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Japanese Journal of Clinical Oncology 2004 34(6):316-322; doi:10.1093/jjco/hyh063
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© 2004 Foundation for Promotion of Cancer Research

Phase II Study of Sequential Methotrexate and 5-Fluorouracil Chemotherapy Against Peritoneally Disseminated Gastric Cancer with Malignant Ascites: a Report from the Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group, JCOG 9603 Trial

Takekazu Yamao1, Yasuhiro Shimada2, Kuniaki Shirao, Atsushi Ohtsu3, Nobumasa Ikeda4, Ichinosuke Hyodo5, Hiroshi Saito6, Hiroaki Iwase7, Yasushi Tsuji8, Takao Tamura9, Seiichiro Yamamoto10 and Shigeaki Yoshida3,+

1 Department of Internal Medicine, Cancer Institute Hospital, Tokyo, 2 Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, 3 Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa, Chiba, 4 Department of Internal Medicine, Mitoyo General Hospital, Mitoyo-gun, Kagawa, 5 Department of Internal Medicine, National Shikoku Cancer Center Hospital, Matsuyama, 6 Department of Internal Medicine, Yamagata Prefectural Hospital, Yamagata, 7 Department of Internal Medicine, National Nagoya Hospital, Nagoya, 8 Department of Internal Medicine, Tonan Hospital, Sapporo, 9 Department of Internal Medicine, Hyogo Medical Center for Adults, Akashi, Hyogo and 10 JCOG Data Center, Cancer Information and Epidemiology Division, National Cancer Center Research Institute, Tokyo, Japan

Background: The efficacy of systemic chemotherapy against peritoneal dissemination from advanced gastric cancer (AGC) remains unclear, because the peritoneal dissemination was not defined as a measurable lesion in conventional phase II studies. In this study, we evaluated the efficacy and toxicity of sequential MTX and 5FU therapy (MF) in chemotherapy-naive patients with AGC accompanied by malignant ascites in a phase II setting.

Methods: The treatment schedule comprised weekly administration of MTX (100 mg/m2, i.v. bolus) followed by 5FU (600 mg/m2, i.v. bolus) with a 3 h interval. Leucovorin rescue (10 mg/m2 every 6 h, for a total of six times) was commenced 24 h after MTX administration.

Results: Thirty-seven chemotherapy-naive patients with AGC presenting with malignant ascites were enrolled in this trial. The median age was 60 years (range, 25–74 years) and most patients (86%) had a performance status of 0–1. In total, 355 administrations of the sequential MTX/5FU therapy were performed. Major toxicity consisted of myelosuppression and gastrointestinal toxicity. Grade 4 neutropenia occurred in 10.8% of the patients. The overall objective response rate was 5.7% (two partial responses in 35 patients; 95% confidence interval: 0.7–19.2%). However, the response rate of ascites was 35.1% (complete disappearance in three patients and apparent decrease in 10 patients; 95% confidence interval: 20.2–52.5%).

Conclusions: Sequential MTX/5FU therapy is effective against AGC with malignant ascites with acceptable toxicity and warrants further investigations in a phase III setting.

+ For reprints and all correspondence: Yasuhiro Shimada, Division of Gastrointestinal Oncology, National Cancer Center Hospital, 5–1–1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. E-mail: yshimada{at}ncc.go.jp


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