Chemotherapy of advanced gastric carcinoma (stage IV): a randomized study of FAM versus 5-FU plus BCNU.

Forty-six patients with advanced gastric carcinoma (Stage IV) were evaluated in a prospective randomized comparison of two chemotherapy regimens (FAM versus 5-FU plus BCNU) to identify therapeutic activity. Treatment groups were well balanced with respect to known prognostic factors. Thirty-three patients had measurable disease and thirteen had only microscopic residual disease in the resection margins. The overall median survival of the entire group was 13.2 months. Two (6%) patients with measurable disease reached complete response (CR), 1 (3%) partial response (PR), 12 (36%) had stable disease (SD) and 18 (56%) had progressive disease (PD). The responders had not reached the median survival yet, the patients with SD had a median survival of 14.7 months and the PD 9.5 months. In the FAM arm there were 3 (18%) responders (2 CR and 1 PR), 7 (41%) SD and 7 (41%) PD, versus O responders, 5 (31%) SD and 11 (69%) PD in the 5-FU plus BCNU arm. In the FAM arm the median survival was 15.7 months versus 9.9 months in the other therapeutic arm. The statistical analysis indicated that survival associated with FAM regimen was superior to that reached with the 5-FU plus BCNU regimen. Thirteen patients with unmeasurable disease had a median survival of 15.9 months.