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Improved Breast Cancer Detection with Ultrasound Screening in High-Risk Women

Learn how ultrasound screening, funded by Avon Foundation and National Cancer Institute, aids in early breast cancer detection. Understand the benefits of combining mammography with ultrasound and how it impacts treatment outcomes and mortality rates. Discover the importance of regular screenings for optimal breast health.

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Improved Breast Cancer Detection with Ultrasound Screening in High-Risk Women

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  1. Screening Breast Ultrasound in High-Risk Women Made possible by grants from the Avon Foundation and National Cancer Institute (CA80098) ACRIN Protocol 6666

  2. Contacts • Site Contacts • Principal Investigator: • Research Associate: • Trial Personnel: • Principal Investigator: Wendie Berg, MD, PhD • American Radiology Services. Johns Hopkins at Greenspring • Co-Investigator: Ellen Mendelson, MD • Northwestern University • Statistician: Jeffery Blume, PhD • Brown Unversity

  3. Objectives • Background • Review principles of screening • What we have learned from mammography • Review results from single center trials of screening US • Protocol 6666 Overview • Aims • Eligibility • Participant Enrollment

  4. Screening • Early detection and resulting treatment will alter the course of the disease • Healthy women will not be harmed • Early detection will allow breast conservation more often and less harmful treatments

  5. Mammography • Mammography is the only screening test to date which has been shown to reduce deaths due to breast cancer • Screen-detected cancers have better prognosis than clinically-detected cancers Good Intermed Poor Screen-detect 50% 32% 18% Clinically found 19 34 47 Tabar, Rad Clin N Amer 2000;38:625-651

  6. Survival by Prognostic Category Tabar Rad Clin NA 2000;38:625-652

  7. Prognostic Categories GoodIntermed.Poor DCIS Node - Node + Gr 1 < 20 mm N-20+; N+<15 N+, ≥15 Gr II < 15 mm 15-29 mm ≥ 30 mm Gr III < 10 mm N-10+, N+<15 N+, ≥15 Lobular < 10 mm 10-29 mm ≥ 30 mm Medullary N-, < 20 N-, ≥ 20 N+_____ Mucinous N-, <10 N-10+, N+<20 N+,≥20_ Tubular N-, <20 N-, 20+ or N+ none___

  8. DCIS • Left untreated, majority of DCIS will progress to invasive carcinoma, but time course may be 20 years or more • First prevalent screen, estimated 37% of DCIS non-progressive • Only 4% of new DCIS detected at annual screens non-progressive • Over treatment may occur at first screen, but is uncommon if test performed annually Yen et al Eur J Cancer 2003;39:1746-1754

  9. DCIS • Analysis of Swedish two-county trial • Majority of mortality reduction was due to stage shifting from stage II invasive or worse to stage I invasive cancer • Detection of DCIS might account for 5-12% of deaths averted Duffy et al Eur J Cancer 2003;39:1755-1760

  10. What can we infer? • Poor prognosis cancers are node positive and larger in size, but fundamentally the same histology as those of good prognosis • Left undetected, good prognosis cancers will progress to those with poor prognosis • Detection of small (< 1 cm) invasive cancers is critical to achieving mortality reduction from screening

  11. Prognosis and Treatment • Prognosis and treatment of a given cancer will depend primarily on size and nodal status • Should be independent of the method of detection

  12. Mortality Reduction: Mammography • 22% reduction in breast cancer mortality ≥ 50 • 15% reduction in breast cancer mortality 40-49 yrs of age US Preventive Services Task Force summary report Ann Intern Med 2002;137:347-360

  13. Mammographic Sensitivity • 98% in women ≥ 50 with fatty breasts • 30-69% sensitivity in women with dense breasts, particularly low if < 50 or at increased risk Kerlikowske et al JAMA 1996;276:33-38 Kolb et al Radiology 2002;225:165-175 Mandelson et al JNCI 2000;92:1081-1087

  14. Summary of US Screening Studies

  15. Screening Ultrasound • 150 US-detected cancers in 126 women • 114 (90.5%) heterogeneously dense or extremely dense breasts • High-risk women are 2-3 times more likely to have US-only detected cancer • 55/110 (50%) were at high-risk

  16. Invasive Cancer vs. DCIS • Of 150 cancers seen only on sonography • 141 (94%) invasive • 99 (70%) were < 1 cm • 30/33 (91%) were stage 0 or stage I • Mean size 9-11 mm across series, range 4-25 mm • In 25,753 exams, mammo reported • Another 56 cancers seen only on mammo • 42 (75%) DCIS and 14 (25%) invasive

  17. Cancers Seen Only on US • Early invasive cancers with good prognosis • Additional detection virtually all in dense and heterogeneously dense breasts • Half of the cancers seen only on US were in women at high risk (7-9 per 1000)

  18. Why do a multicenter trial? • In all but Kolb’s series, only a single prevalent screen performed • No estimate of the role of annual sonography • Single center studies, may not be generalizable • Prior studies not blinded to mammographic results, artificially inflates US performance • Screening: need for rational basis to subject healthy women to testing

  19. Specific Aims • Primary Aim: Diagnostic yield of screening mammography + US compared to mammography alone • Independent read, blinded to the other study • Secondary Aim: Diagnostic yield of US and mammography independently • Effect of breast density and heterogeneity of echotexture

  20. Protocol 6666 • Approximately 2800 women at high risk of breast cancer • Annual mammogram and whole breast bilateral screening US, physician performed, independently read • Screenings at 0, 12, 24 months

  21. Eligibility Criteria • Women ≥ 25 yrs • Breast tissue at least moderately dense as viewed on mammogram • AND at least ONE of the following applies: • Known mutation in BRCA-1 or -2 gene • Personal hx breast cancer at least one year ago • Stong family hx of breast cancer (25% lifetime risk as determined by the Gail or Claus models) • Prior LCIS • Radiation treatment to the chest (before age 30 and at least 8 years ago) • Prior ADH, ALH, atypical papilloma

  22. Ineligibility Criteria • Fail to meet eligibility requirements • Male • Implants • Clinically abnormal or indication other than routine • < 1 yr following dx breast cancer or with known distant mets • Pregnant or plan to be within 2 years

  23. Ineligibility Criteria • Contrast-enhanced breast MRI within 1 yr prior (or plan within 2 yrs of entry) • Bilateral whole breast US within 1 yr prior • Injection of sonographic or mammographic contrast or tomosynthesis or plan to undergo within 2 yrs of study entry • Mammograms cannot be double read or undergo CAD • Breast procedure (other than cyst asp) within 1 yr prior

  24. Imaging • Pt randomized to initial US or mammogram • Study US and mammogram at same site within 2 weeks of each other • Independent interpretation of US and mammogram, each radiologist qualified in study protocol and each must read some US and some mammo

  25. Participant Education • Participant Brochures • Available from Research Associate • Letter to potential participants • Electronic file available for practice customization from Research Associate • Clinical Trial Websites • NCI: cancer.gov • CenterWatch: centerwatch.org • ACRIN: acrin.org (full protocol available)

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