Spiro, SG;
Shah, PL;
Rintoul, RC;
George, J;
Janes, S;
Callister, M;
Novelli, M;
... Hackshaw, A; + view all
(2019)
Sequential screening for lung cancer in a high-risk group: randomised controlled trial.
European Respiratory Journal
, 54
(4)
, Article 1900581. 10.1183/13993003.00581-2019.
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Abstract
BACKGROUND: Low-dose CT (LDCT) screening detects early stage lung cancer and reduces mortality. We proposed a sequential approach targeted to a high-risk group as a potentially efficient screening strategy. METHODS: LungSEARCH was a national multicentre randomised trial. Current/former smokers with mild/moderate COPD were allocated (1:1) to have 5 years surveillance or not. Screened participants provided annual sputum samples for cytology and cytometry, and if abnormal were offered annual LDCT and autofluorescence bronchoscopy (AFB). Those with normal sputum provided annual samples. Primary endpoint was the percentage of lung cancers diagnosed at stage I/II (non-small cell) or limited disease (small cell). RESULTS: 1568 individuals were randomised 2007-2011, from 10 UK centres. 85.2% of those screened provided an adequate baseline sputum sample. There were 42 lung cancers among 785 screened and 36 among 783 controls. 54.8% (23/42) screened versus 45.2% (14/31) controls with known staging were diagnosed with early stage disease (one-sided p=0.24). Relative risk 1.21 (95%CI 0.75-1.95) or 0.82 (95%CI 0.52-1.31) for early stage or advanced cancers respectively. Overall sensitivity for sputum (in those randomised to surveillance) was low (40.5%) and cumulative false-positive rate (FPR) 32.8%. 55% of cancers had normal sputum results throughout. Among sputum-positive individuals who had AFB, sensitivity was 45.5% and cumulative FPR 39.5%; the corresponding measures for those who had LDCT were 100% and 16.1%. CONCLUSIONS: Our sequential strategy, using sputum cytology/cytometry to select high-risk individuals for AFB and LDCT, did not lead to a clear stage shift, and did not improve the efficiency of lung cancer screening.
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