1. Lung Cancer Prevention in South Carolina and Beyond K. Michael Cummings, PhD, MPH Professor, Department of Psychiatry & Behavioral Sciences and Co-Director of Tobacco Policy and Control Hollings Cancer

2. Education & Experience Education BS, Health Education, Miami University (Ohio), 1975 MPH, Health Behavior, University of Michigan, 1977 PhD, Health Behavior, University of Michigan, 1980 Past Experience Senior Scientist & Chair, Department of Health Behavior, Roswell Park Cancer Institute Professor, Department of Social & Preventive Medicine, SUNY @ Buffalo Founder and Director, New York State Smokers’ Quit Line Consultant to the FDA, CDC, and several state based tobacco coalitions Recipient of numerous (>40) NIH grants and contracts Contributor to several past Surgeon General’s Reports, IOM reports, NIH and IARC monographs, and author/co-author of >300 peer reviewed papers

3. Preventing Lung Cancer

4. Background 1/3 rd of cancer deaths are the result of cigarette smoking 85-90% of lung cancer is due to smoking Duration of smoking is the strongest predictor of cancer risk Nicotine addiction is the primary reason by people continue to smoke for decades despite awareness of health risks

5. Annual number of reported lung cancer deaths 1890-2009 (USA) (1) 1890’s145 1930<3,000 195018,000 195527,000 196241,000 (1)1964 Surgeon General’s Advisory Committee (Page 25) and the American Cancer Society. Cancer Facts & Figures 2009 2009159,390

6. Changes In Tobacco Use Behaviors Trends in Per Capita Consumption of Various Tobacco Products – United States, 1880-2003 Source: Tobacco Situation and Outlook Report, U.S. Department of Agriculture, U.S. Census Note:Among persons > 18 years old. Beginning in 1982, fine-cut chewing tobacco was reclassified as snuff. Estimates for 2002 and 2003 are preliminary.

7. Camel, 1913 Chesterfield, 1918 Lucky Strike, 1916

8. My goal… The overarching goal of my research program is to move the mortality curve from tobacco induced cancers downward.

9. This is not a pipe dream... Annual change = -0.5%* Annual change= -1.6%* Rates are per 100,000 and age-adjusted to the 2000 U.S. standard (19 age groups). * The annual percent change is significantly different from zero (p<0.05). Source: Cancer Surveillance Section. Prepared by: California Department of Public Health, California Tobacco Control Program, 2008.

10. Our Challenge: Speed of Action Matters 190 340 500 0 70 220 520 Estimated cumulative tobacco deaths 1950-2050 300 400 500 2025205020001950 100 200 Year Tobacco deaths (millions) World Bank. Curbing the epidemic: Governments and the economics of tobacco control. World Bank Publications, 1999. p80. Impact of policies depends on factors including: – Intervention date – Effect size A reduction of 10% in cigarette consumption today would prevent an estimated 10 million cancer deaths by 2030

11. Research Themes How do we get fewer people to use tobacco? What is the impact of government policies on uptake of tobacco (taxes, smoke-free rules, warning labels, marketing restrictions, product regulations) How can we get more tobacco users to quit using tobacco? What tobacco cessation methods or combination of methods work best and how can outcomes be improved upon by matching treatments to patient characteristics? What factors influence a person’s motivation to quit? What factors influence a person’s ability to quit permanently (i.e., biology vs environment)?

12. Research themes Among those either unwilling or unable to quit, are their strategies to mitigate their risk of developing cancer? Are smokers willing to substitute less dangerous alternative forms of nicotine delivery? How can tobacco products be made safer to use and what is the impact of product modifications on continued tobacco use (e.g., lower nicotine levels in products; ban filter vents; alter tobacco blends) Among those who do stop using tobacco, but remain at elevated risk of cancer is there anything they can do to lower their future risk of cancer? What factor predict someone’s future risk of developing a tobacco caused cancer? What screening methods or combination of methods can reduce cancer mortality? What are unintended consequences of screening? What screening protocols work best (i.e., who and how often)?

13. Outline Examples of past and current research International tobacco control policy research project Future vision South Carolina Lung Cancer Prevention Study Center of Excellence for research focused on the recalcitrant smoker Enhancing evidence based tobacco control in South Carolina

15. Goal – build the evidence base for public health interventions to control tobacco Goal 1: Conduct rigorous evaluation of national-level tobacco control policies of the WHO’s Framework Convention on Tobacco Control (FCTC) Goal 2: To understand how and why these policies work (if they work) ? PolicyBehavior What’s inside the black box? Goal 3: Compare how policy effects work across different countries (high v. low income)

16. Key requirements of FCTC  Price and tax measures to reduce demand (Article 6)  Protection from exposure to tobacco smoke (Article 8)  Regulation of the contents of tobacco products (Article 9)  Regulation of tobacco product disclosures (Article 10)  Packaging and labelling (Article 11) Warnings Elimination of misleading descriptors (e.g., “light” “mild”)  Education, communication, training, public awareness (Article 12)  Ban tobacco advertising, sponsorship and promotion (Article 13)  Dependence and cessation treatments (Article 14)

17. Call for research to find ways to speed up population level changes in tobacco use behaviors to minimize tobacco related deaths

18. A global problem requires a global solution Framework Convention on Tobacco Control (FCTC) adopted in 2003 >170 Contracting Parties

19. The FCTC offers a unique, time-limited opportunity to study policy interventions within and between countries What does effective mean? An urgency to act. Over 100 countries must enhance their warning labels within 3 years

20. The FCTC has provided us a laboratory for testing the effectiveness of tobacco control policies as they are been implemented in countries around the world Research on FCTC policy effects will help inform how the FDA regulates tobacco

21. Common features of ITC Projects Natural experiments Strategic selection of different countries based on policies Common set of measures Theory driven mediational model of how policies work Common data collection protocols Cohort studies with probability samples of smokers (n~2000) surveyed annually in each country

22. ITC 2004…ITC 2011… Six countries: USA, Canada, UK, Australia, Thailand, Malaysia 21 countries

24. Translating research to practice… US Product warnings The rest of there world

26. Vision for the future... South Carolina Lung Cancer Prevention Study Center of Excellence for research focused on the recalcitrant smoker Enhancing evidence based tobacco control in South Carolina

27. South Carolina Lung Cancer Prevention Study: a population based initiative to… Recruit high risk (30+ pack years) current and former smokers through primary care offices, hospitals, quit lines, and self-referral Provide incentives to stop smoking and get screened Track participants to ensure repeat screening and maintenance of smoking cessation Compare rates of late stage lung cancer over time

28. The problem… Today, ~50% of lung cancers are found in former cigarette smokers > 2/3rds of lung cancer are found in a late stage where therapeutic interventions are largely unsuccessful A Solution… Early detection and surveillance with low dose spiral CT scanning can find cancers early and reverse the trend in late stage detection

29. Questions examined in the NSLT 1. Does CT lead to more cancers diagnosed that would not progress to deadly cancers? 2. Does CT screening lead to unnecessary biopsies and resections?

30. Key Findings from NLST 20% reduction in lung cancer mortality in the LDCT group compared to the CXR group. All cause mortality was lower in the LDCT group compared to the CXR group. The stage of lung cancer was shifted to earlier, resectable cancers in the LDCT group compared to the CXR group.

31. Key Findings There were dramatically more positive tests in the LDCT group.

32. The challenge… How should we translate the NSLT findings into a population based intervention that in South Carolina can reduce late stage lung cancer detection? How will we get the people who will benefit the most from screening, screened? How do we use screening as an opportunity to promote smoking cessation? How do we ensure high quality service delivery and repeat screening?

33. The problem with current standard of care Delivery of smoking cessation and early detection services are haphazard and rarely done in combination Interventions when delivered are often only done once even though long term adherence is necessary to get the benefit

34. Recruitment – create a registry High Risk: 55-74 years of age 30 pack-years of smoking Potentially some restriction by years since quitting smoking OR 50 years old or greater > 20 pack-years of smoking One other lung cancer risk factor (COPD, asbestos exposure, family history) The Plan

35. Enrollment-Three Channels for Client Access: 1.Health Care Setting Enrollment 2.Call Center Enrollment (Quit Line) 3. Self-referral vis online enrollment

36. For those recruited… Add an Integrated Technology Solution Combining IVR & Smart Card Technology A “SmartCard” sent to them in the mail that offers discounts on purchases for… Stop smoking medications Low dose spiral CT scanning at approve screening centers to ensure quality control Routine reminders and counseling via phone, e-mail, text messaging to keep participants engaged in the intervention

37. Proven mechanism for distribution and tracking of medications and medical services Allows for choice and flexibility since incentives can be varied and altered over time Data capture is time stamped and real-time. Smart Card Technology

38. Follow-up / Triage IVR - an evidence based method of communicating with patients systematically Scheduled emails with linkage to secure web pages Mobile smart phone Apps Connects clients to live counseling when needed

39. Primary outcomes % of late stage lung cancer in defined region, e.g., state of South Carolina % of lung cancer patients alive after 10 years

40. We will learn if a combined prevention and screening regimen can accelerate the decline in lung cancer mortality (if this works – this will be the standard of care) The recruited cohort of subjects could be used to spin off additional studies within the program, e.g.,… –Methods for subject recruitment and ways to reduce disparities in delivery of lung cancer prevention interventions –Optimum screening protocols and studies of how to handle patients with positive screening findings –The value of different biomarkers for early detection of disease –Testing of new tobacco cessation treatments and combinations The result…

41. Questions