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Japanese Journal of Clinical Oncology Advance Access originally published online on July 15, 2005
Japanese Journal of Clinical Oncology 2005 35(8):439-443; doi:10.1093/jjco/hyi131
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© 2005 Foundation for Promotion of Cancer Research

A Phase II Trial of Uracil–Tegafur (UFT) in Patients with Advanced Biliary Tract Carcinoma

Masafumi Ikeda1, Takuji Okusaka1, Hideki Ueno1, Chigusa Morizane1, Junji Furuse2 and Hiroshi Ishii2

1 Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo and 2 Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital East, Kashiwa, Chiba, Japan

For reprints and all correspondence: Masafumi Ikeda, Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. E-mail: masikeda{at}ncc.go.jp

Received February 15, 2005; accepted June 12, 2005

Background: Uracil–tegafur (UFT) has been reported to have broad antitumor activity in a variety of malignancies. However, its activity in biliary tract carcinoma has not been fully evaluated. The aim of this study was to evaluate the antitumor activity and toxicity of UFT in chemotherapy-naive patients with advanced biliary tract carcinoma.

Methods: Nineteen patients with advanced biliary tract carcinoma that was histologically confirmed as adenocarcinoma were enrolled in this phase II trial of UFT. A dose of 360 mg/m2/day of UFT was administered orally if there was no evidence of tumor progression or there was unacceptable toxicity.

Results: Of the 19 patients evaluable for response, one patient (5%) achieved a partial response with a duration of 2.0 months. Six patients (32%) showed no change and the remaining 12 (63%) had progressive disease. The median survival, 6-month survival rate and 1-year survival rate for all patients were 8.8 months, 52.6 and 21.1%, respectively. The chemotherapy was well tolerated, because grades 3 or 4 toxicity were not observed.

Conclusion: UFT appears to have little activity as a single agent in treating patients with advanced biliary tract carcinoma. These findings do not support its use in practice, and further trials with this regimen in patients with biliary tract carcinoma are not recommended.

Key Words: biliary tract carcinoma • chemotherapy • phase II study • uracil–tegafur


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