Multicentre randomised study of adjuvant chemotherapy with mitomycin C and tegafur or tegafur-uracil in gastric cancer.

OBJECTIVE

To compare therapeutic results and five year survival after two regimens of adjuvant chemotherapy after resections for gastric cancer.

DESIGN

Prospective randomised multicentre trial.

SETTINGS

21 departments of surgery.

SUBJECTS

243 patients with stage II, III, or IV gastric cancer.

INTERVENTIONS

All patients received an intravenous bolus of mitomycin C 20 mg on the day of operation, and 10 mg on the first postoperative day. They were then randomised to receive either tegafur 600 mg or tegafur-uracil 600 mg orally daily beginning two weeks after operation and continuing for two years. Patients with histological confirmed stage IV disease also received mitomycin C 10 mg every three months starting one month after operation.

MAIN OUTCOME MEASURES

Survival and side effects.

RESULTS

13 patients (5%) were withdrawn from the study, leaving 230 for analysis. There were no serious side effects and both drugs were safe when given continuously for two years. There were no significant differences in 5 year survival (though patients who were given tegafur-uracil tended to live longer), except when patients who had histological curative resections were compared with and those with poorly differentiated adenocarcinoma (p = 0.04).