25th scientific day of the Geneva pulmonary league, Lung cancer screening with low-dose CT: an Update. Background
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1 25th scientific day of the Geneva pulmonary league, Lung cancer screening with low-dose CT: an Update S. Diederich Department of Diagnostic and Interventional Radiology Marien Hospital Düsseldorf Background > 1.3 million deaths / year from lung cancer worldwide < 15% overall survival 5-year-survival better in early stages 1
2 Background Risk groups well defined active, former cigarette smokers (> 85%) workers with asbestos, radon,.. exposure No early symptoms diagnostic tests for early dx Stop smoking / never start smoking easiest, cheapest and best way to prevent death from lung cancer (and many other diseases) politically not pursued (13.4 billion /year tax in Germany in 2010) only 17% of world population reached by antismoking programmes 2
3 Prognosis in NSCLC Stage TNM-classification 5-year survival (pathologic stage) I A T1 N0 M0 67% I B T2 N0 M0 57% II A T1 N1 M0 55% 25% II B T2 N1 M0 39% T3 N0 M0 38% III A T3 N1 M0 25% T1-3 N2 M0 23% 25% III B T4 N0-2 M0 7% T1-4 N3 M0 3% IV T1-4 N0-3 M1 1% 50% Screening studies with CXR / Sputum Studies in > smokers in the 1970 s USA National lung cancer trial: > smokers (Johns Hopkins, Mayo Clinic, Memorial Sloan Kettering) Frost 1983 ARRS 130: 549 Fontana 1984 ARRS 130: 561 Melamed 1984 Chest 86: 44 Study in Czechoslovakia: > smokers Kubik & Polak 1986, Cancer 57:
4 Screening studies with CXR / Sputum Higher detection rate of lung cancer in screening groups No reduction of mortality in screening group No recommendations to screen for lung cancer with CXR or sputum cytology Eddy 1989, Ann Int Med 111: 232 Screening studies with CXR / Sputum Mayo lung project 109 cancers detected 92 cancers at CXR (50 peripheral) Size at diagnosis <1cm 2 23 (27%) cm cm (73%) > 2.9 cm 35 4
5 PLCO trial (Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial) since 1992 randomised controlled trial by NCI participants (male and female) years assesses different screening tests for potential reduction of cancer specific mortality Lung cancer: Screening arm: 4 x (smoker) / 3 x (non-smoker) CXR p.a. 1 x year control arm: usual medical care Prorok et al. (2000) Control Clin Trials. 21; 273S-309S PLCO trial (Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial) Incidence lung cancer CXR usual care (per person years) Stage 1 and Stage 3 and Mortality Oken et al JAMA 306:
6 Lung cancer Are there better tests today for early detection of lung cancer? molecular markers in blood, sputum, exhaled air autofluorescence fibreoptic bronchoscopy low-radiation-dose CT Sensitivity of CXR/CT 6
7 Sensitivity of Spiral CT for pulmonary nodules Single slice-spiral-ct spiral sensitivity for pulm. nodules < 6 mm 69 % > 5 mm 95 % > 10 mm 100 % Diederich et al. 1999; Am J Roentgenol 172: 353 Dose reduction to 10-20% of standard dose chest-ct is feasible (Low-dose CT): 2 5 x CXR p.a. and lat. Gartenschläger et al. 1996; Eur Radiol 8: 609 Rusinek et al. 1998; Radiology 209: 243 Diederich et al. 1999; Radiology 213: 289 CT-presentation of early lung cancer? 95% pulmonary nodule, (5% endobronchial lesion) however, > 100 other causes for pulmonary nodules Benign or malignant? 7
8 Feasibility studies Kaneko 1996, Radiology 201: 798 Sone 1998; Lancet 351: 1242 Henschke 1999, Lancet 354: 99 Diederich 2002, Radiology 222: 773 Swensen 2002, Am J Respir Crit Care Med 165: 508 Nawa 2002, Chest 122: 15 Tiitola 2002, Lung Cancer 35: 17 Pastorino 2003, Lancet 362: 593 and many more Feasibility studies Most focussed on risk group of smokers Kaneko 1996, Radiology 201: 798 Sone 1998; Lancet 351: 1242 Henschke 1999, Lancet 354: 99 Diederich 2002, Radiology 222: 773 Swensen 2002, Am J Respir Crit Care Med 165: 508 Nawa 2002, Chest 122: 15 Tiitola 2002, Lung Cancer 35: 17 Pastorino 2003, Lancet 362: 593 and many more 8
9 Feasibility studies Most focussed on risk group of smokers Most annual unenhanced low-dose CT Kaneko 1996, Radiology 201: 798 Sone 1998; Lancet 351: 1242 Henschke 1999, Lancet 354: 99 Diederich 2002, Radiology 222: 773 Swensen 2002, Am J Respir Crit Care Med 165: 508 Nawa 2002, Chest 122: 15 Tiitola 2002, Lung Cancer 35: 17 Pastorino 2003, Lancet 362: 593 and many more Feasibility studies Most focussed on risk group of smokers Most annual unenhanced low-dose CT Work-up of detected lesions based on size small lesions follow-up with low dose CT large lesions biopsy, CE-CT, PET (small: <= 10 mm maximum diameter or <= 8 mm average diameter) Kaneko 1996, Radiology 201: 798 Sone 1998; Lancet 351: 1242 Henschke 1999, Lancet 354: 99 Diederich 2002, Radiology 222: 773 Swensen 2002, Am J Respir Crit Care Med 165: 508 Nawa 2002, Chest 122: 15 Tiitola 2002, Lung Cancer 35: 17 Pastorino 2003, Lancet 362: 593 and many more 9
10 Feasibility studies: CT Screening in smokers Prevalence Patients NSCLC Stage I ALCA (1,1%) 14 (93%) Shinshu (0,5%) 16 (84%) ELCAP (2,7%) 23 (85%) Münster (1,3%) 7 (64%) Mayo Clinic (1,2%) 12 (63%) Hitachi (0,5%) 31 (82%) Helsinki (0,8%) 3 (64%) Milan (1,1%) 6 (55%) Feasibility studies: CT Screening in smokers Incidence Patients NSCLC Stage I ALCA (0,3%) 34 (87%) Shinshu (0,4%) 35 (88%) ELCAP (0,5%) 5 (84%) Münster (1,5%) 7 (70%) Mayo Clinic (0,5%) 5 (63%) Hitachi (0,5%) 31 (82%) Helsinki (0,3%) Milan (1,1%) 11 (100%) 10
11 Feasibility studies: CT Screening in smokers Invasive procedures for benign lesions Biopsies benign (%) ALCA (55%) Shinshu 43 9 (21%) ELCAP 7 1 (14%) Münster 13 3 (23%) Mayo Clinic 40 8 (20%) Hitachi 6 2 (33%) Milan 28 6 (22%) (30%) Results of feasibility studies High proportion (- 66%) of subjects with non-calcified nodules 11
12 Results of feasibility studies High proportion (- 66%) of subjects with non-calcified nodules High number of nodules detected Results of feasibility studies High proportion (- 66%) of subjects with non-calcified nodules High number of nodules detected > 95 % of nodules small (<= 8 mm / 10 mm) 12
13 Results of feasibility studies High proportion (- 66%) of subjects with non-calcified nodules High number of nodules detected > 95 % of nodules small (<= 8 mm / 10 mm) Only 3 % of nodules malignant Results of feasibility studies High proportion (- 66%) of subjects with non-calcified nodules High number of nodules detected > 95 % of nodules small (<= 8 mm / 10 mm) Only 3 % of nodules malignant mainly non-invasive work-up with f-u CT 13
14 Detection of growth Month 0 Month 12 Computer-assisted Diagnosis: Growth? 0 Month 6 Months V: +25% 14
15 Spread of malignancy during follow-up? 5201 baseline CT scans, 4821 annual follow-up (93%) <= 5 mm: follow-up after 12 months > 5-8 mm: follow-up after 3 months > 8 mm: PET / CE-CT 2754 subjects (53%) with non-calcified nodule(s) 37 incidence id cancers 17 baseline nodule stage 1 after 12 months 7 baseline nodule > stage 1 after 12 months (0.25%) 13 new nodule Veronesi et al., Lung cancer 61: 340 Results of feasibility studies High ( %) prevalence of NSCLC Kaneko 1996, Radiology 201: 798 Sone 1998; Lancet 351: 1242 Henschke 1999, Lancet 354: 99 Diederich 2002, Radiology 222: 773 Swensen 2002, Am J Respir Crit Care Med 165: 508 Nawa 2002, Chest 122: 15 Tiitola 2002, Lung Cancer 35: 17 Pastorino 2003, Lancet 362: 593 and many more 15
16 Results of feasibility studies High ( %) prevalence of NSCLC Lower ( %) incidence of NSCLC Kaneko 1996, Radiology 201: 798 Sone 1998; Lancet 351: 1242 Henschke 1999, Lancet 354: 99 Diederich 2002, Radiology 222: 773 Swensen 2002, Am J Respir Crit Care Med 165: 508 Nawa 2002, Chest 122: 15 Tiitola 2002, Lung Cancer 35: 17 Pastorino 2003, Lancet 362: 593 and many more Results of feasibility studies High ( %) prevalence of NSCLC Lower ( %) incidence of NSCLC High (55-100%) proportion of stage I NSCLC Kaneko 1996, Radiology 201: 798 Sone 1998; Lancet 351: 1242 Henschke 1999, Lancet 354: 99 Diederich 2002, Radiology 222: 773 Swensen 2002, Am J Respir Crit Care Med 165: 508 Nawa 2002, Chest 122: 15 Tiitola 2002, Lung Cancer 35: 17 Pastorino 2003, Lancet 362: 593 and many more 16
17 Results of feasibility studies High ( %) prevalence of NSCLC Lower ( %) incidence of NSCLC High (55-100%) proportion of stage I NSCLC Acceptabel (30%) proportion of invasive procedures for benign lesions Kaneko 1996, Radiology 201: 798 Sone 1998; Lancet 351: 1242 Henschke 1999, Lancet 354: 99 Diederich 2002, Radiology 222: 773 Swensen 2002, Am J Respir Crit Care Med 165: 508 Nawa 2002, Chest 122: 15 Tiitola 2002, Lung Cancer 35: 17 Pastorino 2003, Lancet 362: 593 and many more Mortality reduction? Results of multi center LDCT-Studie > subjects if: - clinically stage 1 - therapy within 1 month estimated 10 year-survival: 92% I-ELCAP, NEJM 2006; 355:
18 Mortality reduction? comparison - Results of 3 CT-Screening studies -Predictionof results from models more: cancers, lung resections identical: advanced stage cancer, mortality Bach PB, JAMA 2007; 297: 953 Why may lung cancer screening not work? screen detected cancer may be insignificant cancer may grow slowly and may not metastasize Patient may die from other cause (CAD, stroke, other cancer) screening may be unable to detect t aggressive cancers detection of suspicious lesions may cause more harm than good (concerns in benign lesions, biopsy, surgery) 18
19 Screening: Lead-time Bias Patz et al. NEJM 2000; 343: 1627 Screening: Overdiagnosis Bias Patz et al. NEJM 2000; 343:
20 Screening: Length Bias Screening Screening Screening Patz et al. NEJM 2000; 343: 1627 Efficacy of cancer screening not useful: size of tumor at diagnosis resectability of tumor stage distribution median survival percentage of 5-year survival 20
21 Screening: proof of efficacy prospective, randomised controlled trials (RCT): screening arm with diagnostic test control arm without diagnostic test comparison of cancer mortality Randomised controlled trials (RCT) USA: NLST (National Lung Screening Trial): > subjects recruited from Netherlands/Belgium (NELSON): subjects: not yet recruited several smaller studies: most likely no significant results pooling of data (Pisa-Statement) 21
22 Process and outcomes in the NLST Radiology 2011;258: NLST (National Lung Screening Trial) active or ex-smokers (<= 15 years) years at inclusion >= 30 pack years 3 x annual screening low-dose CT CXR p.a. and lateral 5 year follow-up 22
23 participating institutions Examination parameters 23
24 Interpretation of Findings at CT or Chest Radiographic Screening If abnormal findings mail to subject and health care provider if suspicious for lung cancer further procedures (different in different institutions) diagnostic procedures depend on health care provider 24
25 NLST-ACRIN Substudies use of ressources and outcome cost-effectiveness analysis (quality-adjusted life-years) smoking habits effect of screening overall pos. screening-result neg. screening-result Biospecimen collection (blood, urine, sputum, histology of resected lung cancer) Results subjects recruited maximum follow-up 8 years annual interim analysis since
26 Results subjects recruited maximum follow-up 8 years annual interim analysis since /2010 data & safety monitoring board press conference: 354 lung cancer deaths: screening arm 442 lung cancer deaths: control arm NLST (National Lung Screening Trial) LDCT CXR Positive findings 24.2% 6.9% Death from lung cancer Lung cancer mortality (per pack years) lung cancer mortality reduction through LDCT: 20% overall mortality reduction: 7% NEJM 2011; 365:
27 NEJM 2011; 365: A. cumulative numbers of lung cancer cases from randomisation until B. cumulative numbers of lung cancer deaths from randomisation until Results of 3 rounds of screening NEJM 2011; 365:
28 Diagnostic follow-up of positive screening results in the 3 screening rounds NEJM 2011; 365: Stage and histologic type of lung cancer in the two screening groups NEJM 2011; 365:
29 histologic type of lung cancer in the two screening groups according to tumor stages NEJM 2011; 365: NLST Cause of death on the death certificate for CT- and control group NEJM 2011; 365:
30 Limitations of NLST No detailled analysis available on: procedures for indeterminate findings sub group analysis of age, sex, race etc. Advantage of CT versus no screening uncertain Advantage of longer screening uncertain Limitations of NLST only (ex-)smokers years >= 30 pack years Results transferable to other groups? Subjects in larger urban centers Results transferable to subjects in rural areas etc.? Study conducted at large university hospitals Results transferable to other institutions? 30
31 Recommendations in Germany Consensus statement of German Röntgen Society and German Society of chest medicine Low-dose CT is acceptable in asymptomatic smokers if: active or ex-smoker years >= 30 pack years quality control Recommendations in Germany Quality control: informed consent examination technique radiation exposure interpretation of CT scans recommendations for further management Pneumologe
32 Expert meeting at the German Federal office for Radiation Protection representatives of German Roentgen Society, German society of chest physicians, national health insurances, private heath insurances, Radiation Protection board, secretary of health, secretary of the environment etc. Project suggested certified multidisciplinary lung cancer centers CT funded by health insurances smoking cessation, statistics, epidemiology etc. funded by secretaries of health and environment November 21st, 2011 Meeting of : secretary of health secretary of environment health insurances radiation protection board 32
33 25th scientific day of the Geneva pulmonary league, Thank you for your attention! Lung cancer screening with low-dose CT: an Update S. Diederich Department of Diagnostic and Interventional Radiology Marien Hospital Düsseldorf 33
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