BIOLOGICAL AND CLINICAL-EVALUATION OF LANREOTIDE (BIM-23014), A SOMATOSTATIN ANALOG, IN THE TREATMENT OF ADVANCED BREAST-CANCER

Biological data support the development of clinical trials designed to evaluate the activity of somatostatin (SMS) analogues in advanced bre ast cancer (ABC). Although previous clinical trials have failed to sho w antitumor activity, various factors may have biased their results. I n an attempt to improve our understanding of the role of SMS analogues in ABC, 10 patients with favourable prognostic factors and who had no t been heavily pretreated for advanced disease were treated with lanre otide 30 mg i.m. fortnightly (depot formulation). Blood samples were p eriodically taken to evaluate the effect of the drug on growth hormone (GH) and insulin-like growth factor 1 (IGF-1) and to determine drug s erum levels. Although the drug was well tolerated, no clinical activit y was observed. Serum GH and IGF-1 levels were not properly suppressed over time and drug serum concentrations fluctuated widely In conclusi on, SMS analogues cannot be recommended even as palliative treatment o f ABC. Further studies should be undertaken to investigate the effect of higher drug doses, given subcutaneously or by means of continuous i nfusion, in suppressing GH and IGF-1 serum levels.