Treatment of hepatocellular carcinoma with octreotide: a randomised controlled study. Gut 42: 442–447

Background—Standard treatment of in-operable hepatocellular carcinoma has not been established. Somatostatin has been shown to possess antimitotic activity against a variety of non-endocrine tu-mours. Aims—To assess the presence of somato-statin receptors in human liver and to treat advanced hepatocellular carcinoma with the somatostatin analogue, octre-otide. Methods—Somatostatin receptors were measured in liver tissue homogenates from patients with acute and chronic hepatitis, cirrhosis, and hepatocellular carcinoma. Fifty eight patients with ad-vanced hepatocellular carcinoma were randomised to receive either subcutane-ous octreotide 250 µg twice daily, or no treatment. Groups were comparable with respect to age, sex, Okuda classification, presence of cirrhosis, and liver biochem-istry and virology. Results—Various amounts of somatosta-tin receptors were identified in liver tissue of all patients including those with hepato-cellular carcinoma. Treated patients had an increased median survival (13 months versus four months, p=0.002, log rank test) and an increased cumulative survival rate at six and 12 months (75 % versus 37%, and 56 % versus 13 % respectively). Octreotide administration significantly reduced á fetoprotein levels at six months. When a multivariable Cox’s proportional hazards model was fitted, variables associated with increased survival were: treatment ad-ministration, absence of cirrhosis, in-creased serum albumin, and small tumours. Treated patients clearly had a lower hazard (0.383) in the multivariate analysis. Conclusions—Octreotide administration significantly improves survival and is a valuable alternative in the treatment of inoperable hepatocellular carcinoma. (Gut 1998;42:442–447