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

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 smoke...

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Published inJournal of thoracic oncology Vol. 8; no. 7; pp. 866 - 875
Main Authors Pegna, Andrea Lopes, Picozzi, Giulia, Falaschi, Fabio, Carrozzi, Laura, Falchini, Massimo, Carozzi, Francesca Maria, Pistelli, Francesco, Comin, Camilla, Deliperi, Annalisa, Grazzini, Michela, Innocenti, Florio, Maddau, Cristina, Vella, Alessandra, Vaggelli, Luca, Paci, Eugenio, Mascalchi, Mario
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 01.07.2013
International Association for the Study of Lung Cancer
Subjects
Adenocarcinoma - diagnosis
Adenocarcinoma - surgery
Aged
Biopsy, Fine-Needle
Cancer
Carcinoma, Non-Small-Cell Lung - diagnosis
Carcinoma, Non-Small-Cell Lung - surgery
Case-Control Studies
Computed tomography
Early Detection of Cancer
Female
Fluorodeoxyglucose F18
Follow-Up Studies
Humans
Lung Neoplasms - diagnosis
Lung Neoplasms - surgery
Lymph Nodes - pathology
Lymph Nodes - surgery
Male
Middle Aged
Neoplasm Staging
Nuclear medicine
Positron-Emission Tomography
Prognosis
Pulmonary biopsy
Radiopharmaceuticals
Small Cell Lung Carcinoma - diagnosis
Small Cell Lung Carcinoma - surgery
Time Factors
Tomography, X-Ray Computed
Nuclear medicine
Computed tomography
Pulmonary biopsy
Cancer
Online AccessGet full text
ISSN1556-0864
1556-1380
1556-1380
DOI10.1097/JTO.0b013e31828f68d6

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Abstract 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.
AbstractList 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.
INTRODUCTION: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-[F]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.
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.INTRODUCTIONRecruitment 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).METHODSThree 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.RESULTSOne 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.CONCLUSIONSHigh-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.
Author Vella, Alessandra
Picozzi, Giulia
Pegna, Andrea Lopes
Grazzini, Michela
Falaschi, Fabio
Carozzi, Francesca Maria
Vaggelli, Luca
Comin, Camilla
Paci, Eugenio
Carrozzi, Laura
Falchini, Massimo
Mascalchi, Mario
Pistelli, Francesco
Deliperi, Annalisa
Innocenti, Florio
Maddau, Cristina
AuthorAffiliation Pneumonology Department, Careggi Hospital, Florence, Italy; †Radiodiagnostic Unit, Institute for Oncological Study and Prevention, Florence, Italy; ‡2nd Radiology Department, University Hospital of Pisa, Italy; §Cardiopulmonary Department, University Hospital, Pisa, Italy; ‖Radiodiagnostic Section, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Italy; ¶Analytical Cytology and Bio-Molecular Unit, Institute for Oncological Study and Prevention, Florence, Italy; #Pathology Department, Careggi Hospital, University of Florence, Italy; Pneumonology, Hospital of Pistoia, Italy; ††Nuclear Medicine Unit, Le Scotte University Hospital, Siena, Italy; ‖‖Nuclear Medicine Unit, Careggi Hospital, Florence, Italy; and ¶¶Department of Epidemiology, Institute for Oncological Study and Prevention, Florence, Italy
AuthorAffiliation_xml – name: Pneumonology Department, Careggi Hospital, Florence, Italy; †Radiodiagnostic Unit, Institute for Oncological Study and Prevention, Florence, Italy; ‡2nd Radiology Department, University Hospital of Pisa, Italy; §Cardiopulmonary Department, University Hospital, Pisa, Italy; ‖Radiodiagnostic Section, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Italy; ¶Analytical Cytology and Bio-Molecular Unit, Institute for Oncological Study and Prevention, Florence, Italy; #Pathology Department, Careggi Hospital, University of Florence, Italy; Pneumonology, Hospital of Pistoia, Italy; ††Nuclear Medicine Unit, Le Scotte University Hospital, Siena, Italy; ‖‖Nuclear Medicine Unit, Careggi Hospital, Florence, Italy; and ¶¶Department of Epidemiology, Institute for Oncological Study and Prevention, Florence, Italy
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  organization: Radiodiagnostic Section, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Italy
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  organization: Pathology Department, Careggi Hospital, University of Florence, Italy
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  surname: Vaggelli
  fullname: Vaggelli, Luca
  organization: Nuclear Medicine Unit, Careggi Hospital, Florence, Italy
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  surname: Paci
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  organization: Department of Epidemiology, Institute for Oncological Study and Prevention, Florence, Italy
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  givenname: Mario
  surname: Mascalchi
  fullname: Mascalchi, Mario
  email: m.mascalchi@dfc.unifi.it
  organization: Radiodiagnostic Section, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Italy
BackLink https://www.ncbi.nlm.nih.gov/pubmed/23612465$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Contributor De Francisci, Agostino
Vella, Alessandra
Gabbrielli, Silvia
Gadda, Davide
Janni, Alberto
Picozzi, Giulia
Vannucchi, Letizia
Lucchi, Marco
Battola, Luigi
Spinelli, Cheti
Falaschi, Fabio
Cordopatri, Giovanna
Cini, Stella
Carozzi, Francesca Maria
Ronchi, Cristina
Crisci, Elena
De Liperi, Anna Lisa
Paci, Eugenio
Niccolai, Franco
Tognetti, Adele Renza
Bianchi, Roberto
Mussi, Alfredo
De Santis, Mariella
Tavanti, Laura
Innocenti, Florio
Bartolucci, Maurizio
Fontanini, Gabriella
Lopes Pegna, Andrea
Esposito, Ida
Aquilini, Ferruccio
Natali, Ilaria
Grazzini, Michela
Roselli, Giuliana
Vaggelli, Luca
Neri, Anna Talina
Comin, Camilla
Baliva, Filomena
Carrozzi, Laura
Chella, Antonio
Falchini, Massimo
Mascalchi, Mario
Giusti, Francesco
Pistelli, Francesco
Masi, Andrea
Petruzzelli, Alessia
Maddau, Cristina
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  surname: Lopes Pegna
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  surname: Bianchi
  fullname: Bianchi, Roberto
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  givenname: Cristina
  surname: Ronchi
  fullname: Ronchi, Cristina
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  surname: Carrozzi
  fullname: Carrozzi, Laura
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Snippet Recruitment and nodule management are critical issues of lung cancer screening with low-dose computed tomography (LDCT). We report subjects’ compliance and...
INTRODUCTION:Recruitment and nodule management are critical issues of lung cancer screening with low-dose computed tomography (LDCT). We report subjects’...
Recruitment and nodule management are critical issues of lung cancer screening with low-dose computed tomography (LDCT). We report subjects' compliance and...
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SubjectTerms Adenocarcinoma - diagnosis
Adenocarcinoma - surgery
Aged
Biopsy, Fine-Needle
Cancer
Carcinoma, Non-Small-Cell Lung - diagnosis
Carcinoma, Non-Small-Cell Lung - surgery
Case-Control Studies
Computed tomography
Early Detection of Cancer
Female
Fluorodeoxyglucose F18
Follow-Up Studies
Humans
Lung Neoplasms - diagnosis
Lung Neoplasms - surgery
Lymph Nodes - pathology
Lymph Nodes - surgery
Male
Middle Aged
Neoplasm Staging
Nuclear medicine
Positron-Emission Tomography
Prognosis
Pulmonary biopsy
Radiopharmaceuticals
Small Cell Lung Carcinoma - diagnosis
Small Cell Lung Carcinoma - surgery
Time Factors
Tomography, X-Ray Computed
Title Four-Year Results of Low-Dose CT Screening and Nodule Management in the ITALUNG Trial
URI https://dx.doi.org/10.1097/JTO.0b013e31828f68d6
https://www.ncbi.nlm.nih.gov/pubmed/23612465
https://www.proquest.com/docview/1419343872
Volume 8
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