Lung Cancer Screening. Ashish Maskey MD Interventional Pulmonology UK Health Care Dec 1 st 2017

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1 Lung Cancer Screening Ashish Maskey MD Interventional Pulmonology UK Health Care Dec 1 st 2017

2 Nearly one in six American adults currently smoke cigarettes An estimated 40 million adults in the United States currently smoke cigarettes Centers for Disease Control and Prevention. Current Cigarette Smoking Among Adults United States, Morbidity and Mortality Weekly Report 2015;64(44): [accessed 2016 Nov 14].

3 Trends in lung cancer mortality rates by sex in select countries, Ahmedin Jemal et al. Cancer Epidemiol Biomarkers Prev 2010;19: by American Association for Cancer Research

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6 Cancer statistics, 2016 CA: A Cancer Journal for Clinicians Volume 66, Issue 1, pages 7-30, 7 JAN 2016 DOI: /caac

7 Kentucky Cancer Registry

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9 BENEFITS OF SCREENING High morbidity and mortality Significant prevalence Identified risk factors allowing targeted screening for high-risk individuals Clinical outcome is directly related to stage at the time of diagnosis The potential of screening to detect early cancers may both increase the overall cure rate and allow more limited surgical resection to achieve cure

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11 Canine Scent Detection in the diagnosis of lung cancer 4 dogs trained Sensitivity 71% Specificity 93% Electronic nose Volatile Organic compounds.

12 Questions with Lung Cancer Screening Who to screen? What age to start? How to define positive examination? How to follow up? Appropriate interval for screening? Benefits of screening? Harmful effect of screening? Cost effectiveness?

13 53,454 subjects. 33 medical centers 26,722 in the low dose CT group 24.2 % rate of positive screen, 23.3 false positive 96.4 % of positive screens was false positive 645/100,000 per year 247 deaths from lung cancer per 100,000 Relative reduction in Mortality 20% Reduction in rate of death from any cause 6.7 N Engl J Med 2011; 365:

14 ELIGIBLE PARTICIPANTS and 74 years of age at the time of randomization 2. History of cigarette smoking of at least 30 pack- years 3. If former smokers, had quit within the previous 15 years. ***These selection criteria were intended to increase the yield of lung cancers, but they exclude many known risk factors for lung cancer

15 AUG 2002 APRIL E N R O L L E D S C R E E N I N G F O L L O W E D SEP 2007 DEC 2009 Interim analysis Screened once a year for 3 years and were then followed for 3.5 additional years with no screening.

16 The rate of positive tests in both groups was noticeably lower at T2 than at T0 or T1 because the NLST protocol allowed tests showing abnormalities at T2 that were suspicious for cancer but were stable across all three rounds to be categorized as negative with minor abnormalities

17 false positive Across the three rounds, 96.4% of the positive results in the low-dose CT group and 94.5% of those in the radiography group were false positive results

18 (27.3%) Diagnostic Follow-up of Positive Screening Results in the Three Screening Rounds National Lung Screening Trial Research Team. (2013). Results of initial low-dose computed tomographic screening for lung cancer. N Engl J Med, 2013(368),

19 More than 90% of the positive screening tests in the first round of screening (T0) led to a diagnostic evaluation

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21 Stage and Histologic Type of Lung Cancers in the Two Screening Groups, According to the Result of Screening

22 Participants who would need to be screened to prevent one lung-cancer death decreased from 5276 among the 20% of participants at lowest risk to 161 among the 20% of those at highest risk. Kovalchik, S. A., Tammemagi, M., Berg, C. D., Caporaso, N. E., Riley, T. L., Korch, M.,... & Katki, H. A. (2013). Targeting of low-dose CT screening according to the risk of lung-cancer death. New England Journal of Medicine, 369(3),

23 Gierada, D. S., Pinsky, P., Nath, H., Chiles, C., Duan, F., & Aberle, D. R. (2014). Projected outcomes using different nodule sizes to define a positive CT lung cancer screening examination. Journal of the National Cancer Institute, 106(11), dju284.

24 False-positive CT screenings and medical resource utilization would be substantially reduced by raising the nodule size threshold for a positive screen Gierada, D. S., Pinsky, P., Nath, H., Chiles, C., Duan, F., & Aberle, D. R. (2014). Projected outcomes using different nodule sizes to define a positive CT lung cancer screening examination. Journal of the National Cancer Institute, 106(11), dju284.

25 Concerns Over diagnosis Yale: 525 lung cancer in 16,000 autopsies Higher incidence of Bronchoalveolar carcinoma( adeno) Unnecessary procedure Ct guided biopsy Bronchoscopy Surgical procedures ( VATS, wedge, lobectomy, pneumonectomy) Radiation exposure Annual CT screening of a50% people between in USA 36,000 radiation induced lung cancer

26 * Medicare Evidence Development & Coverage Advisory Committee

27 LUNG CANCER SCREEING PROGRAM Fintelmann, F. J., Bernheim, A., Digumarthy, S. R., Lennes, I. T., Kalra, M. K., Gilman, M. D.,... & Shepard, J. A. O. (2015). The 10 pillars of lung cancer screening: rationale and logistics of a lung cancer screening program. Radiographics, 35(7),

28 Lung Cancer Screening Recommendations American Cancer Society American College of Chest Physicians American Society of Clinical Oncology American Thoracic Society U.S. Preventative Services Task Force International Association for the study of Lung Cancer American Association of Thoracic Surgery National Comprehensive Cancer Network American Lung Association American Academy of Family Physicians

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30 ELIGIBILITY

31 DUCATION Education of all stakeholders Referral base Patients Radiologists Shared decision making Create/maintain an online information for the patients

32 58% percent of providers were aware of lung cancer screening guidelines[many could not recall the exact patient eligibility criteria.]# All providers assessed smoking behavior, but only 23% referred active smokers for formal cessation services. PCPs cited time constraints as a reason for lack of appropriate counseling and shared decision making. Few PCPs believed statistical approaches to counseling would confuse patients. # instead relied on alerts embedded in the EMR Kanodra, N. M., Pope, C., H. Halbert, C., Silvestri, G. A., Rice, L. J., & Tanner, N. T. (2016). Primary Care Provider and Patient Perspectives on Lung Cancer Screening: A Qualitative Study. Annals of the American Thoracic Society, (ja).

33 Patients found the term nodule mystifying Patients have little understanding of what nodules are, the likelihood of malignancy, and the follow-up plan. Plain language explanations of : What are nodules Reason why they appear on imaging Relationship of nodules to cancer Reasoning behind the extended approach to surveillance Slatore, C. G., Press, N., Au, D. H., Curtis, J. R., Wiener, R. S., & Ganzini, L. (2013). What the heck is a nodule? A qualitative study of veterans with pulmonary nodules. Annals of the American Thoracic Society, 10(4),

34 UNCERTAINTY is inherent in the LDCT screening and nodule evaluation process, and this may be quite distressing for some patients. Challenge- figuring out how best to implement shared decision-making and patient decision aids in practice Wiener, R. S. (2016). Opening the Black Box of Communication and Decision-Making for Lung Cancer Screening and Nodule Evaluation. Implications for Policy and Practice.

35 SMOKING CESSATION This service is inadequately addressed - Time constraints - Limited reimbursement for such services - Lung cancer screening may serve as a 'teachable moment' for smoking cessation Smoking cessation program should be an integral part of future screening programs At minimum, the screening program should have a connection to a tobacco cessation program and be prepared to provide information to the patient about resources in the community Pedersen, J. H., Tønnesen, P., & Ashraf, H. (2016). Smoking cessation and lung cancer screening. Annals of translational medicine, 4(8).

36 COMMUNICATION Clear and concise communication of screening results Structured reporting For the purpose of LCS, the report should contain the following items 1. Technique 2. Comparison date 3. Description of findings 4. Impression 5. Lung Imaging Reporting and Data System (Lung-RADS) category 6. Specific management recommendation

37 Ruparel, M., Quaife, S. L., Navani, N., Wardle, J., Janes, S. M., & Baldwin, D. R. (2016). Pulmonary nodules and CT screening: the past, present and future. Thorax, thoraxjnl-2015.

38 Fleischner Society 2017 Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images. Solid Nodules, the minimum threshold size for routine follow-up has been increased, and fewer follow-up exam are recommended for stable Nodules Sub-solid nodules, a longer period is recommended before initial follow-up, and the total length of followup has been extended to 5 years.

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41 Future Possibilities Automated quantitative imaging cytometry Detection of Heterogenous nucleat ribonucleorotein ( hn RNP) and P53, ras mutation Promotor hypermethylation Breath analysis Volatile organic compounds Gas Chromatography- mass spectrometry ( GC-MS) Chemical sensors ( electronic nose) Blood Biomarkers DNA, DNA hypermethylation, micro satellite alteration, gene mutation, protein markers. Urine testing for tobacco specific nitrosamine metabolite ( NNAL)

42 October 2017

43 June 2014

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48 April 2016 MVA May 2007

49 Aug 2017

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