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| |  Sunitinib Prolongs Progression-Free Survival in Patients With Advanced Pancreatic Neuroendocrine Tumours: Presented at ENETS By Karen Dente BERLIN -- March 13, 2010 -- The tyrosine kinase inhibitor (TKI) sunitinib has shown efficacy in patients with advanced pancreatic neuroendocrine tumours (NETs), according to findings presented here at the 7th European Neuroendocrine Tumor Society Conference (ENETS). The study led by Eric Raymond, MD, Hôpital Beaujon, Clichy, France, was a phase 3 multinational, randomised, double-blind trial investigating the effects and safety of sunitinib versus placebo in patients with advanced pancreatic NETs. Sunitinib is an oral multi-targeted TKI that is approved for use in advanced renal cell carcinoma and imatinib-resistant gastrointestinal stromal tumours that has demonstrated efficacy in animal models and early-stage clinical trials against pancreatic NETs. Between June 2007 and August 2009, 171 patients with locally advanced or metastatic well-differentiated pancreatic endocrine tumours were randomised to receive of sunitinib 37.5 mg/day (n = 86) or placebo (n = 85). “The most frequently reported adverse effects for patients receiving the drug were as expected for treatment with sunitinib and included diarrhoea, nausea, vomiting, and fatigue,” the authors wrote. Serious grade 3/4 adverse events included neutropenia (12% vs 0%), hypertension (10% vs 0%), and palmar-plantar erythrodysesthesia (6% vs 0%) for patients receiving sunitinib compared with placebo. Nine patients in the drug arm and 21 in the placebo arm died. Because of differences in efficacy, the trial was stopped early on recommendations by the independent data monitoring committee. The mean progression-free survival was 11.4 months with sunitinib patients and 5.5 months with placebo (95% confidence interval [CI], 0.263-0.662; P = .0001). Median overall survival was not reached, although the hazard ratio (0.409) favoured treatment with sunitinib (95% CI, 0.187-0.894; P = .0204). The researchers concluded that “sunitinib prolonged progression-free survival in patients with advanced pancreatic NETs versus placebo, and these findings support the clinical efficacy and safety of sunitinib in this population with limited treatment options.” Funding for this study was provided by Pfizer. [Presentation title: Sunitinib for the Treatment of Advanced, Progressive Pancreatic Neuroendocrine Tumors. Abstract C83]
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