PHASE-II-III CHEMOTHERAPY STUDIES IN ADVANCED GASTRIC-CANCER

Abstract

Eligible and evaluable patients (139) 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 [methyl-1-(2-chloroethyl)-3-cyclohexyl-1-nitrosurea]. Objective responses were seen in 8 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 mo., respectively. Patients (61) were treated after previous failure to other chemotherapy regimens. Response rates were seen in 7 of 47 patients (15%) receiving adriamycin, in 2 of 9 receiving 5-FU plus mitomycin C, and in 1 of 5 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 > 17 wk, and there was no meaningful or significant survival difference between the 3 treatment groups.