andrea mckee, m.d. chairman department radiation oncology sophia gordon cancer center lahey clinic...

www.Lahey.org/LungScreening1-855-CT-CHEST

Andrea McKee, M.D.Chairman Department Radiation Oncology

Sophia Gordon Cancer CenterLahey Clinic

May 15, 2012


Disclosures

• None


Outline• Lung Cancer Background

• Incidence/Mortality• National Lung Screening Trial (NLST)• National Comprehensive Cancer Network (NCCN)

• Lung Cancer Screening at Lahey Clinic• Program Structure• Structured Reporting

– LUNG-RADS Classification System• Challenges

• Rescue Lung, Rescue Life


Lung CancerIncidence/Mortality: US

• Number one cause of cancer-related death in the US and World

• Kills more women than Breast, Ovarian, and Uterus Cancer Combined

200K new cases/yr 160K deaths/yr


Risk Factors?


Tobacco Trends

• History of tobacco use– <20% in 2006– 42% in 1965– Demonization campaign

• Higher prevalence– Military (1 in 3) vs (1 in 5)

– Less educated• Higher risk

– Rescue workers– Occupational exposure


Tobacco Trends

Competition has been tough - tobacco industry, Hollywood, press

Guard against withholding of health care services or advocacy based on social history – slippery slope



Primary Prevention (Smoking Cessation) Success Decreased number of overall lung cancer deaths in US Despite success 160K still die every year from lung cancer Most people who die from lung cancer now are FORMER SMOKERS




35% of Lung Cancer Diagnosis Current Smokers 50% of Lung Cancer Diagnosis Former Smokers 15% of Lung Cancer Diagnosis Never Smokers

Lung Cancer 5-Year Overall Survival Remains Unchanged 1975 12%, Current 15%




Lung Cancer 5-Year Overall Survival 1975 12%, Current 15%

Stagnant survival result of absent Secondary Prevention FORMER SMOKERS cannot benefit from PRIMARY PREVENTION Secondary Prevention = LUNG SCREENING LUNG SCREENING Find disease at early more treatable stage LUNG SCREENING GOAL Decrease Mortality not Incidence


Lung Cancer ScreeningData to support screening been around awhile

• NEJM October 2006– 31,567 patients baseline screened with low dose

CT from 1993-2005– 484 lung cancers detected (85% clinical stage I)– 10 year survival 92% for those having surgery– 8 patients refusing therapy died within 5 years of

diagnosis


Lung Cancer TreatmentNSCLC: Unscreened Population

NSCLC• Stage I, II, IIIA

– Potential Cure• Surgical resection• Radiotherapy• Chemotherapy

• Stage IIIB/IV – Palliative

Goldstraw P, Crowley J, Chansky K, et al. (2007) The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol 2:706–714.


National Lung Screening TrialResults: Stage Shift


Stage IV NSCLC

<1% = 5 year OS


Incidental Finding on CXR

58% 5-year Overall Survival

Stage T1BN0

Goldstraw P, Crowley J, Chansky K, et al. (2007) The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol 2:706–714.


Annals of Internal MedicineOctober 2011

• 62 year-old female with a history of well-controlled hypertension presents for routine follow-up. She is asymptomatic and feels well. She has jogged 3 miles 3 times weekly for years with no recent change in exercise tolerance. She has a 30 pack-year history of tobacco use but quit 10 years ago. Normal physical exam. She read a recent study that found a benefit to screening with LDCT and inquires if this is appropriate for her?

• What should you recommend?


Secondary PreventionPreclinical Diagnosis: Screening Awareness

What is this patient’s 5-year overall survival?

5mm nodule

6 month fu diagnostic CT recommended

7mm NSCLC treated with lobectomy and nodal evaluation

T1aN0 (screened)



92% = 5 year OS



Asymptomatic

Screening

Stage I92% 10-year OS

85% of patients in screened population have stage I lung cancer

58% 5-year OS

Stage IV1% 5-year OS

Symptomatic


US Cancer Mortality RatesSecondary Prevention

U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2007 Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2010. Available at: www.cdc.gov/uscs.


US Cancer Mortality RatesSecondary Prevention

PSA

Mammography

Colonoscopy

U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2007 Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2010. Available at: www.cdc.gov/uscs.


National Lung Screening Trial(NLST): 6/29/2011

National Lung Screening Trial Research Team (2011) Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365(5):395–409.


National Lung Screening TrialDesign Overview

• Multicenter Randomized Controlled Trial– Sponsor: NCI Division of Cancer Treatment and Diagnosis– 33 US Screening Centers

• NCI Division of Cancer Prevention (LSS)• American College of Radiology Imaging Network (ACRIN)

• $300,000,000 +



• 53,456 participants

• Enrolled 2002 – 2004

• Ages 55-74

• Greater than 30 pack-year smoking history

• Active or quit < 15 years

Exclusions Metallic implants chest or back Treatment or evidence of cancer in previous 5

years History of lung cancer Prior lung resection except needle biopsy Home O2 requirement Symptoms: Hemoptysis, weight loss, treated

respiratory infection within past 12 weeks Chest CT within previous 18 months Participation in other cancer screening/prevention

trial Unable to lie on back with arms above head

National Lung Screening Trial Research Team (2011) Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365(5):395–409.



• Treatment Arms: – Low Dose Chest CT (1.5 mSv)– PA Chest Radiograph (0.02 mSv)

• Screening Intervals: – T0: Baseline prevalence screen – T1: Year 1 incidence screen– T2: Year 2 incidence screen

• Positive Test– Non-calcified nodule greater than 4mm in mean diameter– Other findings suspicious for lung cancer (adenopathy, effusion…)– Workup of positives determined by PCPs not NLST

• NLST reading radiologist recommendation available


National Lung Screening TrialResults: Mortality

• Lung cancer specific mortality– 20% reduction in lung cancer specific mortality– LDCT = 356 deaths, CXR = 443 deaths– Median follow-up 6.5 years

• Overall mortality– 6.6% reduction in overall mortality– LDCT = 1877 deaths, CXR = 2000 deaths– Not statistically significant when lung cancer deaths

excludedNational Lung Screening Trial Research Team (2011) Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365(5):395–409.


National Lung Screening TrialResults: Other

• Lung cancer prevalence: 1%– 1 in 100 at risk patients have cancer

• Lung cancer annual incidence: 0.5 – 0.8%– Decrease in # of late stage cancers in CT group vs CXR– Real stage shift not just overdiagnosis

• Small cell lung cancer– Not detected at earlier stage– Overrepresented as interval cancers

• Number Needed to Screen (NNS) is 320National Lung Screening Trial Research Team (2011) Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365(5):395–409.


National Lung Screening TrialResults: Rate of Positive ScreeningsAq

• CT (24.2%) > 3x more sensitive than CXR (6.9%) – T0 & T1 Rate: 27-28%– T2 Rate: 16.8%

• 2 year stability benign (Fleischner Guidelines)• Expected rate for ongoing LDCT screening

• At least one positive result (3 screens): 39.1%• Significant incidental finding:

7.5%

• Not screening everyone – highly selected group (3%)National Lung Screening Trial Research Team (2011) Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365(5):395–409.


National Lung Screening TrialResults: Positive Workup/Adverse Events

• False Positives– Most have noninvasive imaging follow-up

• CXR: 14.4%• Chest CT: 49.8%• PET/CT: 8.3%

– Invasive diagnostic procedures: 2.6 %– Complication rate: 1.4%– Major complication rate: 0.06%

• True Positives– Invasive procedure major complication: 11.2%– Surgical resection mortality: 1%


NLSTResults: False Positive Workup/Adverse Events

• False Positive Rate:– 20-25%: Chance you will end up with a false positive– ~10-12% for Mammography (“Call back”)

• False Discovery Rate (1-PPV): – 96%: Chance if you are positive you do not have cancer– Same as mammography

• False Positive Biopsy Rate– 0.4-2.4%: Chance if screened you will have an unnecessary invasive

procedure (LDCT)– 7-15%: Chance if you end up having a biopsy it will be negative

(mammography).


NLST NEJM 6/29/2011 NCCN 10/26/2011

NLST Summary

• 20% lung cancer mortality benefit• 7% overall mortality benefit• 1 in 100 has lung cancer• NNT = 320• Opportunity to save 30,000 lives/yr

NCCN Considerations

• Prolonged debate• Cost to Society• Patient anxiety• Radiation exposure• False positives/informed consent• Operational concerns


National Comprehensive Cancer Network (NCCN): 10/26/2011

NCCN Guidelines® for Lung Cancer Screening (V.1.2012) www.nccn.org


NCCN RecommendationCategories



NCCNHigh-Risk Groups


NCCN High-Risk Group 2Risk Factors

• Personal Cancer History– Lung, lymphoma, smoking related cancers

• Family History Lung Cancer in 1st Degree Relative

• Chronic Lung Disease– Emphysema– Pulmonary Fibrosis

• Carcinogen Exposure– Arsenic, asbestos, cadmium, chromium, diesel fumes, nickel,

radon, silica


NCCN GuidelinesSolid or Part Solid Nodules Follow-up



Lung Cancer ScreeningRisks and Benefits (NCCN)



Overdiagnosis, Survival, Mortality

Diagnosis Death

Survival


Diagnosis Death

Survival

Mortality

Overdiagnosis, Survival, Mortality


Diagnosis Death

Survival

Mortality

Death due to lung cancer = 20%

Lung Cancer Mortality

365

443


Diagnosis Death

Survival

Mortality

Death due to any cause across entire group= 6.6%

Overall Mortality

1877

2000


Overall Survival Benefit 7%Adjuvant Therapy Reduces Risk

• Breast cancer• ACT chemotherapy• 5 years anti-estrogen therapy• Post-mastectomy RT

• Prostate Cancer• Post prostatectomy RT

• Head and Neck cancer• Post-operative chemoRT

• Cervix Cancer• Post-operative chemoRT

• Medical-legal consequences


Diagnosis Death

Mortality

OverdiagnosisDetermine time and cause of death in those patients diagnosed and treated for lung cancer


CT Lung Cancer ScreeningMorbidity

• Radiation exposure– MDCT resolution allows for dose reduction– LDCT <1mSv, Mammography 0.7mSv

1 mSv 10 mSv


Radiation Exposure LDCT <1 mSv Years of annual

lung screeningMammogram .7 mSv

Lumbar Spine Films 2 mSv 2

Diagnostic Chest CT 10 mSv 10

Triphasic CT AB/P 25 mSv 25

Background Exposure Colorado

3 mSv/year4.5 mSv/year

34.5

Occupational Exposure 50 mSv/year 50

Transatlantic Flight .1 mSv 7 flights = 1 LDCT

10 -30 year latency period to develop secondary malignancies from RT exposure

Average age of patients in screening trials is 62


LUNG-RADSOverview

• Purpose: Establish a standardized quality assurance tool to mirror the tool widely utilized in Mammography (BI-RADS).

• Objectives: – Standardize terminology– Organized reporting and assessment structure– Data collection tool to facilitate outcome monitoring


LUNG RADSLung Number Category

• Category 1: Negative (12mo)• Category 2: Negative with

benign pulmonary findings (12mo)

• Category 3: Positive/likely benign (follow-up per NCCN guidelines)

• Category 4: Positive/suspicious for malignancy

• Category 5: Known cancer

“S” Category

• Positive for extra-pulmonary finding not suspicious for lung cancer but requiring clinical follow-up– Thyroid mass– Aneurysm– Kidney Mass


LUNG RADSLung Number Category

• Category 1: Negative (12mo)• Category 2: Negative with

benign pulmonary findings (12mo)

• Category 3: Positive/likely benign (FU per NCCN guidelines)

• Category 4: Positive/suspicious for malignancy

• Category 5: Known cancer

“S” Category• Positive for extra-pulmonary

finding not suspicious for lung cancer but requiring clinical follow-up– Thyroid mass– Aneurysm– Kidney Mass– Fracture


An Actuarial Analysis Shows That Offering Lung Cancer Screening As An Insurance Benefit Would Save Lives At Relatively Low Cost

• Cost per life-year saved would be below $19,000

Pyenson et al, Health Affairs 31, No.4 770-779: April 2012


Cost-EffectivenessPrivate Insurance Coverage• 11/2011 Anthem California• 12/2011 Wellpoint


Productivity Loss due to Cancer


Who Is Screening?• MDACC• Brigham and Women’s Hospital• Georgetown University• Thomas Jefferson University

Hospital• UCSF• Cedars-Sinai Medical Center• Yale University Cancer Center• Mayo Clinic• John Hopkins Medical Center• Memorial Sloan Kettering Cancer

Center• Lahey Clinic• Self pay rate $170 to $1000

(Average $230)

• Oncology Round Table Survey 3/2012– 32% Currently screening (n=104) – 77% Starting screening program

(n=77)– Most CT lung screening programs

have been launched in the past 9 months

– Mean # of patient’s screened in 2011 = 70

– 88% of patients pay out of pocket

The Advisory Board Company 3/12


The Advisory Board Company 3/12


Barriers to Screening

• Applicability to patients outside study group?

• Duration of screening?

• Education/awareness/endorsement

• Access to care in the absence of established reimbursement – Rescue Lung, Rescue Life


Lung Cancer Screening Practices of Primary Care Physicians: Results From a National Survey

• 962 family physicians, general practitioners and general internists surveyed in 2006-2007– 38% no test– 55% CXR– 22% LDCT– <5% sputum cytology

• Multivariate modeling: – Lung cancer screening endorsed by expert groups– Screening shown to be effective– Patients ask about screening

Klabunde, PhD et al: Annals of Family Medicine Vol. 10, No.2 March/April 2012


Lung Cancer Screening Practices of Primary Care Physicians: Results From a National Survey

• “To date, because of a lack of evidence from rigorous studies, major expert groups have not recommended screening asymptomatic individuals, even those with heavy or long-term smoking histories, for lung cancer”– US Preventative Services Task Force– American Cancer Society 2009 guidelines– American College of Chest Physicians

Klabunde, PhD et al: Annals of Family Medicine Vol. 10, No.2 March/April 2012


Screening Endorsements• NCCN – Category I recommendation to screen

high-risk patients October 2011• American Lung Association – April 2012

– Best way to prevent lung cancer is to never smoke or quit– LDCT for NLST group (does not give parameters on frequency)– Do not screen with CXR– LDCT not for everyone– ALA to develop public health materials to educate patients– Call to action to hospitals and screening centers to screen responsibly


• James Mulshine, MD, associate provost and vice president for research at Rush University Medical Center

• "With this positive trial result, we have the opportunity to realize the greatest single reduction of cancer mortality in the history of the war on cancer.”


Why Free?• Ethical

– Make lung screening available for all socioeconomic groups until CMS reimburses

• Power of Free– Human Motivation– Few people screened when charge– Helping to Raise Awareness

• Multidisciplinary centers may not need to charge (TBD)

• Seize Opportunities to fulfill Hospital Mission• Save Lives, Growth, • Innovation, Sustainability, Teamwork


How Free?• Existing Infrastructure

– Pilot – Use existing time in CT schedule (30 slots on PET/CT per week)– 1-855-CTCHEST

– Use downtime on installed CT Scanners• M – F: 6PM-9PM (12 scans per shift)• Additional capacity exists at LCN and Burlington• Sat/Sun: 12Hrs x 2

– IT - build/manage database of findings

– January 9th started free lung screening


LDCT Lung ScreeningPatient Flow

Intake StaffEvaluate Eligibility

FAQ Given

PCP Order

Patient Calls(855-CT-CHEST)



Group 3(Refer to PCP)


FAQ Given

PCP Order


Don’t Qualify





FAQ Given

PCP Order


Call Back(Cancer History, Risk Factors)

Don’t Qualify

May Qualify

Don’t Qualify





FAQ given

PCP Order



Don’t Qualify

May Qualify

Don’t Qualify

Group 1 & Group 21. Record PCP2. Assign Lahey PCP if no PCP3. Schedule Appointment4. Asymptomatic Disclosure

Do Qualify

Do Qualify





FAQ Given

Screen Patient1. No IV2. No changing3. Scan < 10 sec

PCP Order



Don’t Qualify

May Qualify

Don’t Qualify


Do Qualify

Do Qualify

Obtain PCP Order

Appt Reminder Call(48 hrs before exam)





FAQ Given


PCP Order

Credentialed RadiologistInterpretation



Don’t Qualify

May Qualify

Don’t Qualify


Do Qualify

Do Qualify

Obtain PCP Order






FAQ Given


PCP Order

(2/3 Screenings)

Schedule Rescreen (<74y)




Don’t Qualify

May Qualify

Don’t Qualify


Do Qualify

Do Qualify

Obtain PCP Order


S Negative &Lung-Rads 1, 2





FAQ Given


PCP Order

(2/3 Screenings)

(1/3 Screenings)

Schedule Rescreen (<74y)

Follow NCCN Guidelines




Don’t Qualify

May Qualify

Don’t Qualify


Do Qualify

Do Qualify

Obtain PCP Order


S Negative &Lung-Rads 1, 2

S Positive or Lung Rads 3, 4, 5


CT Lung Screen Pilot Statistics

• As of the week of 2/24/12– Patients verbally screened 209– Patients scheduled

179 85%– Patients scanned* 105

59%– Lahey patients*

156 87%– Non Lahey Patients* 23

13%

* percentage of Patients Scheduled


Patient Survey


Statistical Correlation to the NLST StudyLahey Pilot NLST study• Finalized cases 101

– Negative (cat 1,2) 70

– Positive (cat 3,4,) 31– Incidentals (S pos) 3

– Lahey PCP assigned 1

• Total Screened26,000• Negative 72.7%• Positive

27.3%• Incidentals 7.5%• Cancers found 1%


How did you start?• Multidisciplinary

coordinated effort • Steering Committee• Evidence based• Business plan• Legal• Compliance• Education and CME

• Concerns– Informed consent – Involvement of PCP– Education regarding screening

as process– Enticement or hidden cost– Uninsured– Volume overload of radiology,

PCPs, and specialists– Perception of outside hospitals

and clinicians– How long before

reimbursement is established?


Rescue Lung, Rescue Life MovementSteering Committee:

• Radiology– Brady McKee, MD– Sebastian Flacke, MD– Robert French, MD– Christoph Wald, MD

• Oncology– Andrea McKee, MD– Paul Hesketh, MD

• GIM– Guy Napolitana, MD– Brendan Connell, MD

• Pulmonary– Andrew Villanueva,MD– Anthony Campagna, MD– Jeffrey Klenz, MD– Carla Lamb, MD

• Administration– Richard Guarino– Jeffery O’Brien– Samuel Skura– Patricia Grady– Patricia Doyle– Angela Tambini

• Marketing– Erika Clapp

• Finance– Kevin Bennett

• Business Development– Robert Toporoff

• Philanthropy– Elizabeth Garvin


Volume ReassuranceMammography LDCT Screen

US Population 60,000,000 9,000,000 (high-risk)

Lahey 30,000 4500

100 screenings per week




Lahey 30,000 4500


1 cancer per week




Lahey 30,000 4500


1 cancer per week

27 positives




Lahey 30,000 4500


1 cancer per week

27 positives

7 potentially significant findings




Lahey 30,000 4500


1 cancer per week

27 positives


After 2 years we will save 1 life every 3 weeks


Volume Reassurance


1 cancer per week

27 positives


After 2 years we will save 1 life every 3 weeks

~75 patients: Qualify for lung screening (NCCN high-risk)~20 patients: Positive for a lung nodule ~5 patients: Potentially significant incidental findings

Clinic

Example Individual PCP: 2500 Patient Panel


When Will CMS Reimburse?Lung vs Breast Screening

Lung Cancer Breast Cancer5 Yr Overall Survival 1975 12% 75%5 Yr Overall Survival 2007 15% 89%Screening Modality LDCT MammogramScreening Frequency Annual Annual/BiannualPatient Population 30PY, 55-74y Females 40-80yPatient Number Estimates 9,000,000 60,000,000Cost of Exam $300 $100 Per Year Cost of 1 Screen $2.1 B $6 BRadiation Exposure 0.5-1.7 mSv 0.7 mSvMortality Reduction 20% 10-35%NNS 320 1250 (40-49y)Overdiagnosis < 17% vs CXR* 5-50%False Positive Rate ~35%/ 3 years 30-35%/10 years (annual)

Cost/QALY < $50,000 $38K - 58K (40-80y)


Risks of Free Screening

• States where health insurance is not required by law– Massachusetts >98% insured– US Population statistics – ~ <4% of high-risk patients will not have

insurance

• Operational endeavor – Instructional CD

• Potential for patient harm - Lung Cancer Alliance National Framework For Excellence


Rescue Lung, Rescue Life MovementMission:

Save lives through the early detection of lung cancer with responsible CT lung screening

Encourage the government to establish reimbursement for CT lung screening

Encourage other centers of excellence in the treatment of lung cancer to offer FREE CT lung screening until CMS establishes reimbursement

Break down barriers and prejudice faced by those at risk for lung cancer

Raise public awareness of the power of CT lung screening to save lives


Thank You

andrea mckee, m.d. chairman department radiation oncology sophia gordon cancer center lahey clinic...

Documents

lung cancer statistics

cause of cancer

worldlung cancer

uterine cancer

breast cancer awareness

lung cancerincidencemortality

global cancer statistics

ca cancer j clin