OBJECTIVES: To compare clinical efficacy and safety of sunitinib (SUN) and best supportive care (BSC) versus placebo (PL) and best supportive care (BSC) in the treatment of patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression. METHODS: The review was conducted in accordance with the Cochrane Collaboration guidelines and the Polish Agency for Health Technology Assessment (AOTM) recommendations. Calculations were performed using the StatsDirect® 2.6.8 statistical package. RESULTS: As a result of systematic search of publications, 1 primary randomized clinical trial (subtype II A), satisfying the inclusion criteria was found (Raymond 2011). It was shown that the use of SUN+BSC results in a statistically significant higher clinical efficacy in respect of progression free survival (PFS), overall survival (OS) and objective response rate in comparison with the control (PL+BSC). The median PFS was over two fold greater in sunitinib treated patients (11.4 months) than in placebo group (5.5 months). The objective response rate was 9.3% in the sunitinib group versus 0% in the placebo group. In the sunitinib group 9 deaths (10%) were reported compared with 21 deaths (25%) in the placebo group (HR = 0.40; 95% CI, 0.18 to 0.86). Sunitinib is safe and well-tollerated therapy. The most frequent adverse events in the sunitinib group were diarrhea, nausea, vomiting, asthenia, and fatigue. In most cases, analysed adverse events were of low severity grade. CONCLUSIONS: The results of the presented analysis clearly prove that sunitinib administered in a 37,5 mg dose is an effective and safe therapy in the treatment of patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression.