with overall 77.5% disease control rate. The combination was tolerable with limited grade 3/4 toxicity, mainly peripheral neurotoxicity and fatigue. CONCLUSIONS: The combination appeared effective and safe, and the results were encouraging. Further investigation should be considered. Cancer 2011. © 2011 American Cancer Society.