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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1/Regorafenib | All patients with at least 1 treatment with regorafenib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Drug | Product is used in accordance with SmPC |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure (TTF) | Time to treatment failure is defined as days between the first drug delivery to the health care provider and date of treatment discontinuation due to any reason, including death | Retrospective analysis of 2 year period |
| Time to progression (TTP) |
Inclusion Criteria:
Exclusion Criteria:
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The study population will be all patients who met the criteria within the SmPC. 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.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Budapest | Hungary |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
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Time to progression is defined as days between the first drug delivery to the health care provider and the date of progression defined by the medical doctor |
| Retrospective analysis of 2 year period |
| Characteristics of patients with better response | Patients with "better response" are defined as receiving more cycles of regorafenib treatment than the median number of cycles (2 cycles). Their distribution is analyzed by KRAS status, by the location of the primary tumour, by age, by prior cancer therapies and by location of metastases. | Retropsective analysis of 2 year period |
| Time frame between the baseline computed tomography and the first drug delivery | Time frame between the date of the baseline computed tomography (CT) and the date of the first drug delivery to the health care provider | Retrospective analysis of 2 year period |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |