Among subjects at high risk for lung cancer who were screened in three rounds of CT scanning and in whom noncalcified pulmonary nodules were evaluated according to volume and volume-doubling time, the chances of finding lung cancer 1 and 2 years after a negative first-round test were 1 in 1000 and 3 in 1000, respectively. (Current Controlled Trials number, ISRCTN63545820.)

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...

BACKGROUND. Computed tomography (CT) screening is an important new tool for the early detection of lung cancer. In the current study, the authors assessed the discomfort associated with CT scanning and the subsequent wait for results and health‐related quality of life (HRQoL) over time. METHODS. A total of 351 participants in the Dutch‐Belgian randomized controlled trial for lung cancer screening in high‐risk subjects (the NELSON trial) who had an appointment for a baseline CT scan were asked to complete questionnaires regarding their experienced discomfort and HRQoL before, 1 day after, and approximately 6 months after the CT scan. HRQoL was measured as generic HRQoL (12‐item Short Form [SF‐12] and EuroQol questionnaire [EQ‐5D]), generic anxiety (State‐Trait Anxiety Inventory [STAI‐6]), and lung cancer‐specific distress (Impact of Event Scale [IES]). Approximately 76.9% of the participants completed all 3 questionnaires. RESULTS. Approximately 87% to 99% of participants reported experiencing no discomfort related to the CT scan. The median SF‐12, EQ‐5D, STAI‐6, and IES scores did not appear to change relevantly over time. Approximately 46.0% and 51.3%, respectively, of the participants reported discomfort in connection with having to wait for the results of the CT scan and dreading those results. These patients had relevantly higher STAI‐6 and IES scores (P < .01) (unfavorable) at all 3 assessments. CONCLUSIONS. The current evaluation of the potential adverse effects of CT screening for lung cancer on HRQoL demonstrated no negative effects. However, waiting for the CT scan results was reported to be discomforting by approximately half of the participants. Minimizing the waiting time for the test results is therefore recommended. Cancer 2008. © 2008 American Cancer Society.