Lung Cancer Screening: Now What?
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1 Lung Cancer Screening: Now What? Gerold Bepler, M.D., Ph.D. Director, President & CEO Michigan Cancer Consortium, 2013 Annual Meeting, Lansing, MI, 11/20/13
2 Lung Cancer #1 Cause of Cancer Death for & * 437 deaths per day Only 16% survive longer than 5 years ~15% localized ~22% regional ~56% distant *27.5% (159,480/580,350) Wender et al, CA Cancer J Clin 2013
3 Lung Cancer Mortality and (Incidence) Incidence 228, , , , ,640 Cancer Facts and Figures, ACS 2013
4 Strategies to Improve Outcome Prevention Early Detection Therapy
5 KM Survival by Stage LC Staging V7, Chansky et al, JTO 4:
6 Screening Requirements High Number of Cases High Number of Deaths High Expenses* Known Natural History (?) Effective Intervention (?) (Screening should be inexpensive, tolerable, save, high sensitivity & specificity) >$5.5 billion per year *$25,000 per case
7 Natural History of Lung Cancer Well known epidemiology Incomplete knowledge on histopathological progression Evolving knowledge on molecular progression
8 Screening by CXR (PLCO results) 154,900 individual, age 55-74, smokers & NS, randomized to CXR vs usual care for 4 years 86% at baseline, 79-84% thereafter, 11% in usual care arm had screening No LC mortality reduction by CXR screening Data consistent with experience UK Trial, Brett, Thorax 1968 Mayo Trial, Fontana et al, J Occup Med 1986 Czech Trial, Kubik et al, Cancer 1986 JAMA 306: , 2011
9 Factors to Consider Incidence Mortality Survival (median or 5-y) Stage Shift
10 Lead Time Bias Patz, Goodman, Bepler, NEJM 2000
11 Lead Time Bias Incidence Mortality Survival (median or 5-y) Stage Shift
12 Length Time Bias Patz, Goodman, Bepler, NEJM 2000
13 Length Time Bias Incidence Mortality Survival (median or 5-y) Stage Shift
14 Overdiagnosis Patz, Goodman, Bepler, NEJM 2000
15 Overdiagnosis Incidence Mortality Survival (median or 5-y) Stage Shift
16 Overdiagnosis (Incident Cases) Total Operable Inoperable Cases Cases Cases Mayo Screen Mayo Control Czech Screen Czech Control
17 Screening for Lung Cancer (until 2010) Not recommended Use in study-setting only
18 The Age of CT (1990 to 2010) ELCAP Mayo Muenster Japan Moffitt Selected, single-arm, cohort studies Indeterminate pulmonary nodule detection: ELCAP 23%, Henschke et al, Lancet 354: 99, 1999 Mayo 51%, Swenson et al, Am J Respir Crit Care Med 165: 508, 2002 Germany 43%, Diederich et al, Radiology 222: 773, 2002 Japan 5-12%, Sone et al, Br J Cancer 84: 25, 2001, Sobue et al, J Clin Oncol 20: 911, 2002 Moffitt 32%, Tockman et al, unpublished
19 SUMMARY for single arm CT studies > 12,000 individuals screened Age is an important determinant of LC risk age 0-39 age age age >70 Male 0.03 (1 in 3,646) 0.93 (1 in 108) 2.29 (1 in 44) 6.70 (1 in 15) Female 0.03 (1 in 3,185) 0.77 (1 in 130) 1.74 (1 in 57) 4.90 (1 in 20) Smoking and COPD are important determinants of LC risk Indeterminate Nodules are found in 23-51% of (ex)smokers age >40 years
20 CT Screening: NLST (overview) NLST Study Prospective Randomized Study Duration: 8/02 9/07 (F/U to 12/31/2009) 33 Centers in the US N = 53,454 (PLCO and ACRIN) First published June 6, 2011 NEJM 365: 395, 2011; NEJM 368: 1980, 2013; NEJM 369: 245, 2013; NEJM 369: 920, 2013
21 CT Screening: NLST (design) Eligibility: Test: Other: age 55-74, (wo)men >30 PY, quit <15 y, no active cancer or h/o LC, no CT <18m T0 (entry) T1 (12 months) T2 (24 months) CXR CXR CXR CT CT CT biospecimens, survey, spirometry NEJM 365: 395, 2011; NEJM 368: 1980, 2013; NEJM 369: 245, 2013; NEJM 369: 920, 2013
22 CT Screening: NLST (work-up) Definition: any solitary nodule that is non-calcified non-fat attenuation new (stable < 2y) Work up: <4 mm 4-10 mm >10 mm no intervention repeat q3m or enhanced or Bx TTNA or VATS-Bx NLST Protocol Recommendation
23 CT Screening: NLST (results) Follow-up diagnostic procedures CT (27%) CXR (9%) > One procedure 90% (N=297) 93% (N=121) Chest CT 73% 66% PET 10% 8% Bronchoscopy 4.3% 4.6% Transthoracic Bx 2.2% 3.5% Surgery (diagnostic) 4.2% 5.2% NEJM 365: 395, 2011; NEJM 368: 1980, 2013; NEJM 369: 245, 2013; NEJM 369: 920, 2013
24 CT Screening: NLST (results) Median follow-up: 6.5 years Adherence: 95% for CT, 93% for CXR Annual CTs done on CXR arm: 4.3% NEJM 365: 395, 2011; NEJM 368: 1980, 2013; NEJM 369: 245, 2013; NEJM 369: 920, 2013
25 CT Screening: NLST (results from 2011) CT CXR # subjects 26,722 26,732 # cancers 1, # resectable cancers Mortality Reduction* 2.47 /1000 prs-y 3.09 /1000 prs-y Unresectable Disease Reduction (=stage shift) Positive CT (CXR) test (>4 mm non-calcified) % 6.9% False positive test 96.4% *20% risk reduction p=0.004; 6.7% risk reduction from all cause mortality Mayo CXR Trial Mortality: CXR:3.2 vs Control:3.0/1000 prs-years Unresectable Disease: CXR:112 vs Control: 109 NEJM 365: 395, 2011
26 CT Screening: MCC Position Statement 2011 The Michigan Cancer Consortium has concluded that the current scientific evidence supports the use of annual low-dose spiral computed axial tomography (CT scans) for lung cancer screening in asymptomatic individuals who smoke or who have quit smoking (quit smoking for 15 years), who have a 30 pack-year history of tobacco use (pack-year history is equal to the average number of packs smoked per day times the number of years smoked), and are years of age. MCC Early Detection Working Group Co-Chairs: Gregory Kalemkerian and Gerold Bepler Members: Kevin Berger, Paul Kvale, Vicki Rakowski, Farid Shamo, Mary Jo Voelpel Staff: Carol Garlinghouse, Steve Springer, May Yassine Michigan Cancer Consortium, Position Statement for Health Care Providers on Lung Cancer Screening, 2011
27 CT Screening: NLST (results) Number of cancers detected CT CXR T T T Total Note: lung cancer detection appears to continue at a stable rate per year, suggesting that screening should continue (annually?). NEJM 365: 395, 2011; NEJM 368: 1980, 2013; NEJM 369: 245, 2013; NEJM 369: 920, 2013
28 CT Screening: NLST (results) Stage Shift for T1 and T2 screens CT CXR T1-Stage I 49.2% 31.8% T1-Stage IIIB/IV 30.8% 48.6% T2-Stage I 48.1% 33.6% T2-Stage IIIB/IV 29.9% 45.5% NEJM 365: 395, 2011; NEJM 368: 1980, 2013; NEJM 369: 245, 2013; NEJM 369: 920, 2013
29 CT Screening: NLST (results) True and False Positive Rates (>4 mm) CT T0 CT T1 CT T2 CXR T0 CXR T1 CXR T2 Positive Screen 7,193 6,902 4,052 2,387 1,482 1,175 Lung Cancer 4% (270) 2% (168) 5% (211) 6% (136) 4% (65) 7% (78) No Lung Cancer 96% 98% 95% 94% 96% 93% NEJM 365: 395, 2011; NEJM 368: 1980, 2013; NEJM 369: 245, 2013; NEJM 369: 920, 2013
30 CT Screening: NLST (results) Sensitivity, specificity, PPV, and NPV for CT T0 T1 T2 Sensitivity 93.8% 94.4% 93.0% Specificity 73.4% 72.6% 83.9% PPV 3.8% 2.4% 5.2% NPV 99.9% 99.9% Sensitivity = TP/(TP+FN) Specificity = TN/(FP+TN) PPV = TP/(TP+FP) NPV = TN/(FN+TN) NEJM 365: 395, 2011; NEJM 368: 1980, 2013; NEJM 369: 245, 2013; NEJM 369: 920, 2013
31 CT Screening: NLST (results) PPV by nodule size Size PPV >4 mm 3.8% 4-6 mm 0.5% 7-10 mm 1.7% mm 11.9% mm 29.7% >30 mm 41.3% Adenopathy 18.5% NEJM 365: 395, 2011; NEJM 368: 1980, 2013; NEJM 369: 245, 2013; NEJM 369: 920, 2013
32 CT Screening: NLST (results) Other notable findings in CT arm T1 T2 PPV with Biopsy 58.2% 65.8% Surgery for Benign Disease 18.9% 15.9% Total number of surgeries mediastinoscopy, thoracotomy, thoracoscopy 24% of surgeries for benign disease (164/673) NEJM 365: 395, 2011; NEJM 368: 1980, 2013; NEJM 369: 245, 2013; NEJM 369: 920, 2013
33 Impact on US Population 8.6 million Americans meet the NLST screening criteria 30% of people between meet NLST criteria 12,000 lung cancer deaths could be averted each year 27% of all lung cancers would be detected and approximately 68% of lung cancers in people between that meet NLST criteria Ma et al, Cancer 199: 1381, 2013; Pinsky and Berg, J Med Screen 19: 154, 2012
34 Comparison with Other Cancers Numbers needed to prevent one death Mammography age 40-49: 1,904 age 50-59: 1,339 age 60-79: 337 Fecal Occult Blood (annual x5): 1,374 Flexible Sigmoidoscopy: 871 PSA: 1,410 Chest CT (by NLST criteria): 320
35 USPSTF Recommendations Annual screening for persons age (yes 79) >30 PY, active or quit <15 years B recommendation (categories A, B, C, D, I), so insurances should cover this B = The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. The practice suggestion is to offer or provide this service. USPSTF Draft recommendation, July 30, 2013
36 ACS Recommendations Annual screening for persons age >30 PY, active or quit <15 years In centers with high volume, high quality, and discuss pros and cons American Cancer Society, January 13, 2013
37 Other Organizations That Endorse Screening (for high-risk persons) American Association of Thoracic Surgery American College of Chest Physicians American Lung Association American Society of Clinical Oncology American Thoracic Society National Comprehensive Cancer Network
38 The Future of Lung Cancer Screening Development of a model for risk prediction. The PPV depends on disease prevalence. Kovalchik et al, NEJM 369: 245, 2013
39 Thank You
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