Optimizing Cancer Screening With MCED Technologies: From Science to Practical Application - Module 3 - Implementing MCED testing in clinical practice through case studies
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In Module 3 of our CME microlearning series, experts explore the practical implementation of multicancer early detection (MCED) tests in clinical practice. This module provides valuable insights into how these innovations can transform cancer screening and improve patient outcomes. Charles Vega, MD, is a Clinical Professor in Department of Family Medicine at the University of California (UC) Irvine. He is also Director of the UC Irvine Program in Medical Education for the Latino Community and Assistant Dean for Culture and Community Education at the UC Irvine School of Medicine. Dr. Vega specializes in Family Medicine, and his academic interests focus on access to quality medical care for underserved populations and the development of training programs to promote compassionate healthcare. He has given over 200 invited presentations at national and regional conferences, and he has authored more than 1,000 continuing medical education reviews. STATEMENT OF NEED Approximately 2 million new cancer cases are expected in the United States in 2024, with an anticipated 611,720 deaths (ACS, 2024). Screening is associated with earlier stage at diagnosis and improved outcomes (Kim et al, 2011; Plumb et al, 2016). However, cancers that are not routinely screened for account for 78% of all cancer deaths in the United States (ACS, 2024; Pinsky & Berg, 2012; USPSTF, 2024). Multicancer early detection (MCED) is a novel form of blood-based cancer screening testing that can screen for multiple cancers simultaneously (ACS, 2024). Numerous questions need to be addressed as MCED is incorporated into practice, such as determining cost and insurance coverage, identifying individuals who are suitable candidates, and counseling patients regarding testing options, results, and next steps after receiving a positive or negative result (Kim et al, 2022; Chambers et al, 2023). In Module 3 of this activity, Dr. Charles Vega, Clinical Professor of Family Medicine in the School of Medicine at the University of California, Irvine, will discuss the practical application of MCED testing, the process for ordering and follow-up of results, and individual cases underscoring the optimal use of MCED testing in clinical practice. TARGET AUDIENCE Oncologists, gastroenterologists, obstetrician-gynecologists, hematologists, advanced practice providers, and other healthcare providers involved in cancer screening
![Best Practices for MCED Implementation
Gelhorn, et al, 2023; Hackshaw et al,
2022; Dana-Farber Cancer Institute, 2024.
Eligible populations for existing tests
Patients aged 50 years and older at elevated cancer risk
Not recommended for individuals who are pregnant, aged 21 years
or younger, or undergoing active cancer treatment
Importance of interpretation of results as 1 tool in a set of
therapeutic screening options
Important and continuing role of other tests (eg, mammography,
colonoscopy, prostate-specific antigen [PSA] screening, cervical
cancer screening)
Effective Discussions With Patients
No MCED tests are currently approved by the FDA.](https://image.slidesharecdn.com/228mcedmodule3final-250714153644-050fc115/85/Optimizing-Cancer-Screening-With-MCED-Technologies-From-Science-to-Practical-Application-Module-3-Implementing-MCED-testing-in-clinical-practice-through-case-studies-13-320.jpg)
![Discussing MCED Testing Results With Patients
Kim et al, 2022.
Explain the meaning of signal detection and the potential for
false-positive or false-negative results
Psychosocial impact of screening is relatively low overall and
short-lived, even with false-positive results
Those at high cancer risk tend to experience more symptoms
of anxiety
Discuss more intensive screening (eg, positron emission
tomography-computed tomography [PET-CT] scan) for
patients with a positive signal](https://image.slidesharecdn.com/228mcedmodule3final-250714153644-050fc115/85/Optimizing-Cancer-Screening-With-MCED-Technologies-From-Science-to-Practical-Application-Module-3-Implementing-MCED-testing-in-clinical-practice-through-case-studies-14-320.jpg)
Optimizing Cancer Screening With MCED Technologies: From Science to Practical Application - Module 3 - Implementing MCED testing in clinical practice through case studies
- 1. Charles Vega, MD Clinical Professor, Family Medicine, School of Medicine Director, UC Irvine Program in Medical Education for the Latino Community (PRIME-LC) Associate Dean, School of Medicine University of California, Irvine Optimizing Cancer Screening With MCED Technologies: From Science to Practical Application Module 3: Implementing MCED Testing in Clinical Practice Through Case Studies
- 2. Disclosures Consultant: Boehringer Ingelheim, GlaxoSmithKline i3 Health has mitigated all relevant financial relationships
- 3. Learning Objectives MCED = multicancer early detection. Differentiate MCED tests from other blood-based screening tests Explain how MCED testing complements existing screening and diagnostic methods in gastrointestinal, gynecologic, and hematologic cancers Assess current and emerging data supporting the use of MCED tests in clinical practice Discuss tactics to promote the widespread adoption of cancer screening in the community Apply practical tools and strategies for integrating the latest cancer screening technologies into the clinical workflow
- 4. USPSTF Recommendations for Cancer Screening USPSTF = United States Preventive Services Task Force; LDCT = low-dose computed tomography. USPSTF, 2024; CMS, 2015; CMS, 2023; Congress.gov, 1997; USPSTF, 2018; CMS, 2022. Cancer Grade Population Modality/ Recommendation Pathway and Outcome Cervical A Women aged 21-65 years Regular screening (3-5 years) using cervical cytology and/or human papillomavirus (HPV) tests HPV testing: USPSTF Centers for → Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) Colon A/B Adults aged 45-75 years Regular annual screening, multiple effective methods available Legislation CMS NCD → Also has USPSTF “A” rating Breast B Women aged 40-74 years Biennial screening mammography Mandate for coverage with no cost sharing (Balanced Budget Act of 1997, Section 4101) Lung B Adults aged 50-80 years, with a history of smoking Annual LDCT screening USPSTF CMS NCD → Prostate C Men aged 55-69 years Periodic prostate-specific antigen screening on a case-by-case basis Not applicable (N/A)
- 5. 5-Year Overall Survival by Cancer Type SEER, 2024. Local vs Metastatic Breast Cervical Colon Esophagus Liver Lung M elanom a M yelom a O vary Pancreas Prostate Thyroid U terus -20.00% 0.00% 20.00% 40.00% 60.00% 80.00% 100.00% Localized Metastatic Survival %
- 6. How to Increase Cancer Screening Rates The Community Guide, 2023. Very effective Community health workers/patient navigators Patient reminders 1-on-1 education Provider assessment and feedback Provider reminder and recall systems Needs more evidence Mass media Patient or provider incentives Reducing costs (??!!) Community Services Preventive Task Force
- 7. a USPSTF-recommended screening includes breast, cervical, and colorectal cancer, and 27% of lung cancer based on estimated proportion of lung cancers that occur in screen-eligible individuals older than 40 years. ACS, 2024; Pinsky & Berg, 2012. 78% 22% Deaths due to cancers with standard screeninga Deaths due to cancers without standard screeninga Cancers without screening tests account for 78% of all cancer deaths in the US (in 2024, age 50-79 years) Cancers With and Without Standard Screening
- 8. Cumulative False-Positive Rate From Single-Cancer Screening Pinsky et al, 2015; Melnikow et al, 2018; US FDA, 2013; Lehman et al, 2017. Each false positive requires follow-up tests or interventions Cumulative risks are not well understood at the population level because current paradigms only evaluate 1 cancer at a time A 60-year-old female with a history of smoking screened for 4 cancers would have a 43.6% false-positive rate (FPR) 12.8% FPR for low-dose computed tomography 7.4% FPR for cervical screening 13.4% FPR for stool-based colon cancer screening 10.0% FPR for mammography
- 9. Barriers to MCED Use Chambers et al, 2023. Patient acceptance Time to introduce/explain the test Time to run the test Understanding the results Cost/insurance coverage Providers
- 10. MCED Implementation: From Discussion to Results Images from Microsoft 365 Stock Images, used under license. Administration of test Patient/provider discussion Laboratory analysis (10-14 days) Delivery of results
- 11. Current Commercially Available MCED Test (Not FDA-Approved) Galleri.com, 2024. To order the test: List price: $949 (may vary depending on practice/provider) Complete a blood draw per test instructions Receive results through provider portal, typically within 10 days of reception of blood specimen Results Result 1: cancer signal NOT detected Result 2: cancer signal detected, with signal origin; confirm with diagnostic testing How to Order No MCED tests are currently approved by the FDA.
- 12. Workup of Positive Blood-Based Screen With Cancer Signal Origin CT = computed tomography. Slide courtesy of Sana Raoof, MD, PhD. CRC Blood work + whole-body CT Lung Breast Liver Head and neck Ovarian Esophageal Gastric Multiple myeloma Lymphoma Indeterminate Endoscopy Pancreatic Imaging Blood work and physical exam Biopsy Imaging Treat
- 13. Best Practices for MCED Implementation Gelhorn, et al, 2023; Hackshaw et al, 2022; Dana-Farber Cancer Institute, 2024. Eligible populations for existing tests Patients aged 50 years and older at elevated cancer risk Not recommended for individuals who are pregnant, aged 21 years or younger, or undergoing active cancer treatment Importance of interpretation of results as 1 tool in a set of therapeutic screening options Important and continuing role of other tests (eg, mammography, colonoscopy, prostate-specific antigen [PSA] screening, cervical cancer screening) Effective Discussions With Patients No MCED tests are currently approved by the FDA.
- 14. Discussing MCED Testing Results With Patients Kim et al, 2022. Explain the meaning of signal detection and the potential for false-positive or false-negative results Psychosocial impact of screening is relatively low overall and short-lived, even with false-positive results Those at high cancer risk tend to experience more symptoms of anxiety Discuss more intensive screening (eg, positron emission tomography-computed tomography [PET-CT] scan) for patients with a positive signal
- 15. Barriers to Seeking Further Detection Schear et al, 2022. After Positive Cancer Screening Psychological Barriers Access Barriers • In shock/don’t believe results/no symptoms • Don’t know or understand next steps or where to go • Fear • Don’t believe traditional treatments such as chemotherapy are safe • Don’t understand how serious this may be • Medical centers are far away • Need practical support such as transportation or childcare • Can’t take time off from work • Don’t have a loved one to serve as a caregiver • Cost
- 16. Case Studies
- 17. Case Study 1 PMH = past medical history; HTN = hypertension; FIT = fecal immunochemical test. Irina, Age 66 Feels well at routine follow-up visit PMH: obesity, type 2 diabetes, HTN Habits: 35 pack-year smoking history, smokes half pack/day now Family history: mother with colorectal cancer diagnosed “in her 70s” Screening history Cervical cancer: normal cytology and negative HPV test 3 years ago Breast cancer: normal mammogram 4 years ago Colorectal cancer: FIT ordered x4, no results Lung cancer: no previous screening
- 18. Case Study 2 BRCA = breast cancer gene. Julia, Age 49 Healthy woman presenting for cancer screening Up to date on cervical and colorectal screening Older sister was diagnosed with breast cancer at age 41 Julia is negative for all hereditary breast cancer genetic tests (eg, BRCA1/BRCA2) and up to date on her current mammography screening Due to her increased risk, she also undergoes annual breast magnetic resonance imaging (MRI) with contrast
- 19. Case Study 3 Healthy male—“I want to get my health optimized since I hit the big 5-0” PMH: none Previous cancer screening: none Habits: no nicotine products; alcohol, 3 drinks/week; no other substances “I really don’t have time to get a bunch of different appointments. What about one of those blood tests for cancer? That way everything gets done at once” Leon, Age 50
- 20. Key Takeaways MCEDs can help to alleviate major barriers to cancer screening, including multiple appointments and uncomfortable procedures Workflow for MCEDs is fairly straightforward However, they are expensive and not for everyone Ideal MCED candidates have multiple cancer risk factors but incomplete cancer screening Workup for positive MCED test needs to be discussed BEFORE testing, but it is generally a covered benefit
- 21. Thank you! To learn more, check out modules 1 and 2 of this activity!
- 22. References American Cancer Society (ACS) (2024). Cancer Facts & Figures, 2024. Available at: https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2024-cancer-facts- figures.html Centers for Medicare & Medicaid Services National Coverage Determination (2023). National Coverage Determination: colorectal cancer screening tests. Available at:https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=281 Centers for Medicare & Medicaid Services National Coverage Determination (2022). National Coverage Determination: lung cancer screening with low dose computed tomography (LDCT). Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=364 Centers for Medicare & Medicaid Services National Coverage Determination (2015). National Coverage Determination: screening for cervical cancer with human papillomavirus (HPV). Available at:https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=365 Chambers CV, Leach WT, Davis K & Meyers RE (2023). Primary care provider receptivity to multi-cancer early detection test use in cancer screening. J Pers Merd, 13(12):1673. DOI:10.3390/jpm13121673 The Community Guide (2023). CPSTF findings for cancer prevention and control. Available at: https://www.thecommunityguide.org/pages/task-force-findings-cancer-prevention-and- control.html Congress.gov (1997). H.R.2015 – balanced budget act of 1997. Available at: https://www.congress.gov/bill/105th-congress/house-bill/2015 Dana-Farber Cancer Institute (2024). Multi-cancer early detection clinic. Available at: https://www.dana-farber.org/cancer-care/treatment/early-detection-interception/multi-cancer- early-detection-clinic Galleri.com (2024). FAQs for providers about the Galleri® test. Available at: https://www.galleri.com/hcp/faqs Gelhorn H, Ross, MM, Kansal AR, et al (2023). Patient preferences for multi-cancer early detection (MCED) screening tests. Patient, 16(1):43-56. DOI:10.1007/s40271-022-00589-5 Hackshaw A, Clarke CA & Hartman AR (2022). New genomic technologies for multi-cancer early detection: rethinking the scope of cancer screening. Cancer Cell, 40(2):109-113. DOI:10.1016/j.ccell.2022.01.012 Kim A, Chung KC, Keir C & Patrick DL (2022). Patient-reported outcomes associated with cancer screening: a systematic review. BMC Cancer, 22:223. DOI:10.1186/s12885-022-09261-5
- 23. References (cont.) Lehman CD, Arao RF, Sprague BL, et al (2017). National performance benchmarks for modern screening digital mammography: update from the Breast Cancer Surveillance Consortium. Radiology, 283(1):49-58. DOI:10.1148/radiol.2016161174 Melnikow J, Henderson JT, Burda BU, et al (2018). Screening for cervical cancer with high-risk human papillomavirus testing. JAMA, 320(7):687-705. DOI:10.1001/jama.2018.10400 Pinsky PF & Berg CD (2012). Applying the National Lung Screening Trial eligibility criteria to the US population: what percent of the population and of incident lung cancers would be covered? J Med Screen, 19(3):154-156. DOI:10.1258/jms.2012.012010 Pinsky PF, Gierada DS, Black W, et al (2015). Performance of Lung-RADS in the National Lung Screening Trial: a retrospective assessment. Ann Intern Med, 162(7):485-491. DOI:10.7326/M14-2086 Schear RM, Hoyos JM, Davis AQ, et al (2022). Patient engagement and advocacy considerations in development and implementation of a multicancer early detection program. Cancer, 128(suppl_4):909-917. DOI:10.1002/cncr.34047. Surveillance, Epidemiology, and End Results Program (2024). Cancer Stat Facts. Available at: seer.cancer.gov/statfacts US Food & Drug Administration (2013). Premarket approval (PMA) Cologuard. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130017 US Preventive Services Task Force (2018). Prostate cancer: screening. Available at: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/prostate-cancer-screening US Preventive Services Task Force (2024). A & B recommendations. Available at: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-a-and-b- recommendations#bcf