Purpose: The aim of this prospective study was to assess the diagnostic value of the tumour markers carcinoembryonic antigen (CEA), cytokeratin 19 fragment marker (CYFRA 21-1) and neuron-specific enolase (NSE) in the differentiation of malignant (MSPLs) from benign solitary pulmonary lesions (BSPLs).
Methods: Solitary pulmonary lesions (SPLs) were diagnosed using plain radiography and spiral computed tomography (SCT) and then completely removed by surgery in 104 consecutive patients (MSPLs; n = 81, BSPLs; n = 23). The serum concentrations of the tumour markers were determined 1-3 days prior to surgery by ELISA for CEA and CYFRA 21-1 and by IRMA for NSE using commercially available assay kits. The cut-off values were set at 3 ng/ml (for non-smokers) and 5 ng/ml (for smokers) for CEA, at 3.3 ng/ml for CYFRA 21-1 and at 12.5 ng/ml for NSE.
Results: MSPLs were identified with a sensitivity between 13.6 and 45.7%, a specificity between 87.0 and 100% and an accuracy between 32.7 and 54.8%. Using the tumour markers alone, the highest sensitivity (27.2%) and accuracy (40.4%) was found with CEA, the highest specificity (100%) with CYFRA 21-1 and with NSE. Primary lung cancers (n = 39) were identified with a sensitivity between 17.9 and 61.5%, a specificity between 87.0 and 100% and an accuracy between 48.4 and 71.0%. Using the tumour markers alone, the highest sensitivity (35.9%) and accuracy (59.7%) was found with CYFRA 21-1, the highest specificity (100%) with CYFRA 21-1 and with NSE. The combination of all three tumour markers resulted in a greater sensitivity and greater diagnostic accuracy but a loss in specificity compared with CYFRA 21-1 and NSE.
Conclusion: The use of the tumour markers alone or in combination showed a low sensitivity and low accuracy for the diagnostic differentiation of MSPLs from BSPLs and primary lung cancers from BSPLs. However, both CYFRA 21-1 and NSE exhibited a specificity of 100% and may be useful complements to standard clinical imaging methods.