[Phase III multi-center study of levamisole (LMS)--a randomized evaluation in advanced gastrointestinal cancer, with special reference to stomach cancer]

Abstract

A randomized study of 5-FU + adriamycin (the control group) vs 5-FU + adriamycin + levamisole (LMS group) was conducted by an envelope method in 167 patients with advanced gastrointestinal cancer for clinical evaluation of LMS against advanced gastrointestinal cancer. There was a significant increase in survival with the LMS group (p less than 0.05). Median survivals were 3.7 months for the control group and 6.1 months for the LMS group of all patients with gastrointestinal cancer and patients with gastric cancer, respectively. There were no differences in response rate and duration of response between both groups, but the number of PD (progressive disease) cases was significantly smaller in the LMS group than in the control group (p = 0.001). Adverse reactions occurred more frequently in the LMS group, but there was no significant difference in incidence between both groups.