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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    ABSTRACT: Background: There is considerable interest in the possibility of provision of lung cancer screening services in many developed countries. There is, however, no consensus on the target population or optimal screening regimen. Methods: In this paper, we demonstrate the use of published results on lung cancer screening and natural history parameters to estimate the likely effects of annual and biennial screening programmes in different risk populations, in terms of deaths prevented and of human costs, including screening episodes, further investigation rates and overdiagnosis. Results: Annual screening with the UK Lung Screening Study eligibility criteria was estimated to result in 956 lung cancer deaths prevented and 457 overdiagnosed cancers from 330 000 screening episodes. Biennial screening would result in 802 lung cancer deaths prevented and 383 overdiagnosed cancers for 180 000 screening episodes. Interpretation/conclusion: The predictions suggest that the intervention effect could justify the human costs. The evidence base for low-dose CT screening for lung cancer pertains almost entirely to annual screening. The benefit of biennial screening is subject to additional uncertainty but the issue merits further empirical research.
    British Journal of Cancer 02/2014; 110(7). DOI:10.1038/bjc.2014.63 · 4.84 Impact Factor
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    • "Today, in lung cancer screening more and more professionals vote for low-dose CT screening [10] according to methodological aspects, however a number of parameters do not have uniform criteria: the age of included people varies in different countries [11,12] (in Hungary it is between 40 and 65 years), the interval of screening also varies: one or two [13] year intervals can be found. "
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    ABSTRACT: Lung cancer is the most common fatal malignacy and also the primary cause of cancer mortality. Participation in lung screening is an important step in diagnosing patient in early stage and it can promise better outcomes. The aim of this preliminary study was to determinate the differences in the participation rate of smokers and non-smokers in lung cancer screening and to determine the communication strategies to increase the participation rate. In the given period of time (from May to August 2012) out of 1426 people who participated in the lung screening program 1,060 adult volunteers (331 males and 729 females, average age 54.0+/-9.3years), completed fully and anonymously author's questionnaire that contained 28 questions. 25.7% of the respondents were smokers (n=272), 64.6% have never smoked, while 9.7% were former smokers. Mostly former smokers considered lung screening as an effective method for early detection of pulmonary diseases (86.4%). The most important source (41.0%) of information was the general practitioner. The participation rate of non-smokers is higher in lung screening than the ratio of non-smokers in the population. The unclear data suggest that smokers need distinct, concise messages to know why they should regularly undergo lung screening and doctors have a major role in this. We found that smokers significantly more frequently took part in lung screening annually. It is positive that the participation rate of former smokers is higher than non-smokers, it is just a bit lower than the participation rate of smokers---both in annual and biannual participation. The participation rate of non-smokers is higher in lung screening than the rate of non-smokers in the population.
    BMC Public Health 10/2013; 13(1):914. DOI:10.1186/1471-2458-13-914 · 2.26 Impact Factor
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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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    ABSTRACT: Lung nodules are commonly found on computed tomography (CT) and need a standardized approach in order to avoid misdiagnosing lung cancer and delaying surgical excision whilst simultaneously avoiding unnecessary invasive procedures if the lesions prove to be benign. Great advances have been made in the last decade in various areas affecting the management of lung nodules: the understanding of the molecular mechanisms behind carcinogenesis, a new classification of lung adenocarcinoma, new data on lung cancer screening, widespread use of multi-detector row CT and development of volumetric analysis software for nodules. Recent decision-making algorithms are based on the size, density and follow-up of the nodule. The distinction between solid nodules, sub-solid nodules and pure ground glass nodules is fundamental, and has a strong correlation with the histologic spectrum of adenocarcinoma. In the absence of criteria suggesting benign disease, the radiologist's report should offer one of the following two options: follow-up based on the recommendations if the nodule is equivocal, or multidisciplinary discussion to consider invasive management if the nodule is highly suspicious of malignancy. Recent data from this statement are reviewed and practical guidelines are offered based on international expert consensus opinion.
    Diagnostic and interventional imaging 09/2013; 94(11). DOI:10.1016/j.diii.2013.05.007
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