Gastric carcinoma is considered moderately chemosensitive, but a 'standard' chemotherapy regimen has not yet been found. Encouraging results in terms of activity and tolerability have been reported with a combination of i.v. leucovorin, fluorouracil and etoposide. However, etoposide and fluorouracil have demonstrated a schedule-dependency with high activity for the former when administered orally and for the latter when administered as a continuous infusion. In order to improve clinical results, we tested the activity and feasibility of the following combination: oral L-leucovorin, 5 mg/m(2) days 1-14; oral etoposide, 50 mg/m(2) days 1-14; fluorouracil, 200 mg/m(2)/day by continuous infusion days 1-14; cycles repeated every 28 days. A total of 26 patients [male/ female, 17/9; median age, 65 years (range, 42-75); performance status, 0-2] have been enrolled and are evaluable for response and side effects. A total of 78 cycles has been delivered (median/patient, 3 cycles). Two complete remissions (8%), 11 partial remissions (42%), 4 stabilizations of disease, and 9 progressions have been observed, for an overall response rate of 50% (95% confidence interval 30-70%). Median time to disease progression was 4.5 months and median survival 9.5 months. No toxic death or grade III-IV toxicity has been observed. Mild or moderate side effects included mucositis (42%), nausea/vomiting (19%) and leukopenia (8%). In conclusion, our results indicate that the schedule is safe, well tolerated and highly effective in advanced gastric cancer.

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