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The aim of this local NIS(Non-Interventional Study) is to determine the proportion of Belgian patients with a duration of treatment(DoT) to Stivarga of 4 months or more in relation to the total population of Belgian metastatic colorectal cancer(mCRC) patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017. In addition, this study aims to describe the clinical characteristics of Belgian patients with a short- or long-term DoT to Stivarga.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regorafenib_DoT<4 months | DoT < 4 months |
| |
| Regorafenib_4 months ≤ DoT < 12 months | 4 months ≤ DoT < 12 months |
| |
| Regorafenib_DoT ≥ 12 months | DoT ≥ 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Drug | Antineoplastic agents, protein kinase inhibitor (L01XE21) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sample | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | |
| ECOG performance status (0, 1) | ECOG: Eastern Cooperative Oncology Group | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 |
| Primary site of disease | Rectum, Left-sided colon, Right-sided colon, Colon and rectum, Transverse, Unknown (in colon) | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 |
| Tumor resection (yes, no, unknown) | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | |
| Specific site of metastasis | Lung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknown | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 |
| KRAS mutation (yes, no, unknown) | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | |
| RAS mutation (yes, no, unknown) | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | |
| BRAF mutation (yes, no, unknown) | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 |
| Measure | Description | Time Frame |
|---|---|---|
| Start date of Stivarga treatment | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | |
| Number of prior treatment lines for metastatic cancer larger than 3 (yes, no, unknown) | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 |
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Inclusion Criteria:
Exclusion Criteria:
- Patients participating in an investigational program/clinical trial with interventions outside of routine clinical practice during the observational period.
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Belgian mCRC patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belgium | Multiple Locations | Belgium |
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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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| Reason for discontinuation of Stivarga treatment | progression - symptomatic, Progression - radiological, Progression - radiological + symptomatic, Progression - unknown, Intolerability, Death, other, unknown, not applicable | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 |
| Subsequent mCRC treatment | Chemotherapy IV, Chemotherapy oral, Biologic therapy, Chemotherapy + biologic therapy, BSC, Other, Unknown, Not applicable | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 |
| Last daily Stivarga dose | 80 mg, 120 mg, 160 mg, other, unknown | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 |
| Duration of treatment (months) | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |