Learning Objectives. 1. Identify which patients meet criteria for annual lung cancer screening

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2 Disclosure I, Taylor Rowlett, DO NOT have a financial interest /arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3 Learning Objectives 1. Identify which patients meet criteria for annual lung cancer screening 2. Identify the four main assessment categories in Lung-RADS reporting

4 Outline Scope of the problem Importance of early detection Low Dose chest CT screening Reporting of screening CT results What do I do with the results?

5 Scope of the problem

6 Lung Cancer Mortality Lung cancer is the leading cause of cancer death in the United States in both men and women Over 200,000 Americans are diagnosed with lung cancer each year An estimated 158,000 Americans were expected to die from lung cancer in 2016, representing 27% of all cancer deaths The number of deaths from lung cancer peaked in 2005 and has since decreased by 2.3% in 2014

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9 Incidence by State Leading Incidence Rates (per 100,000 people) by State, Kentucky West Virginia Arkansas Mississippi Tennessee Maine 72.1

10 Incidence by State Leading Incidence Rates (per 100,000 people) by State, Kentucky West Virginia Arkansas Mississippi Tennessee Maine 72.1

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13 Death rate by State Leading Death Rates (per 100,000 people) by State, Kentucky West Virginia t. Tennessee t. Mississippi Arkansas Missouri 53.7

14 Importance of early detection 5 year survival rate of less than 20% in advanced stage lung cancer Screening high risk individuals may dramatically improve survival rates by finding the disease at an earlier, more treatable stage.

15 National Lung Screening Trial, 2011 Low dose chest CT vs CXR >50,000 participants 20% relative mortality decrease Fintelmann et al. The 10 Pillars of Lung Cancer screening. Radiographics volume 35 number 7 pg 1895

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22 The fine print on ordering the exam..

23 Patient and Physician Guide: National Lung Screening Trial (NLST) What is the purpose of this guide? To explain the benefits and harms of low-dose computed tomography (CT) screening for lung cancer in people at high risk for the disease. The NLST showed a reduction in deaths from CT screening compared to chest X-ray screening. The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial recently showed that chest X-ray screening (compared to no screening) did NOT reduce the chance of dying from lung cancer. Who participated in the NLST? Current or former cigarette smokers within the past 15 years, 55 to 74 years of age, with at least 30 pack-years of smoking [Pack-years = packs per day x number of years smoking]. Participants must have had no symptoms or signs of lung cancer or other serious medical conditions, and be medically fit for surgery. Study Findings: Low-dose CT versus Chest X-ray screening 53,454 current and former smokers were randomly assigned to be screened once a year for 3 years with low-dose CT or chest X-ray. Here s what happened after an average of 6.5 years: Benefit: How did CT scans help compared to chest X-ray, an ineffective screening test? Low-dose CT 26,722 people Chest X-ray 26,732 people 3 in 1,000 fewer died from lung cancer 18 in 1,000 versus 21 in 1,000 5 in 1,000 fewer died from all causes 70 in 1,000 versus 75 in 1,000 Harm: What problems did CT scans cause compared to chest X-ray? 223 in 1,000 more had at least one false alarm 365 in 1,000 versus 142 in 1, in 1,000 more had a false alarm leading to an invasive procedure, such as bronchoscopy, biopsy, or surgery 25 in 1,000 versus 7 in 1,000 2 in 1,000 more had a major complication from Invasive procedures 3 in 1,000 versus 1 in 1,000 Take home messages Lung cancer screening with CT scans is the only screening test shown to lower the chance of dying from lung cancer. The effect of screening may vary depending on how similar you are to the people who participated in the study. The benefit of screening may be bigger if your lung cancer risk is higher. The harm may be bigger if you have more medical problems (like heart or severe lung disease), which could increase problems from biopsies and surgery. For perspective, the reduction in deaths from lung cancer with CT screening is larger than the reduction in deaths from the target cancers of other common screening tests, such as mammograms for breast cancer. There is a tradeoff: CT screening decreases your chance of death but increases your chance of having a false alarm. If you choose to have CT screening, it is important to have it done at a medical center with special expertise in lung cancer screening and treatment. Most important thing you can do DON T SMOKE. Regardless of your screening decision, avoiding cigarettes is the most powerful way to lower your chance of dying overall or suffering or dying from a variety of diseases, such as lung cancer, emphysema, heart or vascular disease. For example, at age sixty-five, 89 in 1,000 male current smokers will die of lung cancer in the next 10 years versus 4 in 1,000 never smokers. For women, the corresponding figures are 55 in 1,000 versus 5 in 1,000. For help quitting, call QUIT-NOW. Cancer.gov Thoracic.org

24 The fine print on ordering the exam.. Find out if the patient has any prior chest CTs

25 Screening & Early Detection Screening high risk individuals with low dose chest CT could reduce lung cancer mortality by 20% compared to chest x-ray. At least 8.6 million Americans qualify as high risk for lung cancer and are recommended to receive annual screening with low dose CT.

26 Low dose chest CT screening

27 Image Acquisition 16 detector row (or more) CT scanner No IV contrast Full chest in field of view 2.5 mm or less section thickness ALARA (as low as reasonably achievable dose less than 3 mgy (absorbed dose, equals 1.5 msv effective dose)

28 Radiation exposure comparison Low dose chest CT equals 6 months of natural background radiation 1 spine x-ray ½ of a calcium score CT RadiologyInfo.org

29 Image Review Interpreting-Physician Criterion Board Certification Training Experience Continuing Education

30 Image Review Goal is two part: 1. Detect signs of early lung cancer such as pulmonary nodules 2. Not to miss potentially important incidental findings (COPD, adenopathy, atherosclerosis, aneurysm, cholelithiasis, & indeterminate thyroid, breast, liver, kidney, adrenal lesions)

31 Image Review Nodule characterization Size matters Size = average of longest and shortest diameter Measured on lung windows in axial plane Density Calcified, solid, part solid, ground glass Margins Circumscribed, irregular, spiculated Change over time Must compare to any available prior (CT neck, chest, abdomen, PET, calcium score CT )

32 Reporting of screening CT results

33 Lung Cancer Screening (LCS) CT report CT scan report should contain: Technique Comparison date Findings description Impression Lung Imaging Reporting and Data System (Lung- RADS) category & specific management recommendations

34 LCS CT report Findings section to contain a description of each nodule including: Location Size Attenuation Morphology Margins Interval change

35 Lung-RADS Structured reporting Quality assurance Reduce confusion Monitor outcomes Version 1.0 released April 2014

36 Lung RADS Version 1.0 Assessment Categories Release date: April 28, 2014 Category Category Descriptor Category Findings Management prior chest CT examination(s) being located for comparison Additional lung cancer screening CT images and/or Incomplete 0 n/a part or all of lungs cannot be evaluated comparison to prior chest CT examinations is needed Negative Suspicious Other Prior Lung Cancer No nodules and definitely benign nodules Nodules with a very low Benign likelihood of becoming a Appearance clinically active cancer due or Behavior to size or lack of growth Probably benign finding(s) short term follow up suggested; Probably includes nodules with a Benign low likelihood of becoming a clinically active cancer Findings for which additional diagnostic testing and/or tissue sampling is recommended Clinically Significant or Potentially Clinically Significant Findings (non lung cancer) Modifier for patients with a prior diagnosis of lung cancer who return to screening no lung nodules nodule(s) with specific calcifications: complete, central, popcorn, concentric rings and fat containing nodules solid nodule(s): < 6 mm new < 4 mm part solid nodule(s): < 6 mm total diameter on baseline screening non solid nodule(s) (GGN): < 20 mm OR 20 mm and unchanged or slowly growing category 3 or 4 nodules unchanged for 3 months solid nodule(s): 6 to < 8 mm at baseline OR new 4 mm to < 6 mm part solid nodule(s) 6 mm total diameter with solid component < 6 mm OR new < 6 mm total diameter non solid nodule(s) (GGN) 20 mm on baseline CT or new solid nodule(s): 8 to < 15 mm at baseline OR growing < 8 mm OR new 6 to < 8 mm 3 month LDCT; PET/CT may be used when there is 4A 5 15% part solid nodule(s: a 8 mm solid component 4B 4X 6 mm with solid component 6 mm to < 8 mm OR with a new or growing < 4 mm solid component endobronchial nodule solid nodule(s) 15 mm OR new or growing, and 8 mm part solid nodule(s) with: a solid component 8 mm OR a new or growing 4 mm solid component Category 3 or 4 nodules with additional features or imaging findings that increases the suspicion of malignancy Continue annual screening with LDCT in 12 months 6 month LDCT chest CT with or without contrast, PET/CT and/or tissue sampling depending on the *probability of malignancy and comorbidities. PET/CT may be used when there is a 8 mm solid component. Estimated Probability of Population Malignancy Prevalence S modifier may add on to category 0 4 coding As appropriate to the specific finding n/a 10% C modifier may add on to category 0 4 coding < 1% 1% 90% 1 2% 5% 2% > 15% 2% IMPORTANT NOTES FOR USE: 1) Negative screen: does not mean that an individual does not have lung cancer 2) Size: nodules should be measured on lung windows and reported as the average diameter rounded to the nearest whole number; for round nodules only a single diameter measurement is necessary 3) Size Thresholds: apply to nodules at first detection, and that grow and reach a higher size category 4) Growth: an increase in size of > 1.5 mm 5) Exam Category: each exam should be coded 0 4 based on the nodule(s) with the highest degree of suspicion 6) Exam Modifiers: S and C modifiers may be added to the 0 4 category 7) Lung Cancer Diagnosis: Once a patient is diagnosed with lung cancer, further management (including additional imaging such as PET/CT) may be performed for purposes of lung cancer staging; this is no longer screening 8) Practice audit definitions: a negative screen is defined as categories 1 and 2; a positive screen is defined as categories 3 and 4 9) Category 4B Management: this is predicated on the probability of malignancy based on patient evaluation, patient preference and risk of malignancy; radiologists are encouraged to use the McWilliams et al assessment tool when making recommendations 10) Category 4X: nodules with additional imaging findings that increase the suspicion of lung cancer, such as spiculation, GGN that doubles in size in 1 year, enlarged lymph nodes etc 11) Nodules with features of an intrapulmonary lymph node should be managed by mean diameter and the 0 4 numerical category classification 12) Category 3 and 4A nodules that are unchanged on interval CT should be coded as category 2, and individuals returned to screening in 12 months 13) LDCT: low dose chest CT *Link to McWilliams Lung Cancer Risk Calculator Upon request from the authors at: cancer risk calculator At UptoDate solitary pulmonary nodule malignancy risk brock university cancer prediction equation

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38 Lung-RADS Category 0 Assessment: Incomplete Findings: Prior chest CT exam(s) being located for comparison Part or all of lungs cannot be evaluated Management: Additional lung cancer screening CT images and/or comparison to prior chest CT exam is needed Estimated population prevalence: 1%

39 Lung-RADS Category 1 Assessment: Negative Findings: No lung nodules Nodule(s) with specific calcifications: complete, central, popcorn, concentric rings and fat containing nodules Management: Continue annual screening with low dose chest CT in 12 months Probability of malignancy: < 1% Estimated prevalence (with category 2): 90% CHI Memorial prevalence: 89% (Cat 1: 72%, Cat 2: 17%)

40 Lung-RADS Category 2 Assessment: Benign Appearance or Behavior Nodules with a very low likelihood of becoming a clinically active cancer due to size or lack of growth Management: Annual screening in 12 months Findings: Probability of malignancy: <1 % Estimated population prevalence (with category 1): 90% CHI Memorial prevalence: 89% (Cat 1: 72%, Cat 2: 17%)

41 Lung-RADS Category 2

42 Lung-RADS Category 2

43 Lung-RADS Category 3 Assessment: Probably Benign Findings: Nodules with a low likelihood of becoming a clinically active cancer Management: 6 month follow-up low dose chest CT Probability of malignancy: 1 2% Estimated population prevalence: 5% CHI Memorial prevalence: 6%

44 Lung-RADS Category 3 7 mm irregular nodule Lung-RADS 3 Awaiting 6 month follow up CT

45 Lung-RADS Category 4A Assessment: Suspicious Findings for which additional diagnostic testing and/or tissue sampling is recommended Management: 3 month follow-up LDCT; PET- CT may be used when there is a >= 8 mm solid component Findings: Probability of malignancy: 5 15% CHI Memorial malignancy rate for 4A and 4B combined = 26% Estimated population prevalence: 2% CHI Memorial prevalence 4A & 4B: 5%

46 RLL circumscribed 8 mm Nodule = Lung-RADS 4A At 3 month follow up -> Stable; now category 2 1 cm RLL irregular nodule Lung-RADS 4A Awaiting follow-up; 3 month follow up CT or PET-CT

47 Lung-RADS Category 4B Assessment: Suspicious Findings for which additional diagnostic testing and/or tissue sampling is recommended Management: PET-CT and/or tissue sampling depending on the probability of malignancy & comorbidities. Findings: Probability of malignancy: > 15% CHI Memorial malignancy rate for 4A and 4B combined = 26% Estimated population prevalence: 2% CHI Memorial prevalence 4A & 4B: 5%

48 June 2016 wellness CXR January 2017 screening CT 2.4 x 1.6 cm irregular nodule Lung-RADS category 4B

49 PET-CT showed Stage IA cancer; No evidence of nodal spread of disease or distant metastases CT guided biopsy performed = Poorly differentiated squamous cell carcinoma

50 Lung-RADS Modifiers Category 4X: Category 3 or 4 nodules with additional features or imaging findings that increase the suspicion of malignancy S modifier Added to category 0-4 Clinically significant or potentially clinically significant findings (non lung cancer) C modifier Added to category 0-4 Added to the category for patients with a prior diagnosis of lung cancer who return to screening

51 What do I do with the results?

52 CHI Memorial Experience Cancer detection rate: 1.4% % of cancers that are Stage I: 61.5%