A phase I study of combination chemotherapy with gemcitabine and oral S-1 for advanced pancreatic cancer

Hideki Ueno, Takuji Okusaka, Masafumi Ikeda, Yoriko Ishiguro, Chigusa Morizane, Junichi Matsubara, Junji Furuse, Hiroshi Ishii, Michitaka Nagase, Kohei Nakachi

Research output: Contribution to journalArticlepeer-review

50 Scopus citations


Objective: The aim of this study was to determine the maximum-tolerated dose and dose-limiting toxicity (DLT) of combination therapy with gemcitabine and S-1 in patients with advanced pancreatic cancer. Methods: Chemotherapy-naive patients with histologically or cytologically proven unresectable or metastatic pancreatic cancer were enrolled. The patients received gemcitabine intravenously over 30 min on days 1 and 8 and S-1 orally twice daily from days 1 to 14. Cycles were repeated every 21 days until disease progression. Patients were scheduled to receive gemcitabine (mg/m2/week) and S-1 (mg/m 2/day) at four dose levels: 800/60 (level 1), 1,000/60 (level 2), 1,000/70 (level 3) and 1,000/80 (level 4). Results: Eighteen patients were enrolled in this study. The maximum-tolerated dose was not reached even at the highest dose level (level 4) because only 2 of the 6 patients at this level experienced DLT. The DLTs were neutropenia and rash. Six (33%) of the 18 patients achieved a partial response and median overall survival time was 7.6 months. Conclusions: Combination chemotherapy with gemcitabine and S-1 was well tolerated and showed good antitumor activity in the treatment of pancreatic cancer. We recommend a gemcitabine dose of 1,000 mg/m2/week and an S-1 dose of 80 mg/m2/day in further studies with this schedule.

Original languageEnglish
Pages (from-to)421-427
Number of pages7
Issue number5
StatePublished - Dec 2005
Externally publishedYes


  • 5-Fluorouracil
  • Gemcitabine
  • Pancreatic cancer
  • S-1


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