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What Physicians Need To Know About Lung Cancer Screening
Glenn M. VanOtteren, MD
June 2, 2017
Objectives – Lung Cancer Screening
• Better understand the epidemiology of lung cancer
• Learn the potential benefits and harms
• Review current guidelines and recommendations on CT
screening
• Discuss importance of combining screening with tobacco
cessation counseling
• Introduce Spectrum Health’s Lung Cancer Screening
Program
2
Case CH
• 76 y/o male smoker
• Smoked 1 ppd from age 17 (59 pack years)
• Otherwise asymptomatic
• PMHx significant for hypertension, sleep apnea and GERD
• Presented to Lung Screening clinic for counseling visit on
November 15, 2015
3
Case CH – Low dose CT screening exam20mm irregular non-calcified RUL nodule.
4
Case CH – PET/CT exam
20 mm markedly FDG avid nodule RUL, with no adenopathy or other
areas of FDG avidity.
5
Case CH
• Histology confirmed a 20 mm squamous cell lung cancer
• Nodal stations 4R, 7 & 10R all negative for tumor
• T1a N0 Mx (Stage IA)
• Surveillance CT scans all negative for recurrence (18
months)
6
Epidemiology of Lung Cancer
• Lung cancer is the leading cause of cancer death among
men and women in the US.
• Approximately 160,000 people die from the disease each
year.
• Last year, 323 Spectrum patients were diagnosed with lung
cancer.
• Early detection of lung cancer is key to significantly
decreasing lung cancer deaths.
7
8
Lung Cancer: Key Facts (American Cancer Society)
• 2nd most common cancer in men and women.(excluding skin cancer)
• Accounts for more deaths annually than any other form of
cancer, in both men and women.
• There are approximately 225,000 new cases of lung cancer
diagnosed every year.
• 1 out of 3 people diagnosed with lung cancer are less than 65
years of age.
• Each year, more people die of lung cancer than of colon,
breast, and prostate cancers combined.
Lung Cancer as compared to other cancers
9
10
11
Lung Cancer Death Rates - Male
12
Lung Cancer Death Rates – Female
13
14
15
Smoking Kills…
16
17
• Cigarette smoking is a major
cause of lung cancer
• 85% of lung cancers occur in
smokers or former smokers
• 1 in 9 smokers eventually develop
lung cancer
• 15% occur in never smokers• Radon
• Asbestos
• Passive tobacco smoke
exposure
• Hereditary
Approximate Cancer Stage at Diagnosis
0%
20%
40%
60%
80%
100%
Breast Prostate Colorectal Lung
% o
f A
ll S
tage
s
I II III-IV
American Cancer Society. Cancer Facts & Figures–1999.
Lung Cancer is unlike other cancers
Incidence
176,300
94,700
171,600179,300
Mortality
37,000
158,900
47,90043,700
0
50,000
100,000
150,000
200,000
Breast Colon LungProstate
5-year Survival by Stage
20
Survival vs Stage
Mountain CF. Chest 1986;89(suppl):225-233.
Rationale for Screening
• Lung cancer is common
• Most lung cancer is diagnosed at an advanced stage
• Early intervention clearly saves lives
• With lung cancer, one can more easily identify a high risk
cohort that would be appropriate for screening (i.e. those
who smoke or who have smoked)
• Given these factors, screening for lung cancer makes perfect
sense
22
Definition: Screening
Screening can be defined as the systematic testing
of individuals who are asymptomatic with respect to
some target disease.
The purpose of screening is to prevent, interrupt, or
delay the development of advanced disease in the subset
with a pre-clinical form of the target disease through early
detection and treatment.
Hillman et al. JACR 2004;1(11):861-864
Death fromDisease orOther causes
Signs orSymptoms
Detectableby Test
Onset ofDisease
Detectable Pre-clinical Period
Screening Effective
Critical Point
Death fromDisease orOther causes
Signs orSymptoms
Detectableby Test
Onset ofDisease
DPCP
Screening Ineffective
Critical Point
Death fromDisease orOther causes
Signs orSymptoms
Detectableby Test
Onset ofDisease
DPCP
Screening Unnecessary
Critical Point
Overdiagnosis is the “diagnosis” of disease that will
Never cause symptoms or death in a patient’s ordinarily
expected lifetime. Overdiagnosis is a side effect of
screening for early forms of disease.
Over Diagnosis Bias
Over Diagnosis Bias
28
Growth Rate of Lung Cancer
• Median doubling time = 181 days
• 22% doubling time >= 465 days
• 94% of lung cancers have a 1 year
growth measuring 0.5-3.0 cm
Winer-Muram. Radiology 2002;223(3):798-
805.
Potential Benefits from Screening
• Decrease morbidity and mortality from lung cancer
• Decrease morbidity and mortality from treatment
• Decrease anxiety about the disease (True negatives)
• Improvement in healthy lifestyles
• Discovery of other significant occult health risks
• Decrease total costs of therapy
Potential Harms from Screening
• Direct harmful consequences of testing (Radiation)
• Increasing anxiety about disease (False positives)
• Adding morbidity and mortality triggered by screening
with subsequent diagnostic workup
• Costs/Overdiagnosis
• False reassurance (False negatives)
• Identifying unimportant incidental findings
15%
22%
56%
7%
Lung Cancer Stage at Diagnosis
I (Localized)
II and III (Regional)
IV (Distant)
Unknown
http://seer.cancer.gov/statfacts/html/lungb.html
Chest radiography
• Two dimensional image
• Good resolution but poor contrast
• Fast
• Inexpensive
• Low dose of radiation
• Extensively studied and never shown to provide survival
benefit as a screening tool
33
Knox PA
• Hamartoma
Using the CT scan to detect lung cancer
35
Computerized Tomography – Low Dose
• 3D Imaging
• Good resolution and contrast
• High sensitivity
• Fast (single breath hold)
• More expensive than radiograph
• Low dose of radiation – 1.5 mSv (20% of conventional
CT), but more than chest radiography (about 15X)
• Early retrospective studies showed no reduction in
mortality, but did demonstrate increase nodule recognition36
SPN 4-10mm
• Scoble
Original Article
Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening
The National Lung Screening Trial Research Team
N Engl J MedVolume 1056 10):1-15
June 29, 2011
• Largest randomized controlled trial to date
• High risk patients: Age 55-74, >30 pack years tobacco.
• 53,464 current or former smokers.
• Underwent LDCT or chest x-ray annually for three years.
• Primary endpoint was measure of lung cancer mortality.
Original Article
Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening
The National Lung Screening Trial Research Team
N Engl J MedVolume 1056 10):1-15
June 29, 2011
• Positive initial screening test in 24% by CT (39% total for
three years) and 7% by Chest x-ray
• 90% of positive tests required further testing.
• 96% of positive tests were false positive tests (95% for
Chest x-ray).
• 4% of positive tests proved to represent lung cancer.
Lung Cancer Dx: CT (n = 1060)
649 from positive screens (61.8%)
44 after negative screens
367 in those who missed screens
or after trial completed
Lung Cancer Dx: CXR (n = 941)
279 from positive screens (29.6%)
137 after negative screens
535 in those who missed screens
or after trial completed
20% reduction in lung-
cancer specific mortality
with LDCT
6.7% reduction in overall
mortality with LDCT
N Engl J Med 2011;365:395-409
N Engl J Med 2011;365:395-409
50%
49%
NLST: Stage Groupings
Original Article
Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening
The National Lung Screening Trial Research Team
N Engl J MedVolume 1056 10):1-15
June 29, 2011
• Relative reduction of lung cancer death by 20%
• Relative reduction of overall mortality by 6.7%.
• 50% of cancers identified by LDCT were stage I.
• Number needed to screen to prevent one death was 320.
• Average LDCT costs about $400.
• 24.2% of CT screens were deemed positive in
the first screening exam.
96.4%
3.6%FalsePositive
TruePositive
NLST- False Positives
NLST- Positive Studies
• 92% of positive CT screens necessitated a
diagnostic evaluation
- 16 deaths among 1,705 patients within 60 days
- 6 of 16 had benign pathology
8.4%
Overdiagnosis:
Lung Cancer (LDCT) 18%
Breast Cancer (Mammography) 30-54%
Prostate Cancer (PSA) 29-44%
Etzioni et al. JNCI 2002; 94: 981-990
Maximizing Benefits of Screening
• Limiting screening to people who are at high risk
• Accurately interpreting findings from LDCT
• Resolving most false-positive results without invasive
procedures.
• In the US, there are 94 million current or former smokers.
• Approximately 7 million fit the high risk demographic
appropriate for screening.
• Potential to save 20,000 lives from CT screening.
47
Current Guidelines
CMS
Primary
Criteria
• 55 – 79 years
• > 30 pack-yrs
• 55 – 74 years
• > 30 pack-yrs
• Current
smoker or quit
< 15 yrs
• Asymptomatic
• 55 – 80 years
• > 30 pack-yrs
• Current
smoker or quit
< 15 yrs
• Asymptomatic
• 55 – 77 years
• > 30 pack-yrs
• Current
smoker or quit
< 15 yrs
• Asymptomatic
Secondary
Criteria
• Lung cancer
survivor
• > 50 years
• > 20 pack-yrs
AND
Added >5% risk of
lung CA within 5 years
• > 50 years
• > 20 pack-yrs
• At least one
other risk
factor (not
second-hand
smoke)
None None
Grade B
Recommendation
Exclusion Criteria
• Asymptomatic (No change in respiratory symptoms)
• Must be a surgical candidate (acceptable PFT’s, limited
comorbidities, etc)
• Must be willing to consider a surgical option for treatment (or
possibly SBRT)
• No history of lung cancer
• No other active cancer diagnoses within 3 years (excluding
non-melanoma skin cancer or minimally aggressive bladder
cancer)
• No unexplained weight loss >15#
• No Chest CT in last 12 months49
Lung-RADS Nodule
Scoring System
50
NCCN Guidelines for Initial Screening – Solid Nodules
51
TOBACCO CESSATION IS THE MOST
EFFECTIVE MEANS TO THE END SOUGHT
THROUGH LUNG CANCER SCREENING
• Effective tobacco cessation cuts risk for lung cancer mortality
up to 90%.
• Tobacco health costs:
• $ 289 billion/year
• $ 10.28 per pack of cigarettes
• The tobacco industry spent $ 8.4 billion on advertising in 2011.
• Modeling used to estimate QALYs saved by lung cancer
screening and treatment
• Included cost of “intensive” cessation programs
• Generic NRT vs. buproprion vs. varenicline
• Hypothetical cohort 50-64 yo with > 30 p-y smoking
• 2/3 current smokers
• 1/3 former smokers
Rationale for Including Tobacco Cessation Counseling with LCS
• We have the patient’s attention
• Decreases risk of lung cancer and other
smoking-related conditions
• Increases cost effectiveness of lung cancer
screening
• It is the right thing to do
• Required by CMS for reimbursement
• Initial LDCT must be ordered during a lung cancer screening counseling and shared decision making visit
• Documentation
1. Eligibility Criteria are all met and documented
2. One or more decision aids to discuss benefits, harms, follow-up diagnostic testing, over-diagnosis, false positive rate, total radiation exposure
3. Counseling on importance of adherence to annual LDCT screening, impact of comorbidities, willingness to undergo diagnosis and/or treatment
4. Counseling on smoking cessation (or continued abstinence), including offering additional tobacco cessation counseling services if appropriate
CMS: Additional Requirements
CMS: Additional Requirements
• Must be performed at specialized centers
• Radiology imaging center with appropriate expertise,
equipment
• Must collect and submit data to a CMS-approved national
registry
59
Provider and
Patient Education
60
Lung Mass and Cancer Multispecialty Team
• Weekly multispecialty team
meetings
• Rapid Diagnosis, “saved spots”
• Expedited Treatment
• Dedicated nurse navigators
• Supportive & Palliative Care
• Follow National (NCCN)
Guidelines
• Lung Cancer Alliance Program
of Excellence
[Slide Master name: Text with Photo or Graphic]
Electromagnetic Navigational Bronchoscopy
63
64
Advanced stage lung cancer
65
66
67
Total Screening CT Scans
77
324
202
0
50
100
150
200
250
300
3502015
2016
Jan 2017 -April 2017
68
Screening referrals – ’16 to present
69
70
Followed by LHCP vs PCP in 2015 & 2016
87
314
PCP
LHCP
71
March 2015 – April 2017 RADS Scores
252272
4921
5 40
50
100
150
200
250
300
1
2
3
4A
4B
4X
72
Procedures March 2015 through April 2017
23
5
5
6PET
Bronchoscopy
Biopsy
Surgery
Identified Cancers – Program through May ‘17
• Lung Cancers - 9 Stage 1A – 5
Stage 1B – 0
Stage 2A – 2
Stage 2B – 0
Stage 3A – 0
Stage 3B – 1
Stage 4 – 0
Staging pending = 1
73
Identified Incidental Cancers
74
• Incidental Cancers - 3
Kidney – 1
Liver – 1
Thymus – 1
Other incidental findings
Aortic aneurysm
Coronary artery calcification
Other
75
Lung Cancer Screening - Summary
• One low-dose CT scan each year for a minimum of 3
years for individuals between 55 and 80 (77) years old
who are at high risk for lung cancer.
• This includes:
• Active smokers who have 30 or more packs-years of
cigarette history (packs-years = packs per day x years
smoked)
• Former smokers who quit within the last 15 years
• Considered a candidate for surgery
• For more information call 616.486.LUNG
Summary
• Screening for Lung Cancer with LDCT saves lives; reduces
lung cancer deaths by 20%.
• CT screening has a high false-positive rate, which needs to
be managed carefully.
• The NSLT showed that 320 people at risk for lung cancer
needed to be screened to prevent 1 death from lung cancer.
• False-positive results may cause unnecessary testing and
follow-up. Most false-positive tests are resolved by
performing a regular CT scan, but others may lead to
invasive testing.
76
Summary
• Potential harms of CT screening include radiation exposure
and the need for additional tests, some of which may require
invasive procedures and can create anxiety.
• The best results are obtained when the screening program is
tightly linked and coordinated with a multidisciplinary team
dedicated to the comprehensive diagnostic and treatment
approach for the care of lung cancer patients.
• Tobacco cessation is key to improving the mortality rates for
lung cancer.
• Screening with LDCT is not a test, but a PROCESS.
77
Thank You For
Listening!
Any Questions?...
78
End of slideshow
79
80
EBUS Bronchoscopy
81
Endobronchial Ultrasound - Guided Bronchoscopy (EBUS)
Solitary nodule detected by CT
83
Ideal Patient Population for Screening
• High risk for preclinical disease
• No clinical signs or symptoms of disease
• Willing and able to undergo screening or not
• Willing and able to undergo workup and treatment
• Willing and able to undergo follow-up
True positive, effective
True positive, ineffective
True negative
False positive
False negative
Overdiagnosis
Major benefit. Death postponed,
Morbidity decreased
Knowledge vs longer dx & rx
Reassurance
Probable Harm. Work up
Possible delayed diagnosis
Probable Harm. Unnecessary
treatment
Cancer Screening Outcomes and Values
• Falsely increases sensitivity of test
• Falsely increases PPV of test
• Falsely increases incidence of disease
• Falsely improves stage distribution
• Falsely improves case survival
• Does not decrease population mortality
Effects of Overdiagnosis
87
Lead Time Bias - Definition
Lead time is the length of time between the detection of
a disease (usually based on new, experimental criteria)
and its usual clinical presentation and diagnosis (based
on traditional criteria).
Death fromDisease
WITH TEST
Signs or symptoms
Positive test
LEADTIME
SURVIVAL
WITHOUT TEST
SURVIVAL
Lead Time Bias
Length Time Bias - Definition
Length time bias is a form of selection bias, a statistical
distortion of results that can lead to incorrect conclusions
about the data.
Length time bias can occur when the lengths of
intervals are analyzed by selecting intervals that occupy
randomly chosen points in time.
TIME
Slowly
progressive
Rapidly
progressive
Length Bias
TEST
TIME
Slowly
progressive
Rapidly
progressive
Length Bias
TEST
TIME
Slowly
progressive
Rapidly
progressive
Length Bias
TEST
94
• Retrospective analysis of I-ELCAP data
• N = 21,136
• Measured frequency of positive results and delays in
diagnosis using more restrictive size thresholds
• 10.2% positives using 6 mm threshold
Ann Intern Med 2013; 158:248-252.
Frequency of a positive result and cases of lung
cancer diagnosed within 12 months of enrollment
Ann Intern Med 2013; 158:248-252.
Signs orSymptoms
Detectableby Test
Onset ofDisease
Death fromDisease orOther causes
Pre-Clinical Clinical
DPCP
Timeline of Disease
Critical Point - Definition
The time point in the natural history of a disease
before which a particular therapy(s) is proven to
be more effective.
•Lead time bias
•Length bias
•Overdiagnosis bias
Biases of Early Detection
Screening the Population
100
• Developed by leadership of ACCP/ATS
• Endorsed by AATS, American Cancer Society, ASCO
• Describes 9 essential components / 21 policy statements
• Who is offered screening, and for how long
• Technical aspects of LDCT scans
• Interpretation of scans / definition of “positive”
• Standardized reporting
• Management algorithms
• Patient and provider education
• Data collection
• Smoking cessation
Overdiagnosis Bias
102
• Estimated mean life-years, QALYs, costs per person
• Used 3 alternative strategies
• Screening with LDCT
• Screening with radiography
• No screening
• Conclusions
• LDCT cost $81,000 / QALY gained
• Caveat: “Modest changes” in assumptions would greatly alter results
104
Number of Lung Cancer Deaths
105
