Clinical Newswire, June 26, 2009 (BARCELONA, Spain) -Sunitinib therapy has shown a significant 2-fold improvement in progression-free survival (PFS) in patients with pancreatic islet cell tumors, according to phase III trial data presented at the World Congress on Gastrointestinal Cancer in Barcelona, Spain. The positive results, presented by Eric Raymond, MD, head of medical oncology at the University Hospital in Bichat-Beaujon, Clichy, France, led to a halt in the trial even before half of the intended patient population had enrolled.
Pancreatic islet cell tumors are uncommon tumors of the pancreas that arise from islet cells, which produce hormones that regulate a variety of bodily functions, such as blood sugar level and the production of stomach acid. Islet cell tumors include gastrinomas, glucagonomas, and insulinomas, named after the type of hormone secreted by the affected cells. Patients with islet cell tumors have previously had few treatment options.
The trial was performed over a 20 month period on 169 patients with local, locally advanced, or metastatic, well-differentiated pancreatic islet cell tumors not amenable to curative therapy, and who had progressed in the 12 months prior to the study. Patients were randomized to receive either sunitinib (37.5 mg/day) or placebo as a continuous oral dose, with best supportive care. Primary endpoint was PFS, and safety and tolerability were also assessed.
After treatment, PFS increased to 11.1 months in the sunitinib group, compared with 5.5 months in the placebo group (hazard ratio, 0.397; P < .001). Five patients died in the sunitinib arm and 15 in the placebo arm.
An independent Data Monitoring Committee recommended that the study be halted early, and patients on placebo were notified and given the opportunity to cross over to sunitinib.
No major safety concerns were seen with the drug; similar to previous sunitinib studies for other types of cancers. Most common grade 3/4 adverse events in the sunitinib group were neutropenia (12.3%), hypertension (8.8%), abdominal pain (7%), diarrhea (97%), hypoglycemia (7%), and hand-foot syndrome (7%).
Dr. Raymond and colleagues concluded that in patients with progressive well-differentiated pancreatic endocrine tumours, sunitinib significantly prolongs PFS, and has an acceptable safety profile. “This important finding opens possibilities for future treatment of pancreatic islet cell tumours", the authors wrote.
Overall survival analysis is ongoing.
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