RESEARCH QUESTION

RESEARCH QUESTION 1: UPDATE OF BENEFIT ASSESSMENT S19-02: As an update of IQWiG report S19-02, the aim of this investigation is to assess the benefit of lung cancer screening using low-dose computed tomography (CT) versus no (or no systematic) screening. The target population is current and former smokers without suspected lung cancer. RESEARCH QUESTION 2: BENEFIT ASSESSMENT OF VARIANTS OF LUNG CANCER SCREENING: The aim of this investigation is to assess the benefit of variants of lung cancer screening using low-dose CT based on informative randomized controlled trials (RCTs) that at least address the following aspects: screening intervals, technical equipment standards, performance of image evaluation, and algorithms for clarifying abnormal or equivocal test results. The target population is people without suspected lung cancer or with test results requiring clarification based on previous imaging as part of a screening test.

CONCLUSION

RESEARCH QUESTION 1: UPDATE OF BENEFIT ASSESSMENT S19-02: For the update of report S19-02, 2 additional documents with usable data from 2 RCTs already included in report S19-02 were identified (LUSI and UKLS). Overall, results from 9 studies were thus available for the benefit assessment of screening for lung cancer using low-dose CT versus no screening. After updating the analyses, there was still no hint of a benefit of low-dose CT screening versus no screening for overall survival. After updating the analyses, there is proof of a benefit of low-dose CT screening for lung cancer-specific mortality. Compared with report S19-02, the certainty of the conclusions for this outcome was upgraded from an “indication” to “proof” based on the new evidence. The results continue to support the previous assumption that screening also has a positive effect on all-cause mortality. The respective estimates and the associated confidence intervals for the absolute effect on all-cause mortality and lung cancer-specific mortality are of a similar magnitude. Considering these two mortality outcomes together therefore provides an indication of a benefit of low-dose CT screening for the outcome of mortality. Thus, overall the certainty of conclusions for this outcome was upgraded from a “hint” to an “indication” compared with report S19-02. No new data were reported for adverse events (AEs) and consequences of incorrect screening results. Therefore, based on the analyses in report S19-02, the conclusions about the evidence for these outcomes remain unchanged: For AEs, there is a hint of harm from low-dose CT screening. For “consequences of incorrect screening results”, there is proof of harm from low-dose CT screening based on the results for consequences of false-positive screening results. After updating the analyses, as in report S19-02, there is proof of harm from low-dose CT screening for the outcome of overdiagnosis. As in report S19-02, there are no usable data for the outcome of health-related quality of life. The new data from 2 studies identified in the update further substantiated the benefit of low-dose CT screening for the outcome of mortality. The proof of harm from low-dose CT screening in terms of overdiagnosis still remains after the update of the results, but this does not call into question the indication of a benefit of low-dose CT screening for mortality. In summary, the data show that there is an indication of a benefit of low-dose CT screening versus no screening and that the benefit of low-dose CT screening outweighs harm in (former) heavy smokers. This leads to a change in the overall conclusion compared with the assessment of report S19-02. The certainty of conclusions was upgraded from a “hint” to an “indication”. RESEARCH QUESTION 2: BENEFIT ASSESSMENT OF VARIANTS OF LUNG CANCER SCREENING: There was only 1 study for the benefit assessment of variants of lung cancer screening. It compared screening intervals of different lengths (biennial versus annual low-dose CT screening). Therefore, the assessment of variants of low-dose CT screening was limited to the aspect of the frequency of screening and was restricted to the variants of annual and biennial screening. For the outcomes of mortality, AEs, consequences of false-positive screening results and overdiagnosis, there was no hint of a greater benefit or greater harm from biennial versus annual low-dose CT screening. No data were available on the outcomes of consequences of false-negative screening results and health-related quality of life. In the overall assessment across outcomes, therefore no hint was derived with regard to a greater benefit or greater harm of biennial versus annual low-dose CT screening.