Colorectal Neoplasms
Conditions
Keywords
Metastatic colorectal cancer
Brief summary
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.
Interventions
DRUGRegorafenib (Stivarga, BAY73-4506)
Product is used in accordance with SmPC
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of treatment for each treatment episode | Retrospective analysis of 2 year period | 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 |
| Number of participants with treatment emergent adverse events as a measure of safety and tolerability | Retrospective analysis of 2 year period | — |
| Overall Survival (OS) | Retrospective analysis of 2 year period | — |
| Progression Free Survival (PFS) | Retrospective analysis of 2 year period | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resource utilization per patient | Retrospective analysis of 2 year period | Costs per patient for the reimbursed healthcare service e.g. inpatient care, outpatient visit, emergency departement visit, pharmaceutical dispensing |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to treatment failure (TTF) | Retrospective analysis of 2 year period | 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 |
| Time frame between the baseline computed tomography and the first drug delivery | Retrospective analysis of 2 year period | Time frame between the date of the baseline computed tomography (CT) and the date of the first drug delivery to the health care provider |
| Characteristics of patients with better response | Retropsective analysis of 2 year period | 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. |
| Time to progression (TTP) | Retrospective analysis of 2 year period | 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 |
Countries
Hungary
Outcome results
None listed