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S128 Lungsearch: a randomised controlled trial of surveillance for the early detection of lung cancer in a high risk group
  1. S Spiro1,
  2. P Shah2,
  3. R Rintoul3,
  4. J George4,
  5. S Janes1,
  6. M Callister5,
  7. M Novelli1,
  8. P Shaw4,
  9. C Griffths6,
  10. M Falzon1,
  11. G Kocjan1,
  12. R Booton7,
  13. N Magee8,
  14. M Peake9,
  15. P Dhillon10,
  16. K Sridharan11,
  17. J Allen1,
  18. N Chinyanganya1,
  19. V Ashford-Turner5,
  20. N Counsell1,
  21. A Hackshaw1
  1. 1UCL, London, UK
  2. 2Royal Brompton Hospital, London, UK
  3. 3Papworth Hospital, Cambridge, UK
  4. 4ULCH, London, UK
  5. 5St James’s University Hospital, Leeds, UK
  6. 6Queen Mary, London, UK
  7. 7University Hospital South Manchester, Manchester, UK
  8. 8Queens University Belfast, Belfast, UK
  9. 9Glenfield Hospital, Leicester, UK
  10. 10University Hospital Coventry, Coventry, UK
  11. 11Sunderland Royal Hospital, Sunderland, UK

Abstract

Screening for the early detection of lung cancers should increase the percentage of operable tumours, thus improving cure rates. A large randomised US trial showed that CT screening moderate/heavy smokers is effective but expensive, with a high false-positive rate. We designed LungSEARCH in 2006 to target screening in higher-risk subjects. Because most tumours in the UK were of squamous-histology, we hypothesised that sputum cytology plus cytometry would be an effective initial screen, only offering more intensive/expensive tests to those with abnormal sputum.

Eligibility criteria were: current/former smokers (≥20 pack-years and/or smoked ≥20 years), GOLD-defined COPD, no prior cancer. Subjects were randomised to surveillance or a control group, and each followed for 5 years. Screened subjects provided sputum for central assessment, and those with abnormal results (cytology: low/high-grade squamous intraepithelial lesions, and/or cytometry: abnormal ploidy) were referred for annual low-dose CT and autofluorescence bronchoscopy (AFB) for the remainder of the trial, with diagnostic investigations when cancer suspected by abnormal CT/AFB. Sputum-negatives provided annual sputum samples only. Control subjects had a chest X-ray when they reached 5 years. Primary objective: to show a higher proportion of early stage cancers using surveillance than controls.

1568 subjects were recruited (target 1300) from GPs or chest clinics around 10 UK centres (August 2007–March 2011): 785 screened, 783 controls. Mean age 63 years; males 52%; current (56%), former (44%) smokers; mild (25%), moderate (75%) COPD; from GPs (79%). >90% screened subjects provided sputum samples in their first year. After 5 years, the overall sputum-positive rate is 33%; 30% (236/785) had a CT scan and 25% (193/785) had an AFB at any time. Of those who had a CT scan 19% (45/236) were abnormal (lung nodule(s) ≥9 mm); and of those who had AFB 3% (5/193) had severe dysplasia or worse.

79 lung cancers have been identified to date via the centres/national registry: 43 surveillance and 36 control. But awaiting staging details for 6 surveillance and 14 control cases. Preliminary results are promising: 57% (surveillance) versus 41% (controls) of cancers were diagnosed with stage I/II non-small-cell-lung cancer or limited disease small-cell-lung cancer. Final data available later in 2016.

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