A Phase III study of combination therapy of the oral fluorinated pyrimidine compound tegafur-uracil (UFT) with low dose cisplatin compared with UFT alone in patients with locally advanced gastric cancer as postoperative adjuvant chemotherapy

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概要

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• Background: While surgery remains the sole mainstay of any curative treatment for gastric cancer, the relapse rate is high and survival remains low even after surgical resection with curative intent.Methods: Based on biochemical modulation theory, this trial was assigned for gastric cancer patients as post operative adjuvant setting with at least 4 cycles of either UFT (UF group) or 5-FU plus low dose cisplatin (CF) and UFT (CD group). The planned 4 cycles of CF treatment was received by 95% of patients in the CD group. One year of UFT was received by 93 (99%) and 91 (97%) of the patients in the groups administered UFT and cisplatin/5FU+UFT, respectively.Results: The result suggests better 5 year survival rate in the combination treatment group, with a reduction in risk of 13%. 5 year DFS was also showed benefit of combination therapy over UFT alone, with a reduction in risk of 15%. Conclusion: These findings from our phase III randomized trial suggest that low dose cisplatin+5-FU followed by UFT may hold promise as a treatment for curatively resected locally advanced gastric cancer patients.

著者

• TOMINAGA Suketami

  Aichi Cancer Center

• Sakamoto Junichi

  Young Leaders Program in Healthcare Administration, Nagoya University Graduate School of Medicine

• SHIRASAKA TETSUHIKO

  Kitasato Institute for Life Science, Kitasato University

• Yamaguchi Yoshiyuki

  Department Of Applied Mathematics And Physics Kyoto University

• Shirasaka Tetsuhiko

  Kitasato Institute For Life Science Kitasato University

• Tanemura Hiromi

  Department Of Surgery Gifu Municipal Hospital

• Hirata Koichi

  First Department Of Surgery Cancer Research Institute Sapporo Medical University

• Shibata Masahiko

  First Department Of Pathology Faculty Of Medicine Hokkaido University

• Saji Shigetoyo

  Japanese Foundation for Multidisciplinary Treatment of Cancer [JFMC]

• Gochi Akira

  First Department of Surgery, Okayama University Medical School

• Kai Yoshiki

  Department of Surgery, Miyoshi Central Hospital

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