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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic colorectal cancer | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antineoplastic Agents | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Exhaustive population of metastatic colorectal cancers in the French county Calvados registry diagnosed between 2004 and 2014 (synchrone and metachrone diagnosis).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joachim Alexandre, MD, PhD | Contact | +33231064670 | alexandre-j@chu-caen.fr | |
| Charles Dolladille, MD | Contact | +33231064670 | dolladille-c@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Joachim Alexandre, MD, PhD | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen | Caen | Normandy | 14000 | France |
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| ID | Term |
|---|---|
| D000970 | Antineoplastic Agents |
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| D000077150 | Oxaliplatin |
| D000068258 | Bevacizumab |
| C533178 | aflibercept |
| D000069287 | Capecitabine |
| D000068818 | Cetuximab |
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D014498 | Uracil |
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|
|
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 |
| D011744 |
| Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |