Transcript Document

Lung Cancer Screening Implementation:
Promises, Challenges, Opportunities
Jamie L. Studts, PhD
Associate Professor of Behavioral Science
Assistant Director of Cancer Prevention and Control
Low-Dose CT for Lung Cancer Screening
Promises
Challenges
Estimated Cancer Deaths in the US in 2013
Lung Cancer Epidemiology
 Lung


USA
Kentucky:
 Lung



84.4 (men)
130.1 (men)
55.7 (women)
79.5 (women)
cancer mortality rate
USA:
Kentucky:
 Adult

cancer incidence rate
67.4 (men)
103.0 (men)
40.1 (women)
56.1 (women)
smoking rate (2011)
USA
Kentucky
21.2%
29.0%
American Cancer Society (2013). Cancer facts and figures – 2013.
Note: All rates are per 100,000. Rates are age-adjusted to the 2000 U.S. Standard Million Population.
Lung Cancer Mortality in Kentucky
Impacting our Catchment Area (CCSG)
 “To
decrease cancer incidence and mortality among
populations within its catchment area, including minority and
underserved populations, it also establishes partnerships
with other health delivery systems and state and community
agencies for dissemination of evidence-based findings.”
 “In
addition to scientific questions of broad applicability, it
should use its available expertise and resources to address
cancer research within the catchment area.”
http://grants.nih.gov/grants/guide/pa-files/PAR-13-386.html
Overview
 Lung
Cancer Screening: A Case Study in Clinical
and Translational Science



NLST Data
Guideline Development and Policy Considerations
What is Quality Lung Cancer Screening?
 Implementing




a Lung Cancer Screening Program
Distinguishing Lung Cancer Screening
The Role of Shared Decision Making
The Role of Tobacco Treatment
The Role of Patient Navigation/Coordination
Lung Cancer Screening:
An Ongoing Case Study in
Clinical and Translational Science
National Lung Screening Trial

Primary Results



20% relative reduction in lung
cancer mortality with LDCT
6.7% reduction in all-cause
mortality with LDCT
Additional Results

Positive/False Positive Screens


LDCT: 39% had 1+ pos. screen
CXR: 16% had 1+ pos. screen
NLST (2011) NEJM, 365, 395-409.
Population Impact of NLST (LDCT)
 Data
from NLST was applied to the population to
estimate the number of lung cancer deaths that
could be averted by LDCT screening
 8.6

million Americans eligible for LDCT per NLST
5.2m American men/3.4m American women
 Results



12,250 lung cancer deaths averted each year
8,990 American men/3,260 American women
7.6% of all American lung cancer deaths each year
(Ma et al., 2013, Cancer)
Generalizability/Eligibility Data
 Assessed
variation in efficacy,
false positive rates, and lungcancer deaths prevented
according to quintile of LC risk.
Deaths
Prevented Per
10,000 P/Y
20
 Results

Benefit increased with risk

FP rate decreased with risk

60% (Q1-3) accounted for 88% of

10
0
Q1 Q2 Q3 Q4 Q5
FP Rate Per
Prevented Death
prevented deaths and 64% of false
2000
positive results
1000
20% at lowest risk (Q1) accounted for
only 1% of prevented deaths
0
Q1 Q2 Q3 Q4 Q5
(Kovalchik et al., 2013, Targeting of low-dose CT screening according to the risk of lung-cancer death, NEJM)
Cost-Effectiveness of LDCT Screening in
the National Lung Screening Trial (NLST)

Examination of mean life-years, quality-adjusted life-years (QALYs),
costs per person and incremental cost-effectiveness ratios (ICERS)
for LDCT, CXR, and no screening.

Cost Per Person


$0
No screen

$469
CXR

$1,631
LDCT
ICERs for LDCT

$52,000 per life-year gained (95% CI: $34,000 to $106,000)

$81,000 per QALY gained (95% CI: $52,000 to $186,000)
(Black et al., 2014, NEJM, 371, 1793-1802)
USPSTF Final Guidelines for
Lung Cancer Screening
(Posted July 29, 2013)
(Affirmed December 31, 2013)
GRADE B: The USPSTF recommends the service. There is high
certainty that the net benefit is moderate or there is moderate
certainty that the net benefit is moderate to substantial.
(Humphrey et al., 2013, Annals of Internal Medicine, online)
(Moyer et al., 2013, Annals of Internal Medicine, online)
http://www.uspreventiveservicestaskforce.org/uspstf13/lungcan/lungcanfact.pdf
USPSTF Final Guideline for
Lung Cancer Screening
 High




Risk Status/Eligibility
age 55 through 80 years old, and
have a history of heavy smoking (30 p/y+), and
are either current smoker or quit within 15 years
other minor criteria and considerations
 Points



from Draft to Final Guideline
upper age criteria extended (up to 80)
specifically calls for integration of tobacco cessation
specifically calls for shared decision making
(Humphrey et al., 2013, Annals of Internal Medicine, Online)
(Moyer et al., 2013, Annals of Internal Medicine, Online)
http://www.uspreventiveservicestaskforce.org/uspstf13/lungcan/lungcanfact.pdf
American Academy of Family Physicians
 Evidence
Lacking to Support or Oppose Low-dose CT Screening
for Lung Cancer, AAFP Releases an “I” Recommendation

“The AAFP concludes that the evidence is insufficient to recommend for or
against screening for lung cancer with low-dose computed tomography
(LDCT) in persons at high risk for lung cancer based on age and smoking
history.”

"People need to understand that their life expectancy could be extended by
this, but on the other hand, their life expectancy could be shortened by it.”

"A shared-decision-making discussion between the clinician and patient
should occur regarding the benefits and potential harms of screening for
lung cancer.”
http://www.aafp.org/news/health-of-the-public/20140113aafplungcarec.html
http://www.aafp.org/patient-care/clinical-recommendations/all/lung-cancer.html
Centers for Medicare
and Medicaid Services
“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
5, 2015)are
program only if the following (February
conditions
met…”
http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274
Implementing a
Lung Cancer Screening Program
Lung Cancer Screening Implementation
The novelty and complexity of LCS decisions
make LCS choices a unique clinical venture.
Other
Detection
Cost
Early
Detection
OverDx
Reassurance
Mortality
Reduction
Radiation
Risks
False
Positive
Scans
Lung cancer screening needs to be implemented
differently than other cancer screenings.
Screening as
Guideline Compliance
vs. a Personal Choice
Screening as
an Event vs.
an Algorithm
At least 3 reasons why lung cancer
screening should (must) be different.
①
The risk benefit profile is enhanced on both sides, creating
greater decision making burden.
②
The eligibility criteria are targeted (not population-based),
and the target population might be considered vulnerable.
③
There are some factors that aren’t that different, but we
don’t do them well now—lung cancer screening is a chance
to re-design and re-implement cancer screening
 Screening
is a process/algorithm, not an event
 Screening is a patient choice, not a mandate
 Screening has harms that are meaningful to some (not all) individuals
Lung Cancer Screening Programs
National Framework for Excellence In Lung
Cancer Screening and Continuum of Care
Lung Cancer Alliance
Necessary Components of
High Quality Lung Cancer Screening:
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
(Mazzone et al., 2015, ACCP-ATS Statement, Chest, pre-print online)
Comprehensive LCS Program
 Shared
 Lung
Decision Making & Patient Education
Cancer Screening via LDCT
 Evidence-based
Tobacco Cessation
(Treating Tobacco Use and Dependence, 2008)
 Multidisciplinary
 Radon
 Patient
Team and Management Plan
Awareness/Other Risk-reduction efforts
Navigation/Coordinator and Support
Role of Navigator/Coordinator
in Lung Cancer Screening
Maintain
agnostic perspective on screening:
inform rather than persuade
Support
patient engagement and
informed/shared decision making
Integrate
Facilitate
evidence-based tobacco cessation
subsequent screening, diagnostic
workups, and lung cancer care when needed
Lung Cancer Screening & Tobacco Cessation

Integrating evidence-based tobacco cessation into lung cancer screening
programs could broaden utility by adding a primary prevention strategy
to an evidence-based secondary prevention strategy.

Current data is mixed with regard to the impact of screening on tobacco
use, some studies reporting higher rates of cessation and others
demonstrating no impact of screening on tobacco use.

Fairly consistent results indicate that abnormal/suspicious scans are
associated with tobacco cessation/lower rates of tobacco use.

Regrettably, there are no intervention studies examining the impact of
tobacco cessation in the lung cancer screening setting (although pilot
studies are underway). The NCI has recently announced an RFA to
address this important question.
Dissemination and implementation research is
needed to insure high quality lung cancer
screening program development.
Pt
Care
LCS Program
Implementation
Patient Education
Provider Training
Community Awareness
• Lung Cancer
• Education
• Awareness
• Detection
• Survivorship
www.kentuckyleads.org
Kentucky LEADS Collaborative
Prevention & Early Detection (PD)
• In the PD component, we hypothesize that the
program will demonstrate
– greater implementation of quality indicators for lung
cancer screening, including optimal referral patterns
for evidence-based lung cancer care, use of strong
patient navigation, integration of evidence-based
tobacco treatment, use of shared decision making,
and established protocols for follow-up services and
program retention.
Prevention & Early Detection (PD)
Lung Cancer Screening
Clinical Research Trajectory
Excellence Project
KY LEADS
UK
Conclusions
1.
Results of the NLST and subsequent policy developments
create a unique opportunity to reduce lung cancer mortality.
(Promise)
2.
However, implementation of lung cancer screening needs to
proceed differently than current cancer screening processes.
(Challenge)
3.
We have a brief window to create optimal, high quality lung
cancer screening programs that can fulfill the promise and
meet the challenge, and SDM is a reasonable path to achieve
these aims.
4.
There are tremendous implementation research opportunities
to address key questions about lung cancer screening.
National Comprehensive Cancer Network
 Eligibility



Age 55 – 74 and…
≥ 30 pack year smoking history
Current smoker or quit within past 15 years
 Eligibility



A (NLST Consistent)
B (Extension)
Age 50 – 74 and
≥ 20 pack year smoking history, and
One or more of the following risk factors…
 Exposure to radon, silica, metals, diesel fumes
 Personal history of cancer
 COPD or pulmonary fibrosis
 A family history of lung cancer
(NCCN Guidelines for Patients TM: Lung Cancer Screening Version 1.2012)
Centers for Medicare
and Medicaid Services
•
•
•
•
•
Age 55-77
Asymptomatic
Tobacco exposure of 30+ pack/years
Current or former smoker with 15 years
Written order for LDCT-based lung cancer screening
with…
• Determination of eligibility
• Documentation of an SDM consultation
• Documentation of adherence/screening counseling
• Tobacco cessation intervention
http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274
Treating Tobacco Use and Dependence:
Clinical Practice Guideline (USPHS, 2008)
• Assists in identifying and assessing
tobacco users and in delivering
effective tobacco dependence
interventions
• Provides strategies and
recommendations for clinicians
• Offers a detailed description of the
5 A’s of treating tobacco
dependence
• Identifies 10 key findings that
clinicians should use with patients
Kentucky LEADS Collaborative
Dedicated to reducing the burden of
lung cancer in Kentucky and beyond
through development, evaluation, and
dissemination of novel, communitybased interventions to promote
provider education, survivorship care,
and prevention and early detection
regarding lung cancer.