Phase 2 trial of bevacizumab, capecitabine, and oxaliplatin in treatment of advanced hepatocellular carcinoma

• Published in: Cancer 2011-07, Vol.117 (14), p.3187-3192
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Adult; advanced; Aged; Aged, 80 and over; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; anti‐angiogenesis; Bevacizumab; Biological and medical sciences; Capecitabine; Carcinoma, Hepatocellular - drug therapy; Carcinoma, Hepatocellular - pathology; chemotherapy; cirrhosis; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Disease-Free Survival; Female; Fluorouracil - administration & dosage; Fluorouracil - analogs & derivatives; Gastroenterology. Liver. Pancreas. Abdomen; hepatocellular carcinoma; Humans; Liver Neoplasms - drug therapy; Liver Neoplasms - pathology; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; Medical sciences; metastatic; Middle Aged; Neoplasm Metastasis; Organoplatinum Compounds - administration & dosage; oxaliplatin; phase 2; Tumors
• ISSN: 0008-543X; 1097-0142
• DOI: 10.1002/cncr.25889

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/m2 on day 1 of each cycle, and capecitabine 825 mg/m2 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. Anti‐angiogenesis agents have shown effectiveness in treatment of hepatocellular carcinoma (HCC). The combination of bevacizumab, oxaliplatin, and capecitabine showed encouraging results in both effective and safe profiles in treatment of patients with advanced unresectable and untransplantable HCC, especially in those patients with suboptimal performance status and liver function.