Prospective, double-blind, placebo-controlled randomized trial of cimetidine in gastric cancer

Cimetidine is thought to inhibit suppressor T-lymphocyte function and preli minary evidence from a randomized trial indicated that it might prolong sur vival for patients with operable and inoperable gastric cancer. The British Stomach Cancer Group conducted a randomized, double-blind, placebo-control led trial examining the effects of cimetidine (400 mg or 800 mg twice a day ) on the survival of patients with early (stages I, II and III: n = 229) an d advanced (stages IVa and IVb: n = 201) gastric cancer. The primary end po int was death. A total of 442 patients were randomized by 59 consultants in 39 hospitals between February 1990 and March 1995. Log-rank survival analy sis was used to assess differences between the groups. Three hundred and fo rty patients died during the study: 166 (49%) in the cimetidine treatment g roups and 174 (51%) in the placebo groups. Median survival for patients rec eiving cimetidine was 13 months (95% confidence interval (CI) 9-16 months) and 11 months in the placebo arm (95% CI 9-14 months). There was no signifi cant difference in survival between the two treatment groups (P = 0.42) or between different doses of cimetidine tablets (P = 0.46). Five-year surviva l of those patients randomized to cimetidine was 21% compared to 18% for th ose patients randomized to placebo. Cimetidine at a dose of 400 mg or 800 m g twice a day does not have a significant influence on the survival of pati ents with gastric cancer compared to placebo, (C) 1999 Cancer Research Camp aign.