Colorectal Neoplasms
Conditions
Keywords
Metastatic Colorectal Cancer
Brief summary
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.
Interventions
DRUGRegorafenib (Stivarga, BAY73-4506)
Antineoplastic agents, protein kinase inhibitor (L01XE21)
Sponsors
Bayer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients ≥ 18 years of age. * Patients who suffer from mCRC and who started treatment with Stivarga between the 1st of July 2015 and 31 July 2017. * Patients who already received alternative treatment options before Stivarga for the treatment of mCRC or who were not eligible for other treatment options. * Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 at start of Stivarga treatment. * Sufficient kidney, liver and bone marrow function start of Stivarga treatment. * Life expectancy ≥ 3 months at start of Stivarga treatment
Exclusion criteria
\- Patients participating in an investigational program/clinical trial with interventions outside of routine clinical practice during the observational period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BRAF mutation (yes, no, unknown) | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | — |
| 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) | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | ECOG: Eastern Cooperative Oncology Group |
| Primary site of disease | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | Rectum, Left-sided colon, Right-sided colon, Colon and rectum, Transverse, Unknown (in colon) |
| Specific site of metastasis | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | Lung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknown |
| 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 | — |
| Tumor resection (yes, no, unknown) | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Reason for discontinuation of Stivarga treatment | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | progression - symptomatic, Progression - radiological, Progression - radiological + symptomatic, Progression - unknown, Intolerability, Death, other, unknown, not applicable |
| Subsequent mCRC treatment | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | Chemotherapy IV, Chemotherapy oral, Biologic therapy, Chemotherapy + biologic therapy, BSC, Other, Unknown, Not applicable |
| Last daily Stivarga dose | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | 80 mg, 120 mg, 160 mg, other, unknown |
| Duration of treatment (months) | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | — |
| Start date of Stivarga treatment | Retrospective chart review from 1-Jul-2015 to 1-Dec-2017 | — |
Countries
Belgium
Outcome results
None listed