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To investigate the expression intensity and prognostic significance of TGF-β1 protein in non-small cell lung cancer (NSCLC) at quantitative level.Immunohistochemical study for TGF-β1 protein was carried out in 194 cases of NSCLC and 24 cases of normal lung tissues by SP methods.The PU (positive unit) value was used to assess the TGF-β1 protein expression intensity of positive cells from systematically selected fields under the microscope with Leica Q500MC image analysis system.In our study we found that the TGF-β1 PU value was nearly twice higher in NSCLC tissues than that in normal lung tissues (P=0.000).TGF-β1 protein expression intensity was associated with TNM stages (P=0.000) and lymph node metastases (P=0.000),but not to patient’s age,gender,smoking history,tumor differentiation,histological subtypes and tumor location (P>0.05).Univariate analysis indicated that patients with high TGF-β1 protein expression and lymph node metastases carried a poor prognosis (P=0.000,P=0.000 respectively).Multivariate analysis showed that TGF-β1 protein expression (RR = 2.565,P=0.002) and lymph node metastases (RR = 1.874,P= 0.030) were independent prognostic factors in patients with NSCLC.Thus,TGF-β1 protein expression may be correlated to oncogenesis and serves as an independent prognostic biomarker for NSCLC.