SCBT-MR 2016 Lung Cancer Screening in Practice: State of the Art

Transcription

1 SCBT-MR 2016 Lung Cancer Screening in Practice: State of the Art Reginald F. Munden MD, DMD, MBA I have no conflicts of interest to report

2 National Lung Cancer Screening Trial 20% lung cancer mortality reduction 6.9% all cause mortality reduction 320 individuals to save 1 from lung cancer death

3 NLST 24% of all screens - called positive study T0-27%, T1-28%, T2-17% 4% of positive studies - cancer False positive rate 96% (100 - PPV) or 25% (100 - specificty) At least one positive study in participant: CT 39%; CXR 16% Complications: 0.4% CT; 1.6% CXR 16 deaths (within 60 days) of CT (10 lung cancer) False negative - missed rate? NLST Research Team. NEJM, 2011

4 2180 LDCT screening between 1/ /2014 Reclassified using LungRADS Lung-RADS: Reduced positive screen rate from 27.6% to 10.6% No false negatives in the 152 patients with >12-month follow-up reclassified as benign Increased PPV for malignancy from 6.9% to 17.3%

5 ACR LungRADS Performance in the NLST: A Retrospective Assessment Reclassified NLST CT screening exams using LungRADS 26,722 LDCT arm subjects (26,309 baseline; 48,671 post-baseline) BASELINE POST BASELINE LungRADS (NLST) LungRADS (NLST) FPR (1-Specificity) 12.8% (26.6%) 5.3% (21.8%) Sensitivity 84.9% (93.5%) 78.6% (93.8%) PPV 6.9% (3.8%) 11.0% (3.5%) Pinsky et al. Annals Internal Medicine. 2015

6 Lung cancer screening works!

7 NOT? HCPCS Dollar % Code Descriptor APC Payment APC Payment Difference Change G0296 LDCT-LCS Shared Decision-making Session 5822 $ $ % G0297 Low-dose Lung Cancer Screening 5570 $ $ %

8 Lung Cancer Screening Assemble a multidisciplinary team: Radiologist PCP, surgeon, pulmonologist, prevention physician Oncologist, XRT physician, physicist Coordinator the face of the program Important for referring physicians Administrator, nurse, research coordinator Philanthropist, patient advocate Others?

9 CMS Screening Eligibility: 1. Age years; 2. Asymptomatic (no signs or symptoms of lung cancer); 3. Tobacco smoking history of at least 30 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes); 4. Current smoker or one who has quit smoking within the last 15 years; and Requirements Facility, Radiologists Written Order Shared Decision Process Registry

10 CMS Screening Radiology imaging facility eligibility criteria: 1. Performs LDCT with volumetric CT dose index (CTDIvol) of 3.0 mgy (milligray) for standard size patients (defined to be 5 7 and approximately 155 pounds) with appropriate reductions in CTDIvol for smaller patients and appropriate increases in CTDIvol for larger patients; 2. Utilizes a standardized lung nodule identification, classification and reporting system; - LungRads 3. Makes available smoking cessation interventions for current smokers; and 4. Collects and submits data to a CMS-approved registry for each LDCT lung cancer screening performed. The data collected and submitted to a CMSapproved registry must include, at minimum, all of the following elements:

11 CMS Screening Reading radiologist eligibility criteria: 1. Board certification or board eligibility with the American Board of Radiology or equivalent organization; 2. Documented training in diagnostic radiology and radiation safety; 3. Involvement in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past 3 years; 4. Documented participation in continuing medical education in accordance with current American College of Radiology standards; and 5. Furnish lung cancer screening with LDCT in a radiology imaging facility that meets the radiology imaging facility eligibility criteria below.

12 CMS Screening Written Order: A. For the initial LDCT lung cancer screening service: 1. Must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision making visit, furnished by a physician (as defined in Section 1861(r)(1) of the Social Security Act) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in 1861(aa)(5) of the Social Security Act). 2. A lung cancer screening counseling and shared decision making visit includes the following elements (and is appropriately documented in the beneficiary s medical records): 1. Determination of beneficiary eligibility including age, absence of signs or symptoms of lung cancer, a specific calculation of cigarette smoking pack-years; and if a former smoker, the number of years since quitting; 2. Shared decision making, including the use of one or more decision aids, to include benefits and harms of screening, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure; 3. Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment; 4. Counseling on the importance of maintaining cigarette smoking abstinence if former smoker; or the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions; and 5. If appropriate, the furnishing of a written order for lung cancer screening with LDCT. B. For subsequent LDCT lung cancer screenings: 1. the beneficiary must receive a written order for LDCT lung cancer screening, which may be furnished during any appropriate visit with a physician (as defined in Section 1861(r)(1) of the Social Security Act) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in Section 1861(aa)(5) of the Social Security Act). 2. If a physician or qualified non-physician practitioner elects to provide a lung cancer screening counseling and shared decision making visit for subsequent lung cancer screenings with LDCT, the visit must meet the criteria described above for a counseling and shared decision making visit.

13 NOT? HCPCS Dollar % Code Descriptor APC Payment APC Payment Difference Change G0296 LDCT-LCS Shared Decision-making Session 5822 $ $ % G0297 Low-dose Lung Cancer Screening 5570 $ $ %

14 CMS Registry CMS-approved registry must include all of the following elements: Data Type Minimum Required Data Elements Facility Radiologist (reading) Patient Ordering Practitioner CT scanner Indication System Smoking history Effective radiation dose Screening Identifier National Provider Identifier (NPI) Identifier National Provider Identifier (NPI) Manufacturer, Model. Lung cancer LDCT screening absence of signs or symptoms of lung cancer Lung nodule identification, classification and reporting system Current status (current, former, never). If former smoker, years since quitting. Pack-years as reported by the ordering practitioner. For current smokers, smoking cessation interventions available. CT Dose Index (CTDIvol). Screen date Initial screen or subsequent screen

15 CMS Registry Registry: ,000 registered Category 1 = 42%; Category 2 = 37%; Category 4A = 5%; Category 4B = 2.6% Abnormal Interpretation Rate Overall 2015 = 21.25% 2016 = 19.86% Baseline 2015 = 21.7% 2016 = 20.8% Annual 2015 = 14.2% 2016 = 10.9%

16 Lung Cancer Screening: Standardized lung nodule identification ACR LungRADS

17 LungRads Planned Modifications LungRads likely reviewed for changes on a yearly base Perifissural nodules Size reporting New large lesions on annual CT

18 ACR LungRads Category Category Descriptor Primary Category no lung nodules Findings Management Probability of Malignancy Estimated Population Prevalence Negative No nodules and definitely benign nodules 1 nodule(s) with specific calcifications: complete, central, popcorn, concentric rings and fat containing nodules and perifissural lymph nodes* solid nodule(s): < 6 mm new < 4 mm part solid nodule(s): < 6 mm total diameter on baseline screening Continue annual screening with LDCT in 12 months < 1% 90% Benign finding(s) Nodules with a very low likelihood of becoming a clinically active cancer due to size or lack of growth 2 non solid nodule(s) (GGN): < 20 mm OR 20 mm and unchanged or slowly growing category 3 or 4 nodules unchanged for 3 months * Perifissural nodules is defined as a solid nodule with smooth margins, an oval, lentiform or triangular shape and is < 6 mm in mean diameter

19 LungRads: Rationale 1) A perifissural nodule is a fissure-attached, homogeneous, solid nodule that had smooth margins and an oval, lentiform, or triangular shape [1]. They represent about 20% of nodules detected in lung cancer screening, are invariably benign, and do not require follow-up [1,2,3]. 2) More broadly, smooth or attached NCNs comprised 83% of all indeterminate solid pulmonary nodules detected in the NELSON trial [4]. At 1 year follow-up, no cancer was found in smooth (0/654) or attached (0/503) nodules. Xu et al concluded that 1 year follow-up is sufficient. References: 1. Collins J, Sterns EJ. Solitary and multiple pulmonary nodules. 3 ed. Collins J, Sterns EJ, editors. Philadelphia: Wolters Kluwer; p. 2. de Hoop B, van Ginneken B, Gietema H, Prokop M. Pulmonary perifissural nodules on CT scans: rapid growth is not a predictor of malignancy. Radiology Nov;265(2): PubMed PMID: Xu DM, van der Zaag-Loonen HJ, Oudkerk M, Wang Y, Vliegenthart R, Scholten ET, et al. Smooth or attached solid indeterminate nodules detected at baseline CT screening in the NELSON study: cancer risk during 1 year of follow-up. Radiology Jan;250(1): PubMed PMID:

20 LungRads Planned Modifications LungRads likely reviewed for changes on a yearly base Perifissural nodules Size reporting New large lesions on annual CT

21 LungRads 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

22 LungRads Old 2) New 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 Size: to calculate nodule mean diameter, measure both the long and short axis to one decimal point, and report the mean nodule diameter to one decimal point Rationale: Rounding to the whole number too many positive false positive studies Example: Old: 5.5 x 6.0 is reported as 6 x 6 = 6 - Positive study New: 5.5 x 6.0 is reported as 5.5 x 6.0 = Negative study

23 LungRads Planned Modifications LungRads likely reviewed for changes on a yearly base Perifissural nodules Size reporting New large lesions on annual CT

24 ACR LungRADS Category Category Descriptor Category Findings Management Probability of Malignancy Estimated Population Prevalence Solid nodule(s): 8 to < 15 mm at baseline OR growing < 8 mm OR new 6 to < 8 mm 3 month LDCT; 4A Part solid nodule(s): 6 mm with solid component 6 mm to < 8 mm OR PET/CT may be used when there is a 8 mm solid component 5-15% 2% Suspicious Findings for which additional diagnostic testing and/or tissue sampling is recommended 4B 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 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. > 15% 2% 4X Category 3 or 4 nodules with additional features or imaging findings that increases the suspicion of malignancy For new large nodules (>15 mm) on annual repeat screening CT, a 1 month LDCT may be considered * * The likelihood of cancer in a new large nodule that develops on an annual repeat screening CT is considerably lower than when found on baseline. Many of these nodules decrease or resolve on short term follow LDCT

25 LungRads Planned Modifications LungRads likely reviewed for changes on a yearly base Perifissural nodules Size reporting New large lesions on annual CT Thoughts/Comments?

26 Baseline Follow-up 4A Management

27 4A - Solid Nodule Findings > 8 to < 15mm at baseline Growing < 8mm or New 6 to < 8mm Endobronchial nodule Management: 3 month LDCT PET/CT if solid component is > 8mm

28 Follow up 3 months PET/CT 4A Solid > 8mm to < 15mm at baselline

29 4A: Growing < 8m One year

30 4A Endobronchial

31 Category 4A Part-solid Nodule Category Category Descriptor Category Findings Management Probability of Malignancy Estimated Population Prevalence Suspicious Findings for which additional diagnostic testing and/or tissue sampling is recommended 4A Part solid nodule(s): 6 mm with solid component 6mm to < 8 mm OR with a new or growing < 4 mm solid component 3 month LDCT; PET/CT may be used when there is a 8 mm solid component 5-15% 2%

32 Findings: > 6 mm with solid component > 6mm to < 8mm or with a new or growing < 4mm solid component Management: 3 month LDCT PET/CT if solid component is > 8mm 4A Part Solid Nodule

33 New < 4mm Solid Component 4A Part Solid Nodule

34 Follow-up Volumetric analysis

35 Follow-up Volumetric analysis

36 Category 4B Solid Nodule Category Category Descriptor Category Findings Management Suspicious Findings for which additional diagnostic testing and/or tissue sampling is recommended 4B Solid nodule(s) 15 mm OR new or growing, and 8 mm 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. Probability of Malignancy Estimated Population Prevalence > 15% 2%

37 4B Solid Nodule Findings > 15mm at baseline or New or growing, and > 8mm Management Chest CT w/w/o contrast PET/CT and/or tissue sampling depending on probability of malignancy

38 4B - Growing and > 8mm

39 Category 4B Part-Solid Nodule Category Category Descriptor Category Findings Management Probability of Malignancy Estimated Population Prevalence Suspicious Findings for which additional diagnostic testing and/or tissue sampling is recommended 4B Part solid nodule(s) with: a solid component 8 mm OR a new or growing 4 mm solid component 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. > 15% 2%

40 4B > 8mm solid

41 4B Growing Solid Component

42 4x Category Category Descriptor Category Findings Management Probability of Malignancy Estimated Population Prevalence Chest CT with or without contrast; Suspicious Findings for which additional diagnostic testing and/or tissue sampling is recommended 4X Category 3 or 4 nodules with additional features or imaging findings that increases the suspicion of malignancy 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. > 15% 2% Increases the suspicion of malignancy: Spiculations, edge contours Hilar/central mass small cell cancer GGN doubles in size in 1 year Calcification

43 Findings Additional imaging features that increase the suspicion of malignancy: Spiculations, hilar/central mass, GGN doubles in size in 1 year Management Chest CT w/w/o contrast PET/CT and/or tissue sampling depending on probability of malignancy 4x - Other Stuff

44 4x Other suspicious

45 4B Management Factors Patient preference Probability of malignancy based on patient evaluation McWilliams Lung Cancer Risk Calculator

46 McWilliams Lung Cancer Risk Calculator

47 Category S and C Category Category Descriptor Category Findings Management Probability of Malignancy Estimated Population Prevalence Other Clinically Significant or Potentially Significant Findings (non-lung cancer) S Modifier - may add on to category 0 4 coding As appropriate to the specific findings n/a 10% Prior Lung Cancer Modifier for patients with a prior diagnosis of lung cancer who return to screening C Modifier may add on to category 0 4 coding

48 Coronary Artery Calcification as a Predictor of Morality in the NLST 1575 NLST CTs graded for CAC 210 CHD deaths, 315 all cause deaths, 1050 alive Agatston score, qualitative vessel, overall visual CAC classification HR overall assessment HR vessel-specific segments HR Agatston score None/0/ Mild/1-5/ Moderate/6-11/101-1, Heavy/12-30/>1, Chiles, et al. Radiology2014

49 Thank You Reginald F. Munden MD, DMD, MBA