Real-World Experience

Control with SUTENT®: because of its long standing real-world experience1–6

Adapted from Motzer RJ, et al. 2009. Gore ME, et al. 2015. Morales JMR, et al. 2016. Noize P, et al. 2017. Lalani AA, et al. 2017.
No cross-trial comparisons may be made, since trials were conducted using different methodologies and at different time points. 
Final and investigator review analyses unless otherwise stated. 
*Progression-free survival results in this trial reported as time to treatment failure.

Study Information

Registration trial

Randomised, multicentre, Phase III trial in 750 treatment-naïve patients with mRCC, comparing the efficacy and safety of SUTENT® 50 mg/day on a 4/2 schedule and IFN-alpha SC TIW at 3 MU per dose the first week, 6 MU the second week and 9 MU thereafter.2

Expanded Access Programme

Global, open label, EAP of SUTENT® 50 mg/day on a 4/2 schedule in 4543 treatment-naïve or previously treated mRCC patients. The primary objective of the study was to provide SUTENT® to mRCC patients without access to the treatment. Secondary objectives included assessment of efficacy and safety in the overall population and subgroups of interest.3

International mRCC Database Consortium

Observational analysis of the IMDC to assess OS, PFS and RR and performed proportional hazard regression, adjusting for IMDC prognostic groups.4

SANTORIN real-world study

Observational study in 302 mRCC patients initiating treatment with SUTENT®. The primary objective of the study was to describe patterns of use and estimate survival outcomes in a real-life setting.5

The Canadian Experience

Observational study in 670 patients with mRCC treated with SUTENT® (n=577) or pazopanib (n=93) to evaluate OS and to compare dose-modifying toxicities in a real-world setting.6

EAP, Expanded Access Programme. IFN-α. interferon-alpha. IMDC, International mRCC. Database Consortium. mPFS, median progression-free survival. mRCC, metastatic renal cell carcinoma. MU, million units. OS, overall survival. PFS, progression-free survival. RR, response rate. SC, subcutaneous. TIW, three times weekly.

References:

  1. SUTENT® Summary of Product Characteristics. 
  2. Motzer RJ, et al. J Clin Oncol 2009;27:3584–3590.
  3. Gore ME, et al. Br J Cancer 2015;113:12–19.
  4. Morales JMR, et al. Eur J Cancer 2016;65:102–108.
  5. Noize P, et al. Pharmacoepidemiol Drug Saf  2017;36:1561–1569.
  6. Lalani AA, et al. Can Urol Assoc J 2017;11:112–117.

PP-SUT-IRL-0137  September 2020