Stivarga Real Life Evidence in Hungary

Study Overview
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Brief Summary
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The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study should provide information about clinical characteristics of Hungarian regorafenib patients as well as information about safety and efficacy of regorafenib in Hungarian patients with metastatic colorectal cancer. This much needed data is required by the National Health Insurance Fund in order to accept regorafenib into the regular reimbursement system. This study is proposed to be based on patient data from the Hungarian National Health Insurance Fund's Database. Data to be analyzed includes patient demography and baseline tumor characteristics, overall survival, time to treatment failure, duration of treatment, average dose and dose modifications, and adverse events. Further, treatment costs will be estimated.

Official Title
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Effectiveness of Stivarga (Regorafenib) for Patients With Metastatic Colorectal Cancer in the Hungarian Real World Setting

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Drug: Regorafenib (Stivarga, BAY73-4506)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Using the National Health Insurance Database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle (=28 days). Exclusion Criteria: Not applicable
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 |
| --- | --- |
| Cohort1/Regorafenib<br>All patients with at least 1 treatment with regorafenib | Drug: Regorafenib (Stivarga, BAY73-4506)<br>* Product is used in accordance with SmPC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of treatment for each treatment episode | The length of each treatment episode will be calculated based on the duration between the initiation date of a treatment episode and the end date of the same treatment episode | Retrospective analysis of 2 year period | 
| Progression Free Survival (PFS) | PFS will be defined as days between start of the therapy and the date of the medical doctors opinion about progression (confirmed by radiology or clinical assessment) | Retrospective analysis of 2 year period | 
| Overall Survival (OS) |  | Retrospective analysis of 2 year period | 
| Number of participants with treatment emergent adverse events as a measure of safety and tolerability |  | Retrospective analysis of 2 year period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resource utilization per patient | Costs per patient for the reimbursed healthcare service e.g. inpatient care, outpatient visit, emergency departement visit, pharmaceutical dispensing | Retrospective analysis of 2 year period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic colorectal cancer