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

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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.

Key Words

cancer
low-dose CT
lung
randomized trial
screening

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Disclosure: C.P.H is Head of Diagnostic and Interventional Radiology with Nuclear Medicine, Thoraxklinik, Heidelberg. He is a Member of the German Center for Lung Research. He has Stada and GSK stock ownership in medical industry. He has the following patent: Method and Device for Representing the Microstructure of the Lungs. IPC8 Class: AA61B5055FI, PAN: 20080208038, Inventors: W Schreiber, U Wolf, AW Scholz, CP Heussel. He received consultation or other fees from the following organizations: Schering-Plough 2009, 2010; Pfizer 20082014; Basilea 2008, 2009, 2010; Boehringer Ingelheim 20102014; Novartis 2010, 2012; Roche 2010; Astellas 2011, 2012; Gilead 20112014; MSD 20112013; Lilly 2011; Intermune 20132014; and Fresenius 2013, 2014. He received research funding from the following organizations: Siemens 20122014; Pfizer 20122014; MeVis 2012, 2013; and Boehringer Ingelheim 2014. He receive lecture fees from the following organizations: Gilead 20082014; Essex 2008, 2009, 2010; Schering-Plough 2008, 2009, 2010; AstraZeneca 20082012; Lilly 2008, 2009, 2012; Roche 2008, 2009; MSD 20092014; Pfizer 20102014; Bracco 2010, 2011; MEDA Pharma 2011; Intermune 20112014; Chiesi 2012; Siemens 2012; Covidien 2012; Pierre Fabre 2012; Boehringer Ingelheim 2012 2013, 2014; Grifols 2012 and Novartis 2013, 2014. He has no expert testimony. He is not related to tobacco Industry. He is a Chief executive officer of the chest working group of the German Roentgen society (guidelines: bronchial carcinoma, mesothelioma, COPD, screening for bronchial carcinoma, CT and MR imaging of the chest). He is a Consultant of ECIL-3, ECCMID, EORTC (guideline for diagnosis of infections in immunocompromized hosts). He is a Founder member of the working team in infections in immunocompromized hosts of the German society of Hematology/Oncology (guideline for diagnosis of infections in immunocompromized hosts). He is a Faculty member of the European Society of Thoracic Radiology (ESTI). He is an Editor of “Medizinische Klinik, Intensivmedizin und Notfallmedizin” at Dr. Dietrich Steinkopff (Springer) publishing. The other authors declare no conflict of interest.

Funding: Deutsche Forschungsgemeinschaft, Dietmar Hopp Stiftung.