S-1 and Gemcitabine as an Outpatient-based Regimen in Patients with Advanced or Metastatic Pancreatic Cancer

Objective: The standard beneficial chemotherapy proved for patients with pancreatic cancer is a regimen containing gemcitabine. Novel oral fluoropyrimidine, S-1, can be added to gemcitabine to improve the efficacy of chemotherapy and to provide better convenience for patients. We aimed to evaluate the efficacy and safety of S-1 plus gemcitabine combi-nation chemotherapy as a first-line treatment in patients with locally advanced or metastatic pancreatic cancer. Methods: Patients with histologically confirmed, bidimensionally measurable advanced/ metastatic pancreatic cancer were eligible for the study. Chemotherapy consisted of S-1 (30 mg/m2 p.o. bid from Day 1 to 14) and gemcitabine (1000 mg/m2 on Days 8 and 15) every 3 weeks based on the results of a previously reported Phase I trial. Treatment was repeated until disease progression or unacceptable toxicity occurred. Results: From January 2005 to August 2007, 22 patients were enrolled. Median age was 62 years (range, 50–73). Nineteen patients (86.3%) had metastases and of these, 11 patients (57.9%) had multiple liver metastases. The overall response rate was 27.3 % (95 % CI, 8.7–45.9), with a partial response in six patients, stable disease in nine (40.9%) an