Background ITALUNG is contributing to the European evaluation of low-dose CT (LDCT) screening for lung cancer (LC).
Methods Eligible subjects aged 55–69 years, smokers or ex-smokers (at least 20 pack-years in the last 10 years), were randomised to receive an annual invitation for LDCT screening for 4 years (active group) or to usual care (control group). All participants were followed up for vital status and cause of death (at the end of 2014) and LC incidence (at the end of 2013). Pathological and clinical information was collected from the Tuscan Cancer Registry data.
Results 1613 subjects were randomly assigned to the active group and 1593 to the control group. At the end of the follow-up period 67 LC cases were diagnosed in the active group and 71 in the control group (rate ratio (RR)=0.93; 95% CI 0.67 to 1.30). A greater proportion of stage I LC was observed in the active group (36% vs 11%, p<0.001). Non-significant reductions of 17% (RR=0.83; 95% CI 0.67 to 1.03) for overall mortality and 30% (RR=0.70; 95% CI 0.47 to 1.03) for LC-specific mortality were estimated.
Conclusions Despite the lack of statistical significance, the ITALUNG trial outcomes suggest that LDCT screening could reduce LC and overall mortality. Moreover, the comparison of the number of LC cases diagnosed in the two groups does not show overdiagnosis after an adequate follow-up period. A pooled analysis of all European screening trials is advocated to assess the benefit-to-harm ratio of LDCT screening and its implementation in public health settings.
Trial registration number Results, NCT02777996.
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Collaborators Members of the ITALUNG Working Group: Eugenio Paci (retired, PI), Donella Puliti, Marco Zappa, Cristina Ocello, Gianfranco Manneschi, Carmen Visioli, Giovanna Cordopatri, Francesco Giusti, Ida Esposito: Clinical Epidemiology Unit, ISPO—Cancer Research and Prevention Institute, Florence, Italy. Andrea Lopes Pegna, Roberto Bianchi, Cristina Ronchi: Pneumonology Department, Careggi Hospital, Florence Italy. Laura Carrozzi, Ferruccio Aquilini, Stella Cini, Mariella De Santis, Francesco Pistelli, Filomena Baliva, Antonio Chella, Laura Tavanti: Cardiothoracic and Vascular Department, University Hospital of Pisa, Italy. Michela Grazzini, Florio Innocenti, Ilaria Natali: Pneumonology Department, Hospital of Pistoia, Italy. Mario Mascalchi, Maurizio Bartolucci, Elena Crisci, Agostino De Francisci, Massimo Falchini, Silvia Gabbrielli, Giuliana Roselli, Andrea Masi: Radiology Department, Careggi Hospital, University of Florence, Italy. Fabio Falaschi, Luigi Battola, Annalisa De Liperi, Cheti Spinelli: Radiology Department, University Hospital of Pisa, Italy. Letizia Vannucchi, Alessia Petruzzelli, Davide Gadda, Anna Talina Neri, Franco Niccolai: Radiology Department, Hospital of Pistoia, Italy. Luca Vaggelli: Nuclear Medicine Department, Careggi Hospital, Florence, Italy. Alessandra Vella: Nuclear Medicine Department, Le Scotte University Hospital, Siena, Italy. Francesca Maria Carozzi, Cristina Maddau, Simonetta Bisanzi: Regional Prevention Laboratory Unit, Institute for Oncological Study and Prevention, Florence, Italy. Giulia Picozzi: Radiodiagnostic Unit, ISPO—Cancer Research and Prevention Institute, Florence, Italy. Alberto Janni: Thoracic Surgery Department, Careggi Hospital, Florence, Italy. Alfredo Mussi, Marco Lucchi: Thoracic Surgery Unit, Cardiothoracic and Vascular Department, University Hospital of Pisa, Italy. Camilla Comin: Pathology Department, Careggi Hospital, University of Florence, Italy. Gabriella Fontanini, Adele Renza Tognetti: Pathology Department, University Hospital of Pisa, Italy. Laura Iacuzio: University of Modena and Reggio Emilia, Italy. Members of the Cause of Death Review Panel: Adele Caldarella, Alessandro Barchielli, Tuscany Cancer Registry, ISPO—Cancer Research and Prevention Institute; Carlo Alberto Goldoni, Epidemiology Unit, Local Health Unit Modena, Italy.
Contributors EP, ALP, LC, GP, FF, FMC, MM conceived the study design and made significant contributions to the implementation of the study. DP, ALP, LC, GP, FF, FP, FA, CO and MM performed data collection and quality control. DP and EP performed statistical analysis. EP, DP, ALP, LC, GP, FF, MZ, FMC and MM interpreted the results. EP, DP and MZ wrote the manuscript. ALP, LC, GP, FF, FP, MZ, FMC and MM critically reviewed the manuscript.
Funding The study was completely funded by the local government of Tuscany (Decree N. 1014 of 02.25.2004) and by a Research Grant (PRIN 2003) to Professor Mario Mascalchi of the Italian Ministry of Education, University and Research.
Competing interests None declared.
Patient consent Obtained.
Ethics approval The study was approved by the Local Ethics Committee of each participating institution (approval number 29-30 of 30 September 2003; number 23 of 27 October 2003; and number 00028543 of 13 May 2004).
Provenance and peer review Not commissioned; externally peer reviewed.
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