title: Early lung cancer action project: overall design and findings from baseline screening.
abstract: The Early Lung Cancer Action Project (ELCAP) is designed to evaluate baseline and annual repeat screening by low radiation dose computed tomography (low-dose CT) in persons at high-risk for lung cancer. The authors report on the baseline screening experience. For full evaluation of screening, they await the results of annual repeat screening.
  
  
  
  Using a novel non-comparative design, enrollment of 1000 asymptomatic persons, 60 years of age or older, with at least 10 pack-years of cigarette smoking, no prior cancer, and who were medically fit to undergo thoracic surgery was initiated in 1993. After a structured interview and informed consent, chest radiographs (CXR) and low-dose CT were obtained on each subject. The diagnostic workup of screen-detected noncalcified pulmonary nodules (NCNs) was guided by ELCAP recommendations which included short-term high-resolution CT (HRCT) follow-up for the smallest NCNs.
  
  
  
  On low-dose CT at baseline as compared to CXR, NCNs were detected three times as commonly (23% vs. 7%), malignancies four times as commonly (2.7% vs. 0.7%), Stage I malignancies six times as commonly (2.3% vs. 0.4%). Of the 27 CT-detected cancers, 96% (26/27) were resectable; 85% (23/27) were Stage I, 19 (83%) of the 23 were not seen on CXR. Following the ELCAP recommendations, biopsies were performed on 28 of the 233 subjects with NCNs; 27 had a malignant NCN and one had a benign one. Another three individuals underwent biopsy outside of the ELCAP recommendations, all had benign NCNs. No one had thoracotomy for a benign nodule.
  
  
  
  The estimated five-year survival rate of baseline CT-detected malignancies of 60%-80% is a marked improvement over the current rate of 15%. Although false-positive CTs are common, they can be managed with minimal use of invasive diagnostic procedures.
authors.affiliation: Department of Radiology, New York Presbyterian Hospital-Weill Cornell Medical Center, New York 10021, USA.
authors.forename: C I
authors.initials: CI
authors.lastname: Henschke
mesh_terms: D000368:Aged; D002986:Clinical Trials as Topic / Q000379:methods; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000473:pathology / Q000601:surgery; D008297:Male; D008400:Mass Chest X-Ray; D009367:Neoplasm Staging; D015995:Prevalence; D013902:Radiography, Thoracic; D012107:Research Design; D012907:Smoking / Q000009:adverse effects; D014057:Tomography, X-Ray Computed