Four-Year Results of Low-Dose CT Screening and Nodule Management in the ITALUNG Trial

• DOI: 10.1097/jto.0b013e31828f68d6
• Publication Date: 2013-04-23T13:25:18Z
• Authors: Andrea Lopes Pegna; Giulia Picozzi; Fabio Falaschi; Laura Carrozzi; Massimo Falchini; Francesca Maria C...; Francesco Pistelli; Camilla Comin; Annalisa Deliperi; Michela Grazzini; Florio Innocenti; Cristina Maddau; Alessandra Vella; Luca Vaggelli; Eugenio Paci; Mario Mascalchi
• Keywords: Pulmonary and Respiratory Medicine; Male; Lung Neoplasms; Time Factors; Biopsy, Fine-Needle; Pulmonary biopsy; Adenocarcinoma; Fluorodeoxyglucose F18; Carcinoma, Non-Small-Cell Lung; Humans; Computed tomography; Early Detection of Cancer; Cancer; Aged; Neoplasm Staging; Cancer, Computed tomography, Nuclear medicine, Pulmonary biopsy.; Middle Aged; Prognosis; Computed tomography; cancer screening; LUNG CANCER; Small Cell Lung Carcinoma; 3. Good health; Oncology; Case-Control Studies; Positron-Emission Tomography; Nuclear medicine; Female; Lymph Nodes; Radiopharmaceuticals; Follow-Up Studies

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.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).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.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.