On December 2nd, Pfizer Inc. announced that the European Commission has approved Sutent for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors with disease progression in adults.
The approval is based on results from a randomized, Phase III trial which demonstrated that Sutent more than doubled the time period that patients were free from disease progression or death. The progression-free survival for Sutent was 11.4 months versus 5.5 months for placebo. 171 patients participated in this randomized study.
These study results were first announced at the 11th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The international, Phase III trial compared Sutent to placebo in patients with progressive, well-differentiated, malignant pancreatic islet cell tumors who had progressed in the last 12 months. Patients were randomized to either the Sutent (n=75) (37.5 mg/day, continuous daily dosing) plus best supportive care arm or the placebo plus best supportive care arm (n=79).
Sutent has been approved for the treatment of advanced renal cell carcinoma and gastrointestinal stromal tumors in the United States. Sutent is considered a molecular targeted therapy, a therapy that blocks the growth and spread of cancer by interfering with specific molecules necessary for tumor growth. Specifically, Sutent is a Vascular Endothelia Growth Factor (VEGF) Inhibitor, a type of molecular targeted therapy, click here to learn more.
Dr. Eric Raymond, principal investigator of the study stated, "As the first anti-VEGF therapy to show a substantial clinical benefit in treating progressive pancreatic NET, Sutent represents a novel therapeutic approach for this difficult-to-treat disease. Physicians in Europe will now be able to use a therapy with proven efficacy to treat this disease."
Serious adverse effects such as hepatic failure and decreases in left ventricular ejection fraction have been observed among patients treated with Sutent. Please discuss any potential treatment such as Sutent with your physician. For help in finding a physician well-versed in treating patients with neuroendocrine tumors please call the Caring for Carcinoid Foundation at 617-848-3977.
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