Efficacy and safety results from a Phase II study of pasireotide (SOM230) in the treatment of patients with metastatic NETs refractory or resistant to octreotide LAR Abstract #131

Introduction: Pasireotide, a multi-receptor targeted somatostatin analogue, has 30-, 5- and 39-fold greater affinity for sst1,3 and sst5 receptors, respectively, and a slightly lower affinity for sst2, than octreotide. Because of this multi-receptor binding profile, pasireotide may be effective in controlling symptoms of carcinoid syndrome in patients with gastroenteropancreatic neuroendocrine tumors (NETs) who are no longer responsive to currently available somatostatin analogues.
Aim(s): Reported here are the final results from a Phase II, open-label, multicenter study of pasireotide in patients with metastatic NETs whose symptoms of carcinoid syndrome (diarrhea and flushing) were inadequately controlled by octreotide LAR.
Materials and methods: Patients had histopathologically confirmed metastatic NETs, elevated 5-HIAA and/or CgA levels, and at least one measurable lesion (excluding bone). Patients initially received pasireotide 300µg sc bid and escalated every three days to a maximum of 1200µg sc bid in patients with suboptimal response to lower doses. Complete symptom control: a mean of ≤3 bowel movements (BM)/day, with ≤3 BM on any day, with no flushing episodes, for 15 consecutive days on a fixed-dose of pasireotide. Partial symptom control: a mean of <4 BM/day with ≤6 BM on any day, and a mean of <2 flushing episodes/day, for 15 consecutive days on a fixed-dose of pasireotide.
Conference: 7th Annual ENETS Conference (2010)
Category: Clinical
Presenting Author: Dr Larry K Kvols

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