Multicentre phase II trial of capecitabine plus oxaliplatin (XELOX) in patients with advanced hepatocellular carcinoma: FFCD 03-03 trial

• Published in: British journal of cancer 2007-10, Vol.97 (7), p.862-867
• Main Authors: Boige, V, Raoul, J-L, Pignon, J-P, Bouché, O, Blanc, J-F, Dahan, L, Jouve, J-L, Dupouy, N, Ducreux, M
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Cancer Research; Carcinoma, Hepatocellular - drug therapy; Carcinoma, Hepatocellular - pathology; Carcinoma, Hepatocellular - virology; Clinical Study; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Drug Combinations; Drug Resistance; Epidemiology; Female; Fluorouracil - analogs & derivatives; Fluorouracil - therapeutic use; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Liver Neoplasms - drug therapy; Liver Neoplasms - secondary; Liver Neoplasms - virology; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; Medical sciences; Middle Aged; Molecular Medicine; Oncology; Organoplatinum Compounds - therapeutic use; Prognosis; Survival Rate; Treatment Outcome; Tumors
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/sj.bjc.6603956

Evaluation of new drug combinations is needed to improve patients' prognosis in advanced hepatocellular carcinoma (HCC). The purpose of this study was to evaluate the safety and efficacy of the capecitabine–oxaliplatine combination (XELOX) in HCC patients. First-line chemotherapy with XELOX regimen consisting of a 3-week cycle of intravenous oxaliplatin (130 mg m −2 ) on Day 1, and oral capecitabine twice daily from Days 1–14 (1000 mg m −2 ) was administered in patients with measurable, unresectable HCC. Fifty patients (male, 88%; median age, 68 years) received a total of 295 cycles (median, 6) of treatment. Disease control (three partial responses, 29 stable diseases) rate was 72% (95% CI 57–83%). Median overall and median progression-free (PFS) survival was 9.3 months and 4.1 months, respectively. Progression-free survival rates at 6 and 12 months were 38% (95% CI 26–52%) and 14% (95% CI 7–26%), respectively. Main grade 3–4 drug-related toxicities included diarrhoea (16%), elevation of aminotransferases and/or bilirubin (16%), thrombocytopenia (12%), and neurotoxicity (6%). Capecitabine plus oxaliplatin regimen showed modest anti-tumour activity with tolerable toxicities in patients with advanced HCC. However, the manageable toxicity profile and the encouraging disease control rate deserve further attention for this convenient, outpatient-based chemotherapy regimen.