Final results of the Lung Screening Study, a randomized feasibility study of spiral CT versus chest X-ray screening for lung cancer

Gohagan, John K.; Marcus, Pamela M.; Fagerstrom, Richard M.; Pinsky, Paul F.; Kramer, Barnett S.; Prorok, Philip C.; Ascher, Susan M.; Bailey, William C.; Brewer, Brenda; Church, Timothy R.; Engelhard, Deborah; Ford, Melissa; Fouad, Mona N.; Freedman, Matthew T.; Gelmann, Edward P.; Gierada, David S.; Hocking, William G.; Inampudi, Subbarao; Irons, Brian K.; Johnson, Christine Cole; Jones, Arthur; Kucera, Gena; Kvale, Paul A.; Lappe, Karen; Manor, William; Moore, Alisha; Nath, Hrudaya; Neff, Sarah; Oken, Martin M.; Plunkett, Michael; Price, Helen; Reding, Douglas J.; Riley, Thomas L.; Schwartz, Martin L.; Spizarny, David L.; Yoffie, Roberta; Zylak, Carl J.

doi:10.1016/j.lungcan.2004.06.007

Cited by 272 publications

(194 citation statements)

References 13 publications

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“…Preliminary data from four randomized controlled trials (RCTs) using CT screening in the intervention arm have been published (16)(17)(18)(19)(20)(21). Three of these trials were conducted in advance of large multi-center national trials to determine the feasibility of enrollment into a randomized trial by generalists (16)(17)(18).…”

Section: Findings From Preliminary Randomized Controlled Trialsmentioning

confidence: 99%

“…Three of these trials were conducted in advance of large multi-center national trials to determine the feasibility of enrollment into a randomized trial by generalists (16)(17)(18). The Depiscan, conducted in France, involved 765 subjects randomized to receive either low dose CT or CXR at baseline and annually for two years.…”

Section: Findings From Preliminary Randomized Controlled Trialsmentioning

confidence: 99%

“…Gohagan et al, representing the Lung Screening Study (LSS) Research Group, reported the final results of the Lung Screening Study, in which 3318 individuals at high risk of lung cancer were equally randomized to receive either low dose CT or CXR for two annual screenings (21). The study was not powered to address differential lung cancer mortality between the two arms, but rather, whether a large scale multicenter randomized trial was feasible in the United States.…”

Section: Findings From Preliminary Randomized Controlled Trialsmentioning

confidence: 99%

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Lung Cancer Screening with CT

Aberle

Brown

2008

Clinics in Chest Medicine

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Lung cancer is the leading cause of cancer death in the United States. In 2007, it is estimated that 160,390 lung cancer deaths will occur in the US, representing 29% of all cancer deaths (1). Roughly 87% of lung cancers are attributed to cigarette smoking (2). Although cancer risk is attenuated by smoking cessation, the risk is not eliminated, and lung cancer now occurs with equal frequency in current and former smokers (3). Moreover, other factors clearly influence risk, including age; family history; chronic obstructive pulmonary disease; pulmonary fibrosis; and exposures to environmental radon, asbestos, and certain other occupational agents (4). Realistically, lung cancer will likely remain at epidemic proportions for decades to come.Non-small cell lung cancer (NSCLC), which accounts for 75-80% of all lung cancers, is typically diagnosed when disease is locally advanced or there are systemic metastases (5), explaining the dismal overall five-year survival of 15% (6). In contrast, the five-year survival of individuals with surgically resected, early stage NSCLC approaches 75% (6,7). These differences have fueled the impetus to find a screening test that can detect NSCLC in its early preclinical stages, when surgical resection is most likely to prolong life and potentially reduce lung cancer mortality. Although earlier randomized controlled trials of lung cancer screening using chest radiography and sputum cytology failed to show reduced lung cancer mortality, computed tomography (CT) is a much more sensitive test for detecting small lung nodules, and has generated considerable enthusiasm as a potential contemporary screening tool for lung cancer.

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Section: Findings From Preliminary Randomized Controlled Trialsmentioning

confidence: 99%

Section: Findings From Preliminary Randomized Controlled Trialsmentioning

confidence: 99%

Section: Findings From Preliminary Randomized Controlled Trialsmentioning

confidence: 99%

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Lung Cancer Screening with CT

Aberle

Brown

2008

Clinics in Chest Medicine

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“…Selection criteria for single armed lung cancer screening studies and ongoing and planned trials show some variability in smoking exposure and age selection criteria. 4,[8][9][10][11][12][13][14][15][16][17] This variability can cause differences in characteristics of the trial population and cancer detection rates. Purpose of this study was to describe a method to come to an optimum selection and recruitment of the eligible population for a lung cancer screening trial, taking into account available resources and screening capacity and the influence that selection criteria have on the estimated lung cancer mortality and the power of such a trial.…”

mentioning

confidence: 99%

Risk‐based selection from the general population in a screening trial: Selection criteria, recruitment and power for the Dutch‐Belgian randomised lung cancer multi‐slice CT screening trial (NELSON)

Iersel

Koning

Draisma

et al. 2006

Intl Journal of Cancer

441

357

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A method to obtain the optimal selection criteria, taking into account available resources and capacity and the impact on power, is presented for the Dutch-Belgian randomised lung cancer screening trial (NELSON). NELSON investigates whether 16-detector multi-slice computed tomography screening will decrease lung cancer mortality compared to no screening. A questionnaire was sent to 335,441 (mainly) men, aged 50-75. Smoking exposure (years smoked, cigarettes/day, years quit) was determined, and expected lung cancer mortality was estimated for different selection scenarios for the 106,931 respondents, using lung cancer mortality data by level of smoking exposure (US Cancer Prevention Study I and II). Selection criteria were chosen so that the required response among eligible subjects to reach sufficient sample size was minimised and the required sample size was within our capacity. Inviting current and former smokers (quit 10 years ago) who smoked >15 cigarettes/day during >25 years or >10 cigarettes/day during >30 years was most optimal. With a power of 80%, 17,300-27,900 participants are needed to show a 20-25% lung cancer mortality reduction 10 years after randomisation. Until October 18, 2005 11,103 (first recruitment round) and 4,325 (second recruitment round) (total 5 15,428) participants have been randomised. Selecting participants for lung cancer screening trials based on risk estimates is feasible and helpful to minimize sample size and costs. When pooling with Danish trial data (n 5 64,000) NELSON is the only trial without screening in controls that is expected to have 80% power to show a lung cancer mortality reduction of at least 25% 10 years after randomisation. ' 2006 Wiley-Liss, Inc.Key words: lung cancer; screening; computed tomography; power; risk estimation Lung cancer is the most common cause of cancer-related death in men and the second most common cause of cancer-related death in women in Europe. 1 Because lung cancer is often in an advanced stage at the time of diagnosis, 5-year-survival is only 15% or less. 2 Japanese studies and the US Early Lung Cancer Action Project (ELCAP) showed that in a high-risk population more lung cancers can be detected by spiral computed tomography (CT) screening than by chest X-ray screening. 3,4 These and other observational studies with spiral CT screening showed that 55-85% of CTdetected lung cancers at baseline screening in a high-risk population of current and former smokers are at a surgically removable stage (stage I). 5 Although these results seem promising, observational studies are prone to lead-time, length-time and overdiagnosis bias. Only in a randomised design, disease-specific mortality between the screened and the unscreened population, instead of survival, can be compared. Lead-time, length-time and overdiagnosis do not bias the analysis in such comparisons. 6 Therefore, in the United States the National Lung Screening Trial (NLST) was launched in 2002 7 and in the Netherlands and Belgium, the NEL-SON trial, a Dutch acronym for ÔDutch-Belgian lu...

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“…Cigarette smoking causes lung cancer, which is by far the major risk factor (4, 5, 6). Lung cancer has a high mortality rate among malignancies, in part because symptoms are frequently absent until disease is already metastatic and is, therefore, incurable (7,8,9). Early detection represents a very promising approach to reduce lung cancer incidence and mortality.…”

mentioning

confidence: 99%

Proteomic Analysis of Human Saliva From Lung Cancer Patients Using Two-Dimensional Difference Gel Electrophoresis and Mass Spectrometry

Xiao¹,

Zhang²,

Zhou³

et al. 2012

Molecular & Cellular Proteomics

161

108

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Lung cancer is often asymptomatic or causes only nonspecific symptoms in its early stages. Early detection represents one of the most promising approaches to reduce the growing lung cancer burden. Human saliva is an attractive diagnostic fluid because its collection is less invasive than that of tissue or blood. Profiling of proteins in saliva over the course of disease progression could reveal potential biomarkers indicative of oral or systematic diseases, which may be used extensively in future medical diagnostics. There were 72 subjects enrolled in this study for saliva sample collection according to the approved protocol. Two-dimensional difference gel electrophoresis combined with MS was the platform for salivary proteome separation, quantification, and identification from two pooled samples. Candidate proteomic biomarkers were verified and prevalidated by using immunoassay methods. There were 16 candidate protein biomarkers discovered by two-dimensional difference gel electrophoresis and MS. Three proteins were further verified in the discovery sample set, prevalidation sample set, and lung cancer cell lines. The discriminatory power of these candidate biomarkers in lung cancer patients and healthy control subjects can reach 88.5% sensitivity and 92.3% specificity with AUC ‫؍‬ 0.90. This preliminary data report demonstrates that proteomic biomarkers are present in human saliva when people develop lung cancer. The discriminatory power of these candidate biomarkers indicate that a simple saliva test might be established for lung cancer clinical screening and detection. Molecular & Cellular Proteomics 11: 10.1074/mcp.M111.012112, 1-12, 2012.Lung cancer has long been a significant worldwide public health issue. In the United States, lung cancer is the most common cause of cancer-related death in men and women. According to the American Cancer Society, the major type of lung cancer is non-small-cell lung cancer (NSCLC) 1 , which comprises ϳ85% of lung cancers (1, 2). Small cell lung cancer (SCLC) is another type of lung cancer, which represents about 15% of cases (3). Cigarette smoking causes lung cancer, which is by far the major risk factor (4, 5, 6). Lung cancer has a high mortality rate among malignancies, in part because symptoms are frequently absent until disease is already metastatic and is, therefore, incurable (7,8,9). Early detection represents a very promising approach to reduce lung cancer incidence and mortality. However, conventional diagnostic methods for lung cancer are unsuitable for widespread screening because they are either expensive and occasionally miss tumors or invasive cancer (10,11,12,13). Computed tomography has been wildly used for lung cancer early screening, although it often produces a high rate of false positives (7,14,15). Better diagnostic methods are urgently needed to improve the detection of lung cancer.Tissue and blood have been extensively used in attempts to detect lung cancer earlier (1,16,17,18). Sputum has also been used to predict lung cancer by detecting its aberra...

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Final results of the Lung Screening Study, a randomized feasibility study of spiral CT versus chest X-ray screening for lung cancer

Cited by 272 publications

References 13 publications

Lung Cancer Screening with CT

Lung Cancer Screening with CT

Risk‐based selection from the general population in a screening trial: Selection criteria, recruitment and power for the Dutch‐Belgian randomised lung cancer multi‐slice CT screening trial (NELSON)

Proteomic Analysis of Human Saliva From Lung Cancer Patients Using Two-Dimensional Difference Gel Electrophoresis and Mass Spectrometry

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