Lung Cancer Screening Benefits, Risks & Challenges

Transcription

1 Lung Cancer Screening Benefits, Risks & Challenges Polly Sather, APRN Yale Lung Screening and Nodule Program (Yale Lung SCAN) A Multidisciplinary Comprehensive Initiative Yale Cancer Center Thoracic Oncology Program

2 Disclosures Polly Sather, APRN is a member of the American Thoracic Society Program Committee

3 Yale Lung SCAN Clinical Team Lynn Tanoue, MD, Director Frank Detterbeck, MD, Co-Director Anne Curtis, MD, Isabel Oliva, MD, Jonathan Killam, MD Polly Sather, APRN, Program Coordinator Support Team Yale Cancer Center Thoracic Oncology Program (TOP) TOP Tumor Board Smilow Cancer Hospital, Program Administration EPIC Ancillary Team - Anne Gormley Diagnostic Radiology, Administrative Director - Cheryl Granucci Diagnostic Imaging Scheduling - Landra Knoth, Sonja Johnson

4 Outline 1. Lung cancer overview 2. Screening the National Lung Screening Trial 3. Implementation and challenges of lung cancer screening 4. Resources

5 Global lung cancer burden

6 Cancer statistics, 2017 CA: A Cancer Journal for Clinicians Volume 67, Issue 1, pages 7-30, 5 JAN 2017 DOI: /caac

7 Cancer statistics, 2017 CA: A Cancer Journal for Clinicians Volume 67, Issue 1, pages 7-30, 5 JAN 2017 DOI: /caac

8 Cancer statistics, 2017 CA: A Cancer Journal for Clinicians Volume 67, Issue 1, pages 7-30, 5 JAN 2017 DOI: /caac

9 NSCLC survival by pathologic staging Goldstraw JTO 2007; 2:706

10 Trends in 5-year relative survival rates (%) by year of diagnosis, United States Site Breast (female) * 90 Colon * 65 Prostate * 99 Lung * 18 *statistically significant compared to

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12 Lung Cancer Statistics ~14% of all new cancers are lung cancer Estimated 222,500 new cases of lung cancer in United States in 2017 Leading cause of cancer death among men and women Improvement in survival related to: Focused research Better treatments Early detection

13 Screening Evaluation for disease in the absence of symptoms Screening makes sense when: 1. Outcomes are better when disease is detected early The gold standard of successful screening outcome is a decrease in mortality 2. Benefits outweigh harm - primum non nocere

14 Lung Cancer Screening PLCO Trial: CXR vs. no screen Prostate Lung Colon Ovarian (PLCO) Screening Trial Oken, M. M. et al. JAMA 2011;306:

15 Lung Cancer Screening National Lung Screening Trial: CXR vs LDCT NLST criteria: Ages 55-74, >30 pk-yrs smoking, currently smoking or quit within 15 years 20% relative reduction in mortality in LDCT screened arm Risk of lung cancer in the study population = 2-3% over 6 years The majority of screen-detected lung cancers were Stage I. Number needed to screen = 302 Conclusion: Screening with low-dose CT reduces mortality from lung cancer Aberle et al. NEJM 2011; 365: 395

16 United States Preventive Services Task Force December 31, 2013 The USPSTF recommends annual screening for lung cancer with low-dose computed tomography in adults ages 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. Moyer VA. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine 2014;160:

17 Medicare approval for lung cancer screening Feb 2015 The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, annual screening for lung cancer with low dose computed tomography (LDCT), as an additional preventive service benefit under the Medicare program

18 Medicare approval for lung cancer screening Feb 2015 only if all of the following criteria are met (42+ pages): Age years; Asymptomatic (no signs or symptoms of lung cancer); Tobacco smoking history of at least 30 pack-years; Current smoker or quit within the last 15 years; Reading radiologist eligibility criteria: Utilizes a standardized lung nodule identification, classification and reporting system; Make available tobacco treatment interventions; For the initial screening service: a lung cancer screening counseling and shared decision making visit Collects and submits data to a CMS-approved registry for each LDCT lung cancer screening performed.

19 LDCT Screening for Lung Cancer: A Balance of Benefit and Risks Benefit 20% relative reduction in lung cancer mortality What does that mean? there were 3 fewer deaths from lung cancer in 1000 people screened 21 in 1,000 would have died from lung cancer 18 in 1,000 still died from lung cancer

20 LDCT Screening for Lung Cancer: A Balance of Benefit and Risks Benefit Risks 20% relative reduction in lung cancer mortality High false positive rate Increase in further noninvasive diagnostic imaging Radiation exposure Increase in invasive diagnostic procedures Surgery ( unnecessary )

21 Pulmonary Nodules Are you seeing spots? ~ 72 million CTs done annually in the US in adults, approximately half are body scans; 2/3 of these are chest CTs = ~24 million chest CTs annually ~40% of Americans are current or former smokers, and would match populations of screening studies On average ~ 25% of individuals undergoing screening LDCT have a new nodule found per year 24 million x 0.40 x 0.25 = 2.4 million nodules/year! (before screening) Brenner DJ and Hall EJ. N Engl J Med 2007;357:22

22 High False Positive Rate in NLST The National Lung Screening Trial Research Team. N Engl J Med 2011;365:

23 Challenge: What standard should be used for LDCT reading? American College of Radiology, Lung C Lung CT Screening Reporting & Data System Lung-RADS American College of Radiology, April 2014 Data System (Lung-RADS TM )

24 LDCT Screening for Lung Cancer: A Balance of Benefit and Risks Benefit Risks 20% relative reduction in lung cancer mortality High false positive rate Increase in further noninvasive diagnostic imaging Radiation exposure Increase in invasive diagnostic procedures Surgery ( unnecessary )

25 NLST: Abnormal results in LDCT arm NLST results: T0 = baseline; T1 = 1 st annual screen; T2 = 2 nd annual screen T0 T1 T2 Number of lung cancers (% of all abnormals) 270 (3.8%) 168 (2.4%) 211 (5.2%) Number of abnormal screens, not lung cancer (% of all abnormals) 6921 (96.2%) 6733 (97.6%) 3843 (94.8%)

26 Challenge: LDCT findings other than pulmonary nodules Yale Lung SCAN free screening events 2014, N = 139 Incidental Pulmonary Findings N (%) Emphysema 51 (37%) Interstitial lung disease 6 (4%) Bronchiectasis 12 (9%) Other (calcified granuloma or pleura, pulmonary artery enlargement, scarring, pulmonary AVM, etc) 65 (47%) Incidental Non-Pulmonary Findings N (%) Coronary artery calcification 98 (71%) Aortic aneurysm 9 (7%) Thyroid nodule 4 (3%) Adrenal nodule 3 (2%) Other (renal cyst, pericardial effusion, esophageal thickening, etc) 39 (28%)

27 Radiation Exposure (effective) Exposure msv Chernobyl 6000 Recommended limit for radiation workers every 5 years Lowest annual dose at which any increase in cancer is clearly evident Airline flight attendant flying NY to Tokyo, annual exposure Ambient radiation per year (sea level) Diagnostic chest CT, no contrast 8 (2-24)* CT pulmonary angiogram 10 (2-30)* CT coronary angiogram 22 (7-39)* Low-dose chest CT, no contrast ; 69:2078 *Smith-Bindman, Arch Int Med

28 LDCT Screening for Lung Cancer: A Balance of Benefit and Risks Benefit Risks 20% relative reduction in lung cancer mortality High false positive rate Increase in further noninvasive diagnostic imaging Radiation exposure Increase in invasive diagnostic procedures Surgery ( unnecessary )

29 Nodule Management Invasive interventions LDCT screening studies: NELSON: Dutch Belgium lung cancer screening trial DLSCT: Danish Lung cancer screening trial NLST: National Lung Screening Trial DANTE: Italian lung cancer screening trial Study Surgical biopsy or procedure, frequency Benign result NELSON % 30% DLCST, % 32% NLST, % 24% DANTE, % 24%

30 Unnecessary procedures NLST LDCT arm 365 in 1,000 had at least 1 false alarm 25 in 1,000 had false alarm invasive procedure 3 in 1,000 had major complication from the procedure

31 Cancer risk prediction for pulmonary nodules identified on screening LDCT

32 Components of a Lung Cancer Screening Program Risks/Issues Specifics Program approach High false positive rate Increase in further imaging and radiation exposure Increase in invasive diagnostic procedures 20% average nodule detection rate per round of screening, most of which are false positives 1%-45% of screened individuals undergo further imaging because of abnormal findings 1.2%-5.6% of screened individuals undergo surgical biopsy or procedure. Benign results found in 24-32% Standardized protocol for performance of LDCT Standardized LDCT reading by trained, committed radiologists: ACR LungRADS Nodule program Nodule Board : Pulmonary, Thoracic Surgery, Radiology Nodule assessment with involvement of pertinent disciplines and standardized management algorithm.

33 Medicare approval for lung cancer screening Feb 2015 only if all of the following criteria are met (42+ pages): Age years; Asymptomatic (no signs or symptoms of lung cancer); Tobacco smoking history of at least 30 pack-years; Current smoker or quit within the last 15 years; Reading radiologist eligibility criteria: Utilizes a standardized lung nodule identification, classification and reporting system; Make available tobacco treatment interventions; For the initial screening service: a lung cancer screening counseling and shared decision making visit Collects and submits data to a CMS-approved registry for each LDCT lung cancer screening performed.

34 Components of a Lung Cancer Screening Program Risks/Issues Specifics Program approach High false positive rate Increase in further imaging and radiation exposure 20% average nodule detection rate per round of screening, most of which are false positives 1%-45% of screened individuals undergo further imaging because of abnormal findings Standardized protocol for performance of LDCT Standardized LDCT reading by trained, committed radiologists: ACR LungRADS Standardization of incidental findings Nodule program Nodule Board : Pulmonary, Thoracic Surgery, Radiology Increase in invasive diagnostic procedures Ongoing smoking 1.2%-5.6% of screened individuals undergo surgical biopsy or procedure. Benign results found in 24-32% Smoking cessation is more powerful than LDCT in reducing lung cancer mortality Nodule assessment with involvement of pertinent disciplines and standardized management algorithm. Smoking cessation program

35 Smoking cessation: Benefit at any age Primary prevention is the most effective means of reducing lung cancer death. Smoking cessation is a far more powerful intervention than LDCT screening in reducing lung cancer mortality. Peto R et al. Smoking, smoking cessation, and lung cancer in the UK since Brit Med J 2000;321:323

36 Components of a Lung Cancer Screening Program Risks/Issues Specifics Program approach High false positive rate Increase in further imaging and radiation exposure Increase in invasive diagnostic procedures Ongoing smoking Patient education and decision support 20% average nodule detection rate per round of screening, most of which are false positives 1%-45% of screened individuals undergo further imaging because of abnormal findings 1.2%-5.6% of screened individuals undergo surgical biopsy or procedure. Benign results found in 24-32% Smoking cessation is more powerful than LDCT in reducing lung cancer mortality Give patients tools to help them understand risk/benefit and participate in decision making Standardized protocol for performance of LDCT Standardized LDCT reading by trained, committed radiologists: ACR LungRADS Nodule program Nodule Board : Pulmonary, Thoracic Surgery, Radiology Nodule assessment with involvement of pertinent disciplines and standardized management algorithm. Smoking cessation program Educational materials Decision support tools

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39 Yale Lung SCAN Patient Education and Decision Support Module 1.amazonaws.com/index.html

40 ATS decision support tool The Decision Aid describes all the considerations for lung cancer screening, including the resources for smoking cessation, benefits of screening, symptoms of lung cancer, risk factors for lung cancer, research about the benefits of screening, harms of screening, physician interventions to prevent screen harms, and screening process. DECISION AID For Lung Cancer Screening with Computerized Tomography (CT)

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42 Components of a Lung Cancer Screening Program Risks/Issues Specifics Program approach High false positive rate Increase in further imaging and radiation exposure Increase in invasive diagnostic procedures Ongoing smoking Patient education and decision support Patient registry 20% average nodule detection rate per round of screening, most of which are false positives 1%-45% of screened individuals undergo further imaging because of abnormal findings 1.2%-5.6% of screened individuals undergo surgical biopsy or procedure. Benign results found in 24-32% Smoking cessation is more powerful than LDCT in reducing lung cancer mortality Give patients tools to help them understand risk/benefit and participate in decision making Document indication, specifics about LDCT, outcomes Standardized protocol for performance of LDCT Standardized LDCT reading by trained, committed radiologists: ACR LungRADS Nodule program Nodule Board : Pulmonary, Thoracic Surgery, Radiology Nodule assessment with involvement of pertinent disciplines and standardized management algorithm. Smoking cessation program Educational materials Decision support tools Purchase or develop registry tool

43 9. Data Collection/ Registry CMS Collects & submits data to a CMS-approved registry Must include: Facility Identifier Radiologist (NPI) Patient Identifier Ordering Practitioner CT Scanner manufacturer/mode Indication Reporting System Smoking history Effective Radiation dose Screening date initial vs. subsequent

44 Lung Cancer Screening Registry American College of Radiology (ACR) Registry Approved by CMS Participation is required to receive CT lung cancer screening payments Online manual data entry, working on electronic entry Data may be submitted retroactively on exams performed starting January 1, Registry/Registration-Process-and-Fee-Structure

45 Component 1. Who is offered lung cancer screening 2. How often, and for how long, to screen 3. How the CT is performed 4. Lung nodule identification 5. Structured reporting 6. Lung nodule management algorithms 7. Smoking cessation 8. Patient and provider education 9. Data collection ACCP/ATS Policy Statement: Components Necessary for High Quality Lung Cancer Screening. Chest 2015 Policy Statement USPSTF Recommendation: Screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening may not be appropriate for patients with substantial comorbid conditions, particularly those who are in the upper end of the screening age range. Lung cancer screening programs should collect data on all enrolled subjects related to the risk of developing lung cancer. USPSTF Recommendation: Annual screening until age 80 Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery A low dose lung cancer screening CT should be performed based on the ACR-STR technical specifications A lung cancer screening program should collect data to ensure the mean radiation dose is in compliance with ACR-STR recommendations A lung cancer screening program should have a policy about the size and characteristics of a nodule to be used to label the test as positive collect data about the number, size, and characteristics of lung nodules from positive tests A lung cancer screening program should use a structured reporting system, such as LungRADS collect data about compliance with the use of the structured reporting system A lung cancer screening program must Include clinicians with expertise in the management of lung nodules and the treatment of lung cancer Have developed lung nodule care pathways Have the ability to characterize concerning nodules through PET imaging, non-surgical and minimally invasive surgical approaches Have an approach to communication with the ordering provider and/or patient Have a means to track nodule management, and Collect data related to the use of, and outcomes from, surveillance and diagnostic imaging, surgical and non-surgical biopsies for the management of screen detected lung nodules A lung cancer screening program must be integrated with a smoking cessation program should collect data related to the smoking cessation interventions that are offered to active smokers enrolled in the screening program A lung cancer screening program Should educate providers so that they can adequately discuss the benefits and harms of screening with their patients Should develop or use available standardized education materials to assist with the education of providers and patients Is responsible for the oversight and supplementation of provider-based patient education A lung cancer screening program must collect data on all enrolled patients related to the quality of the program, including those enrolled in registered clinical research trials. Data collection should include elements related to each of the other 8 components of a lung cancer screening program (as above). In addition, data collection should include the outcomes of testing (complications, cancer diagnoses), and a description of the cancers diagnosed (histology, stage, treatment, survival) A review of the data and subsequent quality improvement plan should be performed at least annually An annual summary of the data collected should be reported to an oversight body with the authority to credential screening program. Standards set forth in the above policy statements should be used by the oversight body to judge areas of compliance and deficiency

46 Is lung cancer screening worth it? Not a perfect test Not an easy process It is a tremendous step forward primarily because of the scope of the problem Need to understand the risks & benefits Need to take time to discuss the risks & benefits with your patients so that they can make informed decisions Screening does need to be done in the context of a broader program with adequate support

47 Resources Centers for Medicare and Medicaid Services (CMS) statement on approval and requirements for lung cancer screening American College of Radiology, Lung CT Screening Reporting and DATA System (Lung- RADS TM ) Lung cancer prediction model (Tammemagi et al. from PLCO trial) ATS decision aid for lung cancer screening: Aberle DR et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 2011; 365:395 Mazzone P et al. Components Necessary for High Quality Lung Cancer Screening. ACCP and ATS Policy Statement Chest 2015; 147:295 Tanoue LT et al. Lung Cancer Screening. Concise Clinical Review. Am J Resp Crit Care Med 2015; 191:19

48 References Aberle DR et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 2011; Bach PB et al. Benefits and Harms of CT Screening for Lung Cancer: a systematic review. JAMA, 2012;307: Berland LL, Silverman SG, Gore RM et al. Managing incidental findings on abdominal CT: White paper of the ACR incidental findings committee. J Am Coll Radiol Oct;7(10): Chilles C, Duan F, Gladish GW et al. Association of Coronary Artery Calcification and Mortality in the National Lung Screening Trial: A Comparison of Three Scoring Methods. Radiology 2015 Jul;276(1):82-90 Hiratzka LF, Bakris GL, Beckman JA et al ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM Guidelines for the diagnosis and management of patients with thoracic aortic disease. J Am Coll Cardiol. 2010;55 (14) Hoang JK, Langer JE, Middleton WD et al. Managing incidental thyroid nodules detected on imaging: White paper on the ACR incidental thyroid findings committee. J Am Coll Radiol. 2014;14:S Mazzone P et al. Components Necessary for High Quality Lung Cancer Screening. ACCP and ATS Policy Statement Chest 2015; Moyer VA. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine 2014;160: Tanoue LT et al. Lung Cancer Screening. Concise Clinical Review. Am J Resp Crit Care Med 2015; 191:196

49 Lung Cancer Risk Models Bach PB, Kattan MW, Thornquist MD, et al. Variations in Lung Cancer Risk Among Smokers. J Natl Cancer Inst 2003; 95: Spitz MR, Hong WK, Amos CL, et al. A Risk Model for Prediction of Lung Cancer. J Natl Cancer Inst 2007; 99: Cassidy AA, Myles JP, van Tongeren MM, et al. The LLP risk model: An Individual Risk Prediction Model for Lung Cancer. British J Cancer 2008; 98: Tammemägi MC, Katki HA, Hocking WG, Church TR, Caporaso N, Kvale PA, Chaturvedi AK, Silvestri GA, Riley TL, Commins J, and Berg CD, Selection Criteria for Lung Cancer Screening. N Engl J Med 2013; 368: Hoggart C, Brennan P, Tjonneland A, et al. A risk model for lung cancer incidence. Cancer Prev Res 2012; 5:

50 Yale Lung Screening and Nodule Program (Yale Lung SCAN) Enrolled in Epic Dashboard and Tracking system Pre-Authorized for Visit & LDCT Smoking Tobacco treatment Referral, if indicated Referral for Initial screen Order for LDCT: PCP Pulmonologist Other Provider No self referrals LUNG (203) 200-LUNG Eligibility Determined by ordering Provider Questionnaire in order set Ages At least 30 pack year smoking Current smoker or quit within 15 years Asymptomatic Ineligible - Ordering Provider referred to DI Chest Service (203) Decision Support Visit MD/APRN Eligibility confirmed Discussion of benefits/risks Individualized Risk Assessment Shared Decision Making Understanding Fears/ Motivators Evidence based Reassurance Same day Coordinated Visit & LDCT Low Dose Screening CT (LDCT) Standardized Reading Protocols LUNGRADS Incidental findings Dedicated Chest Radiologists LDCT results Ordering Provider Reviews LDCT results Communicates plan to patient Manages follow up Manages incidental findings Refers to Thoracic Oncology, Nodule Program as applicable Nodule Program Tumor Board Pulmonologists Thoracic Surgeons Thoracic Interventionists Chest Radiologists Nurse Coordinator Pathologists Medical Oncologists Radiation Oncologists Research Coordinators

51 CMS Codes Health Care Common Procedure Codes (HCPCS) G Counseling visit to discuss need for LDCT ICD diagnosis codes (ICD) Z ICD -10 personal history of tobacco use/personal history of nicotine dependence G0297 Low dose CT scan for lung cancer screen V15.82 ICD -9

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