IngentaConnect A Phase II Trial of UracilTegafur (UFT) in Patients with Advanced...

Authors: Ikeda, Masafumi; Okusaka, Takuji; Ueno, Hideki; Morizane, Chigusa; Furuse, Junji; Ishii, Hiroshi

Source: Japanese Journal of Clinical Oncology, Volume 35, Number 8, August 2005 , pp. 439-443(5)

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JJCO was established in 1971 as the first journal from Japan to publish clinical research on cancer in English. It was a biannual journal for the first 11 years, and as the number of submissions increased, it became quarterly in 1983 and bimonthly in 1991. Since 1998, the JJCO has been published monthly.

Abstract:

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.

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