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

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