Commonly prescribed drugs and association with breast, colorectal and lung cancer progression: a nested case-control study

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

Study drug and medical condition

• Medical condition to be studied:
  Breast cancer female

  Lung carcinoma cell type unspecified stage I

  Lung carcinoma cell type unspecified stage II

  Lung carcinoma cell type unspecified stage III

  Lung carcinoma cell type unspecified stage IV

  Colorectal cancer

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  8398

Study design details

• Main study objective:
  The principal study objective is to investigate the association between commonly prescribed cardiovascular, analgesic and bisphosphonate medications in relation to cancer specific and all cause mortality i.e.: assessment of the odds of dying from cancer or all causes between breast, lung and colorectal cancer patients taking vs. those not taking a variety of commonly prescribed medications.
• Outcomes:
  Primary outcomes of the study will be cancer specific and all cause mortality in relation to regular (>= 3 times/week for one month or more) use of NSAIDs and aspirin (including low dose aspirin (75mg)), angiotensin converting enzyme Inhibitors (ACE inhibitors), angiotensin receptor blockers (ARBs), β-blockers and bisphosphonates post-diagnosis of any stage breast, colorectal and lung cancer. A secondary outcome for this study will be to assess the odds of cancer recurrence (i.e.: a secondary occurence of the primary cancer after a period of remission) between patients using commonly prescribed medications and nonusers.
• Data analysis plan:
  The statistical analysis for all three cancer cohorts (breast, colorectal and lung) will be handled using a time matched nested case-control analysis approach. Cohort members will be defined as a case if they have died from one of the three cancer sites or if they have developed a recurrence of their cancer. Up to 5 controls will be selected (matched on age in 5year intervals and gender) to cohort members (controls) who are still alive/have not developed disease recurrence at the time of the case’s death/cancer recurrence. Conditional logistic regression analysis will be used to calculate the odds of death and 95% confidence limits between those ever exposed vs. those never exposed to each of the intended drugs under study. Analysis will be stratified on age, menopausal status (in breast cancer analysis), gender and cancer site (in colorectal and lung cancer cohorts) and stage (all cancers). Additional analyses will be undertaken to the quantity and duration of drug use.