Assessment of Hepatic Toxicity from Treatment with 90Y-SMT 487 (OctreoTher™) in Patients with Diffuse Somatostatin Receptor Positive Liver Metastases

The purpose of this study was to determine whether there is evidence for hepatocellular radiation injury following treatment with 90Y-SMT487 (90Y-DOTA-tyr3-octreotide, OctreoTherTM) in patients with extensive liver metastases from neuroendocrine tumors. Patients reported in this study participated in a Phase II trial of efficacy and safety of 90Y-SMT487. The trial design called for three treatment cycles of 120 mCi each (4400 MBq) of 90Y-SMT487. 111In-pentetreotide SPECT images were used to determine the extent of liver metastases. Serum AST, ALT, and alkaline phosphatase levels were obtained at baseline and following each cycle of therapy. Least squares fit was applied to the serial liver enzyme measurements in patients with extensive liver metastases. Post-therapy liver enzyme measurements were also evaluated using WHO common toxicity criteria. Repeated-measures ANOVA and paired t-test were applied to the serial enzyme measures. There were 21 subjects. Fifteen of these had hepatic metastases with 12 dem...