Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland

Study Overview
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Brief Summary
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Patient receiving sunitinib according the clinician's independent decision as first-line treatment of advanced renal cell carcinoma (RCC) will be asked for informed consent. Treatment with sunitinib will start and end solely on the treating clinicians and the patients independent discretion. Consenting patients will prospectively answer standardized quality of life questionnaires (15D, EQ-5D) during the treatment. Data on health care resource utilisation will be collected prospectively (outpatient visits, hospital stays, concomitant drugs, investigations, sick-leaves, travels). In addition, after treatment failure anti-cancer drugs, hospital stays and date of death will be recorded. The health economic data during sunitinib treatment and the length of the sunitinib treatment will be compared with the corresponding previously published data collected retrospectively from patients with the same condition treated with IFN-alfa. Stepwise regression analysis will be used to explore whether patient and tumor characteristics explain potential variation in treatment duration and costs that is not explained by the treatment. Health-related quality of life (HRQoL) data will be presented as descriptive data and compared to age-standardized general population. At least four major Finnish oncology centers have consented to participate in this study. The inclusion time will be approximately 24 months, and the study time approximately 48 months. Eighty patients will be included.

Official Title
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Evaluation of the Cost and Effectiveness in the First-line Treatment of Advanced Renal Cell Cancer With Sunitinib Compared to Interferon-alfa in Finland.

Conditions
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Neoplasms, Renal Cell Carcinoma

Intervention / Treatment
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* Drug: sunitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically indicated first-line sunitinib treatment for advanced RCC. Informed consent obtained. Exclusion Criteria: Unable to complete HRQoL forms. Not consenting to collecting register data.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sunitinib<br>advanced renal cell cancer patients treated with sunitinib as first-line therapy | Drug: sunitinib<br>* sunitinib 50 mg, per os, daily for 4 weeks then 2 weeks pause, duration months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental cost per incremental time to treatment failure (TTF) in first-line treatment |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life (HRQoL) |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal cell cancer, sunitinib, costs, quality of life