Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

This prospective study will investigate the characteristics of mRCC patients at time of CR in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some answers/ refection leads to the following questions :

Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify potential predictive serum biomarkers of recurrence? (With the aim of isolating blood biomarker that can help on treatment discontinuation decision?)

The main objective of the study is to describe the characteristics of mRCC patients on CR with Sunitinib (Cases) and compare them to the characteristics of mRCC patients non on CR (controls) in order to identify factors associated with the occurrence of complete remission.

The results obtained on the sample must be representative of the population targeted by the study. The most appropriate method to obtain a representative sample is probability sampling.

A sample size of N = 40 (cases) and N = 80 (Controls) will provide a power of 80% in the detection of a frequency difference between cases and controls corresponding to an OR of 0.24 for a parameter frequency 10% in control arm and an OR of 0.30 for a parameter frequency of around 30% in control arm. The significance level was set at bilateral 5%.

The data will be analyzed using SAS software (version 9.1 - SAS Institute, North Carolina, United States).

• Drug: sunitinib
  
  50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
  Other Name: Cases
• Drug: sunitinib
  
  50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
  Other Name: Controls

• Complete Remission
  
  Complete remission arm in mRCC patients treated with sunitinib.
  Intervention: Drug: sunitinib
• Non Complete Remission
  
  Non complete remission arm in mRCC patients treated with sunitinib.
  Intervention: Drug: sunitinib

Inclusion Criteria:

• Patients with metastatic renal cell carcinoma, histopathologically confirmed
• Treated with sunitinib according to Smpc
• For cases: Achieving a CR (local assessment according to RECIST V1.0 criteria) with Sunitinib in prior 6 months alone OR in combination with local treatment (surgery, radiation therapy, ablative techniques: cryotherapy, RFA)
• For controls: Life expectancy > 3 months No prior Sunitinib treatment
• Patient >18 years

Exclusion Criteria:

• Sunitinib administered in a non-approved label
• For cases: CR occurring without sunitinib treatment
• For controls: Prior systemic treatment