Article: article from journal or magazin.
Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: two parallel, multicentre phase-II trials.
British journal of Cancer
BACKGROUND: Gemcitabine, oxaliplatin and 5-fluorouracil (5-FU) are active in biliary tract cancer and have a potentially synergistic mode of action and non-overlapping toxicity. The objective of these trials was to determine response, survival and toxicity separately in patients with bile duct cancer (BDC) and gallbladder cancer (GBC) treated with gemcitabine/oxaliplatin/5-FU chemotherapy. METHODS: Eligible patients with histologically proven, advanced or metastatic BDC (n=37) or GBC (n=35) were treated with gemcitabine (900 mg m(-2) over 30 min), oxaliplatin (65 mg m(-2)) and 5-FU (1500 mg m(-2) over 24 h) on days 1 and 8 of a 21-day cycle. Tumour response was the primary outcome measure. RESULTS: Response rates were 19% (95% CI: 6-32%) and 23% (95% CI: 9-37%) for BDC and GBC, respectively. Median survivals were 10.0 months (95% CI: 8.6-12.4) and 9.9 months (95% CI: 7.5-12.2) for BDC and GBC, respectively, and 1- and 2-year survival rates were 40 and 23% in BDC and 34 and 6% in GBC (intention-to-treat analysis). Major grade III and IV adverse events were neutropenia, thrombocytopenia, elevated bilirubin and anorexia. CONCLUSION: Triple-drug chemotherapy achieves comparable results for response and survival to previously reported regimens, but with more toxicity.
Adenocarcinoma/drug therapy, Adenocarcinoma/pathology, Adolescent, Adult, Aged, Antimetabolites, Antineoplastic/administration & dosage, Antimetabolites, Antineoplastic/adverse effects, Bile Duct Neoplasms/drug therapy, Bile Duct Neoplasms/pathology, Deoxycytidine/administration & dosage, Deoxycytidine/adverse effects, Female, Fluorouracil/administration & dosage, Fluorouracil/adverse effects, Gallbladder Neoplasms/drug therapy, Gallbladder Neoplasms/pathology, Humans, Male, Middle Aged, Neoplasm Metastasis, Organoplatinum Compounds/administration & dosage, Organoplatinum Compounds/adverse effects, Survival Rate, Treatment Outcome, Young Adult
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