Journal of Clinical Oncology, Vol 1, 107-110, Copyright © 1983 by American Society of Clinical Oncology
Phase I-II studies of oral tegafur (ftorafur)
FJ Ansfield, GJ Kallas and JP Singson
A total of 65 patients with advanced colorectal or breast cancer were given
oral tegafur in the phase I study. Of these, 28 patients had accurately
measurable lesions and were entered into the phase II study. Patients with
liver metastasis, compromised bone marrow, or a decreased oral intake to
less than 50% of their normal intake were given a poor- risk schedule
consisting of 0.75 g/m2/day divided into 4 doses/day X 28 day unless early
toxicity developed. In the absence of any of the above deficits, patients
were given a good-risk schedule of 1.25 g/m2/day X 21 days if no toxicity
appeared. The courses were followed by a 2-3-wk rest period depending upon
the speed to recovery from all reactions and then repeated. Compared with
5-FU, nausea and vomiting occurred more frequently with tegafur while
hematologic toxicity was less common and less severe. The paucity of
significant hematologic toxicity permitted courses of this drug to be given
safely on an outpatient basis even to the point of slight reaction for
optimal dosing. No serious reactions occurred in any of the 65 patients.
The clinical results showed partial regressions in 6 of 21 colorectal
cancer patients and 3 of 7 breast cancer patients. Six of the 9 responses
occurred in patients who had previous 5-FU trials. The average duration of
regression in the colorectal cancer patients on oral tegafur was 9 mo with
a significantly increased survival of the responders.
