Thank you for the opportunity to engage in this exchange of ideas regarding responsible screening for lung cancer through the use of LDCT scanning.

Transcription

1 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 provoca@ve concepts over the next 45 minutes. If you find that you are 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 to develop my thinking on these topics, par@cularly the no@on of offering lung screening for free..which in my experience can take most people a to get used to... 1

2 I have nothing to disclose 2

3 We will begin with some background on lung cancer review the IELCAP and NLST results, and the most recent NCCN and American Lung We will discuss some of the 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 MassachuseHs which will include our system for structured repor@ng, the LUNG:RADS classifica@on system: this system was developed in an effort to reduce unnecessary tes@ng of pa@ents, and ensure appropriate follow- up and communica@on of results to all par@es 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 difficul@es. We will conclude with a discussion of the Rescue Lung, Rescue Life awareness and advocacy campaign with its primary objec@ve..to save lives through open access to responsible screening. 3

4 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 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 sta@s@cs. CA Cancer J Clin 2011; 61:69. - Iatrogenic: Radia@on therapy - Occupa@onal and Environmental exposures: Asbestos, second- hand smoke, arsenic, radon, polycyclic aroma@c hydrocarbons - Cancer.gov (NCI/NIH) 4

5 A current or former history of tobacco use is the primary risk factor for 85% of diagnosed with lung cancer. In this slide you see the cancer here, and the risk factor here on the s anterior chest wall. 5

6 I applaud the efforts of such as the American Cancer Society to reduce the prevalence of tobacco use in this country. Here you see an of a pig smoking a cigarehe.. with the implica@on being that smoking is a dirty habit but unfortunately runs the risk of equa@ng smokers with pigs. This type of adver@sing has been effec@ve along with other legisla@ve efforts to decrease the rates of tobacco use from 42% in 1965 to <20% in Unfortunately, we are not seeing the same paherns of reduced tobacco use in developing countries and there has been a price levied by the demoniza@on campaign developed to achieve this reduc@on. I fear we may be paying that price now, as many people feel we should not be alloca@ng resources to help save the lives of current or former smokers. Put in historical perspec@ve, smoking was at widely accepted. Many s@ll prac@cing in medicine can recall when physicians and nurses smoked in the nurse s sta@on, physician s lounge and surgeon s lounge. There are many outstanding individuals contribu@ng greatly to their respec@ve 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 s@mula@ng and seda@ng effects of nico@ne. Many were given a free carton of cigarehes 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 when the medical and poli@cal communi@es 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 popula@on. 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 occupa@onal exposures, such as fire fighters, rescue workers, Navy ship builders, and construc@on 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. 6

7 Not to the and mixed messaging put forth by the tobacco industry, Hollywood, and a variety of other mul@tude of media venues. Here is a mixed message on this slide. The beauty of ScarleH 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 ac@vity and the variety of other risk factors known and unknown that people engage in everyday. Again.where do you draw the line? 7

8 To be clear, smoking and primary remains of importance in our plight to decrease the overall number of lung cancer deaths. Despite the successes in primary however, one hundred and sixty thousand 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 CA Cancer J Clin 2011; 61:69. - Iatrogenic: Radia@on therapy - Occupa@onal and Environmental exposures: Asbestos, second- hand smoke, arsenic, radon, polycyclic aroma@c hydrocarbons - Cancer.gov (NCI/NIH) 8

9 Only 35% of those diagnosed with lung cancer are smoking. The majority of 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 sta@s@cs. CA Cancer J Clin 2011; 61:69. - Iatrogenic: Radia@on therapy - Occupa@onal and Environmental exposures: Asbestos, second- hand smoke, arsenic, radon, polycyclic aroma@c hydrocarbons - Cancer.gov (NCI/NIH) 9

10 FORMER SMOKERS cannot benefit from primary They have done the heavy liming, 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 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 CA Cancer J Clin 2011; 61:69. - Iatrogenic: Radia@on therapy - Occupa@onal and Environmental exposures: Asbestos, second- hand smoke, arsenic, radon, polycyclic aroma@c hydrocarbons - Cancer.gov (NCI/NIH) 10

11 LDCT for lung screening has been around awhile. Dr. Claudia Henschke and the IELCAP Early Lung Cancer Program) has been 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 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 pa@ents who refused therapy died within 5 years of the diagnosis. Concerns regarding bias and over diagnosis prevented the widespread adop@on of lung screening in the wake of this publica@on. Most physicians and medical associa@ons have been wai@ng for the results of the Na@onal Lung Screening Trial to answer these concerns in a randomized fashion. 11

12 The treatment of lung cancer, similar to other malignancies is stage dependent. Earlier stages are treated in a poten@ally cura@ve fashion with surgery, radia@on, or a combina@on of the above plus chemotherapy. Treatment Stage IIIB and IV is mainly pallia@ve in nature. Survival in an UNSCREENED popula@on ranges from 72% for the earliest stage IA to <10% for the most advanced stages. 12

13 Unfortunately in the unscreened 70% of will present with stage III and IV disease and only 30% will have stage I or II disease at presenta@on. This data from the NLST demonstrates stage shiming where the opposite is seen with LDCT screening 70% of pa@ents present in stage I and II and 30% will have later stage disease at presenta@on. 13

14 Here is a PET scan commonly seen in Oncology of a pa@ent with stage IV NSCLC. The pa@ent has a lem lobe primary tumor with metastases to a contralateral hilar node, the ipsilateral adrenal gland and the liver. The 5- year survival for this pa@ent is <1% 14

15 In the absence of screening, who have been cured of lung cancer, for the most part have had their disease discovered incidentally on a CXR or diagnos@c CT. Only a few symptoma@c pa@ents with lung cancer are cured of their disease. This gentleman has a 58% 5- year overall survival amer his stage IB lung cancer was diagnosed during a pre- opera@ve CXR evalua@on prior to hip replacement. He had no symptoms of lung cancer. 15

16 This case is from an 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 rou@ne follow- up. She has jogged 3 miles a day 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? 16

17 Let s say you discuss the risks and benefits of screening and she makes the informed decision to undergo LDCT tes@ng. 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 pa@ent calls wan@ng 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. 17

18 She is found to have a screened pathologic IA NSCLC at of surgery. The pa@ent has a 92% 5- year OS. 18

19 This is the idea behind secondary 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 wai@ng for symptoms to develop with a dismal prognosis. 19

20 Screening is not an unusual concept in this country. Of the top 4 cancer killers lung, prostate, breast, and colorectal cancer 20

21 We screen for all of these diseases except lung cancer. Now, the data to screen for lung cancer with LDCT is as good or beher than the quality of the data for these other disease sites. So let us review the newest evidence. 21

22 The Lung Screening Trial (or the NLST) was published in the NEJM on- line in June of 2011 and in paper last August. The authors concluded that screening with the use of LDCT reduces mortality of lung cancer. 22

23 The trial was a mul@- ins@tu@onal randomized trial sponsored by the NCI and ACRIN that cost an es@mated $300 million dollars to conduct 23

24 There were almost 54,000 ranging from the age with a >30 Pack year history of tobacco use who were currently smoking or quit within the past 15 yrs. Pa@ents were enrolled between 2002 and Exclusion criteria are listed on the right. Of note, pa@ents had to be medically operable, asymptoma@c, and have no prior history of cancer within the past 5 years. 24

25 were randomized to LDCT vs CXR. Baseline prevalence scans were performed followed by 2 addi@onal screens - so three scans over 2 years. A posi@ve 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 pa@ent s primary care physician, NOT the NLST. HOWEVER, the NLST reading radiologist s recommenda@on was available. 25

26 In November of 2010 the study was halted early when the 20% lung cancer specific mortality 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% reduc@on in overall mortality that was not sta@s@cally significant when lung cancer deaths were excluded. 26

27 The study also demonstrated that one in one hundred of these 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 320. This means that for every 320 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. 27

28 Not surprisingly, LDCT is more approximately more than CXR. On the first 2 screens there is a 27% chance for a lung finding. Amer 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 popula@on or approximately 7 million pa@ents in the US. 28

29 False were handled non- invasively for the most part with CXR, CT or PET/CT for follow up. Invasive procedures on who didn t have cancer were rare at 2.6%. The complica@on rate for pa@ents who didn t have cancer was also rare at 1.4%. The major complica@on rate for those without cancer was very rare at. 06%. FOR PATIENTS WHO HAVE CANCER the risk for major complica@on was 11.2% and the surgical resec@on mortality rate was 1%. But remember, these pa@ents actually have cancer. 29

30 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 addi@onal 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 pa@ent 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 posi@ve biopsy rate (meaning the chance that you have a biopsy when you do NOT have cancer is.4-2.4% for LDCT and 7-15% for mammography. 30

31 Within a few months of the NLST publica@on the NCCN released their new guidelines on lung screening on October 26 th The NCCN or the The Na@onal 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 effec@veness of care provided to pa@ents 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. Amer weighing all these considera@ons 31

32 They issued a category I recommenda@on to screen the NLST popula@on. Category I is uniform consensus based on the highest level of evidence available that the interven@on is appropriate. 32

33 A category 2B was issued for the who are found to be at high risk based on previous non- randomized Category 2B is based on lower level evidence there is NCCN consensus that the is appropriate 33

34 For comparison purposes Mammography has a category 2A recommenda@on to screen. 34

35 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 for when the pa@ent quit and one other risk factor is iden@fied not to include exposure to second hand smoke 35

36 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. 36

37 Here is the decision tree- which is based on the NLST and IELCAP studies. The for imaging follow- up are based on the and the size of the finding. Nodules smaller than 4 mm are not considered posi@ve with 12 month annual screen follow- up. A pa@ent 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. 37

38 Here are the risks and benefits the NCCN anxiety is listed as both a risk and a benefit. In our experience thus far, pa@ents 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 tes@ng, radia@on exposure, and cost in more detail. 38

39 Let s start first with this issue of over diagnosis or pseudo- disease and in so doing develop some clarifica@on on the difference between a survival benefit vs a mortality benefit. Star@ng with survival. If the red star represents diagnosis of lung cancer and the lightning bolt death, the top line represents pa@ents undergoing LDCT and the bohom line is CXR. You can see that in this scenario there is a survival advantage. However, even though technically pa@ents are surviving longer with a diagnosis of cancer, they live no longer than had they been diagnosed later. This difference here is a bias. 39

40 Contrast that with a mortality benefit where again you have LDCT on top and CXR on the bohom. But death due to lung cancer occurs at a point in the LDCT arm. In this scenario, the issue of bias is mi@gated by the fact that pa@ents are in fact living longer than they would have had they been screened with CXR. Sta@s@cians calculate the mortality difference here based on the factors of numbers of pa@ents and how much longer they are alive in a construct known as person years 40

41 When you isolate death sue to lung cancer only, the mortality difference is 20%. Here you see 443 had died at the study endpoint in the CXR arm and MUCH FEWER 365 had died in the LDCT arm. 41

42 When you look at death due to any cause across the group of 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 through the process of screening and treatment of early- detected lung cancer 42

43 What other treatments confer a 7% survival benefit in oncology? Here is a list of interven@ons associated with a similar benefit that we use to treat cancer pa@ents in order confer that advantage.months of risk- adapted systemic chemotherapy or chest wall radiotherapy amer mastectomy in pa@ents with breast cancer, risk- adapted post- opera@ve radiotherapy to men with prostate cancer, risk- based post- opera@ve chemoradiotherapy to pa@ents 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 op@ons for therapy with our pa@ents). In light of the NCCN category I recommenda@on to screen, we in oncology, became concerned about the medical legal risk for our PCPs were they not to systema@cally review the risks and benefits of screening with their at- risk pa@ents. 43

44 Here we look at the!me and cause of death for ONLY the cohort of diagnosed and treated for lung cancer. A pa@ent who dies of other causes, be it they died of heart disease, emphysema, or a fatal ski accident 2 years amer surgery for a low- grade (formerly BAC) adenocarcinoma, or in its most extreme example were hit by a bus 2 days amer their lobectomy for lung cancer was overdiagnosed. Overdiagnosis is inherent to any screening program. It is es@mated to be about 15-20% in lung cancer screening, but we will never actually know. This is because 1) There is no observa@on arm in the NLST. The control arm was CXR which is not observa@on and 2) We must wait for pa@ents 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 it does not increase 44

45 Let s switch gears to radia@on exposure. Here you see 2 CT scans of the same pa@ent. The one on the lem is a LDCT performed with mul@- detector imaging on the right is a standard diagnos@c CT. The LDCT exposes the pa@ent to <1mSv, similar to a bilateral 2- view mammogram, and maintains its diagnos@c capabili@es for pulmonary nodule detec@on at one tenth the dose of the one on the right with its associated 10mSv exposure. 45

46 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. Occupa@onal exposure for a radia@on worker such as myself is 50mSv, I am allowed each year to be exposed to the equivalent of 50 LDCT studies. A transatlan@c flight is.1msv such that 7 transatlan@c flights equals 1 LDCT. Also an important considera@on regarding radia@on risk is the year latency period to develop secondary malignancies as a result of RT exposure. The average age of pa@ents in screening programs is 62. 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 pa@ents has lung cancer. 46

47 In order to reduce the risk for unnecessary standardize terminology, organize 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) 47

48 Our LUNG RADS system has both a lung number category and an S category which is either posi@ve or nega@ve for any poten@ally significant extra pulmonary finding. Category 1 is nega@ve return next year for annual screen Category 2 is nega@ve 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 Posi@ve/likely benign recommenda@on for follow- up per the NCCN guidelines % of your cases will fall into this category depending upon which year of screening the pa@ent is in. Category 4 is posi@ve - suspicious for malignancy. These pa@ents are sent back to their PCP with a recommenda@on for pulmonary consulta@on to determine direc@on of further evalua@on. Category 5 we shouldn t really be seeing because these are pa@ents with recent known lung cancer who should be receiving follow- up care under the direc@on of followed their oncology team. Examples of an S posi@ve study would include findings such as a thyroid mass, aneurysm, or kidney mass. 48

49 Let s talk for a minute about how lung screening differs from screening in other disease sites. Lung screening is a process, which occurs that is how we avoid unnecessary biopsies and invasive procedures, by handling the findings with further radiographic studies and wai@ng to intervene once growth of a small nodule has been established. When we think about screening in breast cancer, or prostate cancer, the pa@ent, and provider hopes to pick up the cancer at the earliest possible screen, - at the first sign of an eleva@on 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 pa@ent has cancer (category 4), you may or may not save that pa@ent 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 pa@ents who actually have cancer will have the poten@al for the 92% survival rate). 49

50 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 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 es@mate for quality adjusted cost per life year saved which by report, a back of the envelope es@ma@on has put the number at $38,000. We can all argue about which model and which assump@ons to use, but the fact of the maher is that 50

51 As of late fall 2011 both Anthem of California and Wellpoint 2 of the na@on s largest insurers are covering this benefit for those pa@ents mee@ng the NLST criteria. One must ask why? I can t imagine they are doing so in order to ahract 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 informa@on given the cost associated with diagnos@c scans, chemotherapy, and radia@on to palliate and treat end- stage disease. 51

52 Not to the considerable lost revenues associated with loss due to lung cancer an 36 billion per year..much greater losses for lung cancer than what is seen for any of the other malignancies listed here considerable indeed. 52

53 There is a growing list of well known centers who currently offer lung screening at a self pay rate. The Advisory Board Company surveyed par@cipa@ng centers in March of 2012 and found that 32% of par@cipa@ng 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 some@me over the past 9 months. The mean number of pa@ents screened in programs that offer screening is 70 for the year % of pa@ents pay out of pocket with a self- pay rate between ( dollars). The average rate across centers who do screen is $

54 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 pa@ent outcomes which is not surprising because most clinicians and administrators are genuinely concerned for the well- being of the pa@ents they care for. For those centers not considering CT screening, the most common reason cited was lack of reimbursement also not surprising. 54

55 Some other barriers to screening we have heard expressed are concern raised over the applicability to outside the study group and how long to screen for? It is true there may be others who will benefit from lung screening. 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 to be saved through screening. The NCCN has given us a good start regarding dura@on of screening based on the evidence we do have. The current lack of public and medical educa@on surrounding the topic, par@cularly in the wake of years and years of debate and confusion associated with lung screening is a barrier which has been compounded by the rela@vely slow endorsement of this modality by expert specialty and advocacy groups. But the number one issue we 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. 55

56 This month a Na@onal Survey of lung screening prac@ces from was published in the Annals of Family Medicine. The study polled 962 general prac@@oners and found that only 38% had not offered screening to pa@ents. The majority of pa@ents screened were offered a CXR with 55% and 22% had been screened with LDCT. On mul@variate 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 effec@ve, or when pa@ents asked about screening. 56

57 Although I found this informa@on interes@ng because it clearly demonstrates a lack of consensus and confusion regarding screening prac@ces in this country, the crux of the ar@cle was upsexng, 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 asymptoma@c individuals, even those with heavy or long term smoking histories, for lung cancer. They go on to site the US Preventa@ve Services Task Force who has openly admihed the need to review their posi@on 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, mul@- ins@tu@onal, NCI funded, randomized trial with 54,000 pa@ents that was closed early due to the sta@s@cally significant mortality advantage a rigorous study, then we probably should not have conducted it. 57

58 Fortunately, the NCCN released their guidelines amer the NLST but perhaps not for the authors to include the NCCN in their In the very same month as the Annals of Family was released, APRIL of 2012 the American Lung released their new guidelines. The American Lung is considered one of the world s leading organiza@ons working to save lives by improving lung health and preven@ng lung disease through Educa@on, 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 omen 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 pa@ents Call to ac@on 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. 58

59 Dr. James Mulshine, Associate Provost and Vice President for Research at Rush University Medical Center has said in reference to the NLST, With this trial result, we have the opportunity to realize the greatest single 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 whose mission is to reduce cancer mortality and improve the health of with lung disorders, cannot remain silent at this in cancer history. Now is to lead. 59

60 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 un@l reimbursement is established. We offered LDCT for 9 months at a self- pay rate of $300 and we screened 4 pa@ents all of whom were from our concierge level execu@ve health program and could afford the screen. Since we started free screening on January the 9 th we have screened over 230 high- risk pa@ents with no adver@sing 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 ahen@on to itself. There is something about the word FREE that calls upon people to listen. People are mo@vated 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, pa@ents, and administrators pay ahen@on to this cri@cally important issue. I imagine some are offended at the no@on of offering a complex, intricate, highly sophis@cated service like CT screening that is not without risk to the pa@ent (or the provider), and requires years of collec@ve training and combined exper@se, for free. Amer 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 solu@on is not perfect. But what choice do we have??? we ARE in the health care industry Is it beher to knowingly let people die? It will likely be several years before CT screening becomes a uniformly covered benefit. In the mean@me, there exists uniform consensus to screen within the NCCN and an American Lung Associa@on recommenda@on to screen high risk pa@ents. Free lung screening is an interim measure a construct developed in response to an in cancer history when we find ourselves absent equitable reimbursement, but now aware of the poten@al 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 na@on. And it just may be that large mul@disciplinary centers can afford to provide this service free of charge un@l reimbursement is established. As long as the hospital is profitable, it may also be possible to apply a por@on of the free program costs toward a center s community service benefit, which was a strong contribu@ng factor for us. By bringing together experts at our ins@tu@on 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, me@culous ahen@on was paid to quality and safety. This is in fact the primary reason our senior administra@on 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 innova@on, sustainability, and teamwork. The development of this program was an extraordinary mul@disciplinary effort, which you will now hear about. 60

61 We developed a low- cost model to u@lize the exis@ng infrastructure on our CT scanners. We have mul@ple scanners throughout our organiza@on and were able to iden@fy 30 slots for a pilot program to screen 30 pa@ents per week. We had approval to use down@me amer hours, bringing in an over@me team if necessary for poten@al overflow. We secured an easy to remember 800 line so pa@ents could call directly for informa@on, but we required that the test be ordered by the pa@ent s PCP. We developed an extensive, rela@onal database to help manage the findings similar to our exis@ng database in mammography, but set to the NCCN guidelines for follow- up recommenda@ons and our structured repor@ng LUNG RADS system. 61

62 Here is the flow. The calls 855- CTCHEST to inquire if they qualify for lung screening. Our schedulers have been trained to assess eligibility. are advised that we must have an order from the s PCP in order to screen. We provide and their PCP with FAQ sheet regarding the risks and benefits of screening to help guide their discussion. 62

63 s who don t qualify are educated as to what cons@tutes high- risk, but they may wish to speak directly to their pcp regarding their par@cular risk. 63

64 Those who fall into the NCCN Group 2 are contacted by our nurse navigator to assess for possible secondary risk factor. 64

65 NCCN group 1 pa@ents and those found to qualify in Group 2 are determined to be asymptoma@c and their PCP is recorded or assigned if necessary 65

66 Order is obtained and 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. 66

67 An internally radiologist interprets the scan and reports according to the LUNG RADS structured system. 67

68 A study (LUNG RADS 1 or 2 S nega@ve) will be scheduled to return in 1 year. This will be 2/3 of cases screened. 68

69 S 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 pa@ents screened. 69

70 As of 2/24/12 when we looked at the first 105 we verbally screened twice that number. 179 had been scheduled. 105 had already been scanned. 156 of scheduled were Lahey 23 were non- Lahey presumably of Lahey employees as we made no effort to market outside of Lahey. 70

71 We learned from our survey that most PCPs did not require a visit prior to ordering the test and pa@ents 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 clarifica@on of what that follow- up meant. 71

72 The 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 pa@ents requiring further evalua@on. One Lahey PCP was assigned to a pa@ent without a PCP. We presented our pilot to senior administra@on and have received approval to offer free LDCT screening for 5 years or un@l reimbursement is established. 72

73 In speaking about this program to others, many clinicians and administrators want to know how we received approval. We started with a mul@disciplinary team and iden@fied physician and administrator champions from representa@ve areas of the organiza@on to be part of a steering commihee - which oversees the program and the educa@on and awareness campaign that is associated with lung screening. We meet every 2 to 3 weeks and share group exchanges regarding any new informa@on that becomes available to anyone on the team for the benefit of the whole group who then imparts such informa@on to their respec@ve disciplines. We focused the program to be evidence- based. We developed a comprehensive business plan based on the NLST experience to allow administra@on 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 educa@on plan, which we con@nue 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, educa@on regarding screening as a process, concern for en@cement or hidden cost to the pa@ent, par@cularly those who are uninsured, worry that we might overload the radiology department, PCPs, or specialists, the percep@on of outside hospitals and clinicians about our poten@al mo@ves for free screening, and concern over what might happen if reimbursement is not established. 73

74 Here is the Rescue Lung, Rescue Life Steering CommiHee. We decided to name the awareness movement Rescue Lung, Rescue Life because we want to draw a parallel to rescue situa@ons. 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 commihee consists of a large group of dedicated and commihed professionals from all aspects of the hospital, many of whom took on addi@onal job responsibili@es just to make this program succeed. I am very proud to be a part of this group. 74

75 We were able to alleviate concerns for volume overload through 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 popula@on numbers should be for our pa@ent base. According to the NLST approximately 3% of the popula@on would qualify for the high- risk group. We verified this number independently through CDC informa@on. We es@mate that approximately 4500 pa@ents per year from our own pa@ent base would screen 75

76 This would result in 100 screenings per week for our radiology department The diagnosis of 1 cancer per week 76

77 27 findings that would require further radiologic CT imaging.. 77

78 and 7 poten@ally significant findings requiring further evalua@on. 78

79 Amer 2 years of screening we will save 1 life every 3 weeks.that is 1 life every 3 week from our own community. 79

80 For an individual PCP who generally has a 2500 pa@ent panel, we es@mate the need to provide counciling and order LDCT scans on 75 pa@ents, issue a follow- up order and manage ques@ons for 20 pa@ents found to have a lung nodule, and manage 5 pa@ents with poten@ally significant incidental findings each year. The database will track all recommended follow- up for the pa@ents, 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 educa@on materials, CME campaign, and selec@ve marke@ng helped to alleviate concerns regarding informed consent, en@cement concerns, and percep@on of outside facili@es. 80

81 Some insurers are already providing LDCT as a covered benefit, but CMS will likely wait at least un@l the US Preventa@ve Services Task Force issues a recommenda@on. 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 poten@al for lost lives through inac@on. Certainly, if we con@nue 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 pa@ent whose insurer provides the benefit. 81

82 Not all centers can offer free screening. Large 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 MassachuseHs residents are required by law to have health insurance, and as such we could minimize concern for subsequent follow- up inherent to the screening process and the dilemma of how to fund treatment for any uninsured s diagnosed with lung cancer via free screening. This issue would need to be assessed and addressed by individual health care considering free screening. Uninsured with lung cancer will eventually present to the health care system at associated costs of treatment are considerable. Most have mechanisms to assist in such can perhaps be evaluated in the context of free lung screening. The number of uninsured 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 diagnos@c and treatment costs to es@mate the poten@al amount necessary for a charitable organiza@on to fund the costs of those uninsured pa@ents par@cipa@ng in the program. As an example, a center whose community saw 10% of pa@ents aged to be uninsured would need to be provide a mechanism for payment of lung cancer treatment for one uninsured pa@ent for every 2000 pa@ents screened. We are looking to share our lung screening experience and materials with interested par@es through the development of an instruc@onal CD. We are in the process of crea@ng an electronic informa@on package which contains the stripped database for tracking and repor@ng findings, our structured repor@ng LUNG RADS paperwork and system, FAQ sheets, CME presenta@ons, 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 opera@onal endeavor of star@ng a responsible, high volume, lung screening program. The Lung Cancer Alliance has issued their Na@onal Framework for Excellence which defines and sets expecta@ons for responsible screening programs, because done without careful ahen@on to guideline recommenda@ons and without the support of a mul@disciplinary team, there is poten@al for pa@ent harm. The LCA website is a good resource for those developing a lung screening program. 82

83 Here is the Mission of the Rescue Lung, Rescue Life Awareness Movement. To save lives through the early of lung cancer with CT lung screening Encourage the government to establish reimbursement for CT lung screening Encourage other centers in a posi@on to do so, to screen for free or low- cost un@l 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 83

84 Thank You for your My hope is that you will now 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 and We would like to help you in whatever way we can. Please feel free to use any of the materials in this and access the free CD that we are offering when it is available. 84