According to the final results of a Phase III trial presented at the ASCO 2010 Gastrointestinal Cancers Symposium (ASCO-GI), sunitinib improves progression-free survival (PFS) in patients with pancreatic neuroendocrine tumours (pNET).
In this study, patients with advanced pancreatic islet cell tumours who had documented disease progression within the last year were randomised to sunitinib 37.5mg/day (n=86) or placebo (n=85), in addition to best supportive care. This study was stopped early due to differences in efficacy, as recommended by the independent Data Monitoring Committee. The median age of participants was 56 years, 52% were female, 50% had nonfunctional tumors, 95% had metastatic disease, and 71% had received various prior treatments.
The primary endpoint of PFS was 11.4 months in those randomised to sunitinib and 5.5 months in those who received placebo (HR 0.418; 95% CI 0.263-0.662; p=0.0001). The objective response rate (ORR) with sunitinib was 9.3% (95% CI: 3.2-15.4%), including two complete and six partial responses (0 responses in the placebo arm; p=0.0066). Median overall survival was not reached in either arm.