NDLI: Sunitinib malate for the treatment of pancreatic neuroendocrine tumors.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Van Cutsem, Eric Dahan, Laetitia Raymond, Eric Vinik, Aaron Ruszniewski, Philippe Chen, Jen-shi Hammel, Pascal Smith, Denis Valle, Juan Raoul, Jean-luc Patyna, Shem Wiedenmann, Bertram Lu, Dongrui Ray Hörsch, Dieter Borbath, Ivan Bang, Yung-jue Lombard-bohas, Catherine Blanckmeister, Carolyn Chao, Richard Metrakos, Peter
Description	Author Affiliation: Raymond E ( Service Inter-Hospitalier de Cancérologie et Service de Gastroenteropancréatologie, Hôpital Beaujon, Clichy, France. eric.raymond@bjn.aphp.fr)
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.).
ISSN	00284793
Issue Number	6
Volume Number	364
e-ISSN	15334406
Journal	New England Journal of Medicine
Language	English
Publisher	Massachusetts Medical Society (United States)
Publisher Date	2011-02-10
Publisher Place	United States
Access Restriction	Subscribed
Subject Keyword	Antineoplastic Agents Therapeutic Use Indoles Neuroendocrine Tumors Drug Therapy Pancreatic Neoplasms Protein Kinase Inhibitors Pyrroles Adult Aged Aged, 80 And Over Adverse Effects Disease Progression Double-Blind Method Female Humans Intention To Treat Analysis Kaplan-Meier Estimate Male Middle Aged Mortality Proportional Hazards Models Quality Of Life Receptors, Vascular Endothelial Growth Factor Antagonists & Inhibitors Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Medicine
Content Type	Text
Resource Type	Article
Subject	Medicine

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