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Abstract
Background: S-1+cisplatin (CDDP) is the standard treatment for advanced gastric cancer (AGC) in Japan and Korea. However, the usefulness of S-1 based chemotherapy for elderly patients is unclear. Therefore, we conducted a multicenter phase II study of S-1 monotherapy for AGC in elderly patients.
Materials and Methods: Chemotherapy-naïve patients aged over 75 years with AGC were enrolled. The starting dose of S-1 was determined on the basis of body surface area and modified according to the creatinine clearance value. S-1 was administered twice a day during a 4-week period followed by a 2-week rest period.
Results: Thirty-five patients were enrolled. The response rate (RR) was 14·3% and the median overall survival was 14·6 months. Grade 3 or more severe adverse events consisted of anaemia (3%), neutropaenia (3%), anorexia (3%), and fatigue (6%). There were no treatment-related deaths.
Conclusion: Our study indicates that S-1 monotherapy is safe and well tolerated in chemotherapy-naïve elderly patients with AGC, but exerts limited activity when given using a tailor-made dosing strategy based on renal function.
We are indebted to the physicians and all other co-medical staff who contributed to this study. We thank J. Patrick Barron of the International Medical Communications Centre of Tokyo Medical University (Tokyo, Japan) for his review of this report. We also thank Ms Akiko Hotta and Ms Hiroko Maruyama at the OGSG data center for their excellent secretarial assistance. We particularly thank Dr T. Shimokawa for support with the statistics. The author thanks Mr Eisuke Matsunaga and Mr Tetsuya Fujita for their helpful advice.
The authors have no conflicts of interest to report.