Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib

Study Overview
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Brief Summary
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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.

Official Title
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COLONG: Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib

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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Regorafenib_DoT<4 months<br>DoT < 4 months | Drug: Regorafenib (Stivarga, BAY73-4506)<br>* Antineoplastic agents, protein kinase inhibitor (L01XE21)<br>|
| Regorafenib_4 months ≤ DoT < 12 months<br>4 months ≤ DoT < 12 months | Drug: Regorafenib (Stivarga, BAY73-4506)<br>* Antineoplastic agents, protein kinase inhibitor (L01XE21)<br>|
| Regorafenib_DoT ≥ 12 months<br>DoT ≥ 12 months | Drug: Regorafenib (Stivarga, BAY73-4506)<br>* Antineoplastic agents, protein kinase inhibitor (L01XE21)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Colorectal Cancer