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Sunitinib Malate for the Treatment of Pancreatic Neuroendocrine Tumors.

Cited 1555 time in Web of Science Cited 1690 time in Scopus
Authors
Raymond, Eric; Dahan, Laetitia; Raoul, Jean-Luc; Bang, Yung-Jue; Borbath, Ivan; Lombard-Bohas, Catherine; Valle, Juan; Metrakos, Peter; Smith, Denis; Vinik, Aaron; Chen, Jen-Shi; Hoersch, Dieter; Hammel, Pascal; Wiedenmann, Bertram; Van Cutsem, Eric; Patyna, Shem; Lu, Dongrui Ray; Blanckmeister, Carolyn; Chao, Richard; Ruszniewski, Philippe
Issue Date
2011-02
Citation
New England Journal of Medicine, Vol.364 No.6, pp.501-513
Abstract
Background: The multitargeted tyrosine kinase inhibitor sunitinib has shown activity against pancreatic neuroendocrine tumors in preclinical models and phase 1 and 2 trials. Methods: We conducted a multinational, randomized, double-blind, placebo-controlled phase 3 trial of sunitinib in patients with advanced, well-differentiated pancreatic neuroendocrine tumors. All patients had Response Evaluation Criteria in Solid Tumors-defined disease progression documented within 12 months before baseline. A total of 171 patients were randomly assigned (in a 1:1 ratio) to receive best supportive care with either sunitinib at a dose of 37.5 mg per day or placebo. The primary end point was progression-free survival; secondary end points included the objective response rate, overall survival, and safety. Results: The study was discontinued early, after the independent data and safety monitoring committee observed more serious adverse events and deaths in the placebo group as well as a difference in progression-free survival favoring sunitinib. Median progression-free survival was 11.4 months in the sunitinib group as compared with 5.5 months in the placebo group (hazard ratio for progression or death, 0.42; 95% confidence interval [CI], 0.26 to 0.66; P<0.001). A Cox proportional-hazards analysis of progression-free survival according to baseline characteristics favored sunitinib in all subgroups studied. The objective response rate was 9.3% in the sunitinib group versus 0% in the placebo group. At the data cutoff point, 9 deaths were reported in the sunitinib group (10%) versus 21 deaths in the placebo group (25%) (hazard ratio for death, 0.41; 95% CI, 0.19 to 0.89; P=0.02). The most frequent adverse events in the sunitinib group were diarrhea, nausea, vomiting, asthenia, and fatigue. Conclusions: Continuous daily administration of sunitinib at a dose of 37.5 mg improved progression-free survival, overall survival, and the objective response rate as compared with placebo among patients with advanced pancreatic neuroendocrine tumors. (Funded by Pfizer; ClinicalTrials.gov number, NCT00428597.) N Engl J Med 2011;364:501-13.
ISSN
0028-4793
URI
https://hdl.handle.net/10371/173241
DOI
https://doi.org/10.1056/NEJMoa1003825
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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