Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada 3

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1 he Cardiovascular Safety of Aromatase Inhibitors and amoxifen in Post-Menopausal Women with Breast Cancer: A Systematic eview and Meta-Analysis of andomized Controlled rials Farzin Khosrow-Khavar MSc 1,2, Kristian B. Filion PhD 1,2,3, Shatha Al-Qurashi MD 4, Nazi orabi MLIS 5, Nathaniel Bouganim MD 6, Samy Suissa PhD 1,2, Laurent Azoulay PhD 1,2,4 1 Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada 2 Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada 3 Division of Clinical Epidemiology, Department of Medicine, McGill University, Montreal, Quebec, Canada 4 Department of Oncology, McGill University, Montreal, Quebec, Canada 5 McGill Library, McGill University, Montreal, Quebec, Canada 6 Department of Oncology, Cedar Cancer Center, McGill University Health Center, Montreal, Quebec, Canada NOYCIA 2016

2 Background Aromatase inhibitors () and tamoxifen are widely used in treatment of post-menopausal women with hormonereceptor positive breast cancer Meta-analysis indicate better efficacy associated with s in Cs directly comparing s to tamoxifen However, these studies also indicate increased risk of cardiovascular adverse events associated with s

3 Burstein HJ et al., JCO 2014 American Society of Clinical Oncology Guidelines

4 Cardioprotective Mechanisms of amoxifen amoxifen decreases levels of total cholesterol, LDL-C, and increases HDL-C levels in Cs amoxifen decreases levels of C-reactive protein and fibrinogen amoxifen has anti-oxidant activities which protect cholesterol from harmful oxidation

5 Objectives o conduct a comprehensive systematic review and meta-analysis of cardiovascular safety of s and tamoxifen Adjuvant rials Extended-Adjuvant rials Upfront vs P vs P vs Sequential P vs P Upfront vs P P Years Years

6 Methods Search Strategy: -Databases: Pubmed, Embase, Cochrane CENAL, WHO ICP, Clinicaltrials.gov -Population: Female -Intervention: Aromatase Inhibitors (letrozole, anastrozole, exemestane) or tamoxifen -British Medical C Hedge where appropriate Inclusion Criteria: -Population: Post-menopausal women with diagnosis of breast-cancer -Outcome: Studies reporting cardiovascular events (excluding VE, hypertension, hypercholesterolemia) Exclusion Criteria: -1 st or 2 nd generations s or raloxifene -Pre-menopausal population -Primary prevention trials -Less 100 patients -Studies where primary indication for endocrine therapy is not breast cancer

7 Quality Assessment and Analysis Quality Assessment: Cochrane collaboration tool for assessing risk of bias Screening and quality assessment conducted independently by two reviewers Analysis: elative risk of cardiovascular adverse events obtained for each C Pooled analysis by C design using DerSimonian-Laird andom- Effects Analysis Secondary analysis: Ischemic heart disease as the outcome Sensitivity Analysis: Fixed-effects analysis

8 Study Flow Diagram Embase (n=5537) PubMed (n=3028) WHO ICP (n=1290) Cochrane CENAL (n=4995) Clinicaltrials.gov (n=502) ecords identified through database search (n=15352) Duplicates (n=5388) ecords undergoing title/abstract screening (n=9964) Not relevant topic-journal title/abstract (n=8957) Not relevant topic-conference abstract (n=394) Full text-does not include CV endpoints (n=217) Prevention Cs (n=149) eviews (n=112) Pre-menopausal population (n=63) Not English (n=22) Observational (n=17) Studies meeting inclusion criteria (n=33) Cs included in the quantitative analysis (n=16)

9 Meta-Analysis of Cardiovascular Adverse Events by C Design

10 Meta-Analysis of Cardiovascular Adverse Events by C Design P N P 0 5

11 Secondary Analysis-Ischemic Heart Disease Upfront Adjuvant vs : 1.30 (95% CI: ) Extended adjuvant vs P : 1.04 (95% CI: ) Extended Adjuvant vs P : 0.91 (95% CI: ) Upfront adjuvant vs P : 0.66 (95% CI: )

12 Conclusions he increased risk of cardiovascular disease associated with s in Cs comparing s to tamoxifen should be interpreted with caution he augmented cardiovascular risk associated with s in adjuvant trials can be accounted for by the cardioprotective effects of tamoxifen his new evidence may guide the assessment of risk and benefit ratio of aromatase inhibitors and tamoxifen

13 Acknowledgements Supervisors Dr. Laurent Azoulay Dr. Samy Suissa Collaborators Dr. Kristian Filion Dr. Shatha Al-Qurashi Dr. Nathaniel Bouganim Nazi orabi

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