TREATMENT OF HEPATOCELLULAR-CARCINOMA WITH OCTREOTIDE - A RANDOMIZED CONTROLLED-STUDY

Background-Standard treatment of inoperable hepatocellular carcinoma h as not been established. Somatostatin has been shown to possess antimi totic activity against a variety of non-endocrine tumours. Aims-To ass ess the presence of somatostatin receptors in human liver and to treat advanced hepatocellular carcinoma with the somatostatin analogue, oct reotide. Methods-Somatostatin receptors were measured in liver tissue homogenates from patients with acute and chronic hepatitis, cirrhosis, and hepatocellular carcinoma. Fifty eight patients with advanced hepa tocellular carcinoma were randomised to receive either subcutaneous oc treotide 250 mu g twice daily, or no treatment. Groups were comparable with respect to age, sex, Okuda classification, presence of cirrhosis , and Liver biochemistry and virology. Results-Various amounts of soma tostatin receptors were identified in liver tissue of all patients inc luding those with hepatocellular carcinoma. Treated patients had an in creased median survival (13 months versus four months, p=0.002, log ra nk test) and an increased cumulative survival rate at six and 12 month s (75% versus 37%, and 56% versus 13% respectively). Octreotide admini stration significantly reduced alpha fetoprotein levels at six months. When a multivariable Cox's proportional hazards model was fitted, var iables associated with increased survival were: treatment administrati on, absence of cirrhosis, increased serum albumin, and small tumours. Treated patients clearly had a lower hazard (0.383) in the multivariat e analysis. Conclusions-Octreotide administration significantly improv es survival and is a valuable alternative in the treatment of inoperab le hepatocellular carcinoma.