Colorectal Cancer Metastatic
Conditions
Brief summary
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
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.
Interventions
DRUGAntineoplastic Agents
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.
Sponsors
University Hospital, Caen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients. | Between 2004 and 2017 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of cardiovascular adverse events (any) for each individual anticancer drug. | Between 2004 and 2017 | Drug exposure will be defined as a binary variable for each drug. (intakes/no intakes). A competing risk model will be used. |
| Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol | Between 2004 and 2017 | Drugs combination will be defined as a binary variable for each protocol. (intakes/no intakes). |
| Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients | Between 2004 and 2017 | 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 |
| Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events | Between 2004 and 2017 | Dose will be approached by the number of cycles of the anticancer drug and by the cumulative dose (in milligram) received. |
| Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events | Between 2004 and 2017 | Dose will be approached by the number of cycles of the anticancer drugs combination/protocol. |
Countries
France
Contacts
Primary ContactJoachim Alexandre, MD, PhD
Backup ContactCharles Dolladille, MD
Outcome results
None listed