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Sutent

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Pancreatic neuroendocrine tumours (pNET)Pancreatic neuroendocrine tumours (pNET)ContraindicationsDosage and AdministrationEfficacyInteractionsMechanism of actionPost-marketing ExperiencePrescribing InformationSafetySpecial PopulationsSpecial Warnings and PrecautionsMetastatic renal cell carcinoma (mRCC)Metastatic renal cell carcinoma (mRCC)ContraindicationsDosage and AdministrationEfficacyInteractionsMechanism of actionPost-marketing ExperiencePrescribing InformationSafetySpecial PopulationsSpecial Warnings and PrecautionsGastrointestinal stromal tumour (GIST)Gastrointestinal stromal tumour (GIST)
ContraindicationsDosage and AdministrationEfficacyInteractionsMechanism of actionPost-marketing ExperiencePrescribing InformationSafetySpecial PopulationsSpecial Warnings and Precautions
EfficacySUTENT® (sunitinib) provides a clinically meaningful improvement in PFS1SUTENT® (sunitinib) delivers an OS improvement2 SUTENT® (sunitinib) delivers an OS improvement2 SUTENT® (sunitinib) prolongs mPFS while preserving quality of life1,3,4 Study information

PFS and OS data from a multinational, randomised, double-blind, placebo-controlled phase III trial of SUTENT® (sunitinib) in patients with advanced, well-differentiated pancreatic neuroendocrine tumours, All patients had RECIST-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 SUTENT® (sunitinib) 37.5 mg daily or placebo. The primary endpoint was progression-free survival, secondary endpoints included objective response rate, overall survival, patient-reported outcomes and safety, Crossover from placebo to open-label SUTENT® (sunitinib) was permitted following disease progression.1,2 

Study analysed patient-reported outcomes in a randomised, double-blind, Phase III trial of patients with progressive, well-differentiated pNETs receiving SUTENT® (sunitinib) 37.5 mg/day continuous daily dosing. Of the 171 randomised patients, 73 in the SUTENT® (sunitinib) group and 71 in the placebo group had at least one post-baseline QLQ-C30 score, respectively.3

Footnotes:CI: confidence interval; HR: hazard ratio; HRQoL: health-related quality of life; ITT: intention to treat; KM: Kaplan–Meier; mPFS: median progression-free survival; mOS: median overall survival; OS: overall survival; PFS: progression-free survival References:Raymond E, Dahan L, Raoul J, et al. Sunitinib Malate for the Treatment of Pancreatic Neuroendocrine Tumors. N Engl J Med 2011;364:501–513.  Raymond E, Niccoli P, Castellano DE, et al. Sunitinib in Patients With Advanced, Progressive Pancreatic Neuroendocrine Tumors: Final Overall Survival Results From a Phase III Randomized Study, Including Adjustment for Crossover. J Clin Oncol 2016;34:(Suppl 4S): Abstract 309. Vinik AI, Banf Y, Raoul J, et al. Patient Patient-reported Outcomes in Patients with Pancreatic Neuroendocrine Tumors (NET) Receiving Sunitinib in a Phase III Trial. J Clin Oncol 2010;28:(Suppl): Abstract 4003. Vinik AI and Raymond E. Pancreatic neuroendocrine tumors: approach to treatment with focus on sunitinib. Ther Adv Gastroenterol 2013;6:396–411.
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