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LUNG CANCER SCREENING REVIEW & UPDATE

LUNG CANCER SCREENING REVIEW & UPDATE. Mark J. Mayson, MD FCCP PALMETTO PULMONARY PALMETTO HEALTH. August 2012. OBJECTIVES. Review lung cancer statistics and characteristics Discuss pros and cons of screening Review literature and recent studies Discuss current guidelines. LUNCH CANCER .

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LUNG CANCER SCREENING REVIEW & UPDATE

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  1. LUNG CANCER SCREENINGREVIEW & UPDATE Mark J. Mayson, MD FCCP PALMETTO PULMONARY PALMETTO HEALTH August 2012

  2. OBJECTIVES • Review lung cancer statistics and characteristics • Discuss pros and cons of screening • Review literature and recent studies • Discuss current guidelines

  3. LUNCH CANCER • What progress have we made?

  4. HIGH INCIDENCE • Lunch cancer is the #1 cancer killer. • 30% of all cancer deaths • More deaths than next 4 deadliest cancers combined: • Colon • Breast • Prostate • Pancreatic

  5. EPIDEMIOLOGY (2012) • American Cancer Society estimates: • 226,160 new cases • 160,340 lung cancer associated deaths • 2008; 1.4 million deaths worldwide

  6. GEOGRAPHIC CONCENTRATION • Southeast has highest incidence of lung cancer. • 90% of lung cancer related to smoking (including second hand). • Lung cancer mortality now decreasing in men, reflecting lower rates. • 24% of US population smoke.

  7. LUNG CANCER TYPING • NSCLCa ~ 80% • Small cell ~ 20%

  8. LUNG CANCER • 75% of patients present with symptoms due to advanced local or metastatic disease. • Only 16% present as No Stage (TNM) • 37% present with regional LN involvement • Five year survival: 16% • NSCLCa Stage 1 disease > 60% • NSCLCa Stage 4 disease < 5% • Small cell better survival with limited disease • Early detection may improve survival.

  9. THE DILEMMA • Should we screen?

  10. IDEAL SCREENING TEST • High sensitivity for detecting early disease • High specificity • Relative safety; low risk • Cost effective • Acceptance to patients and physicians • Reduce mortality and improve quality of life

  11. PROS & CONS OF SCREENING

  12. LUNCH CANCER SCREENING: PROS • High morbidity and mortality • Significant prevalence (0.5-2.2%) • Identified risk factors allows targeted screening • Lengthy preclinical phase • Outcomes improved with early detection

  13. LUNG CANCER SCREENING: CONS • Detection of abnormalities (benign nodules) which need further evaluation with FNA or resection • Radiation from serial imaging • Patient anxiety related to abnormal finding • Over-diagnosis: indolent cancers identified and treated that would have never contributed to morbidity or mortality • Cost

  14. LITERATURE & STUDIES

  15. CXR SCREENING • At least seven large scale trials • Serial CXR screening • Up to 20 year follow-up • No mortality benefit • Northwest London Trial * • 55,000 workers • Biannual CXR for 3 years • No mortality benefit * Brett GZ. The Value of Lung Cancer Detection by SCX Monthly Chest Radiographs. Thorax. 1968; 23: 414.

  16. CXR & SPUTUM SCREENING • Two large randomized control trials • Johns Hopkins * • Memorial Sloan Kettering ^ • > 20,000 subjects • Group 1: annual CXR • Group 2: annual CXR and sputum cytology • No difference in mortality *Frost JK. Early Lung Cancer Detection: Results of the Initial (Prevalence) Radiographic and Cytologic Screening in the Johns Hopkins Study. Am Rev Respir Dis 1984; 130: 549. ^Melamed MR. Screening for Early Lung Cancer. Results of the Memorial Sloan Kettering study in New York. Chest 1984; 86: 44.

  17. MORE AGGRESSIVE SCREENING • Czech study * • 6,364 smokers, age 40-64 • Biannual CXR and sputum cytology for 3 years with annual CXR for 3 more years • 15 year surveillance follow-up ^ • More early stage cancers found • No mortality benefit *Kubik A. Lung Caner Detection. Results of a Randomized Prospective Study in Czechoslovakia. Cancer. 1986; 57: 2427. ^Kubik A. Czech Study on Lung Cancer Screening: Post Trial Follow-up of Lung Cancer Deaths up to 15 Since Enrollment. Cancer. 2000; 89: 2363.

  18. MAYO LUNG PROJECT • 10,993 male smokers • Initial prevalence screening (CXR and sputum cyto) • Randomization: • Group 1: CXR and sputum cyto every 4 month for 6 years • Group 2: usual care for 6 years • Results: • Prevalence screening identified 91 cancers (0.8%) • At 6 years: Group 1 identified 206 new cancers. Group 2 identified 160 new cancers. Fontana RS. Screening for Lung Cancer. A Critique of the Mayo Lung Project. Cancer 1991; 67: 1155.

  19. PLCO CANCER SCREENING TRIAL • 154,942 participants • Ages 55-74 • Enrollment 1992-2001 • Annual CXR x 3 years • Followed x 13 years (86.6% compliance) • Results: • Initial screening: 5,991 (8.9%) CXR’s abnormal • No difference in lung cancer detection • No difference in lunch cancer mortality • Only 20% of cancers occurring in the screening group were detected by screening Oken MM. Baseline Chest Radiograph for Lung Cancer Detection in the Randomized Prostate, Lung, Colon and Ovarian Cancer Screening Trial. J Natl Cancer last 2005; 97: 1832.

  20. LDCT • High resolution imaging • Single breath hold • No contrast • Radiation exposure ~ 1/5 compared to routine CT • Significantly lower cost than standard CT

  21. ELCAP • Observational study • Participants: 1,000 • Asymptomatic • Smoking history > 10 pack year • Age > 59 • At entry: CXR and LDCT performed • Results: • CXR: 68 noncalcified nodules (7%), 7 had malignant disease (0.7%) • LDCT: 233 non calcified nodules (23%), 27 had malignant disease (2.3%) • 23/27 LDCT (85%) Stage 1 disease • 74% of malignant disease not seen on CXR Henschke CI. Early Lung Cancer Action Project: Overall Design and Findings from Baseline Screening. Lancet 1999; 352: 99.

  22. I-ELCAP • 38 community and academic centers • 5 countries • 31,567 participants • Asymptomatic • 16% non-smokers • Baseline CT scans • 27,456 annual screening CT scan • Follow-up according to center protocol

  23. I-ELCAP (cont.) • RESULTS: • 4,186 (13%) abnormal initial scans • 1,460 (5%) abnormal follow-up scans • 484 lung cancers identified • 412/484 (85%) Stage 1 cancer • 405 of these cancers identified at screening • CONCLUSION: • CT screening detects lung cancer at early stage

  24. I-ELCAP (cont.) • WEAKNESS: • Observational • Results do not address mortality • No control group • Lead time bias • Length time bias • Over-diagnosis biases

  25. MAYO CT STUDY • Prospective observational study. • Participants: 1,520 • Age ≥ 50 yo. • Smoking > 20 pack year • Baseline CT • Annual CT x3 years Swensen SJ. CT Screening for Lung Cancer: Five Year Prospective Experience. Radiology 2005; 235: 259.

  26. MAYO CT STUDY (cont.) • RESULTS: • Baseline CTs: 51% with noncalcified nodules, 1.7% primary lung cancer. • After 3 annual CTs: 73.5% of participants identified with noncalcified nodules, 95% of these nodules benign. • 68 lung cancers identified: 61% of these Stage 1, 33% of these State 3 or 4. • No significant improvement in lung cancer mortality. • CONCLUSION: • CT allows detection of early stage lung cancer.

  27. MAYO, EXPANDED • Results pooled with parallel studies in Milan and Florida. • Participants: 3,246 • Asymptomatic • High risk • Baseline screening CT and annual CT x ave 3.9 years • Control group: validated predictive models Bach PB. Computerized Tomography Screening and Lung Cancer Outcomes. JAMA 2007; 297: 953.

  28. MAYO, EXPANDED (cont.) • RESULTS: • 144 participants diagnosed with lung cancer (predictive model 44.5) • 109 lung resections (predictive model 10.9) • 38 deaths from lung cancer (predictive model 38.8) • CONCLUSIONS: • CT identified more lung cancer leading to more resections, but did not improve mortality

  29. NELSON • Participants: 7,557 • Currently or former smokers • Includes five year lung cancer survivors • CT screening vs. no screening • Powered to detect 25% decrease in lung cancer mortality at 10 years • Measures quality of life, smoking cessation cost-effectiveness Van Lersel CA. Risk Based Selection from the General Public in a Screening Trial: Selection Criteria, Recruitment and Power for the Dutch-Belgian Randomized Lung Cancer Multi-slice CT Screening Trial (NELSON). Int J Cancer 2007; 120: 868.

  30. NELSON (cont.) • RESULTS: • 90 participants identified with lung cancer (1.2%) after 2 rounds of screening • Stage 1 cancer identified in 64% • CT results did not impact smoking abstinence

  31. DANTE • Participants: 2,472 • Male smokers • Ages 60-74 • Design: Annual CT screening vs. clinical visits over 5 years. Baseline CXR and sputum cytology in control group. • Measures lung cancer mortality over 10 years. Infante M. DANTE: A Randomized Trial on Lung Cancer Screening with Low Dose Spiral CT (LDCT): Initial Announcement. Chest 2003; 124: 1185.

  32. DANTE (cont.) • RESULTS: • Initial Evaluation: • 2.2% lung cancer in CT group (7.1% Stage 1) • 0.67% lung cancer in control group (50% Stage 1) • 15% CTs abnormal • 4% underwent invasive procedure • Follow-up (average 33.7 months): • 4.7% lung cancer in CT group • 2.8% lung cancer in control group • More Stage 1 cancers identified in CT group, but mortality not different Infante M. Lung Cancer Screening with Spiral CT: Baseline Results of the Randomized DANTE Trial. Lung Caner 2008; 59: 355.

  33. DANISH TRIAL • Coordinated with NELSON trial (pool results) • Participants: 4,104 • >20 pack year smoking • Age 50-70 • Design: • 5 annual LDCT screening exams vs. no screening • Algorithm followed for suspicious nodules Saghir Z. CT Screening for Lung Cancer Brings Forward Early Disease. The Randomized Danish Lung Cancer Screening Trial: Status After Five Annual Screening Rounds with Low Dose CT. Thorax 2012; 67: 296.

  34. DANISH TRIAL (cont.) • RESULTS: • Initial screening: 0.83% lung cancer prevalence • Annual detection rate 0.67% • CONCLUSION: • More early lung cancer identified, but no effect on mortality.

  35. NLST • Enrolled August 2002-April 2004 • 53,454 participants • Age 55-74 • > 30 pack year smoking history • Former smokers who have quit within 15 years • Two arms: • Annual low dose CT chest (26,722) • Annual PA CXR (26,732) • Data collected regarding lung cancer cases and deaths through Dec. 31, 2009

  36. NLST (cont.) • POSITIVE RESULTS: • LDCT 24.2% (96.2 false positive) • CXR 6.9% (94.5 false positive) • Lung cancer rates: • LDCT 645 cases per 10,000 person-years • CXR 572 cases per 100,000 person-years • Deaths from lung cancer: • LDCT 247 per 100,000 person-years • CXR 309 per 100,000 person-years

  37. NLST (cont.) • RESULTS: • Mortality from lung cancer 20% less with LDCT • All cause mortality 6.7% less with LDCT • 80 lives saved • 1 lung cancer death prevented for 320 persons screened • 1 excess death due to radiation exposure per 2500 persons screened

  38. CONCLUSIONS, GUIDELINES, IMPLICATIONS & RECOMMENDATIONS

  39. CONCLUSIONS • CXR and CT screening detect early stage asymptomatic lung cancers • CT screening is more sensitive • CXR screening does not reduce mortality from lung cancer • CXR and CT screening have high rates of false positive findings • One large randomized trial of screening CT demonstrated a significant mortality reduction • Uncertainty exists about potential harms of screening

  40. WHAT ABOUT PET? • Participants: 911 • ≥ 50 years old • ≥ 20 pack years • Baseline CT revealed 11 NSCLC • Annual follow-up revealed 2 NSCLC • FDG-PET correctly diagnosed 19 of 25 indeterminant nodules • Sensitivity 69% • Specificity 91% • Positive predictive value 90% • Negative predictive value 71% Bastavrika G. Early Lung Cancer Detection Using Spinal Computerized Tomography and Position Emission Tomography. AM J Respir Care Med 2005; 171: 1378.

  41. OTHER APPROACHES • Immunostaining or molecular analysis of sputum for tumor markers • Automated image sputum cytometry • Fluorescence bronchoscopy • Exhaled breath analysis of volatile organic compounds • Genomic and proteomic analysis of bronchoscopic samples • Serum protein microarrays for detecting molecular markers

  42. GUIDELINES 2012 • Endorsed by: • American College of Chest Physicians • American Society of Clinical Oncology • National Comprehensive Cancer Network • American Lung Association • American Cancer Society • American Thoracic Society • US Preventive Services Task Force guidelines under review

  43. GUIDELINES 2012 (cont.) • Lung cancer prevention should be encouraged by tobacco use reduction • LDCT should be considered in: • Current or former smokers, aged 55-74 • > 30 pack year smoking history • No history of lung cancer • LDCT should not be offered to everyone • CXR is not effective for lung cancer screening • Screening should be offered: • Only after counseling of risks and benefits • Only in centers where specialized radiologists and surgeons are on staff

  44. SCREENING IMPLICATIONS • 8 million Americans eligible under new guidelines • 4,000 lung cancer deaths prevented • Nodule detection average 20% • (3-30% in RCTs, 5-51% in cohorts) • 1.6 million abnormal scans • > 95% false positive results

  45. WHAT HAPPENS IF I CHOOSE TO BE SCREENED?

  46. RECOMMENDATIONS • Not using CXR for screening (Grade 1A) • Patients who smoke should be strongly counseled to quit • For patients in good health who are felt to have significant risk of lung cancer (same or grater than patients in NLST), who have access to advanced radiologic, diagnostic, and treatment capabilities, and for whom cost is no issue, recommend LDCT screening (Grade 2B) • For patients who do not meet these criteria, recommend not screening (Grade 2C)

  47. REMAINING QUESTIONS • Define optimal populations • Cost effectiveness • Develop consistent protocols • Define optimal work up for abnormal findings • Determine optimal screening interval and duration

  48. THANK YOU!

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