Background and Aims: To investigate the efficacy and safety of a gemcitabine plus oxaliplatin combination regimen and a floxuridine plus oxaliplatin combination regimen used in transcatheter arterial chemoembolization for patients with inoperable hepatocellular carcinoma (HCC).
Methods: From October 2005 to October 2008, 122 chemonaïve patients with newly diagnosed, inoperable HCC were randomized into a gemcitabine plus oxaliplatin combination regimen group (GO group) or a floxuridine plus oxaliplatin combination regimen group (FO group). The GO group was treated with 1,600 mg of gemcitabine and 200 mg of oxaliplatin, and the FO group was treated with 1,000 mg of floxuridine and 200 mg of oxaliplatin. Both groups were treated with glutin and iodolipol as the embolic agent in the transcatheter arterial chemoembolization (TACE).
Results: The progression-free survival, the median survival period, and the median time to progress had no significant difference between the two groups. However, there was a significant difference in the incidence of grade 3/4 thrombocytopenia between the two groups (P = 0.002). Grade 3/4 hematologic toxicity was observed only in the GO group. One patient (1.7%) with grade 3/4 leukopenia and 6 patients (10%) with grade 3/4 thrombocytopenia were observed. A multivariate analysis revealed that the Eastern Cooperative Oncology Group (ECOG) scores and portal vein thrombosis were the only independent prognostic factors that affected progression-free survival.
Conclusions: The floxuridine plus oxaliplatin combination regimen was tolerated better than the gemcitabine plus oxaliplatin combination regimen used in TACE.
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