Effect of smoking cessation counseling within a randomised study on early detection of lung cancer in Germany.

INTRODUCTION: In the German lung cancer screening trial LUSI, smoking cessation counseling (SCC) was offered to all participants at time of randomization, and smoking habits were asked for within annual questionnaire inquiries. We analyzed the smoking habits of the participants within the first 2 years of follow-up and especially the potential effect of the SCC on these habits. MATERIALS AND METHODS: We used the smoking data of the initial inquiry on which the decision on invitation to the study was based, the socio-economic data of the questionnaire filled-in at time of randomization, the psycho-social data obtained during the SCC, and the annual questionnaire data of the first two annual follow-up screening rounds. RESULTS: Smoking prevalence decreased in the entire cohort significantly by 4 %, whereby the decrease was with 4.5 % statistically not significantly higher in the control arm than in the screening arm with 3.4 %. The decline was much stronger in the subgroup of attendees to stop-smoking counseling and mounted up therein to 10 %. In some participants, an increase of readiness to quit smoking was observed during the counseling hour, but did not show effects on smoking status 2 years later. DISCUSSION: We did not see a tendency to increased smoking among participants of the intervention arm or the entire study. The decline of smoking prevalence among the attendees of the counseling might be due to self-selection. Since the issue of effectiveness of smoking cessation counseling is important, further research with randomization into offering counseling or no intervention should be taken into consideration.

Randomized Study on Early Detection of Lung Cancer with MSCT in Germany: Results of the First 3 Years of Follow-up After Randomization.

INTRODUCTION: The German Lung Cancer Screening Intervention Trial (LUSI) is one of the European randomized trials investigating the efficacy of low-dose multislice computed tomography (MSCT) as a screening tool for lung cancer. In the evaluation of the first (prevalence) screening round, we observed exceptionally high early recall rates, which made the routine application of MSCT screening questionable. Because screening may behave differently in subsequent (incidence) screening rounds, we analyzed (a) basic characteristics for the annual rounds 2 to 4, which have now also been completed, and (b) the first 3 years with complete follow-up since time of randomization. METHODS: Data material was the data record of LUSI after the fourth screening round and the 3-year follow-up had been completed. Basic characteristics of screening, e.g., early recall rate, detection rate, and interval cancers as well of proportion of advanced cancers, were descriptively evaluated and, if informative, group differences were tested for statistical significance. RESULTS: Early recall rates were significantly lower in the subsequent screening rounds than in the first one if the MSCT information from the previous screening rounds was available. Detection and biopsy rates were approximately 1% or lower, ratio of benign:malignant biopsies: 1:1.6 to 1:3. CONCLUSION: Our recent data may not only settle one concern regarding high recall rates in routine MSCT screening but also indicate that screening must be strictly organized to be effective. Performance indicators are similar to those in mammography screening. Nevertheless, possible consequences for the participants (diagnostic workup of suspicious findings, biopsies) are more invasive than in mammography screening.

Randomized study on early detection of lung cancer with MSCT in Germany: study design and results of the first screening round.

PURPOSE: Low-dose multislice-CT (MSCT) detects many early-stage lung cancers with good prognosis, but whether it decreases lung cancer mortality and at which costs is yet insufficiently explored. Scope of the present study is to examine within a common European effort whether MSCT screening is capable to reduce the lung cancer mortality by at least 20 % and at which amount of undesired side effects this could be achieved. METHODS: Overall 4,052 heavy smoking men and women were recruited by a population-based approach and randomized into a screening arm with five annual MSCT screens and an initial quit-smoking counseling, and a control arm with initial quit-smoking counseling and five annual questionnaire inquiries. RESULTS: In the first screening round, 2,029 participants received a MSCT providing 1,488 negative and 540 suspicious screens with early recalls (early recall rate 26.6 %) leading to 31 biopsies (biopsy rate 1.5 %) and 22 confirmed lung cancers (detection rate 1.1 %). Among the lung cancers, 15 were adenocarcinomas, 3 squamous cell carcinomas, one small-cell lung cancer, and 3 others, whereby 18 were in clinical stage I, one in stage II, and 3 in stage III. One interval cancer occurred. CONCLUSIONS: The indicated performance indicators fit into the range observed in comparable trials. The study continues finalizing the second screening round and for the first participants even the last screening round. The unresolved issue of the precise amount of side effects and the high early recall rate precludes currently the recommendation of MSCT as screening tool for lung cancer.