Sunitinib for the treatment of advanced, progressive pancreatic neuroendocrine tumors

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Introduction: Sunitinib is an oral, multitargeted tyrosine kinase inhibitor approved for use in advanced renal cell carcinoma and imatinib-resistant/intolerant gastrointestinal stromal tumors. Investigations of sunitinib in the RIP1-Tag2 mouse model and in phase I/II clinical trials provide evidence of antitumor activity against pancreatic neuroendocrine tumors (NET).

Aim(s): This phase III, multinational, randomised, double-blind trial (NCT00428597) investigated the efficacy and safety of sunitinib v. placebo in patients with advanced pancreatic NET.

Materials and methods: Eligible patients had local, locally advanced, or metastatic, well-differentiated pancreatic endocrine tumors and documented disease progression within the past 12 months. Patients were randomized (1:1) to sunitinib 37.5 mg/day continuous daily dosing or placebo. Patients also received best supportive care and somatostatin analogues if indicated. The primary endpoint was progression-free survival (PFS); target enrollment was 340 patients with 260 PFS events. Secondary endpoints included overall survival (OS), objective response rate (ORR) and safety.

Conference: 7th Annual ENETSConcerence (2010)

Presenting Author: Raymond E

Authors: Raymond E, Seitz J, Bang Y, Borbath I, Lombard-Bohas C,

Keywords: Sunitinib, phase III, pancreatic neuroendocrine tumor ,