Adjuvant 5-fluorouracil and BCNU chemotherapy in gastric cancer: 3-year results.

One hundred-three patients with a potentially curative operation of a histologically proven gastric cancer were randomly assigned to a control and chemotherapy group after stratification according to tumor stage II and III. Chemotherapy courses with 5-fluorouracil (10 mg/kg/day) and BCNU (40 mg/m2/day) for 5 days were administered eight times in 6-8 week intervals. Age, sex, and tumor location were matched in the chemotherapy and control groups. Five patients declined treatment after randomization. Three years after initiating the study, the tumor has recurred in 38 of the 103 patients. There were 21 recurrences of 54 controls and 14 recurrences of 44 patients who received chemotherapy, and 17 and ten deaths, respectively, due to tumor relapse. The results of our study to data show a high degree of statistical probability that adjuvant chemotherapy with the regime used has no influence on the recurrence-free interval and survival time in gastric cancer.

RCT Entities:   Population Interventions Outcomes