Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry
Overview
- Phase
- Not Applicable
- Intervention
- Antineoplastic Agents
- Conditions
- Colorectal Cancer Metastatic
- Sponsor
- University Hospital, Caen
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients.
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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)
Intervention: Antineoplastic Agents
Outcomes
Primary Outcomes
Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients.
Time Frame: 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 Outcomes
- Risk of cardiovascular adverse events (any) for each individual anticancer drug.(Between 2004 and 2017)
- Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol(Between 2004 and 2017)
- Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events(Between 2004 and 2017)
- Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events(Between 2004 and 2017)
- Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients(Between 2004 and 2017)