Phase II study of S-1 monotherapy in patients over 75 years of age with advanced gastric cancer (OGSG0404)

作者:Imamura Hiroshi*; Kishimoto Tomono; Takiuchi Hiroya; Kimura Yutaka; Morimoto Takashi; Imano Motohiro; Iijima Shohei; Yamashita Keishi; Maruyama Kentaro; Otsuji Toshio; Kurokawa Yukinori; Furukawa Hiroshi
来源:Journal of Chemotherapy, 2014, 26(1): 57-61.
DOI:10.1179/1973947813Y.0000000116

摘要

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-naive 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-naive elderly patients with AGC, but exerts limited activity when given using a tailor-made dosing strategy based on renal function.

  • 出版日期2014-2