Early Lung Cancer Action Project: overall design and findings from baseline screening.
BACKGROUND
The Early Lung Cancer Action Project (ELCAP) is designed to evaluate baseline and annual repeat screening by low-radiation-dose computed tomography (low-dose CT) in people at high risk of lung cancer. We report the baseline experience.


METHODS
ELCAP has enrolled 1000 symptom-free volunteers, aged 60 years or older, with at least 10 pack-years of cigarette smoking and no previous cancer, who were medically fit to undergo thoracic surgery. After a structured interview and informed consent, chest radiographs and low-dose CT were done for each participant. The diagnostic investigation of screen-detected non-calcified pulmonary nodules was guided by ELCAP recommendations, which included short-term high-resolution CT follow-up for the smallest non-calcified nodules.


RESULTS
Non-calcified nodules were detected in 233 (23% [95% CI 21-26]) participants by low-dose CT at baseline, compared with 68 (7% [5-9]) by chest radiography. Malignant disease was detected in 27 (2.7% [1.8-3.8]) by CT and seven (0.7% [0.3-1.3]) by chest radiography, and stage I malignant disease in 23 (2.3% [1.5-3.3]) and four (0.4% [0.1-0.9]), respectively. Of the 27 CT-detected cancers, 26 were resectable. Biopsies were done on 28 of the 233 participants with non-calcified nodules; 27 had malignant non-calcified nodules and one had a benign nodule. Another three individuals underwent biopsy against the ELCAP recommendations; all had benign non-calcified nodules. No participant had thoracotomy for a benign nodule.


CONCLUSIONS
Low-dose CT can greatly improve the likelihood of detection of small non-calcified nodules, and thus of lung cancer at an earlier and potentially more curable stage. Although false-positive CT results are common, they can be managed with little use of invasive diagnostic procedures.
Henschke
C I
CI
Weill Medical College of Cornell University and New York Presbyterian Hospital, NY 10021, USA. chensch@mail.med.cornell.edu
McCauley
D I
DI
Yankelevitz
D F
DF
Naidich
D P
DP
McGuinness
G
G
Miettinen
O S
OS
Libby
D M
DM
Pasmantier
M W
MW
Koizumi
J
J
Altorki
N K
NK
Smith
J P
JP
D000368:Aged; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000145:classification / Q000000981:diagnostic imaging* / Q000209:etiology / Q000473:pathology; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D015995:Prevalence; D012307:Risk Factors; D012907:Smoking / Q000009:adverse effects*; D014057:Tomography, X-Ray Computed / Q000379:methods