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.


METHODS
Prospective randomised multicentre trial.


METHODS
21 departments of surgery.


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


METHODS
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.


METHODS
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13 patients (5%) were withdrawn from the study, leaving 230 for analysis.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).
Arima
S
S
Northern Kyushu Cooperative Study Group for Cancer Chemotherapy in Japan, Fukuoka.
Ohsato
K
K
Hisatsugu
T
T
Shimura
H
H
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage* / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage* / Q000009:adverse effects
D004338:Drug Combinations; D005641:Tegafur; D016685:Mitomycin; D014498:Uracil