A multiple-center phase II study of biweekly oxaliplatin and tegafur-uracil/leucovorin for chemonaive patients with advanced gastric cancer

Jen Shi Chen, Kun Ming Rau, Yen Yang Chen, Jen Seng Huang, Tsai Shen Yang, Yung Chang Lin, Chi Ting Liau, Kuan Der Lee, Yu Cheih Su, Ruey Ho Kao

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Purpose: The current study assessed the efficacy and safety of biweekly oxaliplatin combining oral tegafur-uracil/leucovorin in treating chemonaive patients with advanced gastric cancer. Methods: Eligible patients were 18-75 years old, had stage IV disease or post-surgery recurrence, no prior palliative chemotherapy, and an ECOG performance status of 0-2. Patients in the current study received 2-h i.v. infusion of oxaliplatin at a dose of 100 mg/m 2 after diluting in 500 mL 5% dextrose/water (dexan premedication), and 5-HT3 antagonist biweekly. Oral tegafur-uracil and leucovorin was given at a dose of 300 mg/m2/day and 60 mg/day three times daily from day 1 to 21, respectively, followed by a 1-week rest. Response assessment was based on the RECIST criteria and was performed every two courses. Toxicity was assessed according to NCI common toxicity criteria version 2. Results: From October 2003 to April 2006, 57 patients were evaluated (55 eligible) with a median age of 61 years (range 31-75). According to the assessment of response in 48 evaluable patients, partial response rate was 24/48 (50.0%) (95% CI: 35.23-64.73%) and stable disease was observed in 11 patients (22.92%), and diseased progressed in 13 patients (27.08%). Mean number of oxaliplatin cycles was 3 (0.5-6.5). Median time to progression was 177 days. Median overall survival was 318 days. Major-grade (III/IV) toxicities were diarrhea 25.5%, vomiting 16.5%, anemia 10.9%, numbness 12.7%, thrombocytopenia 7.3%, neutropenia 3.6% and leucopenia 1.8%. Conclusions: Biweekly, oxaliplatin combining oral tegafur-uracil/ leucovorin in treating patients with advanced gastric cancer showed acceptable activity and manageable toxicity.

Original languageEnglish
Pages (from-to)819-825
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Issue number5
Publication statusPublished - Apr 2009
Externally publishedYes



  • Chemotherapy
  • Gastric cancer
  • Leucovorin
  • Oxaliplatin
  • Tegafur-uracil

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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