Leonard Saltz

Octreotide acetate long-acting formulation versus open-label subcutaneous octreotide acetate in malignant carcinoid syndrome

PURPOSE Subcutaneous (SC) octreotide acetate effectively relieves the diarrhea and flushing associated with carcinoid syndrome but requires long-term multiple injections daily. A microencapsulated long-acting formulation (LAR) of octreotide acetate has been developed for once-monthly intramuscular dosing. PATIENTS AND METHODS A randomized trial compared double-blinded octreotide LAR at 10, 20, and 30 mg every 4 weeks with open-label SC octreotide every 8 hours for the treatment of carcinoid syndrome. Seventy-nine patients controlled with treatment of SC octreotide 0.3 to 0.9 mg/d whose symptoms returned during a washout period and who returned for at least the week 20 evaluation constituted the efficacy-assessable population. RESULTS Complete or partial treatment success was comparable in each of the four arms of the study (SC, 58.3%; 10 mg, 66.7%; 20 mg, 71.4%; 30 mg, 61.9%; P> or =.72 for all pairwise comparisons). Control of stool frequency was similar in all treatment groups. Flushing episodes were best controlled in the 20-mg LAR and SC groups; the 10-mg LAR treatment was least effective in the control of flushing. Treatment was well tolerated by patients in all four groups. CONCLUSION Once octreotide steady-state concentrations are achieved, octreotide LAR controls the symptoms of carcinoid syndrome at least as well as SC octreotide. A starting dose of 20 mg of octreotide LAR is recommended. Supplemental SC octreotide is needed for approximately 2 weeks after initiation of octreotide LAR treatment. Occasional rescue SC injections may be required for possibly 2 to 3 months until steady-state octreotide levels from the LAR formulation are achieved.

Does the underlying etiology of HCC effect outcome? A single-institution analysis.

e14636 Background: Several biologic and clinical factors indicate that the underlying etiology of HCC may impact outcome. METHODS We undertook an Institutional Review Board-approved medical record examination for all HCC patients seen by medical oncologists for consideration of systemic therapy between 2001 and 2006. Demographic and clinicopathologic data were analyzed for correlation with overall survival (OS). Independent prognostic factors for OS were identified using a multivariate Cox regression model which included variables significant at the 0.05 level in univariate Cox models. Treatment factors were not assessed in this analysis. RESULTS Records were examined for 190 patients with advanced HCC. The median age was 63 years (range 24-88): Males 74%, females 26%. Baseline variables with significance in at least univariate analysis are shown in the table. CONCLUSIONS In this multivariate analysis, etiology was unrelated to OS. Both HCV and alcohol showed significance in the univariate analysis for OS. This may be due to the association of these etiologies with more advanced cirrhosis compared to HBV-related HCC. Advanced stages of cancer (T stage, bilobar disease) and cirrhosis (Child-Pugh C) correlated with worse OS in the multivariate analysis. The observation that the African-American race is an independent variable for OS deserves further exploration. [Table: see text].