Tolerability of Breast Cancer Screening, Diagnostic and Biopsy Procedures: An ACRIN 6666 Substudy

1. Tolerability of Breast Cancer Screening, Diagnostic and Biopsy Procedures:An ACRIN 6666 Substudy Mark D. Schleinitz, MD, MS Dina DePalo Jeffrey Blume, PhD Jean Cormack, PhD Etta D. Pisano, MD Wendie A. Berg, MD, PhD

2. Funding • Avon Foundation • NCI U01 CA079778, U01 CA89008

3. Background • In women at elevated risk with mammographically dense breasts the addition of US: • Improves cancer detection • Increases rates of additional imaging and biopsies • What is the trade-off between improved cancer detection and increased healthcare utilization?

4. Objectives • To estimate the tolerability of imaging and biopsies • To compare these results across procedures • To determine if patient factors affect tolerability • To combine tolerability with survival

5. Methods: Process Utility • Place test tolerability on same scale as benefits (survival) • Waiting time trade-off • How long (in days) would you wait to get results and avoid procedure? • How do you feel about waiting? • Combined via multiplication Swan, Med Decis Making 2000, 2006

6. Methods: Combine with Survival • CISNET models of mammography screening strategies • Survival gain • Procedures incurred • Use our data to scale QOL impact of: • Screening • Additional imaging • Negative biopsies Mandelblatt, Ann Intern Med, 2009

7. Results: Imaging

8. Results: Biopsy

9. Results: Patient Factors • Procedures better tolerated by: • Women with prior cancer • Women over 50 • Post-menopausal women

10. Results Mandelblatt, Ann Intern Med, 2009

11. Limitations • Generalizability • Elevated risk • Dense breasts • SES • Trial participants • MRI participation rate • Methodologically • Timing of procedures

12. Conclusions • US better tolerated than mammography • MRI less well-tolerated still • Tolerability, especially for induced procedures, should be considered in setting policy • Variability high, policy may not apply to all