Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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This study is a retrospective observational study that evaluates the rate of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer in the French county Calvados by drug exposure.

Detailed Description
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This study investigates the characteristics of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer. Descriptive analysis will include incidence, type of cardiovascular adverse events. We will explore the incidence of cardiovascular adverse events with regard of the antineoplastic drug exposures. This will provide information about the individual drug safety profiles.

Official Title
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Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry

Conditions
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Colorectal Cancer Metastatic

Intervention / Treatment
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* Drug: Antineoplastic Agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados Exclusion Criteria: Minors < 18 year old Patients without a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados

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 |
| --- | --- |
| Metastatic colorectal cancer<br>The French county Calvados registry of digestive cancers will allow to identify patients with a metastatic colorectal cancer diagnosed between 2004 and 2014. Patients will be included if the cancer was diagnosed at the metastatic stage between 2004 and 2014 or non-metastatic before 2004 that became metastatic between 2004 and 2014 (synchronous and metachronous tumors) | Drug: Antineoplastic Agents<br>* Exposure measurement to any anticancer drug in its therapeutic use for the metastatic colorectal cancer with its posology and duration (the list provided is non-limitative). Exposure to anticancer drugs for another indication than the colorectal cancer will also be collected.<br>* Other names: panitumumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients. | Any cardiovascular adverse event (e.g. the non limitative list: ischaemic heart disease, heart failure, hypertension, ischaemic stroke, embolic or thrombotic events, arrhythmias, conductive disorders) that was the primary diagnosis of a hospital admission. Any anticancer drug (chemotherapy) intake will be considered for the primary analysis. We will use a competing risk statistical model. | Between 2004 and 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of cardiovascular adverse events (any) for each individual anticancer drug. | Drug exposure will be defined as a binary variable for each drug. (intakes/no intakes). A competing risk model will be used. | Between 2004 and 2017 | 
| Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol | Drugs combination will be defined as a binary variable for each protocol. (intakes/no intakes). | Between 2004 and 2017 | 
| Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients | Several individual cardiovascular adverse events will be assessed in separate analyses: ischaemic heart disease, heart failure, hypertension, ischaemic stroke, embolic or thrombotic events, arrhythmias, conductive disorders). A competing risk model will be used | Between 2004 and 2017 | 
| Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events | Dose will be approached by the number of cycles of the anticancer drug and by the cumulative dose (in milligram) received. | Between 2004 and 2017 | 
| Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events | Dose will be approached by the number of cycles of the anticancer drugs combination/protocol. | Between 2004 and 2017 |