RESUMO
Between January 1982 and April 1986 a double-blind randomized placebo controlled study of mopidamol, employed as adjunct therapy to surgery in patients with non-small cell bronchial carcinoma, was performed at 7 hospitals. The main criteria were occurrence of metastases and survival. Mopidamol was given perioperatively at a dose of 2 x mg i.v. daily, and postoperatively orally at a dose of 3 x 500 mg daily. The treatment period was scheduled to at least 2 years and in some of the patients was prolonged to 3 years. The standard therapy of each individual center was given as basic therapy. A total of 270 patients were included in the study, 147 in the placebo and 123 in the mopidamol group. By the end of the study 52 deaths from metastases had occurred in the placebo group (35%) compared with only 32 (26%) in the mopidamol group. This difference is statistically significant at p less than 0.05 with the one-sided test. A comparison of life-tables according to Kaplan-Meier shows a statistically significant difference in favour of the group treated with mopidamol (savage p less than 0.05). Cox's multivariate analysis confirmed the statistically significant difference in favour of the group treated with mopidamol, the inclusion of the risk factors tumour stage and histology in the evaluation results in a p-value of 0.02. With respect to the incidence of metastases there were no appreciable differences between the treatment groups. The incidence of side effects or undesired events was equal in both groups.(ABSTRACT TRUNCATED AT 250 WORDS)