Randomized Phase III Trial of Fluorouracil Alone Versus Fluorouracil Plus Cisplatin Versus Uracil and Tegafur Plus Mitomycin in Patients With Unresectable, Advanced Gastric Cancer: The Japan Clinical Oncology Group Study (JCOG9205)

• DOI: 10.1200/jco.2003.04.130
• Publication Date: 2002-12-28T17:57:17Z
• Authors: Atsushi Ohtsu; Yasuhiro Shimada; Kuniaki Shirao; Narikazu Boku; Ichinosuke Hyodo; Hiroshi Saito; Noboru Yamamichi; Yoshinori Miyata; Nobumasa Ikeda; Seiichiro Yamamoto; Haruhiko Fukuda; Shigeaki Yoshida
• Keywords: Tegafur; Regimen; Interim analysis; Progression-free survival; Mitomycin C

To compare fluorouracil (FU) alone with FU plus cisplatin (FP) and uracil tegafur mitomycin (UFTM) for patients advanced gastric cancer in a prospective, randomized, controlled trial.A total of 280 were randomly allocated analyzed survival, response, toxicity. The survival curves compared between groups by log-rank test on an intent-to-treat basis.At the interim analysis, UFTM arm showed significantly inferior higher incidences hematologic toxic effects than did control alone, registration to was terminated. Both investigational regimens, FP UFTM, had incidence although manageable. overall response rates FU-alone, FP, arms 11%, 34%, 9%, respectively. median progression-free 1.9 months 3.9 2.4 Although demonstrated rate (P <.001) longer <.001), no differences observed arms. times 1-year 7.1 28% FU, 7.3 29% 6.0 16% respectively.Neither regimen, nor advantage as alone. will remain reference our future trial cancer.