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

Unit of Thoracic Surgery, Foundation IRCCS National Cancer Institute of Milan, Via Venezian 1, Milan, Italy.
European journal of cancer prevention: the official journal of the European Cancer Prevention Organisation (ECP) (Impact Factor: 3.03). 05/2012; 21(3):308-15. DOI: 10.1097/CEJ.0b013e328351e1b6
Source: PubMed


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.

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Available from: Ugo Pastorino, Jun 10, 2015
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    • "This was observed in the group offered CT screening in NLST, in association with three annual screens and high compliance rates. Although three other trials have published the effect on lung cancer mortality (Infante et al, 2009; Pastorino et al, 2012; Saghir et al, 2012) these trials were very small and a meta-analysis including all four trials gives a 19% reduction, very close to that of NLST (Field et al, 2013). We therefore use the NLST figure. "
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    • "After a median follow-up period of 6.5 years, lung cancer mortality was reduced to 20.3% in patients in the CT arm. An observational Japanese study reported similar results [57], although two other randomized studies have failed to confirm the results of the NLST [58] [59]. These studies, however, did not have the statistical power of the NLST as they included a smaller number of patients (3000 to 4000 compared to 53,000 in the NLST). "
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