BACKGROUND: Tumor markers have been used in diagnosis, predicting the extent of disease, monitering recurrence after therapy and prediction of prognosis. But the utility of markers in lung cancer has been limited by low sensitivity and specificity. TPA-M is recently developed marker using combined monoclonal antibody of Cytokeratin 8, 18, and 19. This study was conducted to evaluate the efficacy of new tumor marker, TPA-M by comparing the estabilished markers 8CC, CEA, Cyfra2 I - I in hmg cancer. METHODS: An immunoradiometric assay of serum CEA, SCC, Cyfra2l-I, and TPA-M was performed in 49 pathologically confirmed lung cancer patients who visited Keimyung University Hospital from April 1996 to August 1996, and 29 benign lung diseases. Commercially available kits, Ab bead CM (Eiken) to CEA, SCC RIA BEAD (DAINABOT) to SCC, CA21-1 (TEE) to Cyfra21-1, arid TPA-M (DAIICHI) to TPA-M were used for this study. RESULTS: The mean serum values of lung cancer group and control group were 10.05 +/- 38.39 micro/L, l.59+/-0.94 micro/L in CEA, 3.04+/-5.79 micro/L, 1.58+/-2.85 micro/L in SCC, 8.27+/-11.96 micro/L, 1.77+/-2.72 micro/L in Cyfra21-1, and 132.02+/-209.35 U/L, 45.86+/-75.86 U/t in TPA-M respectively. Serum values of Cyfra21-1 and TPA-M in lung cancer group were higher than control group (p<0.05). Using cutoff value recommended by the manufactures, that is 2.5 micro/L, in CEA, 3.0 micro/L in Cyfra21-1, 70.0 U/L in TPA-M, arid 2.0 micro/L in SCC, sensitivity and specificity of lung cancer were 33.3%, 786% in CEA, 50.0%, 89.7% in Cyfra2l-l, 52.3%, 89.7% in TPA-M, 23.8%, 89.3% in SCC. Sensitivity and specificity of nonsmall cell lung cancer were 36.1%, 78.1% in CIA, 50.1%, 89.7% in Cyfra2l-1, 53.1%, 89.7% in TPA-M, 33.8%, 89.3% in SCC. Sensitivity and specificity of small cell king cancer were 25.0%, 78.5% in CEA, 50.0%, 89.6% in Cyfra2l-1, 50.0%, 89.6% in TPA-M, 0%, 89.2% in SCC. Cutoff value according to ROC(Receiver operating characteristics) curve was l.25 micro/L in CEA, 1.5 micro/L in Cyfra2l-1, 35 U/L in TPA-M, 0.6 micro/L in SCC. With this cutoff value, sensitivity, specificity, accuracy and kappa index of Cyfra21-1 and TPA-M were Letter than CEA and SCC. SCC only was related with statistic significance to TNM stages, dividing to operable stages(TNM stage I to IIIA) and inoperable stages (IIIB and IV) (p<0.05). But no tumor markers showed any correlation with significance with tumor size(p>0.05). CONCLUSION: Serum TPA-M and Cyfra21-1 shows higher sensitivity and specificity than CEA and SCC in overall lung cancer and nonsmall cell lung cancer those were confirmed pathologically. SCC has higher specificity in nonsmall cell lung cancer. And the level of serum SCC are significantly related with TNM staging.