Chairman Department Radiation Oncology Sophia Gordon Cancer Center

Chairman Department Radiation Oncology Sophia Gordon Cancer Center
Thank you for the opportunity to engage in this exchange of ideas regarding responsible screening for lung cancer through the use of LDCT scanning. I will ask you to consider several somewhat controversial, novel, and provocative concepts over the next 45 minutes. If you find that you are at times uncomfortable, that’s ok. Please take a few days to consider these ideas before you decide what you surmise of them. I know it has taken me time to develop my thinking on these topics, particularly the notion of offering lung screening for free……..which in my experience can take most people a little time to get used to……... Andrea McKee, M.D. Chairman Department Radiation Oncology Sophia Gordon Cancer Center Lahey Clinic May 15, 2012

Disclosures None I have nothing to disclose

Outline Lung Cancer Background Lung Cancer Screening at Lahey Clinic
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 We will begin with some background information on lung cancer statistics, review the IELCAP and NLST results, and the most recent NCCN and American Lung Association recommendations. We will discuss some of the identified risks and benefits of screening for lung cancer. We will then discuss a model for the delivery of free lung screening developed at my center, the Lahey Clinic in Massachusetts which will include our system for structured reporting, the LUNG:RADS classification system: this system was developed in an effort to reduce unnecessary testing of patients, and ensure appropriate follow-up and communication of results to all parties involved. I will outline some of the challenges we faced during the development of this program and some of the ideas we have to help other centers avoid or minimize such difficulties. We will conclude with a discussion of the Rescue Lung, Rescue Life awareness and advocacy campaign with its primary objective……..to save lives through open access to responsible screening.

Lung Cancer Incidence/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 Lung cancer is the number one cause of cancer-related death in the US and World Lung cancer kills more women than breast, ovarian and uterine cancer combined. If you ask most people they will be surprised by this fact, generally thinking that breast cancer is the number one killer of women. This is probably because of the effective advocacy campaigns in this country for breast cancer awareness and research. NFL and NBA players wearing pink sweatbands and sneakers are a good example of this. References: Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin 2011; 61:69. - Iatrogenic: Radiation therapy Occupational and Environmental exposures: Asbestos, second-hand smoke, arsenic, radon, polycyclic aromatic hydrocarbons Cancer.gov (NCI/NIH) 4

Risk Factors? A current or former history of tobacco use is the primary risk factor for 85% of patients diagnosed with lung cancer. In this slide you see the cancer here, and the risk factor here on the patient’s anterior chest wall.

Tobacco Trends History of tobacco use Higher prevalence Higher risk
<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 I applaud the efforts of organizations such as the American Cancer Society to reduce the prevalence of tobacco use in this country. Here you see an advertisement of a pig smoking a cigarette….. with the implication being that smoking is a dirty habit but unfortunately runs the risk of equating smokers with pigs. This type of advertising has been effective along with other legislative efforts to decrease the rates of tobacco use from 42% in 1965 to <20% in Unfortunately, we are not seeing the same patterns of reduced tobacco use in developing countries and there has been a price levied by the demonization campaign developed to achieve this reduction. I fear we may be paying that price now, as many people feel we should not be allocating resources to help save the lives of current or former smokers. Put in historical perspective, smoking was at one time widely accepted. Many still practicing in medicine can recall a time when physicians and nurses smoked in the nurse’s station, physician’s lounge and surgeon’s lounge. There are many outstanding individuals contributing greatly to their respective fields who died of tobacco related illnesses, Peter Jennings, George Harrison, Babe Ruth, to name just a few. There is a much higher rate of tobacco use among military personnel. Former enlistees in the armed services were encouraged to smoke due to the stimulating and sedating effects of nicotine. Many were given a free carton of cigarettes upon enlistment. I have great respect for the men and women who have risked their lives to defend this country. I feel we are at a point in time when the medical and political communities have an opportunity to demonstrate that respect through awareness and advocacy of lung screening. Even now, there remains a higher prevalence of tobacco use in the military where one in three smoke vs one in five in the general population. Currently, there is also higher smoking prevalence seen amongst lower socio-economic groups. There are groups of current or former smokers who are at higher risk for the development of lung cancer due to occupational exposures, such as fire fighters, rescue workers, Navy ship builders, and construction workers. The medical community must begin the process to educate the public about these combined risks and the evidence which demonstrates we now have a tool to help protect those at risk.

Tobacco Trends Not to mention the stiff competition and mixed messaging put forth by the tobacco industry, Hollywood, and a variety of other multitude of media venues. Here is a mixed message on this slide. The beauty of Scarlett Johansen vs our smoking pig. As a medical community and a society we should probably look to guard against with holding of healthcare services and advocacy based on social history………… for this could result in a very slippery slope. And where do you draw the line? What about obesity, alcohol use, tanning booth usage, unprotected sexual activity and the variety of other risk factors known and unknown that people engage in everyday. Again…….where do you draw the line? 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 To be clear, smoking cessation and primary prevention remains of critical importance in our plight to decrease the overall number of lung cancer deaths. Despite the successes in primary prevention however, one hundred and sixty thousand patients die of lung cancer each year in the US alone. Furthermore MOST people who die from lung cancer nowadays are FORMER SMOKERS References: Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin 2011; 61:69. - Iatrogenic: Radiation therapy Occupational and Environmental exposures: Asbestos, second-hand smoke, arsenic, radon, polycyclic aromatic hydrocarbons Cancer.gov (NCI/NIH) 8

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% Only 35% of those diagnosed with lung cancer are still smoking. The majority of patients at risk for lung cancer are not currently using tobacco products. And despite all the medical advances we have seen over the past several decades the 5 year overall survival for lung cancer remains largely unchanged being 12% in 1975 and now 15% in LDCT is a medical advance that WILL finally allow us to see significant improvements in 5 year overall survival as we will discuss later on in this session. References: Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin 2011; 61:69. - Iatrogenic: Radiation therapy Occupational and Environmental exposures: Asbestos, second-hand smoke, arsenic, radon, polycyclic aromatic hydrocarbons Cancer.gov (NCI/NIH) 9

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 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 FORMER SMOKERS cannot benefit from primary prevention. They have done the heavy lifting, done what we have told them, and quit. Yet, they remain at risk, and they are aware of this. What more can we do to help them? This is where secondary prevention, or lung screening enters the discussion. Find the disease at the earlier more treatable stage and decrease mortality, not incidence. References: Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin 2011; 61:69. - Iatrogenic: Radiation therapy Occupational and Environmental exposures: Asbestos, second-hand smoke, arsenic, radon, polycyclic aromatic hydrocarbons Cancer.gov (NCI/NIH) 10

Lung Cancer Screening Data to support screening been around awhile
NEJM October 2006 31,567 patients baseline screened with low dose CT from 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 LDCT for lung screening has been around awhile. Dr. Claudia Henschke and the IELCAP (International Early Lung Cancer Action Program) has been investigating the use of LDCT for lung screening since the early 1990’s. In 2006 they reported their results in the NEJM on almost 32,000 patients screened from They detected 485 lung cancer 85% of whom were in clinical stage I and demonstrated a 10 year 92% overall survival for those treated surgically. The 8 patients who refused therapy died within 5 years of the diagnosis. Concerns regarding lead-time bias and over diagnosis prevented the widespread adoption of lung screening in the wake of this publication. Most physicians and medical associations have been waiting for the results of the National Lung Screening Trial to answer these concerns in a randomized fashion.

Lung Cancer Treatment NSCLC: Unscreened Population
Stage I, II, IIIA Potential Cure Surgical resection Radiotherapy Chemotherapy Stage IIIB/IV Palliative The treatment of lung cancer, similar to other malignancies is stage dependent. Earlier stages are treated in a potentially curative fashion with surgery, radiation, or a combination of the above plus chemotherapy. Treatment Stage IIIB and IV is mainly palliative in nature. Survival in an UNSCREENED population ranges from 72% for the earliest stage IA to <10% for the most advanced stages. 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 Trial Results: Stage Shift
Unfortunately in the unscreened population 70% of patients will present with stage III and IV disease and only 30% will have stage I or II disease at presentation. This data from the NLST demonstrates stage shifting where the opposite is seen with LDCT screening – 70% of patients present in stage I and II and 30% will have later stage disease at presentation.

Stage IV NSCLC <1% = 5 year OS
Here is a PET scan commonly seen in Oncology of a patient with stage IV NSCLC. The patient has a left lobe primary tumor with metastases to a contralateral hilar node, the ipsilateral adrenal gland and the liver. The 5-year survival for this patient is <1% <1% = 5 year OS

Incidental Finding on CXR
Stage T1BN0 In the absence of screening, patients who have been cured of lung cancer, for the most part have had their disease discovered incidentally on a CXR or diagnostic CT. Only a few symptomatic patients with lung cancer are cured of their disease. This gentleman has a 58% 5-year overall survival after his stage IB lung cancer was diagnosed during a pre-operative CXR evaluation prior to hip replacement. He had no symptoms of lung cancer. 58% 5-year Overall Survival 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 Medicine October 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? This case is from an article in the October 2011 issue of the Annals of Internal Medicine. They present a case of a 62 year-old female with a history of well-controlled hypertension seen in routine follow-up. She has jogged 3 miles a day 3 times a week for years with no recent change in her exercise tolerance. She has a 30 pack-year history of tobacco use but quit 10 years ago. She has a normal physical exam. She recently heard about a study, which demonstrates a benefit to LDCT and inquires if this is appropriate for her. What do you recommend?

Secondary Prevention Preclinical Diagnosis: Screening Awareness
5mm nodule 6 month fu diagnostic CT recommended 7mm NSCLC treated with lobectomy and nodal evaluation T1aN0 (screened) Let’s say you discuss the risks and benefits of screening and she makes the informed decision to undergo LDCT testing. There is a 5 mm nodule found and it is recommended by the radiologist that she have a follow-up CT scan in 6 months. The patient calls wanting to know if she should be worried. What can you tell her? Based on the NLST results this is not uncommon. You can remind her that during the first year of screening, there is a 27% chance that there will be a finding in the lung that requires follow-up. The vast majority of these findings are handled through follow-up imaging. There is a 96% chance that she doesn’t have cancer. If she is one of the 4% who has a screened 5 mm (screened IA) lung cancer, there is a 92% chance that she will be cured with appropriate therapy, that is why she underwent the screening. 6 months later the nodule increases to 7mm. What is this patient’s 5-year overall survival?

She is found to have a screened pathologic IA NSCLC at the time of surgery. The patient has a 92% 5-year OS. 92% = 5 year OS

85% of patients in screened population have stage I lung cancer Asymptomatic 58% 5-year OS This is the idea behind secondary prevention. Detect the disease by looking for it at the more curable 92% survival stage, versus finding it by accident with a 58% 5 year OS, or waiting for symptoms to develop with a dismal prognosis. Screening Symptomatic Stage I 92% 10-year OS Stage IV 1% 5-year OS

US Cancer Mortality Rates Secondary Prevention
Screening is not an unusual concept in this country. Of the top 4 cancer killers…lung, prostate, breast, and colorectal cancer…… 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; Available at:

US Cancer Mortality Rates Secondary Prevention
PSA Mammography Colonoscopy We screen for all of these diseases except lung cancer. Now, the data to screen for lung cancer with LDCT is as good or better than the quality of the data for these other disease sites. So let us review the newest evidence……. 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; Available at:

National Lung Screening Trial (NLST): 6/29/2011
The National Lung Screening Trial (or the NLST) was published in the NEJM on-line in June of 2011 and in paper publication last August. The authors concluded that screening with the use of LDCT reduces mortality of lung cancer. 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 Trial Design 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 + The trial was a multi-institutional randomized trial sponsored by the NCI and ACRIN that cost an estimated $300 million dollars to conduct

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 There were almost 54,000 participants ranging from the age with a >30 Pack year history of tobacco use who were currently smoking or quit within the past 15 yrs. Patients were enrolled between 2002 and Exclusion criteria are listed on the right. Of note, patients had to be medically operable, asymptomatic, and have no prior history of cancer within the past 5 years. 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 Patients were randomized to LDCT vs CXR. Baseline prevalence scans were performed followed by 2 additional screens - so three scans over 2 years. A positive test was defined as a non-calcified nodule greater than 4mm in diameter or other findings suspicious for lung cancer like adenopathy or effusion. Work-up was determined by the patient’s primary care physician, NOT the NLST. HOWEVER, the NLST reading radiologist’s recommendation was available.

National Lung Screening Trial Results: 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 excluded In November of 2010 the study was halted early when the 20% lung cancer specific mortality reduction was realized at 6.5 years there were 365 deaths in the LDCT group and 443 deaths in the CXR group. There was a 6.6% reduction in overall mortality that was not statistically significant when lung cancer deaths were excluded. 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 Trial Results: 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 320 The study also demonstrated that one in one hundred of these patients actually has cancer on the prevalence screen. The annual incidence decreases to .5-.8% (such that one in one hundred and TWENTY FIVE) have cancer on the incidence screens. You will not detect small cell lung cancer at earlier stages and so the screening benefit applies only to non-small cell histologies. The number needed to screen is This means that for every 320 patients screened we will save one life. This will result in tens of thousands of lives saved per year if we implement responsible screening and access across the US. 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 Trial Results: Rate of Positive ScreeningsAq
CT (24.2%) > 3x more sensitive than CXR (6.9%) T0 & T1 Rate: % T2 Rate: % 2 year stability  benign (Fleischner Guidelines) Expected rate for ongoing LDCT screening At least one positive result (3 screens): % Significant incidental finding: % Not screening everyone – highly selected group (3%) Not surprisingly, LDCT is more sensitive approximately (3 times more sensitive) than CXR. On the first 2 screens there is a 27% chance for a lung finding. After that the rate decreases to 16.8% which is the expected rate for an ongoing LDCT screening program. Any solid nodule that has been stable for 2 years is considered benign according to the NLST and Fleischner Guidelines. The risk for a significant incidental finding is 7.5%. The NLST group is a highly selected group and is expected to represent approximately 3% of the population or approximately 7 million patients in the US. 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 Trial Results: Positive Workup/Adverse Events
False Positives Most have noninvasive imaging follow-up CXR: % Chest CT: 49.8% PET/CT: 8.3% Invasive diagnostic procedures: 2.6 % Complication rate: % Major complication rate: % True Positives Invasive procedure major complication: 11.2% Surgical resection mortality: 1% False positives were handled non-invasively for the most part with CXR, CT or PET/CT for follow up. Invasive diagnostic procedures on patients who didn’t have cancer were rare at 2.6%. The complication rate for patients who didn’t have cancer was also rare at 1.4%. The major complication rate for those without cancer was very rare at .06%. FOR PATIENTS WHO HAVE CANCER the risk for major complication was 11.2% and the surgical resection mortality rate was 1%. But remember, these patients actually have cancer.

NLST Results: 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 %: 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). IF we compare to mammography, (something we are all familiar with) the discovery rate (or the chance that you will get a “call-back” for additional imaging) is 20-25% for LDCT and 10-12% for mammography. With LDCT the “call-back” occurs in 3 to 6 months, with mammography, the patient is immediately “called-back”. The false discovery rate – meaning the chance that you don’t have cancer if you get called back is 96% for both LDCT and mammography. The false positive biopsy rate (meaning the chance that you have a biopsy when you do NOT have cancer is % for LDCT and 7-15% for mammography.

NLST Summary NCCN Considerations
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 Within a few months of the NLST publication the NCCN released their new guidelines on lung screening on October 26th The NCCN or the The National Comprehensive Cancer Network is a not-for-profit alliance of 21 of the world's leading cancer centers, which is dedicated to improving the quality and effectiveness of care provided to patients with cancer. The NCCN considered the risks and benefits of lung screening in the development of their guidelines, which I recommend you read, because they are quite well done. After weighing all these considerations……

National Comprehensive Cancer Network (NCCN): 10/26/2011
They issued a category I recommendation to screen the NLST population. Category I is uniform consensus based on the highest level of evidence available that the intervention is appropriate. NCCN Guidelines® for Lung Cancer Screening (V )

NCCN Recommendation Categories
A category 2B recommendation was issued for the patients who are found to be at high risk based on previous non-randomized publications. Category 2B is based on lower level evidence there is NCCN consensus that the intervention is appropriate NCCN Guidelines® for Lung Cancer Screening (V )

NCCN Recommendation Categories
For comparison purposes Mammography has a category 2A recommendation to screen. NCCN Guidelines® for Lung Cancer Screening (V )

NCCN High-Risk Groups Here are the 2 NCCN high-risk groups. These are the 2 high-risk groups to whom we are offering free screening at our center. In Group 2, the age is lowered to 50 and the pack-years is lowered to 20. There is no timeframe for when the patient quit and one other risk factor is identified not to include exposure to second hand smoke

NCCN High-Risk Group 2 Risk 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 Here is a list of the secondary risk factors with family history, previous cancer related tobacco history, COPD or emphysema co-morbidity, and exposure to known carcinogens among them.

NCCN Guidelines Solid or Part Solid Nodules Follow-up
Here is the decision tree-which is based on the NLST and IELCAP studies. The recommendations for imaging follow-up are based on the characteristics and the size of the finding. Nodules smaller than 4 mm are not considered positive with 12 month annual screen follow-up. A patient with a nodule greater than 4mm but less than 6mm should have LDCT scan in 6 months. Nodules between 6 and 8mm should be followed with LDCT in 3 months and any solid or part-solid nodule greater than 8mm is recommended to have more immediate work-up. NCCN Guidelines® for Lung Cancer Screening (V )

Lung Cancer Screening Risks and Benefits (NCCN)
Here are the risks and benefits the NCCN identified. Notice anxiety is listed as both a risk and a benefit. In our experience thus far, patients are less anxious when they are properly informed regarding screening as a process and they are able to access a tool that can help protect them against lung cancer mortality. Let us cover the issues of pseudo-disease (or over diagnosis), unnecessary testing, radiation exposure, and cost in more detail. NCCN Guidelines® for Lung Cancer Screening (V )

Overdiagnosis, Survival, Mortality
Let’s start first with this issue of over diagnosis or pseudo-disease and in so doing develop some clarification on the difference between a survival benefit vs a mortality benefit. Starting with survival. If the red star represents diagnosis of lung cancer and the lightning bolt death, the top line represents patients undergoing LDCT and the bottom line is CXR. You can see that in this scenario there is a survival advantage. However, even though technically patients are surviving longer with a diagnosis of cancer, they live no longer than had they been diagnosed later. This difference here is a lead-time bias. Diagnosis Death

Overdiagnosis, Survival, Mortality
Contrast that with a mortality benefit where again you have LDCT on top and CXR on the bottom. But death due to lung cancer occurs at a later time point in the LDCT arm. In this scenario, the issue of lead-time bias is mitigated by the fact that patients are in fact living longer than they would have had they been screened with CXR. Statisticians calculate the mortality difference here based on the factors of numbers of patients and how much longer they are alive in a construct known as person years Diagnosis Death

Lung Cancer Mortality Survival Mortality Diagnosis Death
When you isolate death sue to lung cancer only, the mortality difference is 20%. Here you see 443 patients had died at the study endpoint in the CXR arm and MUCH FEWER…… 365 patients had died in the LDCT arm. 365 Death due to lung cancer = 20% 443 Diagnosis Death

Overall Mortality Survival Mortality Diagnosis Death
When you look at death due to any cause across the entire group of patients regardless of whether or not they had been diagnosed with lung cancer, the mortality difference is approximately 7% deaths in the CXR arm and 1877 deaths in the LDCT arm, telling us that we are not unduly harming patients through the process of screening and treatment of early-detected lung cancer 1877 Death due to any cause across entire group= 6.6% 2000 Diagnosis Death

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 Medical-legal consequences What other treatments confer a 7% survival benefit in oncology? Here is a list of interventions associated with a similar benefit that we use to treat cancer patients in order confer that advantage…….months of risk-adapted systemic chemotherapy or chest wall radiotherapy after mastectomy in patients with breast cancer, risk-adapted post-operative radiotherapy to men with prostate cancer, risk-based post-operative chemoradiotherapy to patients with head and neck cancer or cervical cancer. These are NOT trivial treatments. Given the survival advantage associated with them, we in oncology would place ourselves at significant medical legal risk were we not to offer them (or at a minimum, discuss these treatments as options for therapy with our patients). In light of the NCCN category I recommendation to screen, we in oncology, became concerned about the medical legal risk for our PCPs were they not to systematically review the risks and benefits of screening with their at-risk patients.

Overdiagnosis Determine time and cause of death in those patients diagnosed and treated for lung cancer Mortality Here we look at the time and cause of death for ONLY the cohort of patients diagnosed and treated for lung cancer. A patient who dies of other causes, be it they died of heart disease, emphysema, or a fatal ski accident 2 years after surgery for a low-grade (formerly BAC) adenocarcinoma, or in its most extreme example were hit by a bus 2 days after their lobectomy for lung cancer was overdiagnosed. Overdiagnosis is inherent to any screening program. It is estimated to be about 15-20% in lung cancer screening, but we will never actually know. This is because 1) There is no observation arm in the NLST. The control arm was CXR which is not observation and 2) We must wait for patients in the study group to die before we can calculate the rate of overdiagnosis, when the NLST halted their trial the CXR group was appropriately advised of the mortality benefit with LDCT and therefore cross-over will prevent us from knowing the true rate of overdiagnosis of LDCT when compared with CXR. We do know that overdiagnosis decreases with time, it does not increase with time. Diagnosis Death

CT Lung Cancer Screening Morbidity
Radiation exposure MDCT resolution allows for dose reduction LDCT <1mSv, Mammography 0.7mSv Let’s switch gears to radiation exposure. Here you see 2 CT scans of the same patient. The one on the left is a LDCT performed with multi-detector imaging on the right is a standard diagnostic CT. The LDCT exposes the patient to <1mSv, similar to a bilateral 2-view mammogram, and maintains its diagnostic capabilities for pulmonary nodule detection at one tenth the dose of the one on the right with its associated 10mSv exposure. 1 mSv 10 mSv

Average age of patients in screening trials is 62
Radiation Exposure LDCT <1 mSv Years of annual lung screening Mammogram .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/year 4.5 mSv/year 3 4.5 Occupational Exposure 50 mSv/year 50 Transatlantic Flight .1 mSv 7 flights = 1 LDCT Here is a chart for comparison purposes. LDCT exposure is similar to a mammogram. A Lumbar spine film series is 2mSv or the equivalent of 2 years of annual LDCT scanning. Triphasic CT abd/pel is 25mSv. Background exposure is 3 mSv at sea level and 4.5mSv in Denver Colorado. Occupational exposure for a radiation worker such as myself is 50mSv, I am allowed each year to be exposed to the equivalent of 50 LDCT studies. A transatlantic flight is .1mSv such that 7 transatlantic flights equals 1 LDCT. Also an important consideration regarding radiation risk is the year latency period to develop secondary malignancies as a result of RT exposure. The average age of patients in screening programs is So…. we are not talking about screening healthy children, teenagers, or even young adults. With a year latency period the risk is acceptable at these exposures, when weighed against the knowledge that one in one hundred of these patients has lung cancer. year latency period to develop secondary malignancies from RT exposure Average age of patients in screening trials is 62

LUNG-RADS Overview 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 In order to reduce the risk for unnecessary testing, standardize terminology, organize reporting, and ensure quality and safety of the program we developed a standardized quality assurance tool to mirror the tool widely used in Mammography (BI-RADS)

LUNG RADS Lung Number Category “S” 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 Positive for extra-pulmonary finding not suspicious for lung cancer but requiring clinical follow-up Thyroid mass Aneurysm Kidney Mass Our LUNG RADS system has both a lung number category and an “S” category which is either positive or negative for any potentially significant extra pulmonary finding. Category 1 is negative – return next year for annual screen Category 2 is negative with benign pulmonary finding such as a nodule than has been stable for more than 2 years – return next year for annual screen. Category 3 is Positive/likely benign – recommendation for follow-up per the NCCN guidelines % of your cases will fall into this category depending upon which year of screening the patient is in. Category 4 is positive - suspicious for malignancy. These patients are sent back to their PCP with a recommendation for pulmonary consultation to determine direction of further evaluation. Category 5 we shouldn’t really be seeing because these are patients with recent known lung cancer who should be receiving follow-up care under the direction of followed their oncology team. Examples of an S positive study would include findings such as a thyroid mass, aneurysm, or kidney mass.

LUNG RADS Lung Number Category “S” 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 Positive for extra-pulmonary finding not suspicious for lung cancer but requiring clinical follow-up Thyroid mass Aneurysm Kidney Mass Fracture Let’s talk for a minute about how lung screening differs from screening in other disease sites. Lung screening is a process, which occurs over time, that is how we avoid unnecessary biopsies and invasive procedures, by handling the findings with further radiographic studies and waiting to intervene once growth of a small nodule has been established. When we think about screening in breast cancer, or prostate cancer, the patient, and provider hopes to pick up the cancer at the earliest possible screen, - at the first sign of an elevation in PSA or abnormality on mammogram. For we tend to intervene early and thus it is less common to wait 6 months to establish a change before moving to path diagnosis. Contrast that with lung screening where if you know right away that the patient has cancer (category 4), you may or may not save that patient’s life. It is the category 3 group (96% of whom don’t actually have cancer) whose lives you will save through screening (the 4% of category 3 patients who actually have cancer will have the potential for the 92% survival rate).

Cost per life-year saved would be below $19,000
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 Last month the Milliman group published this report in Heath Affairs magazine “An Actuarial Analysis Shows That Offering Lung Cancer Screening As An Insurance Benefit Would Save Lives At Relatively Low Cost”. This well known actuarial group developed a model based on the IELCAP data to determine that the cost per life-year saved would be below $19,000. The NLST group are coming out with their own estimate for quality adjusted cost per life year saved which by report, a back of the envelope estimation has put the number at $38,000. We can all argue about which model and which assumptions to use, but the fact of the matter is that…… Pyenson et al, Health Affairs 31, No : April 2012

Cost-Effectiveness Private Insurance Coverage
11/2011 Anthem California 12/2011 Wellpoint As of late fall 2011 both Anthem of California and Wellpoint 2 of the nation’s largest insurers are covering this benefit for those patients meeting the NLST criteria. One must ask why? I can’t imagine they are doing so in order to attract 55 to 74 year old current or former heavy smokers to their programs. They must have reviewed their own actuarial data and determined the cost benefit to be present. Any one of us involved with the treatment of stage III and IV lung cancer should not be surprised by this information given the cost associated with diagnostic scans, chemotherapy, and radiation to palliate and treat end-stage disease.

Productivity Loss due to Cancer
Not to mention the considerable lost revenues associated with productivity loss due to lung cancer – an estimated 36 billion per year……..much greater productivity losses for lung cancer than what is seen for any of the other malignancies listed here…………considerable indeed.

Who Is Screening? Oncology Round Table Survey 3/2012 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 There is a growing list of well known centers who currently offer lung screening at a self pay rate. The Advisory Board Company surveyed participating centers in March of 2012 and found that 32% of participating centers offer lung screening while 77% of those not offering screening plan to do so in the next year. Most LDCT screening programs have started sometime over the past 9 months. The mean number of patients screened in programs that offer screening is 70 for the year % of patients pay out of pocket with a self-pay rate between ( dollars). The average rate across centers who do screen is $230. The Advisory Board Company 3/12

The Advisory Board Company 3/12
Furthermore, the Advisory Board learned through their poll that the key driver for reason to start a lung screening program is the desire to improve patient outcomes – which is not surprising because most clinicians and administrators are genuinely concerned for the well-being of the patients they care for. For those centers not considering CT screening, the most common reason cited was lack of reimbursement – also not surprising. 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 Some other barriers to screening we have heard expressed are concern raised over the applicability to patients outside the study group and how long to screen for? It is true there may be others who will benefit from lung screening. Additional research will be required to determine if there are others who should be screened, but that should not stop us from screening those now whose lives we know have the potential to be saved through screening. The NCCN has given us a good start regarding duration of screening based on the evidence we do have. The current lack of public and medical education surrounding the topic, particularly in the wake of years and years of debate and confusion associated with lung screening is a barrier which has been compounded by the relatively slow endorsement of this modality by expert specialty and advocacy groups. But the number one issue we hear time and time again is how to make the test equally available to those at risk in the absence of established reimbursement and in light of a several hundred dollar self pay rate barrier.

Multivariate modeling:
Lung Cancer Screening Practices of Primary Care Physicians: Results From a National Survey 962 family physicians, general practitioners and general internists surveyed in 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 This month a National Survey of lung screening practices from was published in the Annals of Family Medicine. The study polled 962 general practitioners and found that only 38% had not offered screening to patients. The majority of patients screened were offered a CXR with 55% and 22% had been screened with LDCT. On multivariate modeling the authors found that physicians were more likely to screen if they felt that screening was endorsed by expert groups, was shown to be effective, or when patients asked 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 Although I found this information interesting because it clearly demonstrates a lack of consensus and confusion regarding screening practices in this country, the crux of the article was upsetting, as the authors went on to say “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”. They go on to site the US Preventative Services Task Force who has openly admitted the need to review their position on LDCT lung screening in light of the NLST results; they cite the old 2009 American Cancer Society Guidelines, and the American College of Chest Physicians. I’d like to know what the authors consider a rigorous study, if not the NLST? If we do not consider a 300 million dollar, multi-institutional, NCI funded, randomized trial with 54,000 patients that was closed early due to the statistically significant mortality advantage a rigorous study, then we probably should not have conducted it. 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 Fortunately, the NCCN expeditiously released their guidelines after the NLST publication, but perhaps not in time for the authors to include the NCCN recommendations in their publication. In the very same month as the Annals of Family Practice publication was released, APRIL of 2012 the American Lung Association released their new guidelines. The American Lung Association is considered one of the world’s leading organizations working to save lives by improving lung health and preventing lung disease through Education, Advocacy and Research. There new guidelines are as follows: Best way to prevent lung cancer is to never smoke or quit LDCT for NLST group recommended - they do not say how often or for how long which will need to be clarified by them Do NOT screen with CXR LDCT is not for everyone ALA to develop public health materials to educate patients Call to action to hospitals and screening centers to screen responsibly – including concern over access issues in the absence of reimbursement Now that several important expert groups have endorsed screening, I suspect many more will follow.

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.” Dr. James Mulshine, Associate Provost and Vice President for Research at Rush University Medical Center has said in reference to the NLST, “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.” Barring some unforeseen molecular breakthrough it will likely have the greatest single impact on the field of oncology for the next decade and beyond. Professional Societies whose mission is to reduce cancer mortality and improve the health of patients with lung disorders, cannot remain silent at this pivotal time in cancer history. Now is the time to lead.

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 I’d now like to switch gears to discuss Free Lung Screening and the established program at Lahey Clinic. Let’s start with why free? First, it is a way to provide screening access to all those at high-risk for lung cancer regardless of socioeconomic status until reimbursement is established. We offered LDCT for 9 months at a self-pay rate of $300 and we screened 4 patients all of whom were from our concierge level executive health program and could afford the screen. Since we started free screening on January the 9th we have screened over 230 high-risk patients with no advertising of the program other than a CME campaign, global messaging to our employees, and our hospital Intranet. Second, when something is offered for free, it calls attention to itself. There is something about the word FREE that calls upon people to listen. People are motivated towards reduced pricing and free products. Take the long waits, lines, and chaos associated with Black Friday for example….. Or Taco Bell where people will wait over an hour in line for a free taco that normally costs 99 cents. The FREE nature of this program, is what is helping to make providers, patients, and administrators pay attention to this critically important issue. I imagine some are offended at the notion of offering a complex, intricate, highly sophisticated service like CT screening that is not without risk to the patient (or the provider), and requires years of collective training and combined expertise, for free. After all, we are not in the fast food service industry……. we are in the healthcare industry and offering our services for free devalues the currency of our other services. I agree the solution is not perfect. But what choice do we have???…………we ARE in the health care industry…… Is it better to knowingly let people die? It will likely be several years before CT screening becomes a uniformly covered benefit. In the meantime, there exists uniform consensus to screen within the NCCN and an American Lung Association recommendation to screen high risk patients. Free lung screening is an interim measure…… a construct developed in response to an unprecedented time in cancer history when we find ourselves absent equitable reimbursement, but now aware of the potential to save tens of thousands of lives, but ONLY if we make the service available to the over 9 million at risk in this country. It is not enough for only a few centers to open access…..access must open across the nation. And it just may be that large multidisciplinary centers can afford to provide this service free of charge until reimbursement is established. As long as the hospital is profitable, it may also be possible to apply a portion of the free program costs toward a center’s community service benefit, which was a strong contributing factor for us. By bringing together experts at our institution from a variety of different disciplines and working together as a team, we were able to ensure that despite the free nature of our program, meticulous attention was paid to quality and safety. This is in fact the primary reason our senior administration endorsed the program……. I have been told they were most impressed by the opportunity to fulfill our hospital mission, which is to save lives, grow, demonstrate innovation, sustainability, and teamwork. The development of this program was an extraordinary multidisciplinary effort, which you will now hear about.

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 We developed a low-cost model to utilize the existing infrastructure on our CT scanners. We have multiple scanners throughout our organization and were able to identify 30 slots for a pilot program to screen 30 patients per week. We had approval to use downtime after hours, bringing in an overtime team if necessary for potential overflow. We secured an easy to remember 800 line so patients could call directly for information, but we required that the test be ordered by the patient’s PCP. We developed an extensive, relational database to help manage the findings similar to our existing database in mammography, but set to the NCCN guidelines for follow-up recommendations and our structured reporting LUNG RADS system.

LDCT Lung Screening Patient Flow
Patient Calls (855-CT-CHEST) Intake Staff Evaluate Eligibility FAQ Given PCP Order Here is the patient flow. The patient calls 855-CTCHEST to inquire if they qualify for lung screening. Our schedulers have been trained to assess eligibility. Patients are advised that we must have an order from the patient’s PCP in order to screen. We provide patients and their PCP with FAQ sheet regarding the risks and benefits of screening to help guide their discussion.

Patient Calls (855-CT-CHEST) Group 3 (Refer to PCP) Don’t Qualify Intake Staff Evaluate Eligibility FAQ Given PCP Order Patient’s who don’t qualify are educated as to what constitutes high-risk, but they may wish to speak directly to their pcp regarding their particular risk.

Patient Calls (855-CT-CHEST) Group 3 (Refer to PCP) Don’t Qualify Don’t Qualify Intake Staff Evaluate Eligibility FAQ Given Call Back (Cancer History, Risk Factors) May Qualify PCP Order Those who fall into the NCCN Group 2 are contacted by our nurse navigator to assess for possible secondary risk factor.

Patient Calls (855-CT-CHEST) Group 3 (Refer to PCP) Don’t Qualify Don’t Qualify Intake Staff Evaluate Eligibility FAQ given Call Back (Cancer History, Risk Factors) May Qualify Do Qualify Do Qualify Group 1 & Group 2 1. Record PCP 2. Assign Lahey PCP if no PCP 3. Schedule Appointment 4. Asymptomatic Disclosure PCP Order NCCN group 1 patients and those found to qualify in Group 2 are determined to be asymptomatic and their PCP is recorded or assigned if necessary

Patient Calls (855-CT-CHEST) Group 3 (Refer to PCP) Don’t Qualify Don’t Qualify Intake Staff Evaluate Eligibility FAQ Given Call Back (Cancer History, Risk Factors) May Qualify Do Qualify Do Qualify Group 1 & Group 2 1. Record PCP 2. Assign Lahey PCP if no PCP 3. Schedule Appointment 4. Asymptomatic Disclosure PCP Order Order is obtained and patient is screened. The test is arguably one of the easiest screening tests we perform in oncology. There is no IV, no changing, and the scan takes less than 10 seconds. Contrast that to what is involved with a papsmear, mammogram, or colonoscopy. Obtain PCP Order Appt Reminder Call (48 hrs before exam) Screen Patient No IV No changing Scan < 10 sec

Patient Calls (855-CT-CHEST) Group 3 (Refer to PCP) Don’t Qualify Don’t Qualify Intake Staff Evaluate Eligibility FAQ Given Call Back (Cancer History, Risk Factors) May Qualify Do Qualify Credentialed Radiologist Interpretation Do Qualify Group 1 & Group 2 1. Record PCP 2. Assign Lahey PCP if no PCP 3. Schedule Appointment 4. Asymptomatic Disclosure PCP Order An internally credentialed radiologist interprets the scan and reports according to the LUNG RADS structured reporting system. Obtain PCP Order Appt Reminder Call (48 hrs before exam) Screen Patient No IV No changing Scan < 10 sec

Patient Calls (855-CT-CHEST) Schedule Rescreen (<74y) Group 3 (Refer to PCP) Don’t Qualify Don’t Qualify S Negative & Lung-Rads 1, 2 Intake Staff Evaluate Eligibility FAQ Given Call Back (Cancer History, Risk Factors) (2/3 Screenings) May Qualify Do Qualify Credentialed Radiologist Interpretation Do Qualify Group 1 & Group 2 1. Record PCP 2. Assign Lahey PCP if no PCP 3. Schedule Appointment 4. Asymptomatic Disclosure PCP Order A negative study (LUNG RADS 1 or 2 S negative) will be scheduled to return in 1 year. This will be 2/3 of cases screened. Obtain PCP Order Appt Reminder Call (48 hrs before exam) Screen Patient No IV No changing Scan < 10 sec

Patient Calls (855-CT-CHEST) Schedule Rescreen (<74y) Group 3 (Refer to PCP) Don’t Qualify Don’t Qualify S Negative & Lung-Rads 1, 2 Intake Staff Evaluate Eligibility FAQ Given Call Back (Cancer History, Risk Factors) (2/3 Screenings) May Qualify Do Qualify Credentialed Radiologist Interpretation Do Qualify Group 1 & Group 2 1. Record PCP 2. Assign Lahey PCP if no PCP 3. Schedule Appointment 4. Asymptomatic Disclosure PCP Order S Positive or Lung Rads 3, 4, 5 (1/3 Screenings) S positive or LUNG RADS 3,4, or 5 will be advised according to the NCCN guidelines and follow-up will be scheduled and tracked through the lung screening database. This group comprises approximately one third of patients screened. Obtain PCP Order Follow NCCN Guidelines Appt Reminder Call (48 hrs before exam) Screen Patient No IV No changing Scan < 10 sec

CT Lung Screen Pilot Statistics
As of the week of 2/24/12 Patients verbally screened 209 Patients scheduled % Patients scanned* % Lahey patients* % Non Lahey Patients* % * percentage of Patients Scheduled As of 2/24/12 when we looked at the first 105 patients we verbally screened twice that number had been scheduled had already been scanned of patients scheduled were Lahey patients. 23 patients were non-Lahey patients – presumably relatives of Lahey employees as we made no effort to market outside of Lahey.

Patient Survey We learned from our patient survey that most PCPs did not require a visit prior to ordering the test and patients were for the most part, pleased that they had been screened, especially those with a finding that required follow-up. There were a handful of calls to the program, for clarification of what that follow-up meant.

Statistical Correlation to the NLST Study
Lahey Pilot NLST study Finalized cases Negative (cat 1,2) Positive (cat 3,4,) Incidentals (S pos) Lahey PCP assigned Total Screened 26,000 Negative 72.7% Positive % Incidentals % Cancers found 1% The statistical correlation to the NLST results was striking – with the majority of cases (70) having a category 1 or 2 scan. 31 had category 3 or 4. Significant incidental findings were low with only 3 patients requiring further evaluation. One Lahey PCP was assigned to a patient without a PCP. We presented our pilot to senior administration and have received approval to offer free LDCT screening for 5 years or until reimbursement is established.

How did you start? Concerns Multidisciplinary coordinated effort
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? Multidisciplinary coordinated effort Steering Committee Evidence based Business plan Legal Compliance Education and CME In speaking about this program to others, many clinicians and administrators want to know how we received approval. We started with a multidisciplinary team and identified physician and administrator champions from representative areas of the organization to be part of a steering committee -which oversees the program and the education and awareness campaign that is associated with lung screening. We meet every 2 to 3 weeks and share group exchanges regarding any new information that becomes available to anyone on the team for the benefit of the whole group who then imparts such information to their respective disciplines. We focused the program to be evidence-based. We developed a comprehensive business plan based on the NLST experience to allow administration to become comfortable with the use of our CT scanners in this capacity. We enlisted our legal and compliance departments to give guidance regarding regulatory issues. We developed a comprehensive CME and community education plan, which we continue to unravel. We saw early on that there were several areas of concern to address in order for us to move forward. Among them were issues of informed consent, degree of PCP involvement, education regarding screening as a process, concern for enticement or hidden cost to the patient, particularly those who are uninsured, worry that we might overload the radiology department, PCPs , or specialists, the perception of outside hospitals and clinicians about our potential motives for free screening, and concern over what might happen if reimbursement is not established.

Rescue Lung, Rescue Life Movement Steering 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 Here is the Rescue Lung, Rescue Life Steering Committee. We decided to name the awareness movement Rescue Lung, Rescue Life because we want to draw a parallel to rescue situations. We want to create a sense of urgency similar to rescue efforts. Now that we know we can save tens of thousands of lives per year with screening, it seems appropriate that we do whatever we can to save them. IF we saw a burning building with 30,000 lives inside, we would go to great lengths, even risk our own well-being to save those lives. We must begin to think about the thousands who in the absence of CT screening will otherwise die from lung cancer in the same way. As you can see the steering committee consists of a large group of dedicated and committed professionals from all aspects of the hospital, many of whom took on additional job responsibilities just to make this program succeed. I am very proud to be a part of this group.

Volume Reassurance Mammography LDCT Screen US Population 60,000,000
9,000,000 (high-risk) Lahey 30,000 4500 100 screenings per week We were able to alleviate concerns for volume overload through selective marketing and a volume analysis to show what volume should look like for an individual PCP. On the basis of our breast screening program, we were able to back out a sense of what our population numbers should be for our patient base. According to the NLST approximately 3% of the population would qualify for the high-risk group. We verified this number independently through CDC information. We estimate that approximately 4500 patients per year from our own patient base would screen

9,000,000 (high-risk) Lahey 30,000 4500 1 cancer per week 100 screenings per week This would result in 100 screenings per week for our radiology department The potential diagnosis of 1 cancer per week ……

9,000,000 (high-risk) Lahey 30,000 4500 1 cancer per week 100 screenings per week 27 positives 27 positive findings that would require further radiologic diagnostic CT imaging…..

9,000,000 (high-risk) Lahey 30,000 4500 1 cancer per week 100 screenings per week 27 positives and 7 potentially significant findings requiring further evaluation. 7 potentially significant findings

9,000,000 (high-risk) Lahey 30,000 4500 1 cancer per week 100 screenings per week 27 positives After 2 years of screening we will save 1 life every 3 weeks…….that is 1 life every 3 week from our own community. 7 potentially significant findings After 2 years we will save 1 life every 3 weeks

Volume Reassurance Example Individual PCP: 2500 Patient Panel
~75 patients: Qualify for lung screening (NCCN high-risk) ~20 patients: Positive for a lung nodule ~5 patients: Potentially significant incidental findings 1 cancer per week Clinic 100 screenings per week 27 positives For an individual PCP who generally has a 2500 patient panel, we estimate the need to provide counciling and order LDCT scans on 75 patients, issue a follow-up order and manage questions for 20 patients found to have a lung nodule, and manage 5 patients with potentially significant incidental findings each year. The database will track all recommended follow-up for the patients, and thus avoid the need for primary care to manage scheduling of follow-up studies, in the same way as mammography. We were able to reassure our PCPs with this approach. The development of a 4 page FAQ sheet, physician education materials, CME campaign, and selective marketing helped to alleviate concerns regarding informed consent, enticement concerns, and perception of outside facilities. 7 potentially significant findings After 2 years we will save 1 life every 3 weeks

When Will CMS Reimburse? Lung vs Breast Screening
Lung Cancer Breast Cancer 5 Yr Overall Survival 1975 12% 75% 5 Yr Overall Survival 2007 15% 89% Screening Modality LDCT Mammogram Screening Frequency Annual Annual/Biannual Patient Population 30PY, 55-74y Females y Patient Number Estimates 9,000,000 60,000,000 Cost of Exam $300 $100 Per Year Cost of 1 Screen $2.1 B $6 B Radiation Exposure mSv 0.7 mSv Mortality 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) Some insurers are already providing LDCT as a covered benefit, but CMS will likely wait at least until the US Preventative Services Task Force issues a recommendation. We hope they hear our message of urgency and ask others to join us in our plea to encourage the task force to make this issue a priority given the potential for lost lives through inaction. Certainly, if we continue to screen for breast cancer, it is unavoidable……..LDCT lung screening will become a covered benefit because as a screening modality, the results are at least as favorable, if not more so than what we see with mammography almost across the board. If you offer to free lung screen, for compliance purposes, it must be free to everyone, even a patient whose insurer provides the benefit.

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 Not all centers can offer free screening. Large multidisciplinary centers like ours with lung cancer centers of excellence should evaluate the possibility of offering free lung screening. We encourage all centers to look to develop low-cost efficient models of care delivery to make access to screening as equitable as possible during this period of transition. Massachusetts residents are required by law to have health insurance, and as such we could minimize concern for subsequent follow-up testing inherent to the screening process and the dilemma of how to fund treatment for any uninsured patient’s diagnosed with lung cancer via free screening. This issue would need to be assessed and addressed by individual health care facilities considering free screening. Uninsured patients with lung cancer will eventually present to the health care system at which time associated costs of treatment are considerable. Most facilities have mechanisms to assist in such situations ,which can perhaps be evaluated in the context of free lung screening. The number of uninsured patients in this age group who fit the tobacco profile required for free screening is actually quite low across the US likely less than 4% of the NLST group. We are developing a financial model whereby an individual center can input its community’s demographics, and diagnostic and treatment costs to estimate the potential amount necessary for a charitable organization to fund the costs of those uninsured patients participating in the program. As an example, a center whose community saw 10% of patients aged to be uninsured would need to be provide a mechanism for payment of lung cancer treatment for one uninsured patient for every 2000 patients screened. We are looking to share our lung screening experience and materials with interested parties through the development of an instructional CD. We are in the process of creating an electronic information package which contains the stripped database for tracking and reporting findings, our structured reporting LUNG RADS paperwork and system, FAQ sheets, CME presentations, and business analyses that can be used to develop a quality focused, evidence based lung screening program at other sites. Those interested should contact us so we can send you the materials when available. The goal is to minimize as much as possible the pain associated with the operational endeavor of starting a responsible, high volume, lung screening program. The Lung Cancer Alliance has issued their National Framework for Excellence which defines and sets expectations for responsible screening programs, because done without careful attention to guideline recommendations and without the support of a multidisciplinary team, there is potential for patient harm. The LCA website is a good resource for those developing a lung screening program.

Rescue Lung, Rescue Life Movement Mission:
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 Here is the Mission of the Rescue Lung, Rescue Life Awareness Movement. To save lives through the early detection of lung cancer with CT lung screening Encourage the government to establish reimbursement for CT lung screening Encourage other centers in a position to do so, to screen for free or low-cost until equitable access is established Begin to break down barriers of prejudice faced by those at risk for lung cancer Raise public awareness of the power of responsible CT lung screening to save lives

Thank You Thank You for your attention. My hope is that you will now take time to consider these ideas, talk to your peers and look to see how you can offer responsible and equitable LDCT lung screening in your own communities and institutions. We would like to help you in whatever way we can. Please feel free to use any of the materials in this presentation and access the free informational CD that we are offering when it is available.

Chairman Department Radiation Oncology Sophia Gordon Cancer Center

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