Oral tegafur in the treatment of gastrointestinal tract cancers: a phase II study.

Fifty patients affected by histologically confirmed gastrointestinal tract cancer (GTC) were treated with oral tegafur (TG) 1,000 mg m-2 p.o. on days 1-14 repeated after a 14 day interval. Out of 42 evaluable patients seven patients had a partial response (PR. 17%) with a median duration of 20.5 weeks, three had a minimal response (7%) with a median duration of 23.7 weeks, nine showed a stabilisation which lasted a median of 31.3 weeks, and 23 progressed (55%). No response was obtained in patients affected by carcinoma of the pancreas and the hepatobiliary system. All PRs were achieved in patients with metastatic disease to the liver. No response was seen in patients with bone, lung or nodal metastasis. Three PRs were obtained in patients resistant to 5-fluorouracil. The difference in survival between patients who achieved PR and those who had a stabilisation was not statistically significant. On the other hand the survival of patients with PR was significantly longer than that of patients who progressed. Oral TG was well tolerated by most patients. WHO grade 1-2 gastrointestinal and neurological toxicities were seen respectively in 36% and 25% of cases. Five patients had grade 3 nausea/vomiting and one had grade 3 diarrhoea. Our data suggest that oral TG is effective in the treatment of stomach and colorectal cancers.