Eugenio Paci1, Donella Puliti1, Andrea Lopes Pegna2, Laura Carrozzi3, Giulia Picozzi4, Fabio Falaschi5, Francesco Pistelli3, Ferruccio Aquilini3, Cristina Ocello1, Marco Zappa1, Francesca M Carozzi6, Mario Mascalchi7. 1. Clinical Epidemiology Unit, ISPO-Cancer Research and Prevention Institute, Florence, Italy. 2. Pneumonology Department, Careggi Hospital, Florence, Italy. 3. Pulmonary Unit, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy. 4. Radiodiagnostic Unit, ISPO-Cancer Research and Prevention Institute, Florence, Italy. 5. 2nd Radiology Unit, University Hospital of Pisa, Pisa, Italy. 6. Prevention Laboratory Unit, ISPO-Cancer Research and Prevention Institute, Florence, Italy. 7. Radiodiagnostic Section, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.
Abstract
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
RCT Entities:
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Authors: Miguel Cainzos-Achirica; Philip A Di Carlo; Catherine E Handy; Renato Quispe; Gerard Roura; Xavier Pinto; Roger S Blumenthal; Josep Comin-Colet; Xavier Corbella; Michael J Blaha Journal: Curr Cardiol Rep Date: 2018-07-10 Impact factor: 2.931
Authors: David R Baldwin; Matthew E Callister; Philip A Crosbie; Emma L O'Dowd; Robert C Rintoul; Hilary A Robbins; Robert J C Steele Journal: Eur Respir J Date: 2021-01-14 Impact factor: 16.671