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      A serum circulating miRNA diagnostic test to identify asymptomatic high-risk individuals with early stage lung cancer

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          Abstract

          Lung cancer is the first cause of cancer mortality worldwide, and its early detection is currently the main available strategy to improve disease prognosis. While early diagnosis can be successfully achieved through tomography-based population screenings in high-risk individuals, simple methodologies are needed for effective cancer prevention programs. We developed a test, based on the detection of 34 microRNAs (miRNAs) from serum, that could identify patients with early stage non-small cell lung carcinomas (NSCLCs) in a population of asymptomatic high-risk individuals with 80% accuracy. The signature could assign disease probability accurately either in asymptomatic or symptomatic patients, is able to distinguish between benign and malignant lesions, and to capture the onset of the malignant disease in individual patients over time. Thus, our test displays a number of features of clinical relevance that project its utility in programs for the early detection of NSCLC.

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          Most cited references25

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          The National Lung Screening Trial: overview and study design.

          The National Lung Screening Trial (NLST) is a randomized multicenter study comparing low-dose helical computed tomography (CT) with chest radiography in the screening of older current and former heavy smokers for early detection of lung cancer, which is the leading cause of cancer-related death in the United States. Five-year survival rates approach 70% with surgical resection of stage IA disease; however, more than 75% of individuals have incurable locally advanced or metastatic disease, the latter having a 5-year survival of less than 5%. It is plausible that treatment should be more effective and the likelihood of death decreased if asymptomatic lung cancer is detected through screening early enough in its preclinical phase. For these reasons, there is intense interest and intuitive appeal in lung cancer screening with low-dose CT. The use of survival as the determinant of screening effectiveness is, however, confounded by the well-described biases of lead time, length, and overdiagnosis. Despite previous attempts, no test has been shown to reduce lung cancer mortality, an endpoint that circumvents screening biases and provides a definitive measure of benefit when assessed in a randomized controlled trial that enables comparison of mortality rates between screened individuals and a control group that does not undergo the screening intervention of interest. The NLST is such a trial. The rationale for and design of the NLST are presented. © RSNA, 2010
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            Serum microRNA signatures identified in a genome-wide serum microRNA expression profiling predict survival of non-small-cell lung cancer.

            Recent findings that human serum contains stably expressed microRNA (miRNA) have revealed a great potential of serum miRNA signature as disease fingerprints to predict survival. We used genome-wide serum miRNA expression analysis to investigate the role of serum miRNA in predicting prognosis of non-small-cell lung cancer (NSCLC). To control disease heterogeneity, we used patients with stages I to IIIa lung adenocarcinoma and squamous cell carcinoma, who were treated with both operation and adjuvant chemotherapies. In the discovery stage, Solexa sequencing followed by individual quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) assays was used to test the difference in levels of serum miRNAs between 30 patients with longer survival (alive and mean survival time, 49.54 months) and 30 patients with shorter survival matched by age, sex, and stage (dead and mean survival time, 9.54 months). The detected serum miRNAs then were validated in 243 patients (randomly classified into two subgroups: n = 120 for the training set, and n = 123 for the testing set). Eleven serum miRNAs were found to be altered more than five-fold by Solexa sequencing between longer-survival and shorter-survival groups, and levels of four miRNAs (ie, miR-486, miR-30d, miR-1 and miR-499) were significantly associated with overall survival. The four-miRNA signature also was consistently an independent predictor of overall survival for both training and testing samples. The four-miRNA signature from the serum may serve as a noninvasive predictor for the overall survival of NSCLC.
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              Is Open Access

              Annual Report to the Nation on the Status of Cancer, 1975–2005, Featuring Trends in Lung Cancer, Tobacco Use, and Tobacco Control

              Background The American Cancer Society, the Centers for Disease Control and Prevention (CDC), the National Cancer Institute (NCI), and the North American Association of Central Cancer Registries (NAACCR) collaborate annually to provide updated information on cancer occurrence and trends in the United States. This year’s report includes trends in lung cancer incidence and death rates, tobacco use, and tobacco control by state of residence. Methods Information on invasive cancers was obtained from the NCI, CDC, and NAACCR and information on mortality from the CDC's National Center for Health Statistics. Annual percentage changes in the age-standardized incidence and death rates (2000 US population standard) for all cancers combined and for the top 15 cancers were estimated by joinpoint analysis of long-term (1975–2005) trends and by least squares linear regression of short-term (1996–2005) trends. All statistical tests were two-sided. Results Both incidence and death rates from all cancers combined decreased statistically significantly (P < .05) in men and women overall and in most racial and ethnic populations. These decreases were driven largely by declines in both incidence and death rates for the three most common cancers in men (lung, colorectum, and prostate) and for two of the three leading cancers in women (breast and colorectum), combined with a leveling off of lung cancer death rates in women. Although the national trend in female lung cancer death rates has stabilized since 2003, after increasing for several decades, there is prominent state and regional variation. Lung cancer incidence and/or death rates among women increased in 18 states, 16 of them in the South or Midwest, where, on average, the prevalence of smoking was higher and the annual percentage decrease in current smoking among adult women was lower than in the West and Northeast. California was the only state with decreasing lung cancer incidence and death rates in women. Conclusions Although the decrease in overall cancer incidence and death rates is encouraging, large state and regional differences in lung cancer trends among women underscore the need to maintain and strengthen many state tobacco control programs.
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                Author and article information

                Journal
                EMBO Mol Med
                EMBO Mol Med
                emmm
                EMBO Molecular Medicine
                WILEY-VCH Verlag (Weinheim )
                1757-4676
                1757-4684
                August 2011
                : 3
                : 8
                : 495-503
                Affiliations
                [1 ]simpleIFOM, The FIRC Institute for Molecular Oncology Foundation At the IFOM-IEO Campus, Milan, Italy
                [2 ]simpleDipartimento di Medicina, Chirurgia ed Odontoiatria, Universita' degli Studi di Milano Milan, Italy
                [3 ]simpleDepartment of Experimental Oncology, European Institute of Oncology At the IFOM-IEO Campus, Milan, Italy
                [4 ]simpleCogentech, Consortium for Genomic Technologies at the IFOM-IEO Campus Milan, Italy
                [5 ]simpleDivision of Pathology, European Institute of Oncology Milan, Italy
                [6 ]simpleDivision of Epidemiology and Biostatistics, European Institute of Oncology Milan, Italy
                [7 ]simpleDivision of Thoracic Surgery, European Institute of Oncology Milan, Italy
                Author notes
                * Corresponding author: Tel: +39 02 574303257; Fax: +39 02 94375991; E-mail: pierpaolo.difiore@ 123456ifom-ieo-campus.it
                [†]

                These two authors contributed equally.

                Article
                10.1002/emmm.201100154
                3377091
                21744498
                b0c90654-cc35-4ae7-b8f7-ff6ceef48f30
                Copyright © 2011 EMBO Molecular Medicine
                History
                : 23 March 2011
                : 14 May 2011
                : 31 May 2011
                Categories
                Research Article

                Molecular medicine
                serum,early stage,diagnosis,mirna,lung cancer
                Molecular medicine
                serum, early stage, diagnosis, mirna, lung cancer

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