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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Sunitinib malate for the treatment of pancreatic neuroendocrine tumors
New England Journal of Medicine, Volume 364, No. 6, Year 2011
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Description
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.) Copyright © 2011 Massachusetts Medical Society.
Authors & Co-Authors
Raymond, Éric
France, Clichy
Hôpital Beaujon
Raoul, Jean Luc
France, Rennes
Centre Eugène Marquis Rennes
Bang, Yung–Jue
South Korea, Seoul
Seoul National University Hospital
Borbath, Ivan
Belgium, Brussels
Cliniques Universitaires Saint-luc
Lombard-Bohas, Catheríne H.
France, Lyon
Chu de Lyon
Valle, Juan W.
United Kingdom, Manchester
The Christie Nhs Foundation Trust
Metrakos, Peter P.
Canada, Montreal
Centre Universitaire de Santé Mcgill
Vinik, Aaron I.
United States, Norfolk
Eastern Virginia Medical School
Hammel, Pascal R.
France, Clichy
Hôpital Beaujon
van Cutsem, Éric J.D.G.
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Statistics
Citations: 2,280
Authors: 10
Affiliations: 15
Identifiers
Doi:
10.1056/NEJMoa1003825
ISSN:
00284793
Research Areas
Disability
Environmental