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Lung Cancer Screening Update

Lung Cancer Screening Update. 29 th Annual Denali Oncology Group Reginald F. Munden MD, DMD, MBA. I have no conflicts of interest to report. L. N. T. S. National Lung Screening Trial National Cancer Institute. NLST - ACRIN. Randomized 1:1

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Lung Cancer Screening Update

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  1. Lung Cancer Screening Update 29th Annual Denali Oncology Group Reginald F. Munden MD, DMD, MBA I have no conflicts of interest to report

  2. L N T S National Lung Screening Trial National Cancer Institute

  3. NLST - ACRIN Randomized 1:1 Experimental Arm 1 Control Arm 2 Spirometry Spirometry Baseline Low-Dose Helical CT Baseline PA CXR (Baseline samples blood, urine, sputum) Annual incidence screen x 2 Annual incidence screen x 2 (Low dose helical CT) (PA CXR) Questionnaires: Interval Questionnaires: Interval Health Health Q6 months: Interval health status x 6- 8 years

  4. NLST - ACRIN CT Protocol • Single breath hold • kVp 120-140 • mAs 40 – 100 • Collimation 10 mm, 20mm • Reconstruction slice thickness 2.5mm interval 1.25mm algorithm soft tissue and high spatial frequency

  5. NLST – ACRINInterpretation • Nodule classification • benign – calcified; fat; or < 4mm micronodule • abnormal - >10mm, enlarging > 7mm • indeterminate - 4 – 10mm; enlarging < 7mm

  6. NLST – ACRINInterpretation • Negative screen No significant abnormalities • Negative screen, minor abnormalities not suspicious for lung cancer Benign nodules, micronodules, atelectasis/scar, coronary artery calcification (?) • Negative screen, significant abnormalities not suspicious for lung cancer Aortic aneurysm, mediastinal/thyroid mass, pericardial/pleural effusions, axillary adenopathy, chest wall lesion, spine lesion

  7. NLST – ACRINInterpretation • Positive screen Nodule 4-10mm or enlarging nodule • Positive screen Nodule >10mm, enlarging nodule > 7mm, lung mass, other non-specific abnormality suspicious for lung cancer

  8. NLST - Recommendations • No intervention – continue screening • Comparison with historical • Thin section CT: 3, 6, 12 months • Diagnostic CT • CT nodule densitometry • PET • Biopsy

  9. NLST Design

  10. 33 participating sites LSS si

  11. NLST Cumulative Accrual 53,454 34,614 18,840

  12. ACRIN-NLST Sub-Studies • Serial specimen collection for validation of biomarkers (N=10,260) • Plasma | buffy coat; sputum; urine annually x 3 yrs • Resected lung cancer specimens • Applications to use specimens for research www.acrin.org • Quality of Life • Differential impact of screening of QoL at T0, T1, T2 (SF-36, EQ-5D) • Differential impact of [+] screen on anxiety (SF-36, EQ-5D, STAI) Administered at T0, 30 days post [+] screen and Q 6 months) • Formal CEA (in conjunction with RAND) • Effects of screening on smoking behaviors | beliefs • Short and long term

  13. Comparison: NLST with US census population

  14. Comparison: NLST with US census population

  15. Family history

  16. Screening Exam Compliance

  17. NLST Timeline 1st Interim Analysis 2nd Interim Analysis 4th Interim Analysis 3rd Interim Analysis 5th Interim Analysis 6th Interim Analysis T0 time 9/02 9/03 9/04 9/05 9/06 9/07 9/08 9/09 9/10 10/20/10 T1 T2

  18. Screen Positivity* Rate byScreening Round and Trial Arm *A positive screen is one that may be suspicious for lung cancer **A suspicious abnormality that has been stable for 3 rounds may be called negative

  19. Lung Cancer ScreeningNLST Interim Analysis of Primary Endpoint - Oct. 20, 2010 Deficit of lung cancer deaths in CT arm exceeds that expected by chance

  20. Lung Cancer Screening:NLST All-cause mortality

  21. Lung Cancer Screening:NLST Results CTCXR (%) Positive Clin sig Positive Clin sig TO 27 10 9 3 T1 28 6 6 2 T2 17 6 5 1

  22. NLST Results:Positive Screens • CT - 39% • Clinically significant other than lung cancer – 7.5% • CXR – 16% • Clinically significant other than lung cancer -2.1% • > 90% positive = diagnostic evaluations • 81% - radiology (CXR – 18; CT 73; PET – 10) • Bx – 2.2; Bronch – 4.3; Surgery – 4.2, other 2.4

  23. NLST Results:Lung Cancers • CT - 1060 • 649 on CT • 44 on negative CT • 367 other (missed or detected after screening ended) • CXR - 941 • 279 CXR • 137 negative CXR • 525 other

  24. NLST Results:Lung Cancer Deaths • CT - 356 • 144,103 person years - 247/100,000 person years • CXR - 443 • 143,368 person years – 309/100,000 person years * Person years - The total sum of the number of years that each member of a study population has been under observation

  25. NLST Results:Lung Cancer Deaths • Rate of complication (90 days) • CT = 1.4%; CXR = 1.6% • CT - 16 • 10 had lung cancer • CXR - 10 • 10 had lung cancer

  26. Lung Cancer Screening New Controversies • Who gets screened and when? • Age, how many pack yrs, annually or greater, ex-smokers > 15 yrs • Who pays? • CMS, Private payors, tobacco companies, self pay • Radiation risk • What to do with incidental findings • False positives, false negatives – rates acceptable?- 96%? • Thoracic, extrathoracic non-cancer findings

  27. Lung Cancer Screening New Controversies • What happens if a scan is positive • Can any radiologist do these or is there a learning curve • What about prevention • Is there any difference in men/women; race

  28. Lung Cancer CT Screening

  29. American Cancer Society shift in screening consensus • Benefits of detecting many cancers, especially breast and prostate, have been overstated. • “We don’t want people to panic,” said Dr. Otis Brawley, chief medical officer of the cancer society. “But I’m admitting that American medicine has overpromised when it comes to screening. The advantages to screening have been exaggerated.” New York Times, Oct 21, 2009

  30. Recommendations? • NCCN, AACP/ASCO, AATS, ALA • ?? U.S. Preventive Services Task Force • What age 50 or 55 • Pack years 20 or 30 pk yrs • Other factors?

  31. NCCN guidelines High risk category 1 • Age 55-74 y, and • > 30 pack-year smoking hx, and • Smoking cessation < 15y High risk category 2B • Age > 50 y, and • > 20 pack-year smoking hx, and • One additional risk factor (other than 2nd hand smoke); radon, occupational, family hx, COPD Category 1 - based on high level evidence, uniform NCCN consensus Category 2A - based on lower level evidence, uniform NCCN consensus Category 2B - based on lower-level evidence, NCCN consensus

  32. Guidelines • 55 - 74 yrs of age • Smokers and former smokers (< 15 yrs) • 30 pack year smoking • AATS • 55 – 79 • Lung cancer survivors

  33. Do no harm! • Radiation: effective dose • Low dose CT = 0.65 mSv; CT = 5.8 mSv (cody says 7 mSv) CXR = 0.08 mSv; annual recommendation = 1 mSv • NLST – Ct: 1.4 mSv (std dev 0.5) • 10,000 people exposed 10 mSv = additional 4 deaths; an increase of 0.2% in cancer mortality rate per 10mSv • 50 yr old screened annually until 75 • increased risk of 0.85% added to expected risk of 17%. • 50% current and former smokers 50 – 75 yr old screened annually • estimated increase of 36,000 (1.8%) over expected Brenner, Radiology 2004

  34. Cost Effectiveness of Lung Cancer Screening Cost/quality adjusted life-year saved: • Mahadevia Modeling analysis • $ 116,000 • Cornell - actual screening experience • $ 2,500 • NLST ? Mahadevia, JAMA 2003; Wisnivesky, Chest 2003

  35. Lung Cancer ScreeningFalse positive/negative NLST: • 26% - false negative - “missed rate”

  36. False Negative

  37. False Positive Baseline 3 months follow-up

  38. Positive – not cancer

  39. Lung Cancer Screening • y.o. male 38 pk yrs

  40. Fleischner Recommendations Nodule sizeLow- riskHigh risk < 4mm No follow-up 12 months >4-6 mm 12 months initial 6-12 months then 18, 24 months >6-8mm initial 6-12 initial 3-6 months then + 1 yr then + 6 months, final @ 2 yrs >8mm 3, 9 , and 24 Same as for low risk or dynamic,PET,bx • Subsolid – longer follow-up MacMahon et al, Radiology 237: 395-400, 2005

  41. Fleischner Recommendations Compliance • 13 Case scenarios • 181 members of the Society of Thoracic radiology surveyed • 27% made appropriate recommendation based on Fleischner • Less likely to follow guidelines • Longer years in practice • Radiologist outside the US • Endemic areas Esmaili et al. J Thorac Imaging. In press. epub Jul 9, 2010

  42. Lung Cancer Screening One Year

  43. Lung Cancer Screening 52 y.o. smoker (high risk)

  44. Lung Cancer Screening Incidence of malignancy • Screened population • Subsolid • pure GGO - 18% • semisolid - 63% • Solid - 7% • Non screened population • Nonsolid persistent lesions - 81% (19% other dz) Henschke et al. AJR, 2002; Kim et al. Radiology 2007

  45. Lung Cancer Screening Solitary Lesion GGO < 5-mm No follow-up 5-10mm 3-6 mos (then annual for 3-5 yrs?) >10mm Resect (provided persistence or growth) Mixed any size likely malignant – PET/CT, ? biopsy Multiple lesions GGO <5mm 1 yr follow-up 5-10mm likely AAH or RB > 10mm resect/PET/CT Godoy & Naidich. Radiology December, 2009

  46. Lung Cancer Screening 3 months

  47. Lung Cancer ScreeningNon - Cancer Findings

  48. Lung Cancer ScreeningNon Cancer Findings

  49. Lung Cancer ScreeningNon Cancer Findings

  50. Lung Cancer ScreeningMDACC Lung Cancer Screening Program • Radiology, Prevention, Surgery, Pulmonary • Activate – spring/summer 2010 • Establish standard for screening - multidisciplinary • Advance science of screening/prevention • Model - mammography

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