Locally advanced or metastatic adenocarcinoma of the stomach still carries
a poor prognosis, with 5-year survival rates of < 15%. Palliative chemother
apeutic regimens for this disease are largely 5-FU-based. We have investiga
ted the clinical activity of an oral combination of uracil and tegafur (UFT
) with calcium folinate (Orzel), in patients with measurable metastatic dis
ease. Thirty-six patients received a total of 94 courses of daily UFT 300 m
g/m(2) plus calcium folinate 90 mg for 28 consecutive days followed by a 7-
day rest. Planned treatment doses were maintained in 83% of all evaluable c
ourses. Main toxicities included diarrhea (21 patients) and nausea and vomi
ting (20 patients). Other side effects were asthenia, malaise, stomatitis,
and myelosuppression. At present, 26 patients are evaluable for response. O
f these, one achieved a complete response and three achieved partial remiss
ions. In addition, six patients reached stable disease, yielding an overall
response rate of 27%. We conclude that the combination of UFT and calcium
folinate is a feasible outpatient regimen that warrants further clinical ev
aluation.