Disclosures. Overview. Selection the most accurate statement: Updates in Lung Cancer Screening 5/26/17. No Financial Disclosures

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1 Updates in Lung Cancer Screening Disclosures No Financial Disclosures Neil Trivedi, MD Associate Professor of Clinical Medicine SF VAMC Pulmonary and Critical Care Director, Bronchoscopy & Interventional Pulmonology Overview Lung Cancer: Scope of the problem Risk Factors and Prevention Lung Cancer Screening Trials Limitations and Harms of Screening Current Guidelines Selection the most accurate statement: A. I have been recommending lung cancer screening to my patients that qualify B. I am still trying to decide whether to recommend lung cancer screening to my patients C. I do no think we should be recommending lung cancer screening 1

2 Lung Cancer Facts Lung Cancer in the US 222,500 new cases per year in the US in ,870 deaths from lung cancer in 2016 $12.1 billion spent per year on lung cancer treatments NIH/NCI SEER Cancer Statistics CA Cancer J Clin 2011; 61: CA Cancer J Clin. 2014;64:9-29. Lung Cancer Mortality 5 Year Survival in Common Cancers Site 1970s 1990s Current Prostate 68% 95% 99% Breast 75% 86% 90% Colon 50% 60% 65% Lung 12% 14% 18% CA Cancer J Clin. 2014;64:9-29 SEER/NCI 2

3 5/26/17 Lung Cancer Diagnosis and 5- Year Survival Percentages The Lung Cancer Paradox 60% 50% 52% Diagnosis 5- Year Survival Overview Lung C ancer: Scope o f the p roblem 56% Risk Factors a nd P revention 40% 30% 20% 10% 0% Lung C ancer Screening Trials 24% 22% Limitations a nd H arms o f Screening 15% 4% Localized Regional Distant Current G uidelines Stage at Diagnosis SEER C ancer D atabase Risk Factor(s) for Lung Cancer US Cigarette Consumption US S urgeon General s R eport 1971 Broadcast Ad B an st report l inking smoking t o l ung c ancer 1998 Tobacco M aster Settlement A greement - - $206 b illion Chest ;123(1 S uppl):21s. 3

4 Smoking Consumption and Lung Cancer Per Capita Cigarette Consumption 2010 to year Lag Smoking Cessation and Lung Cancer Risk 80-90% risk reduction for lung cancer after 15 years of quitting If a smoker quits before age 30, lung cancer risk is the same as a never smoker Smoking reduction is only mildly effective Overview Lung Cancer: Scope of the problem Risk Factors and Prevention Lung Cancer Screening Trials Limitations and Harms of Screening Current Guidelines BMJ 2000;321:323-8 Lancet 2013;381:

5 Lung Cancer is the Ideal Target for Screening Is there significant morbidity and mortality? YES Are there known factors that identify high risk populations? YES Will early detection improve survival? YES Is there an effective screening test? Decreases Mortality Minimal Harm Early Trials of Lung Cancer Screening Six large chest x- ray trials conducted between s No reduction in lung cancer mortality Trial of sputum cytology and chest x- ray every 4 months for 6 years No reduction in lung cancer mortality JNCI 2000;92:1308 CHEST CT Versus CXR Trial of 53,454 adults 33 clinical site in the US Chest CT Chest Xray Inclusion Criteria years old 30 pack- years of tobacco exposure Pack- years (packs per day X years smoked) Smoked within past 15 years Medically fit to undergo curative surgery NEJM 2011;365:

6 Patient Exclusion Criteria Home oxygen dependence Unexplained weight loss >15 pounds in past year Recent hemoptysis History of lung cancer Pneumonia in the past 12 weeks Randomly assigned to annual low dose Chest CT (LDCT) for three years VS Annual Chest X- rays After three years of screening, subjects followed for up to 7 years NEJM 2011;365: NEJM 2011;365: Low Dose Chest CT Lung Cancer Screening Results Routine Low-dose 938mGy/cm 15.9 msv 88mGy/cm 1.5 msv Screening Round Total Population Number of New Lung Cancers First Round - Chest CT 26, Second Chest Round CT - Chest CT 24, Third Chest CT 24, After 3 Negative CTs Chest CT can detect lung cancers in high risk people NEJM 2010;; One negative Chest CT is not sufficient screening 6

7 5/26/17 Lung Cancer Screening Results 20% relative reduction Cancer Screening Tests Number Needed To Screen to Save a Life Test Number Needed to Screen Pap Smear for Cervical Cancer 1,140 Mammography Age> Mammography Age ,125 FOBT for Colorectal Cancer Low Dose Chest CT for Lung Cancer 320 Number Needed To Screen = 320 Early Detection with Low dose CT Which of The Following Patients is Most Likely to Benefit from Lung Cancer Screening? A. 52 year old male current smoker with a 40 pack- year history B. 70 year old female current smoker with a 25 pack- year history C. 65 year old male former smoker with 50 pack- year history who quit 5 years ago D. 73 year old male current smoker with 60 pack- year history and O2- dependent severe COPD 7

8 Overview Lung Cancer: Scope of the problem Risk Factors and Prevention Lung Cancer Screening Trials Limitations and Harms of Screening Current Guidelines Harms of Lung Cancer Screening False positives (aka benign lung nodules) on imaging Overdiagnosis Cost Radiation Exposure Benign Lung Nodules are Common 25% of Lung Cancer Screening Chest CTs will show lung nodules ( 4mm) 96% of lung nodules are benign Additional workup of the nodule can cause harm 2.7% had unnecessary invasive procedure 0.6% major complication Patient anxiety NEJM 2011;365: Lessons Learned from NLST LungRADS Nodule Management False positive rate declined from 27.6%à 10.2% No impact on missed cancer rate Ann Intern Med 2013:159:

9 Overdiagnosis and Cancer Screening Detection of Indolent Cancers That Would Never Harm Patients Overdiagnosis and Lung Cancer Screening Thyroid Cancer Incidence Mortality Per 100,000 Per 100, % Change % Change For every life saved by lung cancer screening there is 1.38 overdiagnosed lung cancer 18% of all cancers detected by lung cancer screening seem to be indolent 2 years Lung Adenocarcinoma Eur Resp J : JAMA Intern Med. 2014;174: Cost- effectiveness of Lung Cancer Screening Cost Effectiveness and Cancer Screening 9 million people could be eligible for screening Medicare cost would be $9.3 billion over 5 years $81,000 for each year of quality life gained (QALY) Cancer Screening Cost per Life Year Saved Breast Cancer (digital mammography) $84,500 Lung Cancer (Chest CT) $81,000 Cervical Cancer (pap smear + HPV testing) $78,000 Colon Cancer (colonoscopy) $56,800 Cost in Women = $46,000 Cost in Men = $147,000 Cost in Active smokers = $43,000 Cost in Former smokers = $615,000 NEJM 2014;371: J Clin Oncol 32:5s, 2014 Ann Intern Med 2008;148:1-10 J Natl Cancer Inst 2008;100: Am J Gastro 2013; 108:

10 Harms of Lung Cancer Screening Radiation Exposure Radiation CT scan, full body CT scan, lung cancer screening Natural background radiation from living at high- altitude (e.g. Denver, Salt Lake City) Natural background radiation from living at sea level Newer Multidetector Row CT scanners Amount msv 1.5mSV 6 msv (per year) 3 msv (per year) msv A 59- year- old woman asks you about the risks and benefits of a screening CT scan for lung cancer. She has a 40 pack- year smoking history but quit 7 years ago. She is otherwise well. Which of the following statements regarding low- dose CT (LDCT) for lung cancer screening is true? A. It will lead to unnecessary invasive procedures in at least 10% of patients B. It will reduce mortality from lung cancer by around 20% compared to screening by CXR C. The chance of finding an indolent lung cancer is 10 times greater than finding a life threatening lung cancer D. There is no role for LDCT for this patient since she quit smoking > 5 years ago Cancer 2014;120: Overview US Preventive Services Task Force Lung Cancer: Scope of the problem Risk Factors and Prevention Lung Cancer Screening Trials Limitations and Harms of Screening YES NO INSUFFICIENT EVIDENCE Breast women Ovarian Bladder Cervical women Testicular Oral Colorectal Prostate Thyroid Pancreatic Skin Lung (2004) Current Guidelines 10

11 US Preventive Services Task Force YES NO INSUFFICIENT EVIDENCE Breast women Ovarian Bladder Cervical women Testicular Oral Colorectal Prostate Thyroid Lung (2013) Pancreatic Skin Lung Cancer Screening Guidelines USPSTF Criteria Ages pack- years smoking history Active smoker or quit < 15 years No conditions that are substantially life- limiting Approved in Feb 2015 Coverage of Lung Cancer Screening Medicare and Private Insurers Private Insurers Patient Eligibility Shared Decision Making Screening Facility Eligibility Medicare years pack- years - - Smoke in Past 15 yrs Required - - In Office Visit - - Use of Decision Aids - - Discussion of Benefits and Harms - - Required Low Dose CT - - Use of Standard Reporting System Like Lung RADS - - Data submitted to a registry USPSTF Guidelines years pack- years - - Smoke in Past 15 yrs Recommended Suggested Low Dose CT Smoking Cessation Must be available Recommended Lung Cancer Screening Decision Tool 65 YO Man - Active Smoker - 40 pack- years - COPD 11

12 Lung Cancer Screening Decision Tool - Shared Decision Making Smoking Cessation and Lung Cancer Screening Screening is a teachable moment for smokers Formers smokers who quit for 7 years had a 20% lung cancer mortality reduction, equivalent to Low dose CT screening (LDCT) Smoking cessation and LDCT screening resulted in a 38% reduction in lung cancer mortality Stop LDCT screening once they quit > 15 years AJRCCM 2016;193: Summary Lung cancer is leading cause of cancer- related death Tobacco avoidance is the best strategy to reduce lung cancer risk Annual low dose chest CT is effective tool in lung cancer screening 55- (77-80) year old patients smoked 30 pack- years, active smokers or quit within 15 years in good health Counsel your patients before screening. Shared decision making of risks and benefits Summary My Final Recommendations Follow strict criteria for high risk patients Do it at a center with appropriate radiologic, diagnostic, and treatment capabilities Doctors and patients have to commit to close follow up 12

13 Thank You! Future Directions Lung Cancer Screening Individual Risk- based selection vs Risk- Factor based Biomarkers for lung cancer risk Adherence to annual screening necessary? Maintenance of the high quality seen in the NLST to clinical practice 13