title: Four-year results of low-dose CT screening and nodule management in the ITALUNG trial.
abstract: BACKGROUND
  Recruitment and nodule management are critical issues of lung cancer screening with low-dose computed tomography (LDCT). We report subjects' compliance and results of LDCT screening and management protocol in the active arm of the ITALUNG trial.
  
  
  METHODS
  Three thousand two hundred six smokers or former smokers invited by mail were randomized to receive four annual LDCT (n = 1613) or usual care (n = 1593). Management protocol included follow-up LDCT, 2-[18F]fluoro-2-deoxy-D glucose positron emission tomography (FDG-PET), and CT-guided fine-needle aspiration biopsy (FNAB).
  
  
  RESULTS
  One thousand four hundred six subjects (87%) underwent baseline LDCT, and 1263 (79%) completed four screening rounds. LDCT was positive in 30.3% of the subjects at baseline and 15.8% subsequently. Twenty-one lung tumors in 20 subjects (1.5% detection) were found at baseline, and 20 lung tumors in 18 subjects (0.5% detection) in subsequent screening rounds. Ten of 18 prevalent (55%) and 13 of 17 incident (76%) non-small-cell cancers were in stage I. Interval growth enabled diagnosis of lung cancer in 16 subjects (42%), but at least one follow-up LDCT was obtained in 741 subjects (52.7%) over the screening period. FDG-PET obtained in 6.5% of subjects had 84% sensitivity and 90% specificity for malignant lesions. FNAB obtained in 2.4% of subjects showed 90% sensitivity and 88% specificity. Positivity of both FDG-PET and FNAB invariably predicted malignancy. Surgery for benign lesions was performed on four subjects (10% of procedures) but followed protocol violations on three subjects.
  
  
  CONCLUSIONS
  High-risk subjects recruited by mail who entered LDCT screening showed a high and stable compliance. Efficacy of screening is, however, weakened by low detection rate and specificity. Adhesion to management protocol might lessen surgery for benign lesions.
authors.affiliation: Pneumonology Department, Careggi Hospital, Florence, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Lopes Pegna
authors.forename: Giulia
authors.initials: G
authors.lastname: Picozzi
authors.forename: Fabio
authors.initials: F
authors.lastname: Falaschi
authors.forename: Laura
authors.initials: L
authors.lastname: Carrozzi
authors.forename: Massimo
authors.initials: M
authors.lastname: Falchini
authors.forename: Francesca Maria
authors.initials: FM
authors.lastname: Carozzi
authors.forename: Francesco
authors.initials: F
authors.lastname: Pistelli
authors.forename: Camilla
authors.initials: C
authors.lastname: Comin
authors.forename: Annalisa
authors.initials: A
authors.lastname: Deliperi
authors.forename: Michela
authors.initials: M
authors.lastname: Grazzini
authors.forename: Florio
authors.initials: F
authors.lastname: Innocenti
authors.forename: Cristina
authors.initials: C
authors.lastname: Maddau
authors.forename: Alessandra
authors.initials: A
authors.lastname: Vella
authors.forename: Luca
authors.initials: L
authors.lastname: Vaggelli
authors.forename: Eugenio
authors.initials: E
authors.lastname: Paci
authors.forename: Mario
authors.initials: M
authors.lastname: Mascalchi
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis* / Q000601:surgery; D000368:Aged; D044963:Biopsy, Fine-Needle; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis* / Q000601:surgery; D016022:Case-Control Studies; D055088:Early Detection of Cancer; D005260:Female; D019788:Fluorodeoxyglucose F18; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis* / Q000601:surgery; D008198:Lymph Nodes / Q000473:pathology* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D049268:Positron-Emission Tomography; D011379:Prognosis; D019275:Radiopharmaceuticals; D055752:Small Cell Lung Carcinoma / Q000175:diagnosis* / Q000601:surgery; D013997:Time Factors; D014057:Tomography, X-Ray Computed
chemical_list: D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18