CIMETIDINE AS AN ADJUVANT TREATMENT IN COLORECTAL-CANCER - A DOUBLE-BLIND, RANDOMIZED PILOT-STUDY

PURPOSE: To evaluate the influence of a H-2 receptor antagonist (cimet idine) on survival in patients with colorectal carcinoma, a randomized , controlled pilot study was performed in three university hospitals i n Copenhagen, Denmark. METHODS: A total of 192 patients, who had under gone a resection or an exploratory operation for adenocarcinoma of the colon or rectum between May 1388 and May 1991, were enrolled in the s tudy. After a median observation time of 40 months, outcome was noted for each patient concerning cancer-specific mortality rate. RESULTS: I n patients operated with curative intent (n = 148), no difference was found in cancer-specific mortality between the two treatments. However , a tendency toward reduction in mortality rate was found in patients with curatively operated Dukes Stage C carcinoma (P = 0.11, log-rank t est; difference, 29 percent; 90 percent confidence interval, 2 to 57 p ercent) in the cimetidine-treated group. In patients with disseminated disease no total difference was found between the two treatment group s. CONCLUSIONS: Cimetidine does not seem to reduce mortality in patien ts with colorectal cancer, but there seems to be a tendency toward a s urvival benefit in patients undergoing surgery for Dukes Stage C carci noma. Results seem to justify trials in this patient catagory to revea l a benefit of H2 receptor antagonists in adjuvant therapy of colorect al carcinoma.