ABSTRACT
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)
Subject(s)
Carcinoma, Non-Small-Cell Lung/drug therapy , Lung Neoplasms/drug therapy , Mopidamol/administration & dosage , Pyrimidines/administration & dosage , Aged , Carcinoma, Non-Small-Cell Lung/surgery , Clinical Trials as Topic , Combined Modality Therapy , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Female , Humans , Lung Neoplasms/surgery , Male , Middle Aged , Prospective Studies , Random AllocationABSTRACT
Between 1975 and 1985 76 patients underwent surgery of pulmonary metastases in our hospital. Most often the primary tumor was located in carcinomas of the colon and rectum (19 patients), followed by carcinomas of the kidney (14 patients), the breast (13 patients) and the skin (malignant melanoma: 9 patients). Conditions for pulmonary metastasectomy are radical removal of the primary tumor, metastases located only in the lung, resectability of the metastases and low operative risk. Three years after pulmonary metastasectomy 35% of the patients were still alive, the 5 year survival rate was 18%. The median survival time was 22 months. The prognosis in patients with pulmonary metastases is largely dependant upon tumor type. Pulmonary metastases of breast carcinomas and carcinomas of colon and rectum can be treated best by surgical intervention. (5 year survival rate: 35% and 33%). Hypernephroma and malignant melanoma have a 5 year survival rate of 0% and 23%. Other prognostic factors are the number of pulmonary metastases and the disease-free interval between surgery of the primary tumor and pulmonary metastasectomy. Furthermore resection techniques are of prognostic importance. Lobectomy and segmental resection showed a better 5 year survival rate than pneumonectomy (21%, 24%, 0%). Median sternotomy is recommended as standard access for pulmonary metastasectomy. Surgery of pulmonary metastases is encouraging.
