Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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Real-World Effectiveness of Regorafenib in the Treatment of Patients with Metastatic Colorectal Cancer- A Retrospective, Observational Study

Detailed Description
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To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with metastatic colorectal cancer (mCRC). This retrospective, observational study included clinicopathological and follow-up data of patients with mCRC who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.

Official Title
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Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer-A Retrospective Study

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Other: nonintervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be a pathologically proven colorectal adenocarcinoma Must have been treated with regorafenib Regorafenib must be used after two lines of standard antitumor therapy Exclusion Criteria: Application is less than one course of treatment with regorafenib First - or second-line treatment with regorafenib Patients with multiple primary cancers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 group<br>Patients were given only regorafenib orally | Other: nonintervention<br> <br> |
| Joint group<br>The patient was treated with regorafenib orally and in combination with other medications | Other: nonintervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in overall survival between the two groups calculated by Kaplan-Meier | Survival differences between the monotherapy and combination groups | 2021.7-2022.12 | 
| The difference of OS in patients receiving different doses of regorafenib | In the real world, regorafenib was used in different dosages: 40mg,80mg,120mg,160mg,respectively. The difference in overall survival time of patients with different dosage was compared. | 2021.11-2022.12 | 
| Regorafenib in combination with other drugs | In the real world, regorafenib was used in combination with chemotherapy, immunotherapy or other drugs, and the frequency of occurrence of different conditions was analyzed. | 2021.7-2022.10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival differences among the patients with different clinical phenotypes and genotypes | To compare the survival of patients with mCRC by gender, age, tumor site and other genotypes | 2021.7-2022.10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic colorectal cancer, regorafenib