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An Early Phase II Study of S-1 in Patients with Metastatic Pancreatic Cancer

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.