Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume in Patients With Non-Small Cell Lung Cancer: A Case-Control Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in aortic plaque volume
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
In this study, investigators plan to test whether Immune Checkpoint Inhibitor (ICI) treatment leads to an accelerated progression of atherosclerosis in patients with lung cancer. Atherosclerosis is an immune-mediated inflammatory disease and these same checkpoints being targeted for cancer are critical negative regulators of atherosclerosis in animal and cellular models. Aortic plaque progression will be compared between cases (on ICI) and controls from pre-ICI to post-ICI among patients with non-small cell lung cancer. Groups will be matched for age, cancer type and stage and cardiovascular risk factors. Traditional markers of cardiovascular (CVD) risk and cancer-specific factors (ICI mono- and combination therapy, number of cycles, occurrence of immune-related adverse events, chest radiation, steroid use) will be associated with the change in aortic plaque volume.
Investigators
Tomas G. Neilan, MD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Subjects with non-small cell lung cancer treated with Immune Checkpoint Inhibitors.
- •Available contrast enhanced CT scans of the chest both immediately pre-ICI (\< 1 month) and latest follow-up.
- •Subjects with non-small cell lung cancer, age, cancer stage and cardiovascular risk factor matched to cases.
- •Available contrast enhanced CT scan of the chest at two time-points at a similar interval between scans as the cases.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in aortic plaque volume
Time Frame: Three years
The change of plaque burden after starting ICIs will be calculated and compared with the pre-ICI study. The change in plaque burden in controls will be calculated and compared from two studies at a similar median interval as ICI cases.