CT Screening for lung cancer: diagnoses resulting from the New York Early Lung Cancer Action Project

To evaluate prospectively the diagnostic performance of the New York Early Lung Cancer Action Project (NY-ELCAP) regimen in the diagnosis of early lung cancer at baseline and annual repeat computed tomographic (CT) screenings.

Informed consent and institutional review board approval were obtained for this HIPAA-compliant study of baseline and annual repeat low-dose CT screening performed with a common regimen in asymptomatic individuals at 12 institutions in New York State. All 6295 participants were aged 60 years or older, had smoked for at least 10 pack-years, had no prior cancer, had not undergone chest CT in the previous 3 years, and were medically fit to undergo thoracic surgery. Median age was 66 years, and median smoking history was 40 pack-years. The proportion (and 95% exact confidence intervals [CIs]) of subjects with a positive result, as determined by using nodule size; the diagnoses of lung cancer resulting from subsequent work-up; and the distribution by cancer stage and cell type were determined. When relevant, 95% CIs for the proportions were calculated.

Initial CT imaging led to recommendations for further work-up in 14.4% (95% CI: 13.5%, 15.3%) of the 6295 baseline screenings and 6.0% (95% CI: 5.1%, 6.6%) of the 6014 annual repeat screenings. Of 101 patients in whom the diagnosis of lung cancer resulted from baseline screening and three in whom a diagnosis of lung cancer was prompted by symptoms prior to the first scheduled repeat screening, 95 (91.3%) had no clinical evidence of metastases. Of the 20 patients in whom the diagnosis of lung cancer resulted from annual repeat screening, 17 (85%) showed no evidence of metastases. Of the 134 recommended biopsies, 125 (93.3%) resulted in diagnosis of lung cancer or another malignancy, while none of the 24 biopsies performed outside of the recommendation of the regimen resulted in diagnosis of lung cancer.

The NY-ELCAP regimen of screening revealed that annual CT screening for lung cancer resulted in identification of a high proportion of patients with early-stage disease.