1. Lung Cancer Screening Implementation: Promises, Challenges, Opportunities Jamie L. Studts, PhD Associate Professor of Behavioral Science Assistant Director of Cancer Prevention and Control

2. Low-Dose CT for Lung Cancer Screening PromisesChallenges

3. Estimated Cancer Deaths in the US in 2013

4. Lung Cancer Epidemiology Lung cancer incidence rate − USA 84.4 (men)55.7 (women) − Kentucky:130.1 (men)79.5 (women) Lung cancer mortality rate − USA: 67.4 (men)40.1 (women) − Kentucky:103.0 (men)56.1 (women) Adult smoking rate (2011) − USA21.2% − Kentucky29.0% Note: All rates are per 100,000. Rates are age-adjusted to the 2000 U.S. Standard Million Population. American Cancer Society (2013). Cancer facts and figures – 2013.

5. Lung Cancer Mortality in Kentucky

6. Impacting our Catchment Area (CCSG) “To decrease cancer incidence and mortality among populations within its catchment area, including minority and underserved populations, it also establishes partnerships with other health delivery systems and state and community agencies for dissemination of evidence-based findings.” “In addition to scientific questions of broad applicability, it should use its available expertise and resources to address cancer research within the catchment area.” http://grants.nih.gov/grants/guide/pa-files/PAR-13-386.html

7. Overview Lung Cancer Screening: A Case Study in Clinical and Translational Science − NLST Data − Guideline Development and Policy Considerations − What is Quality Lung Cancer Screening? Implementing a Lung Cancer Screening Program − Distinguishing Lung Cancer Screening − The Role of Shared Decision Making − The Role of Tobacco Treatment − The Role of Patient Navigation/Coordination

8. Lung Cancer Screening: An Ongoing Case Study in Clinical and Translational Science

9. National Lung Screening Trial Primary Results − 20% relative reduction in lung cancer mortality with LDCT − 6.7% reduction in all-cause mortality with LDCT Additional Results − Positive/False Positive Screens − LDCT: 39% had 1+ pos. screen − CXR: 16% had 1+ pos. screen NLST (2011) NEJM, 365, 395-409.

10. Population Impact of NLST (LDCT) Data from NLST was applied to the population to estimate the number of lung cancer deaths that could be averted by LDCT screening 8.6 million Americans eligible for LDCT per NLST − 5.2m American men/3.4m American women Results − 12,250 lung cancer deaths averted each year − 8,990 American men/3,260 American women − 7.6% of all American lung cancer deaths each year (Ma et al., 2013, Cancer)

11. Generalizability/Eligibility Data Assessed variation in efficacy, false positive rates, and lung- cancer deaths prevented according to quintile of LC risk. Results − Benefit increased with risk − FP rate decreased with risk − 60% (Q1-3) accounted for 88% of prevented deaths and 64% of false positive results − 20% at lowest risk (Q1) accounted for only 1% of prevented deaths (Kovalchik et al., 2013, Targeting of low-dose CT screening according to the risk of lung-cancer death, NEJM)

12. Cost-Effectiveness of LDCT Screening in the National Lung Screening Trial (NLST) Examination of mean life-years, quality-adjusted life-years (QALYs), costs per person and incremental cost-effectiveness ratios (ICERS) for LDCT, CXR, and no screening. Cost Per Person − $0No screen − $469CXR − $1,631LDCT ICERs for LDCT − $52,000 per life-year gained (95% CI: $34,000 to $106,000) − $81,000 per QALY gained (95% CI: $52,000 to $186,000) (Black et al., 2014, NEJM, 371, 1793-1802)

13. USPSTF Final Guidelines for Lung Cancer Screening (Posted July 29, 2013) (Affirmed December 31, 2013) (Humphrey et al., 2013, Annals of Internal Medicine, online) (Moyer et al., 2013, Annals of Internal Medicine, online) http://www.uspreventiveservicestaskforce.org/uspstf13/lungcan/lungcanfact.pdf GRADE B: The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.

14. USPSTF Final Guideline for Lung Cancer Screening High Risk Status/Eligibility − age 55 through 80 years old, and − have a history of heavy smoking (30 p/y+), and − are either current smoker or quit within 15 years − other minor criteria and considerations Points from Draft to Final Guideline − upper age criteria extended (up to 80) − specifically calls for integration of tobacco cessation − specifically calls for shared decision making (Humphrey et al., 2013, Annals of Internal Medicine, Online) (Moyer et al., 2013, Annals of Internal Medicine, Online) http://www.uspreventiveservicestaskforce.org/uspstf13/lungcan/lungcanfact.pdf

15. American Academy of Family Physicians Evidence Lacking to Support or Oppose Low-dose CT Screening for Lung Cancer, AAFP Releases an “I” Recommendation − “The AAFP concludes that the evidence is insufficient to recommend for or against screening for lung cancer with low-dose computed tomography (LDCT) in persons at high risk for lung cancer based on age and smoking history.” − "People need to understand that their life expectancy could be extended by this, but on the other hand, their life expectancy could be shortened by it.” − "A shared-decision-making discussion between the clinician and patient should occur regarding the benefits and potential harms of screening for lung cancer.” http://www.aafp.org/news/health-of-the-public/20140113aafplungcarec.html http://www.aafp.org/patient-care/clinical-recommendations/all/lung-cancer.html

16. Centers for Medicare and Medicaid Services “The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, annual screening for lung cancer with low dose computed tomography (LDCT), as an additional preventive service benefit under the Medicare program only if the following conditions are met…” http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274 (February 5, 2015)

17. Implementing a Lung Cancer Screening Program

18. Lung Cancer Screening Implementation

19. The novelty and complexity of LCS decisions make LCS choices a unique clinical venture. Mortality Reduction Reassurance Other Detection Other Detection False Positive Scans False Positive Scans Radiation Risks OverDx Cost Early Detection Early Detection

20. Lung cancer screening needs to be implemented differently than other cancer screenings. Screening as Guideline Compliance vs. a Personal Choice Screening as an Event vs. an Algorithm

21. At least 3 reasons why lung cancer screening should (must) be different. ① The risk benefit profile is enhanced on both sides, creating greater decision making burden. ② The eligibility criteria are targeted (not population-based), and the target population might be considered vulnerable. ③ There are some factors that aren’t that different, but we don’t do them well now—lung cancer screening is a chance to re-design and re-implement cancer screening  Screening is a process/algorithm, not an event  Screening is a patient choice, not a mandate  Screening has harms that are meaningful to some (not all) individuals

22. Lung Cancer Screening Programs National Framework for Excellence In Lung Cancer Screening and Continuum of Care Lung Cancer Alliance

23. Necessary Components of High Quality Lung Cancer Screening: 1) Who is offered lung cancer screening? 2) How often, and for how long, to screen? 3) How the CT is performed? 4) Lung nodule identification 5) Structured reporting 6) Lung nodule management algorithms 7) Smoking cessation 8) Patient and provider education 9) Data collection (Mazzone et al., 2015, ACCP-ATS Statement, Chest, pre-print online)

24. Comprehensive LCS Program Shared Decision Making & Patient Education Lung Cancer Screening via LDCT Evidence-based Tobacco Cessation (Treating Tobacco Use and Dependence, 2008) Multidisciplinary Team and Management Plan Radon Awareness/Other Risk-reduction efforts Patient Navigation/Coordinator and Support

25. Role of Navigator/Coordinator in Lung Cancer Screening Maintain agnostic perspective on screening: inform rather than persuade Support patient engagement and informed/shared decision making Integrate evidence-based tobacco cessation Facilitate subsequent screening, diagnostic workups, and lung cancer care when needed

26. Lung Cancer Screening & Tobacco Cessation Integrating evidence-based tobacco cessation into lung cancer screening programs could broaden utility by adding a primary prevention strategy to an evidence-based secondary prevention strategy. Current data is mixed with regard to the impact of screening on tobacco use, some studies reporting higher rates of cessation and others demonstrating no impact of screening on tobacco use. Fairly consistent results indicate that abnormal/suspicious scans are associated with tobacco cessation/lower rates of tobacco use. Regrettably, there are no intervention studies examining the impact of tobacco cessation in the lung cancer screening setting (although pilot studies are underway). The NCI has recently announced an RFA to address this important question.

27. Dissemination and implementation research is needed to insure high quality lung cancer screening program development. Pt Care LCS Program Implementation Patient Education Provider Training Community Awareness

29. L ung Cancer E ducation A wareness D etection S urvivorship www.kentuckyleads.org

30. Kentucky LEADS Collaborative

31. In the PD component, we hypothesize that the program will demonstrate –greater implementation of quality indicators for lung cancer screening, including optimal referral patterns for evidence-based lung cancer care, use of strong patient navigation, integration of evidence-based tobacco treatment, use of shared decision making, and established protocols for follow-up services and program retention. Prevention & Early Detection (PD)

33. Lung Cancer Screening Clinical Research Trajectory Excellence Project KY LEADS UK

34. Conclusions 1. Results of the NLST and subsequent policy developments create a unique opportunity to reduce lung cancer mortality. (Promise) 2. However, implementation of lung cancer screening needs to proceed differently than current cancer screening processes. (Challenge) 3. We have a brief window to create optimal, high quality lung cancer screening programs that can fulfill the promise and meet the challenge, and SDM is a reasonable path to achieve these aims. 4. There are tremendous implementation research opportunities to address key questions about lung cancer screening.

36. National Comprehensive Cancer Network Eligibility A (NLST Consistent) − Age 55 – 74 and… − ≥ 30 pack year smoking history − Current smoker or quit within past 15 years Eligibility B (Extension) − Age 50 – 74 and − ≥ 20 pack year smoking history, and − One or more of the following risk factors… − Exposure to radon, silica, metals, diesel fumes − Personal history of cancer − COPD or pulmonary fibrosis − A family history of lung cancer (NCCN Guidelines for Patients TM: Lung Cancer Screening Version 1.2012)

37. Centers for Medicare and Medicaid Services Age 55-77 Asymptomatic Tobacco exposure of 30+ pack/years Current or former smoker with 15 years Written order for LDCT-based lung cancer screening with… Determination of eligibility Documentation of an SDM consultation Documentation of adherence/screening counseling Tobacco cessation intervention http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274

38. Treating Tobacco Use and Dependence: Clinical Practice Guideline (USPHS, 2008) Assists in identifying and assessing tobacco users and in delivering effective tobacco dependence interventions Provides strategies and recommendations for clinicians Offers a detailed description of the 5 A’s of treating tobacco dependence Identifies 10 key findings that clinicians should use with patients

39. Dedicated to reducing the burden of lung cancer in Kentucky and beyond through development, evaluation, and dissemination of novel, community- based interventions to promote provider education, survivorship care, and prevention and early detection regarding lung cancer. Kentucky LEADS Collaborative