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Annual or biennial CT screening versus observation in heavy smokers: 5-year results of the MILD trial

Pastorino, Ugoa; Rossi, Martae,f; Rosato, Valentinae,f; Marchianò, Alfonsob; Sverzellati, Nicolag; Morosi, Carlob; Fabbri, Alessandrac; Galeone, Carlottae,f; Negri, Evae; Sozzi, Gabriellad; Pelosi, Giuseppec; La Vecchia, Carloe,f

European Journal of Cancer Prevention: May 2012 - Volume 21 - Issue 3 - p 308–315
doi: 10.1097/CEJ.0b013e328351e1b6
Research Paper: Lifestyle

The efficacy and cost-effectiveness of low-dose spiral computed tomography (LDCT) screening in heavy smokers is currently under evaluation worldwide. Our screening program started with a pilot study on 1035 volunteers in Milan in 2000 and was followed up in 2005 by a randomized trial comparing annual or biennial LDCT with observation, named Multicentric Italian Lung Detection. This included 4099 participants, 1723 randomized to the control group, 1186 to biennial LDCT screening, and 1190 to annual LDCT screening. Follow-up was stopped in November 2011, with 9901 person-years for the pilot study and 17 621 person-years for Multicentric Italian Lung Detection. Forty-nine lung cancers were detected by LDCT (20 in biennial and 29 in the annual arm), of which 17 were identified at baseline examination; 63% were of stage I and 84% were surgically resectable. Stage distribution and resection rates were similar in the two LDCT arms. The cumulative 5-year lung cancer incidence rate was 311/100 000 in the control group, 457 in the biennial, and 620 in the annual LDCT group (P=0.036); lung cancer mortality rates were 109, 109, and 216/100 000 (P=0.21), and total mortality rates were 310, 363, and 558/100 000, respectively (P=0.13). Total mortality in the pilot study was similar to that observed in the annual LDCT arm at 5 years. There was no evidence of a protective effect of annual or biennial LDCT screening. Furthermore, a meta-analysis of the four published randomized trials showed similar overall mortality in the LDCT arms compared with the control arm.

aUnit of Thoracic Surgery

bUnit of Radiology

cDepartment of Pathology

dUnit of Tumor Genomics, Department of Experimental Oncology, Foundation IRCCS National Cancer Institute of Milan

eDepartment of Epidemiology, Mario Negri Institute for Pharmacological Research

fDepartment of Occupational Health, University of Milan, Milan

gDepartment of Clinical Sciences, Section of Radiology, University of Parma, Parma, Italy

Correspondence to Ugo Pastorino, MD, Unit of Thoracic Surgery, Foundation IRCCS National Cancer Institute of Milan, Via Venezian 1, 20133 Milan, Italy Tel: +39 022 390 2906; fax: +39 022 390 2907; e-mail:

Received January 26, 2012

Accepted January 27, 2012

© 2012 Lippincott Williams & Wilkins, Inc.