Phase II-III chemotherapy studies in advanced gastric cancer. Eastern Cooperative Oncology Group.

In this study, 139 eligible and evaluable patients with advanced gastric cancer, measurable disease, and no prior chemotherapy were randomized between treatment with Adriamycin alone, 5-fluorouracil (5-FU) plus mitomycin C, and 5-FU plus methyl-CCNU. Objective responses were seen in eight of 37 patients (22%) receiving Adriamycin, in 17 of 53 (32%) receiving 5-FU plus mitomycin C, and in 12 of 49 (24%) receiving 5-FU plus methyl-CCNU. Median durations of response were 4, 3 1/2, and 8 1/2 months, respectively. Sixty-one patients were treated after previous failure to other chemotherapy regimens. Response rates were seen in seven of 47 patients (15%) receiving Adriamycin, in two of nine receiving 5-FU plus mitomycin C, and in one of five receiving 5-FU plus methyl-CCNU. Complete responses were observed more frequently with Adriamycin and with 5-FU plus methyl-CCNU than with 5-FU plus mitomycin C. Although 5-FU plus methyl-CCNU had a slight advantage in interval to disease progression, this was not statistically significant. Median survival for all previously untreated patients was slightly greater than 17 weeks, and there was no meaningful or significant survival difference between the three treatment groups.