TY - JOUR
T1 - Multicentre phase II trial of capecitabine plus oxaliplatin (XELOX) in patients with advanced hepatocellular carcinoma
T2 - FFCD 03-03 trial
AU - Boige, V.
AU - Raoul, J. L.
AU - Pignon, J. P.
AU - Bouché, O.
AU - Blanc, J. F.
AU - Dahan, L.
AU - Jouve, J. L.
AU - Dupouy, N.
AU - Ducreux, M.
PY - 2007/10/8
Y1 - 2007/10/8
N2 - 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.
AB - 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.
KW - Capecitabine
KW - Chemotherapy
KW - Hepatocellular carcinoma
KW - Oxaliplatin
KW - Phase II clinical trial
KW - XELOX
UR - http://www.scopus.com/inward/record.url?scp=34948837268&partnerID=8YFLogxK
U2 - 10.1038/sj.bjc.6603956
DO - 10.1038/sj.bjc.6603956
M3 - Article
C2 - 17876335
AN - SCOPUS:34948837268
SN - 0007-0920
VL - 97
SP - 862
EP - 867
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 7
ER -