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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) significantly delays progression post-imatinib1,2

Patients receiving SUTENT® (sunitinib) show an almost four-fold increase in time to disease progression compared with those randomised to placebo.1

SUTENT® (sunitinib) delivers an OS improvement2 SUTENT® (sunitinib) demonstrates an OS benefit post-imatinib1

When corrected for crossover (RPSFT method)* SUTENT® (sunitinib) nearly doubled mOS compared with placebo1
Times on treatment after crossover are adjusted to reflect what would have happened if patients had stayed on control. This method assumes that treatment with the experimental drug affects survival time uniformly in all patients.1 This method does not alter the p-value obtained in the conventional ITT analysis. (HR: 0.88 p=0.306 [95% CI: 0.68–1.13]).1
Patients failing on imatinib can still expect to extend their survival with SUTENT® (sunitinib).1Treating beyond progression with SUTENT® (sunitinib) is associated with increased survival2

Patients continue to benefit from treatment with SUTENT® (sunitinib) even after progression2

 Study information

Phase III international randomised double-blind trial evaluating SUTENT® (sunitinib) in GIST patients after imatinib failure. 361 patients randomized to either sunitinib (n=243) or placebo (n=118) with: histologically proven GIST who had failed imatinib treatment due to resistance or intolerance, ECOG PS ≤1 and adequate hepatic, renal, and cardiac function. Patients were randomized 2:1 to receive treatment in repeated 6-week cycles of 4 weeks of daily sunitinib (50 mg) or placebo followed by 2 weeks off treatment.1

A worldwide, open-label, treatment-use study of imatinib-refractory or - intolerant GIST. 1131 patients enrolled; 1124 patients comprised the ITT population. In this post-hoc analysis, patients were stratified based on whether SUTENT® (sunitinib) treatment was continued (n=380) or stopped (n=324) after objective assessment of progressive disease. Treatment continued as long as there was evidence of disease control. Survival was monitored for up to 2 years after the last dose.2

Footnotes:HR: hazard ratio; CI: confidence interval; RPSFT: rank-preserving structural failure time; OS: overall survival; mOS: median overall survival; KM: Kaplan–Meier; ITT: intention to treat; PD: progressive disease; GIST: gastrointestinal stromal tumour; ECOG PS: Eastern Cooperative Oncology Group performance status References:Demetri GD, Garrett CR, Schöffski P, et al. Complete Longitudinal Analyses of the Randomized, Placebo-Controlled, Phase III Trial of Sunitinib in Patients with Gastrointestinal Stromal Tumor following Imatinib Failure. Clin Cancer Res 2012;18:3170–3179. Reichardt P, Kang Y, Rutkowski P, et al. Clinical Outcomes of Patients with Advanced Gastrointestinal Stromal Tumors: Safety and Efficacy in a Worldwide Treatment-use Trial of Sunitinib. Cancer 2015;121:1405–1413. Demetri GD, van Oosterom AT, Garrett CR, et al. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet 2006;368:1329–1338.
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