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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) has proven efficacy across multiple clinical endpoints versus IFN-α1

The efficacy of SUTENT® (sunitinib) is based on an established 50 mg/day 4 weeks on / 2 weeks off (4/2) treatment schedule used in the Phase III pivotal trial and clinical practice.1

SUTENT® (sunitinib) delivers an OS improvement2

A randomised, multicentre trial in 750 treatment-naive patients with metastatic clear-cell renal-cell carcinoma (RCC), assigned to oral SUTENT® (sunitinib) 50 mg/day on a 4/2 treatment schedule or IFN-a at a dose of 9 MU given subcutaneously three times weekly. Median duration of treatment at the final analysis was 11 months for the SUTENT® (sunitinib) group and 4 months for the IFN-a group. Central review of imaging scans was discontinued when the primary endpoint was met at the interim analysis. Therefore, only updated investigator-assessed ORR are reported here.1

Expanded Access Programme: subgroup analysis2 SUTENT® (sunitinib) is an appropriate choice for patients ≥ 65 years of age, patients with non-clear cell histology and patients with brain metastases2 
Survival events including all deaths were collected up to September 2008.  Overall, 324 patients were excluded from the modified intent-to-treat population for PFS analysis because of non-RECIST tumour assessment. Overall, 324 patients were excluded from the modified intent-to-treat population for objective response due to non-RECIST tumour assessments. A further 866 patients were included in the analysis but were not assessed (n = 250), not evaluable (n = 19) or had missing data (n = 597).

Clinical benefit = objective response + stable disease for ≥ 3 months.

Maintaining the optimal SUTENT® (sunitinib) dose and maintaining therapy duration is important for prolonging survival3,4
  • Exposure was significantly associated with longer OS (p = 0.01) and TTP (p = 0.001)†4
  • OS has been shown to be significantly shorter among patients with mRCC who discontinued SUTENT® (sunitinib) treatment within the first 18 to 30 weeks3
While survival remains the main goal of treatment in mRCC, optimal treatment outcomes need to balance maximal efficacy with minimal adverse events5

A pharmacokinetic / pharmacodynamic analysis evaluating the relationship between SUTENT® (sunitinib) exposure and efficacy / tolerability using data from two studies of patients with mRCC (n = 169) assigned to oral SUTENT® (sunitinib) 50 mg/day on a 4/2 treatment schedule.4

Time-to-event analysis. High and low AUCss are AUCss ≥ median and < median, respectively, where median = 0,8 μg·h/mL.

Objective Overall Response Rate with SUTENT® (sunitinib) can improve with longer treatment duration1Maintaining patients on SUTENT® (sunitinib) for as long as clinical benefit is observed optimises both tumour control and survival outcomes4,7-9 Footnotes:AUC: Area Under the Curve; AUCss: Area Under the Curve Steady State; ECOG PS: Eastern Cooperative Oncology Group performance status; ESMO: European Society for Medical Oncology; IFN-α: Interferon alpha; mOS: Median overall survival; mPFS: Median Progression-Free Survival; mRCC: metastatic Renal Cell Carcinoma; ORR: Objective Response Rate; OS: Overall Survival; PFS: Progression Free Survival; RECIST: Response Evaluation Criteria in Solid Tumours; TPP: Time to Tumour Progression References:Motzer RJ, Hutson TE, Tomczak P, et al. Overall Survival and Updated Results for Sunitinib Compared With Interferon Alfa in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2009 Aug;27(22):3584-3590. Gore ME, Szczylik C, Porta C, et al. Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma. British Journal of Cancer. 2015;113:12-19. Porta C, Levy A, Hawkins R, et al. Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first-line sunitinib: a medical chart review across ten centers in five European countries. Cancer Medicine. 2014;3(6):1517-1526. Vinik AI and Raymond E. Pancreatic neuroendocrine tumors: approach to treatment with focus on sunitinib. Ther Adv Gastroenterol 2013;6:396–411. Houk BE, Bello CL, Poland B, et al. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol. 2010 Jul;66(2):357-371. Hutson TE. Targeted Therapies for the Treatment of Metastatic Renal Cell Carcinoma: Clinical Evidence. The Oncologist. 2011;16(suppl 2):14-22. Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-124. Sternberg CN, Calabrò F, Bracarda S, et al. Safety and Efficacy of Sunitinib in Patients from Italy with Metastatic Renal Cell Carcinoma: Final Results from an Expanded-Access Trial. Oncology. 2015;88(5):273-280. Schmidinger M, Larkin J, Ravaud A. Experience with sunitinib in the treatment of metastatic renal cell carcinoma. Ther Adv Urol. 2012;4(5):253-265.

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