Cost Effectiveness Of Sunitinib In Central America And Caribbean

• Rate of patients that present metastasis when consulting for first time [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Rate of use of Sutent, IFN-α and Bevacizumab + IFN-α as first-line treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Hospitalization average with Sutent, with IFN-α, and with Bevacizumab + IFN-α [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Rate of success in first-line treatment with Sutent, in first-line treatment with IFN-α and in first-line treatment with Bevacizumab + IFN-α [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Average number of cycles of Sutent, IFN-α and Bevacizumab + IFN in first-line treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]

• Percentage of adverse effects with the use of Sunitinib, IFN-α and Bevacizumab + IFN [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Quality of life in patients using an approved quality questionnaire [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Costs-benefit of each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• PFY (progression free years) with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• LY (life years) with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• QALYs (quality adjusted life years) with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]

• Percentage of adverse effects with the use of Sunitinib, IFN-α and Bevacizumab + IFN [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Quality of life in patients using an approved quality questionnaire [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Costs-benefit of each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• PFY (progression free years) with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• LY (life years) with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• QALYs (quality adjusted life years) with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Primary Hypothesis: The therapy with Sunitinib represents better cost-effectiveness than IFN-α in first-line treatment for metastatic Renal Cell Carcinoma (mRCC) in Central America and Caribbean countries

This study was terminated on 03Feb2011 due to the fact that the anticipated number of patients expected was not reached. The date of cessation of the drug was January 27, 2011. There was no intervention in the treatment or administration of the drug; the study only observed the treatment and collected data. As the study was dependent on the arrival of new patients with metastatic renal cancer, which was of a very low incidence, the study was terminated. Efficacy, adverse events or other safety issues were not factors in terminating the study. Lack of patients was the only reason.

Adult men and women with mRCC will be evaluated for entering the study. The decision to use Sunitinib, IFN-α or Bevacizumab + IFN must be a joint decision made by the subject and the investigator. The investigator must discuss product information with the subject as per usual practice.

Inclusion Criteria:

• Evidence of a personally signed (or legally acceptable representative) and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
• Adult (18 years old or older) men and women with confirmed diagnosis of mRCC treated with Sutent, IFN-α or Bevacizumab + IFN ; on the selected institutions.

Exclusion Criteria:

• Adult men or women with RCCm treated with any other medication that is not Sutent, IFN-α or Bevacizumab + IFN.
• Adult men or women with mRCC with palliative care.
• Adult men or women with RCC without metastasis.