LDCT Screening. Steven Kirtland, MD. Virginia Mason Medical Center February 27, 2015

Transcription

1 LDCT Screening Steven Kirtland, MD Virginia Mason Medical Center February 27, 2015

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3 Disclosures

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6 Cancer Screening

7 Mrs H 64yo 50 pk year smoker

8 Lung Cancer Epidemiology

9 Leading Cause of Cancer Death 9

10 Lung Cancer 10

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13 Lung Cancer 3 rd most common cancer (14%) Leading cause of cancer death (28%) 85% of US lung cancer related to smoking 37% of US adults are current or former smokers (7 million eligible) Risk increases with age and amount smoked >90% of lung cancer patients die of disease

14 Lung Cancer: Effect of Stage

15 Lung cancer Avg 5 year survival 15-17% (colon 65%, breast 89%, prostate 99%) 52% if diagnosed at early stage ~88% if Stage 1a 15% diagnosed at such stage

16 Lung Cancer Screening Attributes High mortality Significant prevalence Targeted Lengthy preclinical phase Therapy is more effective in early stage disease 16

17 Screening Everyone likes it 48% pf PCP recommend mammograms diagnosed with terminal lung cancer 17

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20 EARLY SCREENING: CXR/Sputum Cytology

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22 Entry Criteria Current or former smokers Occupational Exposure Second-hand smoke (12%) Protocol Baseline screening Workup of nodules >5-8mm Annual Screening Workup of any new nodule >3-5mm

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25 NLST PROTOCOL INCLUSION CRITERIA Age pack-year smoking history Active smokers, or quit <15 years prior 54,454 Yearly LDCT x 3 26,722 Yearly CXR x 3 26,732

26 Cancers Diagnosed LDCT CXR 645/100, /100,000 Lung CA Deaths 247/100, /100,000 Reduction in lung CA mortality: 20% (p=0.004) Reduction in overall mortality: 6.7% (p=0.02)

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29 Limitations Young, fairly well educated, less likely to be current smokers than general US population Large academic centers Effect of gender, race, ethnicity No assessment of radiation risk or psychological stress 29

30 Ongoing LDCT Trials NELSON DANTE Danish Lung Cancer Screening Trial MILD ITALUNG German (LUSI) UKLS 30

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32 CMS Decision (MEDCAC) 3/14 Multiple organizations advocate 4/14

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34 It would be illogical and certainly inappropriate public health policy to deny previously eligible individuals coverage when they reach the age of 65, especially since that age approaches the peak age of 70 for lung cancer incidence and deaths 34

35 Consumer Reports Lung cancer tests: Only for long-term smokers. In 2013, the task force recommended annual low-dose CT scans for certain long-term heavy smokers after a study found that such scans cut the risk of death from the disease by 16 percent in that group. Under the Affordable Care Act, most private insurers must cover tests recommended by the task force. So the news that a Medicare panel advised against it came as a surprise, especially because it meant that people might lose coverage at age 65 when lung cancer risk increases. That prompted more than 40 groups to say that Medicare should reject the advisory panel s advice. CR s take: Consumer Reports experts agree that Medicare should cover the test. But they stress that it should be used only for those ages 55 to 80 who smoked a pack per day for 30 years or two packs per day for 15 years, and either currently smoke or stopped within the past 15 years.

36 CMS (Summary) Given the burden of lung cancer on the United States population, a suitable screening test for lung cancer has been sought for many years. Lung cancer screening has been recommended by the USPSTF with a grade B recommendation for certain individuals. Based on our review of the available evidence, including clinical guidelines and public comments, we find that the evidence is sufficient to conclude that lung cancer screening with LDCT is reasonable and necessary for prevention or early detection of illness or disability and appropriate for Medicare beneficiaries under conditions established in this NCD. These conditions are supported by the evidence reviewed, including conditions in the NLST and evidence-based multi-society, multi-disciplinary recommendations. The results of ongoing trials will provide additional evidence. We believe that specific beneficiary, practitioner, and imaging facility eligibility requirements are necessary to ensure that benefits of screening outweigh harms in the Medicare population, consistent with the NLST. Lung cancer screening with LDCT has not been implemented broadly in any population to date. While we are establishing coverage for this additional preventive service under Medicare part B, we believe we need to proceed in a responsible manner and will continue to monitor the evidence as stewards of the Medicare program

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38 Shared Decision Visit 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 only if all of the following criteria are met: Beneficiary eligibility criteria: Age years Asymptomatic (no signs or symptoms of lung cancer) Tobacco smoking history of at least 30 pack-years (one packyear = smoking one pack per day for one year; 1 pack = 20 cigarettes) Current smoker or one who has quit smoking within the last 15 years; and..

39 For the initial LDCT lung cancer screening service: a beneficiary 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). 39

40 Decision Making Informed Decision Making occurs when an individual understands what the clinical service involves, including potential benefits, harms, limitations, alternatives, & uncertainties has considered personal preferences, as appropriate; has participated in decision making at the desired level makes a decision consistent with those preferences Shared Decision Making connotes a process in which providers and patients collaborate as partners in the decisionmaking process. (Rimer B, Briss P, et al, 2004)

41 American Cancer Society Informed and Shared Decision Making: A process of informed and shared decision-making with a clinician related to the potential benefits, limitations, and harms associated with screening for lung cancer with low-dose computed tomography should occur before any decision is made to initiate lung cancer screening. (Wender et al., American Cancer Society Lung Cancer Screening Guidelines. CA: Cancer Journal for Clinicians).

42 Shared Decision Making: The decision to begin screening should be the result of a thorough discussion of the possible benefits, limitations, and known and uncertain harms.

43 Measures of IDM and SDM (1)Understand the risk or seriousness of the disease or condition. (2) Understand the preventive service, including the risks, benefits, alternatives, and uncertainties. (3) Have weighed his or her values regarding the potential harms and benefits associated with the service. (4) Have engaged in decision-making at a level he or she desires and feels comfortable. McKee et al J Thorac Imaging Volume 30, Number 2, March 2015,120 43

44 Barriers to SDM (1) Physicians time constraint, shortening patient visits for economic reasons. (2) Physicians not conversant in all relevant data. (3) Varying guidelines among specialty physician groups, individual physicians, and patients. (4) Information from physicians being incomplete, not personally relevant, or understandable. (5) Information being delivered during time of extreme stress. 44

45 Provider Visit A lung cancer screening counseling and shared decision making visit includes the following elements (and is appropriately documented in the beneficiary s medical records): 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, generally healthy 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 Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment 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 If appropriate, the furnishing of a written order for lung cancer screening with LDCT 45

46 What is CT? 46

47 Benefits of Screening Lower risk of Lung cancer death Lower risk of all cause death Fewer Stage 4 cancers More Stage 1 and 2 cancers Improved Smoking Cessation 47

48 NNS to prevent cancer death LDCT: 320 Mammography: 1339 Sigmoidoscopy: 817

49 Calculation Nomograms.mskcc.org/Lung/Screening.aspx 49

50 Risk Calculation 50

51 USPSTF Smoking cessation is the most important intervention to prevent NSCLC. Advising smokers to stop smoking and preventing nonsmokers from being exposed to tobacco smoke are the most effective ways to decrease the morbidity and mortality associated with lung cancer. Current smokers should be informed of their continuing risk for lung cancer and offered cessation treatments. Screening with LDCT should be viewed as an adjunct to tobacco cessation interventions. 51

52 Smoking Cessation Mayo Clinic study: 24% vs 7% 98% of nonsmokersremained abstinent at 3 years NELSON trial: 16.6% vs 3-7% DLCST: 11.9 vs 4% Majority negative scans 52

53 Effect of positive scan NLST (15,489) OR for continued smoking.91 (minor ns),.81 (major ns).78 (suspicious but stable).66 (new suspicious) 53

54 Overall 87% of those surveyed said CT screening was major influence Multiple opportunities to engage 54

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56 Harms of Screening Numerous false positives Incidental findings Overdiagnosis Radiation exposure Psychologic distress

57 False Positives 24 % positive, 96% of these F+ 2.5% required additional invasive procedures, ~1.9% of all pts had bx Of >17,000 positive test results, 61 complications, 6 deaths 4.5 complications per 10,000 screened Death < 60 days 0.06% Complication 0.36%

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59 Incidental Findings Emphysema, coronary calcification Bronchiectasis, fibrosis, carcinoids hamartomas 7.5% had clinically significant LDCT non-cancer abnormalities

60 Overdiagnosis Overdiagnosis not reported (estimated at 10%) Some studies have estimated 25% slow growing cancers Will need long term follow up

61 Radiation msv per scan Annual background in US 2.4mSv Mammography 0.7mSv, Head CT 1.7, Abd/Pelvic CT 10 msv Risk depends upon age of screening and cumulative amount 61

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63 Relative Risks Cause of death All types of Cancer 250 MVA 12 Annual dose limit for a radiation worker (50mSv limit per year) Lifetime Odds of Dying per 1000 individuals 2.5 Pedestrian accident 1.6 Radiation-induced fatal cancer from routine abd-pelv CT (10mSv) 0.5

64 Relative Risk of Death Compared to common daily activities radiation doses from 0.1 to 1.0 msv carry an additional risk of death from cancer comparable to the risk of death associated with a flight of 4500 miles doses in the range of 1 to 10 msv are comparable to driving 2000 miles

65 Patient Centered Outcomes Acute anxiety while waiting: 46% Review of 5 LDCT trials: False + s associated with short term increases in distress that return to levels similar to people with negative results Negative results are associated with short term reductions in distress 65

66 Anxiety and Screening "Given that false positive results can never be entirely eliminated from LDCT screening and the suggestion that there is some short-term distress associated with a positive result, careful consideration of eligibility criteria, optimization of diagnostic algorithms, and thorough discussions of risks, benefits, values, preferences, results, implications of results, and follow-up plans with patients may improve patientcentered outcomes." Christopher Slatore., MD

67 Decision Aids Patient hotlines Web-based tools Written materials (FAQs) Community/physician outreach 67

68 NCI 68

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70 Bottom Line Counseling Smoking cessation is a more proven and powerful intervention Screening requires ongoing commitment Most likely positive result is a benign nodule that will require further evaluation, even surgery Generally Healthy Lower Risk groups need counseling 70

71 Written Orders Beneficiary date of birth; Actual pack - year smoking history (number) Current smoking status, and for former smokers, the number of years since quitting smoking Statement that the beneficiary is asymptomatic (no signs or symptoms of lung cancer) National Provider Identifier (NPI) of the ordering practitioner 71

72 LUNG CA SCREENING PROGRAM Well-defined population to be screened Informed consent/sdm Decentralized PCP driven Standardized radiological interpretation Systematic workup/follow-up of positives Multi-disciplinary review panel Ongoing registry of patients/outcomes Mechanism for incorporating new data Smoking cessation program

73 1. Increase women s awareness of lung cancer as their #1 cancer killer 2. Enroll more than 1 million people in the fight against lung cancer 3. Save lives through risk reduction, early detection and new treatment options 73

74 UPCOMING LUNG FORCE Expo March 27 LUNG FORCE WALK May 9 TURQUOISE TAKEOVER For patients and providers Provider Track focused on recommendations and treatments CEUs for nurses and RTs Renton Technical College LUNGFORCE.org/Expo LUNGFORCE.org/Walk Spread the word to patients and colleagues! 74