A comparative clinical assessment of combination chemotherapy in the management of advanced gastric carcinoma: The Gastrointestinal Tumor study Group.

This report summarizes the results of a randomized multi-institutional clinical trial in advanced gastric carcinoma comparing four combination chemotherapy regimens: 5-FU, Adriamycin + mitomycin C (FAMi); 5-FU, Adriamycin + methyl-CCNU (FAMe); 6-FU, ICRF-159 + methyl-CCNU (FIMe); and 5-FU + methyl-CCNU (FMe). One-hundred-eight-one evaluable patients received chemotherapy. These objective tumor response rates were observed among the 59 patients with measurable indicator lesions: FAMi, 3/12 (25%); FAMe3, 3/10 (30%); FIMe, 4/19 (21%); FMe, 1/18 (6%). The survival distributions for the four treatment groups were significantly different (P less than or equal to 0.05), with these median survivals observed (in weeks from the onset of chemotherapy): FAMi, 29.6; FAMe, 34.4; FMe, 22.9; FIMe, 17.4. Two nontreatment variables were found to be significantly associated with survival when analyzed using the Cox covariate model: pretreatment performance status (P less than 0.0001), and presence or absence of measurable metastatic disease (P less than 0.001). After adjustment for the effects of these and other clinical variables, two treatment regimens were found to be associated with improved survival: FAMi therapy (P less than 0.01), and FAMe therapy (P = 0.07). Toxicity was, in general, moderate and consisted primarily of gastrointestinal side effects and myelosuppression. We conclude that the FAMi and FAMe regimens are superior to the FIMe and FMe regimens in the management of advanced gastric cancer.

RCT Entities:   Population Interventions Outcomes