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Japanese Journal of Clinical Oncology 32:90-94 (2002)
© 2002 Foundation for Promotion of Cancer Research

A Phase II Study of Doxifluridine in Elderly Patients with Advanced Gastric Cancer: The Japan Clinical Oncology Group Study (JCOG 9410)

Nobumasa Ikeda1, Yasuhiro Shimada2, Atsushi Ohtsu3, Narikazu Boku, Yasushi Tsuji4, Hiroshi Saito5, Wasaburo Koizumi6, Hiroaki Iwase7, Shigeaki Yoshida3 and Haruhiko Fukuda8,+

1Department of Internal Medicine, Mitoyo General Hospital, Mitoyo-gun, Kagawa, 2Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, 3Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa, 4Department of Internal Medicine, Tonan Hospital, Sapporo, 5Department of Internal Medicine, Yamagata Prefectural Hospital, Yamagata, 6Department of Internal Medicine, Kitasato University East Hospital, Sagamihara, Kanagawa, 7Department of Internal Medicine, National Nagoya Hospital, Nagoya and 8JCOG Data Center, Cancer Information and Epidemiology Division, National Cancer Center Research Institute, Tokyo, Japan

Background: A previous phase II study of doxifluridine in non-elderly patients with advanced gastric cancer demonstrated a favorable survival with mild toxicity, despite a low response rate. The objectives of this study were to evaluate efficacy and feasibility of this agent for elderly patients.

Methods: This study protocol required elderly patients, aged 76–80 years, with advanced gastric cancer and having no prior chemotherapy. Doxifluridine, at a dose of 1400 mg/m2/day, was administered for four consecutive days followed by a 10-day rest.

Results: Between October 1994 and March 1998, 18 patients were registered. The study was then closed because of poor accrual. Toxicity was moderate; three patients suffered from grade 3 anemia and one patient each had grade 3 thrombocytopenia, nausea/vomiting and grade 4 diarrhea. There was one partial response, seven with no change and 10 with progressive disease, yielding a response rate of 5.6%. The median progression-free survival and median survival time for the 18 patients were 55 and 164 days, respectively, with a 1-year survival rate of 5.6%.

Conclusions: Although the number of patients was too small to draw any definitive conclusions, this study failed to demonstrate the survival advantage of doxifluridine.

+ For reprints and all correspondence: Atsushi Ohtsu, Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, 6–5–1, Kashiwanoha, Kashiwa 277-8577, Japan. E-mail: aohtsu@east.ncc.go.jp


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