Researchers involved in an international randomized trial have reported that Sutent® (sunitinib) prolongs progression-free survival (PFS) in patients with progressive well differentiated pancreatic islet cell tumors with an acceptable toxicity profile. The details of this study were presented at the Joint ECCO 15 – 34th ESMO Multidisciplinary Congress in Berlin, September 20-24, 2009.[1]
Pancreatic islet cell tumors are rare and have few treatment options. The current Phase III study was initiated as a result of an earlier Phase II study in which Sutent showed anti-tumor activity in pancreatic neuroendocrine tumors.[2]
Sutent is an oral kinase inhibitor of fms-like tyrosine kinase 3 (Flt3), Kit, vascular endothelial growth factor (VEGF), and platelet-derived growth factor (PDGF) receptors. It produces anticancer effects through these targeted mechanisms that include anti-angiogenesis as well as direct killing of the cancer cell. Sutent is approved for the treatment of advanced renal cell cancer, as well as for the treatment of gastrointestinal stromal tumors after disease progression on, or when intolerant to, Gleevec® (imatinib). Sutent is being evaluated in a variety of cancers. A recent multicenter U.S. trial reported that Sutent is active in patients with heavily pretreated breast cancer. An international multicenter trial demonstrated that Sutent has significant single-agent activity in previously treated, advanced non–small cell lung cancer.
The current study included 154 patients with local, locally advanced, or metastatic well differentiated pancreatic islet cell tumors. All patients were deemed incurable with surgery and had disease progression. These patients were randomly allocated to receive Sutent or placebo with best supportive care. PFS was 11.1 months for the Sutent group and 5.5 months for the placebo group. This study was stopped early and patients in the placebo group were able to crossover and get Sutent. At the time the abstract was written, there were five deaths in the Sutent group and 15 in the placebo group. The most common side effects of Sutent were diarrhea, nausea, vomiting, asthenia, and fatigue.
Comments: These data show that Sutent is active for palliation of patients with pancreatic islet cell tumors.
Reference:
[1] Raoul JL, Niccoli P, Bang YJ, et al. Sunitinib (SU) vs placebo for treatment of progressive, well-differentiated pancreatic islet cell tumours: results of a phase III, randomised, double-blind trial. European Journal of Cancer Supplements, Vol 7, No 2, September 2009, page 361, abstract O6501.
[2] Kulke MH, Lenz HJ, Meropol NJ, et al. Activity of sunitinib in patients with advanced neuroendocrine tumors. Journal of Clinical Oncology. 2008. 26:3403-3410.
© 1998-2007 OncoEd.com All Rights Reserved.
These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
Patient Home
