Precision Breast Cancer Screening: Moving from Debate to Wisdom - - PowerPoint PPT Presentation

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Precision Breast Cancer Screening: Moving from Debate to Wisdom - - PowerPoint PPT Presentation

Aug 19, 2022 12 likes •295 views

Precision Breast Cancer Screening: Moving from Debate to Wisdom _______ Laura Esserman, MD, MBA Diane Heditsian WISDOM Study Research Advocate & Communications Consultant Director, UCSF Carol Franc Buck Breast Care Center @drlauraesserman

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Precision Breast Cancer Screening: Moving from Debate to Wisdom _______

Laura Esserman, MD, MBA

Director, UCSF Carol Franc Buck Breast Care Center @drlauraesserman September 18, 2019

Diane Heditsian

WISDOM Study Research Advocate & Communications Consultant @dianeheditsian

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Laura Esserman

  • Has nothing to disclose.

Diane Heditsian

  • Has nothing to disclose.
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Audience Poll

  • How many women are getting mammography screening for

breast cancer?

  • How many women believe there is complete agreement on when

women should start and how often they should be screened?

  • How many women know their own breast cancer risk?
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Years of Policy Controversy & Conflict

WISDOM will provide data required to inform professional societies and resolve discordant recommendations Professional Society Screening Age Frequency

USPSTF 40 – 49 50 – 74 Shared decision on whether to screen Biennially (for average risk) ACS 45 – 55 55 – until life expectancy < 10 years. Annually Biennially ACR / SBI 40 – until life expectancy < 5 -7 years. Annually NCCN 40 – until life expectancy < 10 years. Annually ACOG 40 – 49 50 – 74 Shared decision on whether to screen Shared decision: Annual or Biennial ACP (new: April 2019) 40 – 49 50 – 74 Shared decision on whether to screen Biennially

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Breast Screening Controversy Puts Women in the Middle

Polarized Views Confuse MDs too

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Old Paradigm

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New Paradigm: Breast Cancer is not a single disease

Tumor progression and Benefit (lack of) from Screening

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Breast Cancer Screening Today

  • Mired in controversy
  • Based on 30-year-old medical science
  • Age-based
  • Low risk women are over-screened
  • false positive recalls and benign biopsies
  • High-risk women are under-screened missing lethal tumors
  • Catchy Public Health Messages miss the complexity
  • “Mammograms Save Lives” and “Early Detection Saves Lives”
  • Resource intensive in aggregate: $8 - $10 billion annually
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“One Size Does NOT Fit All”

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Unprecedented Opportunity:

Advances in Science and Technology

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What Breast Cancer Screening Could Be: Personalized

  • Leverages advances in:
  • Biology of breast cancer
  • Risk-assessment
  • Genetics
  • More effective at finding “clinically meaningful” cancers
  • Personalized and precise for each individual woman
  • Integrated with risk reduction strategies
  • More cost-effective
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Comprehensive risk prediction model

  • Validated high-impact risk factors including
  • Exposures/Lifestyle
  • Breast density
  • 9 breast cancer genes
  • SNPs polygenic risk score
  • 76303 SNPs
  • Tailor screening/prevention plans
  • Age to start/stop
  • Frequency
  • Screening modality
  • Risk reduction
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Pragmatic Trial Design: Preference Tolerant RCT

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Wisdom Study Aims

Determine if personalized screening (as compared to annual screening):

  • 1. Is as safe
  • 2. Is less morbid
  • 3. Is more accepted by women
  • 4. Enables prevention
  • 5. Has greater health care value
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Risk Reduction: Breast Health Decisions Tool

  • Automated integration of risk education tool
  • Includes risk factors and interventions to lower risk
  • Threshold for outreach (personalized arm): Top 2.5 % risk by age group
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Breast Health Decisions Tool

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Transformative Trials That Evolve: WISDOM Study Structure

  • All reporting is automated using the WISDOM platform
  • Offered across several nationwide sites
  • California, Dakotas, Iowa, Minnesota, Illinois, Alabama, Louisiana
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PCORI Principles

  • Results ready in a timely way
  • Used a surrogate endpoint- no increase in stage 2B cancers
  • Tests had to be covered by the study (payors participating)
  • Coverage with Evidence Progression model
  • Compared to annual, cost saving over time
  • Champion: Blue Cross Blue Shield and self-insured employers
  • Stakeholder Engagement
  • Annual stakeholder meetings to project results
  • All guideline makers, payors, providers at the table
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Why is this study critical for women?

  • Answers a big and intractable question
  • Breast cancer screening can leverage precision

medicine

  • Begin to learn who is at risk/for what kind of breast cancer
  • Provides a framework to determine risk, improve screening,

educate/involve women and integrate risk reduction

  • Breaks down barriers so more women can participate
  • Answers will be relevant to all communities of women
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What Does it Take For a Paradigm to Shift?

What results will have enough impact to inform guidelines? What are the right early endpoints? How best to educate MDs and women? Annual Stakeholder Meeting: Full day each year

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WISDOM Innovations

  • Use of established tests in new ways
  • Coverage with evidence development/progression
  • Virtual trial design
  • Trial comes to the participant not vice versa
  • Technology platform with embedded analytics
  • All stakeholders at the table from beginning
  • reduce time to implement trial results
  • Risk model is updated as new data emerges
  • Patient Reported Outcomes
  • Patient education and risk communication (BHD Tool)
  • Bioethics Committee & Embedded Ethics Study
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Wisdom Recruitment over time

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Lessons Learned

  • Opposing views will always be encountered
  • Radiology community in US feels that less than

“annual screening” hurts women

  • Models will always improve
  • Build an infrastructure that allows study to evolve as knowledge evolves
  • Test the concept of personalization based on best knowledge
  • Allow for improvements in models
  • Much more difficult to get payers to partner than anticipated!
  • Recruiting diverse populations takes a big effort
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Patient-Centered and Inclusive

  • Spanish Translation
  • Outreach Materials
  • Plain-language

translation

  • Materials modified

with simpler, 6th grade reading level

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Everyone Benefits When Everyone Participates

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Thank You to Partners & Stakeholders

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Thank You!

Laura Esserman, MD, MBA

Director, UCSF Carol Franc Buck Breast Care Center @drlauraesserman September 18, 2019

Diane Heditsian

WISDOM Study Research Advocate & Communications Consultant @dianeheditsian