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C. Berg

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    PLEN 01 - Lung Cancer Prevention and Screening (ID 50)

    • Event: WCLC 2015
    • Type: Plenary
    • Track: Plenary
    • Presentations: 1
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      PLEN01.01 - Lung Cancer Screening (ID 2038)

      08:15 - 09:45  |  Author(s): C. Berg

      • Abstract
      • Presentation
      • Slides

      Screening of high risk individuals for lung cancer was shown to reduce lung cancer mortality by 20% in the National Lung Screening Trial (NLST) comparing low-dose helical computerized tomography (LDCT) to chest x-ray [1]. Implementation of lung cancer screening will be a serious challenge. Since the time of the IASLC meeting in Sydney in 2013 additional information from the NLST has provided guidance on many aspects of screening and informed public health policy in the United States. The United States Preventive Services Task Force (USPSTF) in December 2013 and the Centers for Medicare and Medicaid Services in February 2015 released decisions favorable to lung cancer screening [2, 3]. The USPSTF recommended it at a Grade B level which means under the terms of the Affordable Care Act (ACA), many insurance companies must reimburse without a deductible. The recommendations followed the NLST criteria but extended the age for screening to cover 55 to 80. CMS also followed NLST extending screening to age 77. The coverage includes a counseling and shared decision making visit with a written order for the procedure. Requirements also included radiologist credentials, image acquisition standards and participation in a CMS registry. The American College of Radiology Lung Cancer Screening Registry has been approved. Coverage decisions acknowledged the known drawbacks of high false-positive rates, overdiagnosis potential, radiation risk, psychosocial consequences, effect on smoking behavior and incidental findings. More efficient screening strategies may use different criteria than the NLST excluding those at lower risk while including those outside NLST criteria that are at identifiable high risk. Several risk prediction models exist. The PLCO~m2012~ model is the best-validated. Selected risk factors included age, race, ethnicity, education, body mass index, self-reported chronic obstructive pulmonary disease, personal and family history of lung cancer, and smoking variables. A risk threshold of 1.5% over 6 years was chosen as below this threshold there was no reliable evidence of screening benefit and much higher numbers needed to screen. Comparing this risk model threshold to the USPSTF criteria in the PLCO CXR arm demonstrates that the PLCO~m2012~ risk model approach is more efficient [4]. Table The American College of Radiology developed the Lung-RADS nodule classification system [5]. When applied retrospectively to NLST data (26,455 baseline scans and 48,671 incidence scans), Lung-RADS 1.0 substantially reduced the false-positive rate (12.8% versus 26.6% at baseline and 5.3% versus 21.8% at incidence scans respectively). However, the trade-off was reduced sensitivity compared to NLST criteria: 84.9% vs. 93.5% at baseline and 78.6% versus 93.8% for incidence scans [6]. Retrospective subset analyses while imperfect are useful, providing some information about potential variations in effectiveness in subgroups. Analysis of performance within the NLST was conducted by age, gender and smoking status with additional detail comparing those less than 65 and ≥ 65 [7]. The mortality risk ratios by age, < 65 and ≥ 65, were 0.82 and 0.87; gender, males and females, 0.92 and 0.73, and by smoking status, current versus former, 0.81 and 0.91. Reassuringly, ninety day postsurgical mortality rates in those less than and ≥ 65 were 1.8% and 1.0% respectively. An estimate of overdiagnosis within the NLST has been done [8]. Using follow-up data extended from that in the primary manuscript, a total of 1089 lung cancers occurred in the LDCT arm compared with 969 in the CXR arm, resulting in 120 additional lung cancer cases in the LDCT arm. Two estimates of the upper bound of overdiagnosis were calculated, 18.5% of the cases detected during screening and 11% of the cases overall. More follow-up would be helpful to determine the extent of continued catch-up in cases in the CXR arm. Current smokers in the Lung Screening Study portion of the NLST were evaluated for smoking cessation and results also analyzed by findings on LDCT [9]. Those with normal scans did show a decline in smoking prevalence that continued for the seven years of assessment. Those with abnormal scans had higher cessations rates; the more abnormal the scan the higher the rates. All lung cancer screening programs should incorporate proven smoking cessation strategies. The cost-effectiveness analysis from the NLST utilized data from medical record abstraction covering in exhaustive detail medical interventions delivered as a consequence of screening [10]. As compared with no screening, screening with low-dose CT cost an additional $1,631 per person and provided an additional 0.0316 life-years per person and 0.0201 Quality Adjusted Live Years (QALY) per person. The corresponding Incremental Cost Effectiveness Ratios were $52,000 per life-year gained and $81,000 per QALY gained but varied widely by underlying risk group. Information from the NLST continues to refine our understanding of lung cancer screening. This should prove invaluable in ensuring that screening is done at a high level to achieve optimal mortality reductions as programs are expanded. References 1. The National Lung Screening Trial Research Team. Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening. N Engl J Med 2011; 365: 395-409. 2. Moyer VA. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Int Med 2014; 160: 330-338. 3. Centers for Medicare and Medicaid Services. Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N). (accessed February 22, 2015). 4.Tammemagi MC, Church TR, Hocking WG et al. Evaluation of the Lung Cancer Risks at Which to Screen Ever- and Never-Smokers: Screening Rules Applied to the PLCO and NLST Cohorts. PLoS Medicine 2014; 11: e10001764. 5. American College of Radiology ACR-STR Practice Guideline for the Performance and Reporting of Lung Cancer Screening Thoracic Computed Tomography (accessed February 22, 2015). 6. Pinsky PF, Gierada DS, Black W et al. Performance of Lung-RADS in the National Lung Screening Trial. Ann Intern Med [Epub ahead of print 10 February 2015] doi:10.7326/M14-2086. 7. Pinsky PF, Gierada DS, Hocking W et al. National Lung Screening Trial Findings by Age: Medicare-Eligible Versus Under-65 Population. Ann Intern Med 2014; 161: 627-633. 8. Patz EF, Pinsky P, Gatsonis CG et al. Overdiagnosis in Low-Dose Computed Tomography Screening for Lung Cancer. JAMA Intern Med 2014: 174: 269-274. 9. Tammemagi MC, Berg CD, Riley TL et al. Impact of Lung Cancer Screening Results on Smoking Cessation. J Natl Cancer Inst 2014;106: dju084. 10. Black WC, Gareen IF, Soneji SS et al. Cost-Effectiveness of CT Screening in the National Lung Screening Trial. N Engl J Med 2014; 371: 1793-1802. TABLE Comparison of PLCO~M2012~, NLST and USPSTF [4]

      PLCO~M2012 ~vs. NLST PLCO~M2012~ vs. USPTF
      PLCO~M2012~ NLST PLCO~M2012 ~ USPSTF
      Selection criteria >1.3455%[1] Age 55-74, current/former smoker ≥30 PY ≥ 1.51%1 Age 55-80, current/former smoker ≥30 PY
      Validation cohort 14,144 PLCO trial screening arm smokers 14,144 PLCO trial screening arm smokers who met NLST criteria 37,327 PLCO trial screening arm smokers 37,327 PLCO trial screening arm smokers who met USPSTF criteria
      Sensitivity, % (95% CI) 83.0 71.1 80.1 (76.8–83.0) 71.2 (67.6–74.6)
      Specificity, % (95% CI) 62.9 62.7 66.2 (65.7–66.7) 62.7 (62.2–63.1)
      Positive Predictive Value, % (95% CI) 4.0 3.4 4.2 (3.9–4.6) 3.4 (3.1–3.7)
      [1] Estimated lung cancer risk over six years

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