Objectives. Why? Why? Background 11/5/ % incurable disease at presentation Locally advanced disease Metastasis. 14% 5 year survival

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1 Objectives Appraise lung cancer screening trials results Review screening guidelines Lung Cancer Screening: Past, Present and Future Chi Wan Koo, MD Discuss recommendations essential to lung cancer screening program design and implementation Project future practice of lung cancer screening 2015 MFMER slide MFMER slide-2 Why? Why? 70% incurable disease at presentation Locally advanced disease Metastasis 14% 5 year survival 2015 MFMER slide MFMER slide-4 The Economics of Lung Cancer Background Effective mass screening of high-risk groups Potentially beneficial Randomized screening trials with CXR ± sputum No reduction lung CA mortality Molecular markers in blood, sputum, & bronchial brushings Unsuitable for clinical application MFMER slide MFMER slide-6 1

2 Observational Studies of CT Screening Randomized Studies of CT Screening Abbreviation: CT=computed tomography; CXR=chest X-ray; DLCST=Danish Lung Cancer Screening Trial; LSS=Lung Screening Study; MILD=Multicentric Italian Lung Detection; NL BM=the Netherlands and Belgium; NLST=National Lung Screening Trial; obs=observational studies.c Abbreviations: CT=computed tomography; NSM=non-smokers; p-y=pack-years. a Median age of participants. b Proportion of non-smokers. c Median pack-years. d Subjects with suspicious non-calcified solid lesions (percentage of participants). e Lung cancers detected at baseline (percentage of participants). f Percentage of lung cancers detected in stage I at baseline. g Lung cancers detected at first annual CT repeat. Pastorino. BJC 2010; 102: MFMER slide-7 Pastorino. BJC 2010; 102: MFMER slide-8 From NLST to Practice Eligibility 8/ /2009 8/ /2013 4/2014 2/2015 NLST Start Data Collection End USPSTF Publication Statement CMS MEDCAC CMS Approval 2015 MFMER slide MFMER slide-10 NLST Participants LDCT (T0) CXR (T0) Positive Screen Nodule 4mm Consolidation Obstructive Atx Nodule enlarge Change density Further follow up Negative Screen Nodule < 4 mm Annual Screen X2 (T1, T2) Positive Screen Nodule or Opacity Further follow up Negative Screen No Nodule Annual Screen X2 (T1, T2) LDCT LCS Early stage lung Ca Prevents advance stage lung CA 20% relative lung Ca mortality Absolute Reduction = 4/1000 (vs. 1/1000 for AAA screen) 6.7% all cause mortality 2015 MFMER slide MFMER slide-12 2

3 Financial Implication Cost Effectiveness Assumptions Mortality only due to lung CA Dropped from $81k $54k when mortality from other causes included Cost effectiveness results Strict adherence to parameters in NLST 2015 MFMER slide MFMER slide-14 USPSTF Recommendations MFMER slide MFMER slide-16 USPSTF Recommendations Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) Patient Protection & Affordable Health Care Act Requires private insurers to cover without co-pay all medical exams with B or higher grade USPSTF No mention of Medicare full national coverage CMS 2 requests for national coverage decision Benefits LCS Early stage lung Ca Prevents advance stage lung CA Reduce lung Ca and all cause mortality Risks Inappropriate screening Radiation Unneeded downstream follow up exams and procedures Procedure related complications 2015 MFMER slide MFMER slide-18 3

4 Positive Screen Complications LDCT CXR Cancer No Cancer Cancer No Cancer N % N % N % N % Positive Screens Major complications Death 60 days after any procedure Death 60 days after invasive procedure < < <0.1 <0.1 The National Lung Screening Trial Research Team. N Engl J Med 2011;365: MFMER slide MFMER slide-20 Present CMS Beneficiary Eligibility Age years Asymptomatic Tobacco smoking history 30 pack-years Quit smoking 15 years Receive written order for LDCT LCS Meet certain criteria 2015 MFMER slide MFMER slide-22 CMS Beneficiary Eligibility Initial Screen Shared decision making Use of 1 or more decision aids Benefits vs. harms of screening Follow-up diagnostic testing Overdiagnosis False positive rate Total Radiation exposure Counsel importance of Maintaining smoking abstinence if former smoker Smoking cessation if current smoker Furnish information on smoking cessation interventions Follow-up Screen Written order Shared Decision Making Collaborative process that allows patients and their providers to make health care decisions together, taking into account the best scientific evidence available, as well as the patient s values and preferences SDM honors both the provider s expert knowledge and the patient s right to be fully informed of all care options and the potential harms and benefits This process provides patients with the support they need to make the best individualized care decisions, while allowing providers to feel confident in the care they prescribe MFMER slide MFMER slide-24 4

5 2015 MFMER slide MFMER slide-26 Shared Decision Making Shared Decision Making 2015 MFMER slide MFMER slide-28 CMS Beneficiary Eligibility Makes available smoking cessation interventions for current smokers CMS Beneficiary Eligibility 2015 MFMER slide MFMER slide-30 5

6 Workflow at Mayo Clinic Workflow at Mayo Clinic MCR: , MCF: , MCA: MFMER slide MFMER slide-32 Shared Decision Making Workflow at Mayo Clinic 2015 MFMER slide MFMER slide-34 Beneficiary DOB Absence of Sx Current smoking status Mayo Order Form Pack-year history No. of years since quitting NPI of ordering physician Attestation of Smoking cessation Counseling Shared decision making visit Separate from routine primary care visit Mayo Order Form 2015 MFMER slide MFMER slide-36 6

7 Scanning CMS Imaging Facility Eligibility CTDIvol 3.0 mgy Standard size patients (5 7, 155 lbs.) Appropriate adjustments in CTDIvol for smaller/larger patients Use standardized lung nodule ID, classification and reporting system Collects and submits data to a CMS-approved registry for each LDCT LCS performed 2015 MFMER slide MFMER slide-38 CMS Imaging Facility Eligibility CTDIvol 3.0 mgy Standard size patients (5 7, 155 lbs.) Appropriate adjustments in CTDIvol for smaller/larger patients ACR Recommended Techniques CTDIvol 3.0 mgy Standard size patients (5 7, 155 lbs.) Appropriate adjustments in CTDIvol for smaller/larger patients Samples of vendor based LCS protocols 2015 MFMER slide MFMER slide-40 ACR Recommended Techniques CTDIvol 3.0 mgy Standard size patients (5 7, 155 lbs.) Appropriate reductions in CTDIvol for smaller/larger patients ACR Recommended Techniques Multidetector row ( 4) helical acquisition Tube modulation: manual or automatic Scan volume: Apex to bases at full inspiration Reconstructed slice thickness 2.5 mm with spacing less than 2.5 mm Reconstruction algorithm: Standard/Sharp Viewed at lung and mediastinal settings MPR and MIP encouraged 2015 MFMER slide MFMER slide-42 7

8 Image Interpretation CMS Radiologist Eligibility Board certified or eligible with ABR Documented training in diagnostic radiology and radiation safety Involvement in supervision and interpretation 300 chest CT acquisitions in past 3 years Documented participation in CME according to current ACR standards Furnish LDCT LCS in a radiology imaging facility that meets imaging criteria 2015 MFMER slide MFMER slide-44 CMS Imaging Facility Eligibility Patient HC CTDIvol 3.0 mgy Standard size patients (5 7, 155 lbs.) Appropriate adjustments in CTDIvol for smaller/larger patients Use standardized lung nodule ID, classification and reporting system Collects and submits data to a CMS-approved registry for each LDCT LCS performed 2015 MFMER slide MFMER slide-46 Terminology Classification of Solid Nodules Malignant Potential Nodule Solid Subsolid (SSN) Pure Groundglass (pggn/pggo) Part Solid/Mixed groundglass 2015 MFMER slide MFMER slide-48 8

9 Disease free survival at 5 yr Terminology Terminology Malignant Potential Solid No`dule Pure Groundglass (pggn/pggo) Subsolid (SSN) Part Solid/Mixed groundglass Solid Air space completely replaced Subsolid (SSN) Pure groundglass (GGN/GGO) Hazy increased opacity of lung Preservation of bronchial & vascular margins Caused by partial filling of airspaces, interstitial thickening (due to fluid, cells, and/or fibrosis), partial collapse of alveoli, increased capillary blood volume, or a combination of these Bottom line: partial displacement of air Part solid/mixed groundglass Groundglass with solid components 2015 MFMER slide MFMER slide-50 IASLC/ATS/ERS Classification AAH AIS MIA Invasive AdenoCa IASLC/ATS/ERS Impact: Prognosis Malignant potential Invasive AdenoCa 2015 MFMER slide MFMER slide-52 Preinvasive Lesions Invasive Lesions Atypical adenomatous hyperplasia (AAH) Bronchoalveolar proliferation Usually < 5 mm (larger lesions more difficult to separate from AIS/MIA) Up to 10 m Adenocarcinoma in situ (AIS) 3 cm with pure lepidic growth Minimally invasive adenocarcinoma (MIA) 3 cm with predominant lepidic growth and 5 mm invasion Invasive adenocarcinoma 5 mm invasion 2015 MFMER slide MFMER slide-54 9

10 Terminology Size Matters! Malignant Potential Nodule Solid Subsolid (SSN) Pure Groundglass (pggn/pggo) Part Solid/Mixed groundglass 2015 MFMER slide MFMER slide-56 Standard Classification Size NLST False Positive Participants Nodule Size LDCT Confirmed Lung CA N (%) Y N? Total 40% of NLST participants 1 FP over 3 years LDCT (T0) CXR (T0) <4mm 0 7 (0.2) 0 7 (0.2) mm 15 (7.1) (52.3) (20.0) (49.9) Positive Screen Nodule 4mm Consolidation Obstructive Atx Nodule enlarge Change density Negative Screen Nodule < 4 mm Positive Screen Nodule or Opacity Negative Screen No Nodule mm 58 (27.5) (27.9) mm 86 (40.8) (13.1) mm 23 (10.9) 77 (2.0) 1 (20.0) (27.9) 588 (14.5) 100 (2.5) 1 Further follow up Annual Screen X2 (T1, T2) Further follow up Annual Screen X2 (T1, T2) >30 mm 20 (9.5) 41 (1.1) (20.0) 62 (1.5) Unknown 1 (0.5) 9 (0.2) 0 10 (0.2) Aberle DR et al. NEJM 2011; 365(5): MFMER slide MFMER slide-58 Alternative Positive Screen Definition Effect of Nodule Size Henschke CI et al. Ann Intern Med. 2013;158: Yip R et al. Radiology 2014; 273(2): MFMER slide MFMER slide-60 10

11 NLST Nodule Size Effect Lung-RADS vs. BI-RADS Lung-RADS Version 1.0 BI-RADS Version 5.0 Gierada DS et al. J Natl Cancer Inst 2014; MFMER slide MFMER slide-62 Lung-RADS vs. BI-RADS Lung-RADS vs. BI-RADS Lung-RADS Version 1.0 BI-RADS Version 5.0 Lung-RADS Version 1.0 BI-RADS Version MFMER slide MFMER slide-64 Lung-RADS vs. BI-RADS Lung-RADS Lung-RADS Version 1.0 BI-RADS Version MFMER slide MFMER slide-66 11

12 Lung-RADS Lung-RADS 2015 MFMER slide MFMER slide-68 Lung-RADS Lung-RADS 2015 MFMER slide MFMER slide-70 Lung-RADS the fine print Nodules should be measured on lung windows Round nodules only a single diameter measurement Otherwise reported as the average diameter Growth = increase in size of > 1.5 mm Once a patient is diagnosed with lung cancer, this is no longer screening D1 D2 D1+D2/ MFMER slide MFMER slide-72 12

13 EXAM: Low Dose lung cancer screening CT scan of the chest without IV contrast enhancement Screening visit: COMPARISON: IMPRESSION: 1. Negative for screening purposes. Tiny nodule(s) identified with very low (<1%) likelihood of malignancy. 2. Interval slight increase in mild aneurysmal dilatation of the thoracic aorta with ascending portion measuring 4.3 cm now. RECOMMENDATION: Follow-up with next annual low-dose screening CT in 12 months. Nodules (indeterminate): As below Solid nodules: Present (1) 2 mm; left upper lobe; image 70 of series 2 (2) 2 mm; left upper lobe; image 105 of series 2 Ground glass nodules: None Coronary calcifications: Moderate Emphysema: Moderate Other potentially significant abnormality: Slightly increased aneurysmal dilatation of the thoracic aorta with ascending portion measuring approximately 4.3 cm and the descending portion measuring 3 cm at the level of the right pulmonary artery compared to prior measurements of 4 cm and 2.9 cm at a similar level. ACR Lung Cancer Screening Registry (LCSR) Approved by CMS as a qualified registry 3/5/15 Open for registration: Now! Data submission: Now and/or Retroactively on exams performed starting January 1, 2015 INCIDENTAL FINDINGS: None LungRADS category:2 S Scanner: CT 5D CTDIvol (mgy): 0.8 DLP (mgy*cm): MFMER slide MFMER slide-74 ACR LCSR Minimum Data Required ACR LCSR Minimum Data Required Facility: Identifier Radiologist: NPI Patient: Identifier Ordering Practitioner: NPI Indication: LDCT LCS, Asymptomatic Smoking History: Current status, years since quitting, pack-years, smoking cessation interventions available Written Order CT scanner: Manufacturer, Model System: Nodule ID, classification and reporting Effective radiation dose: CTDIvol Screening: Screen date, initial vs. subsequent screen Report 2015 MFMER slide MFMER slide-76 ACR LCSR Future Now you can Manually enter data into LCSR Discuss with your institution whether electronic transmission using web services for data submission to the ACR LCSR Get registered and PAY for it 2015 MFMER slide MFMER slide-78 13

14 Future Directions Future Directions CANARY Data from LCSR Science Practice Result from NLST replicated in clinical practice Improve management Volumetric Measurements CAD Linear Measurements 2015 MFMER slide MFMER slide-80 Ultra-Low Dose Screening? Summary A Use of Sn filter, reduced kvp, and iterative reconstruction Adequate imaging with CTDIvol ~ 0.3 mgy B NLST has shown LCS can decrease lung cancer specific and all cause mortality LCS is now covered nationally Insurers (CMS) have requirements that need to be fulfilled in order for facilities to be reimbursed ACR is a valuable resource for fulfilling these requirements Safety/Resources/Lung-Imaging-Resources Start screening! 2015 MFMER slide MFMER slide-82 Thank you! Koo.chiwan@mayo.edu 2015 MFMER slide-83 14