Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L01XC07) bevacizumab
bevacizumab

Medical condition to be studied

Colorectal cancer metastatic
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

16000
Study design details

Main study objective

The main objective of this study is to evaluate the impact of the presence of cardiovascular comorbidities at baseline on 36-month overall survival in elderly mCRC patients treated with bevacizumab.

Outcomes

Occurrence of death from any cause at 36 months. Occurrence of death from any cause at 12 and 24 months. Occurrence of each of the following serious cardiovascular event: heart failure, malignant hypertension and thromboembolic events (including myocardial infarction, venous and arterial thrombosis, stroke and pulmonary embolism) during the follow-up. Occurrence of a composite endpoint of serious cardiovascular events during the follow-up.

Data analysis plan

The probability of death will be evaluated at 12, 24 and 36 months using Kaplan-Meier analyses and will be compared across groups using the log rank test. The impact of cardiovascular comorbidities on 36-month risk of death and on the occurrence of serious cardiovascular events will be evaluated using time-dependent multivariable proportional hazards Cox regression models (for death) and Fine and Gray models taking into account death as a competing risk (for occurrence of cardiovascular events only). A sensitivity “on-treatment” analysis will be carried-out. The safety will be assessed between the first dispensing of bevacizumab and the date of the considered cardiovascular events (separately or combined) or the last dispensing of first-line bevacizumab during the follow-up whichever came first. All analyses will be stratified according to age at mCRC diagnosis: <75 versus ≥75 years old.