An early phase II study of S-1 in patients with metastatic pancreatic cancer

Oncology. 2005;68(2-3):171-8. doi: 10.1159/000086771. Epub 2005 Jul 4.


Objective: The aim of this study was to evaluate the efficacy and toxicity of S-1 in patients with metastatic pancreatic cancer.

Methods: Patients were required to have a histological diagnosis of pancreatic adenocarcinoma with measurable metastatic lesions, and no prior chemotherapy. S-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 14 days as one course. Administration was repeated until the appearance of disease progression or unacceptable toxicity. A pharmacokinetic study was done on day 1 in the initial 8 patients.

Results: Nineteen patients were entered into this study. Four patients (21.1%) achieved a partial response with a 95% confidence interval of 6.1-45.6%. No change was noted in 10 patients (52.6%), and progressive disease in 5 patients (26.3%). The median survival time was 5.6 months with a one-year survival rate of 15.8%. The major adverse events were gastrointestinal toxicities such as nausea and anorexia, though most of them were tolerable and reversible. There were no large differences in the pharmacokinetic parameters of S-1 in patients with pancreatic cancer and those in patients with other cancers.

Conclusion: S-1 is active and tolerated in patients with metastatic pancreatic cancer, which will be confirmed in the following large-scale phase II study.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antimetabolites, Antineoplastic / adverse effects
  • Antimetabolites, Antineoplastic / blood
  • Antimetabolites, Antineoplastic / pharmacokinetics
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Disease Progression
  • Drug Combinations
  • Female
  • Humans
  • Male
  • Middle Aged
  • Oxonic Acid / adverse effects
  • Oxonic Acid / blood
  • Oxonic Acid / pharmacokinetics
  • Oxonic Acid / therapeutic use*
  • Pancreatic Neoplasms / drug therapy*
  • Pancreatic Neoplasms / pathology
  • Pyridines / adverse effects
  • Pyridines / blood
  • Pyridines / pharmacokinetics
  • Pyridines / therapeutic use*
  • Tegafur / adverse effects
  • Tegafur / blood
  • Tegafur / pharmacokinetics
  • Tegafur / therapeutic use*
  • Treatment Outcome


  • Antimetabolites, Antineoplastic
  • Drug Combinations
  • Pyridines
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid